OSE.PA - OSE Immunotherapeutics SA

Paris - Paris Prix différé. Devise en EUR
6,30
+0,16 (+2,61 %)
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Clôture précédente6,14
Ouverture6,14
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Var. jour6,10 - 6,20
Sur 52 semaines2,81 - 8,80
Volume20 538
Volume moyen102 999
Cap. boursière94,222M
Bêta (mensuel sur 5 ans)1,10
Rapport P/E (sur 12 mois)S.O.
BPA (sur 12 mois)S.O.
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Date ex-dividendeS.O.
Objectif sur 1 anS.O.
  • Globe Newswire

    OSE Immunotherapeutics Announces Procedures for Virtual Combined General Meeting

    Live Webcast Login InformationNANTES, France, May 27, 2020 (GLOBE NEWSWIRE) -- OSE Immunotherapeutics (ISIN: FR0012127173; Mnémo: OSE) announces the procedures for participating in the Combined General Meeting, to be held on June 16, 2020 at 2:30 p.m. CET. As indicated in the press release dated May 11, 2020, the Combined General Meeting of June 16, 2020, will be held by live webcast, without the physical presence of shareholders or other persons usually eligible to attend pursuant to the provisions of the ordinances dated March 25, 2020.The prior notice of the General Meeting including the agenda, the resolutions submitted for approval and the main methods of participation and voting, and also serving as notice of the meeting, was published on May 8, 2020 in the French bulletin of mandatory legal announcements (BALO). * Login information The General Meeting will be webcast live (in French) via a web conferencing system and shareholders of OSE Immunotherapeutics are invited to login through the link:https://channel.royalcast.com/webcast/oseimmunotherapeutics/20200616_1/This link allows shareholders to register for the General Meeting as of today (and until June 16 at 2 p.m. CET) by entering their email address. Registrants will receive a registration confirmation in addition to the ability to add the event to their calendar.On June 16, 2020, shareholders will be able to connect via this same link starting at 2 p.m. CET. The General Meeting will start at 2.30 p.m. and attendees will be able to follow the presentation by OSE Immunotherapeutics’ management on their screens.Due to the closed session, it will not be possible for shareholders to amend resolutions or to propose new resolutions during the General Meeting. The shareholders retain their right to request the inclusion of items or draft resolutions on the agenda and to ask written questions before the General Meeting, in accordance with the regulations in force. Shareholders are invited to send their questions from today and at any time during the presentation to the email address: ag2020@ose-immuno.com. They will be answered during the General Meeting's Q&A session. * Appointment of scrutineers In accordance with Decree No. 2020-418, the Company’s Board of Directors has decided to appoint the following shareholders as scrutineers:\- Mrs. Maryvonne Hiance, shareholder and Vice-Chairman of the Board of Directors;\- Mr. Alexis Peyroles, shareholder and CEO of the Company.The General Meeting will be chaired by Mrs. Dominique Costantini, President of the Board of Directors.The Bureau thus constituted will be responsible for ensuring the proper performance of the General Meeting. It will be accompanied by CIC Market Solutions (middle office service of the issuer) which will collect and count the votes of shareholders in registered form or having voted by proxy. * Reminder of voting proceduresTo be taken into account, the duly completed and signed forms must be received no later than the fourth day preceding the date of the Meeting, i.e. no later than June 12, 2020.For registered shareholders: they must return the voting form which will be sent to them with the convening notice either by post to CIC Market Solutions (Service Assemblées - 6 Avenue de Provence - 75452 Paris Cedex 09 - France), or by email to the address: serviceproxy@cic.fr.For bearer shareholders: they can request this voting form from the bank or financial intermediary that manages their securities, from the date of notice of meeting. Once completed and signed by the shareholder, the form will be returned to the account-keeping establishment; the latter will send it, along with a certificate of participation, either by post to OSE Immunotherapeutics (22 Boulevard Benoni Goullin 44200 Nantes - France), or by email to the address: ag2020@ose-immuno.com.Shareholders are invited to regularly consult the section dedicated to the General Meeting on the Company's website: http://ose-immuno.com/documentation/assemblee-generale/ where they will find preparatory documents, including the voting form.ABOUT OSE Immunotherapeutics OSE Immunotherapeutics is a clinical-stage biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases. The company has several scientific and technological platforms including neoepitopes and agonist or antagonist monoclonal antibodies, all ideally positioned to fight cancer and autoimmune diseases. Its first-in-class clinical and preclinical portfolio has a diversified risk profile:  * Tedopi® (innovative combination of neoepitopes): the company’s most advanced product; positive results for Step-1 of the Phase 3 trial (Atalante 1) in Non-Small Cell Lung Cancer post checkpoint inhibitor failure; due to Covid-19, voluntary definitive suspension of new patient accrual in the Step-2 initially planned in the trial. In Phase 2 in pancreatic cancer (TEDOPaM, sponsor GERCOR) in combination with checkpoint inhibitor Opdivo®. * BI 765063 (OSE-172, anti-SIRPα monoclonal antibody): developed in partnership with Boehringer Ingelheim; myeloid checkpoint inhibitor in Phase 1 in advanced solid tumors. * FR104 (anti-CD28 monoclonal antibody): positive Phase 1 results; Phase 2-ready asset in autoimmune diseases or in transplantation. * OSE-127 (humanized monoclonal antibody targeting IL-7 receptor): developed in partnership with Servier; positive Phase 1 results; two independent Phase 2 planned in ulcerative colitis (OSE sponsor) and in Sjögren’s syndrome (Servier sponsor) to start in 2020. * BiCKI®: bispecific fusion protein platform built on the key backbone component anti-PD-1 (OSE-279) combined with new immunotherapy targets; 2nd generation of PD-(L)1 inhibitors to increase antitumor efficacity. Additional innovative research programs. * CoVepiT: a prophylactic vaccine against COVID-19, developed using SARS-CoV-2 optimized neo-epitopes. First preclinical results expected start of H2 2020, possible clinical trial by year end.Due to the COVID-19 crisis, accrual of new patients in the clinical trial TEDOPaM is temporarily suspended and initiation timelines for both Phase 2 trials of OSE-127 could be impacted during the coming months.For more information: https://ose-immuno.com/en/Click and follow us on Twitter and LinkedInhttps://twitter.com/OSEIMMUNO https://www.linkedin.com/company/10929673Contacts OSE Immunotherapeutics Sylvie Détry Sylvie.detry@ose-immuno.com +33 153 198 757 U.S. Media: LifeSci Communications Darren Opland, Ph.D. darren@lifescicomms.com +1 646 627 8387      French Media: FP2COM Florence Portejoie fportejoie@fp2com.fr +33 607 768 283U.S. and European Investors Chris Maggos chris@lifesciadvisors.com +41 79 367 6254     Forward-looking statements This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate.These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Universal Registration Document filed with the AMF on 15 April 2020, including the annual financial report for the fiscal year 2019, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.

  • Globe Newswire

    OSE Immunotherapeutics Signs €7 Million Non-Dilutive Loan Agreement Guaranteed by the French State

    NANTES, France, May 26, 2020 (GLOBE NEWSWIRE) -- OSE Immunotherapeutics (ISIN: FR0012127173; Mnémo: OSE), today announced the signature of a €7 million non-dilutive loan agreement, with a pool of French banks, providing the company with further financing to advance its clinical and preclinical development programs.This loan is part of a loan facility guaranteed by the French State ("Prêt Garanti par l’Etat") and was implemented in the context of the COVID-19 pandemic. This funding strengthens OSE Immunotherapeutics' cash position and extends its cash runway from Q1 2021 to Q3 2021.This loan is guaranteed up to 90% by the French State and has an initial maturity of 12 months, with a 5-year extension option decided by OSE Immunotherapeutics (up to May 2026). This new financing, solicited as part of the French government's initiatives to support companies in the current health crisis, enables OSE Immunotherapeutics to benefit from the support of Bpifrance, BNP Paribas, CIC, Crédit Mutuel.Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics, comments: “We thank the French government and our banking partners for supporting us with this significant financing. Reinforcement of our cash position will help accelerate advancement of our clinical and preclinical programs in immuno-oncology and autoimmune diseases, as well as our recently-announced program to develop a prophylactic vaccine against the pandemic virus SARS-CoV-2.”ABOUT OSE ImmunotherapeuticsOSE Immunotherapeutics is a clinical-stage biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases. The company has several scientific and technological platforms including neoepitopes and agonist or antagonist monoclonal antibodies, all ideally positioned to fight cancer and autoimmune diseases. Its first-in-class clinical and preclinical portfolio has a diversified risk profile: * Tedopi® (innovative combination of neoepitopes) : the company’s most advanced product ; positive results for Step-1 of the Phase 3 trial (Atalante 1) in Non-Small Cell Lung Cancer post checkpoint inhibitor failure; due to Covid-19, voluntary definitive suspension of new patient accrual in the Step-2 initially planned in the trial. In Phase 2 in pancreatic cancer (TEDOPaM, sponsor GERCOR) in combination with checkpoint inhibitor Opdivo®. * BI 765063 (OSE-172, anti-SIRPα monoclonal antibody): developed in partnership with Boehringer Ingelheim; myeloid checkpoint inhibitor in Phase 1 in advanced solid tumors. * FR104 (anti-CD28 monoclonal antibody): positive Phase 1 results; Phase 2-ready asset in autoimmune diseases or in transplantation. * OSE-127 (humanized monoclonal antibody targeting IL-7 receptor): developed in partnership with Servier; positive Phase 1 results; two independent Phase 2 planned in ulcerative colitis (OSE sponsor) and in Sjögren’s syndrome (Servier sponsor) to start in 2020. * BiCKI®: bispecific fusion protein platform built on the key backbone component anti-PD-1 (OSE-279) combined with new immunotherapy targets; 2nd generation of PD-(L)1 inhibitors to increase antitumor efficacity. Additional innovative research programs. * CoVepiT: a prophylactic vaccine against COVID-19, developed using SARS-CoV-2 optimized neo-epitopes. First preclinical results expected start of H2 2020, possible clinical trial by year end.Due to the COVID-19 crisis, accrual of new patients in the clinical trials TEDOPaM and BI 765063 is temporarily suspended and initiation timelines for both Phase 2 trials of OSE-127 could be impacted during the coming months.For more information: https://ose-immuno.com/en/Click and follow us on Twitter and Linkedln https://twitter.com/OSEIMMUNO https://www.linkedin.com/company/10929673ContactsOSE Immunotherapeutics Sylvie Détry Sylvie.detry@ose-immuno.com +33 153 198 757 French Media: FP2COM Florence Portejoie fportejoie@fp2com.fr +33 607 768 283U.S. Media: LifeSci Public Relations Darren Opland, Ph.D. darren@lifescipublicrelations.com +1 646 627 8387 U.S. and European Investors Chris Maggos chris@lifesciadvisors.com +41 79 367 6254 Forward-looking statements This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate. These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Universal Registration Document filed with the AMF on 15 April 2020, including the annual financial report for the fiscal year 2019, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.

  • Globe Newswire

    OSE Immunotherapeutics Presents CLEC-1, Novel Myeloid Immune Checkpoint Target for Cancer Immunotherapy

    Oral Presentation at AACR Virtual Meeting II 2020 – June 22-24 * Tumor cells inhibit myeloid cell phagocytosis and dendritic cell antigen presentation through the novel “Don’t eat me” signal mediated by CLEC-1 * CLEC-1 represents a new therapeutic target for immuno-oncology * Antagonists of the CLEC-1 myeloid checkpoint pathway represent an innovative cancer immunotherapy approachNANTES, France, May 18, 2020 (GLOBE NEWSWIRE) -- OSE Immunotherapeutics (ISIN: FR0012127173; Mnémo: OSE), today announced that new preclinical data identifying a novel myeloid immune checkpoint target for cancer immunotherapy, CLEC-1 (a C-type lectin receptor) have been selected for oral presentation(1) at the American Association of Cancer Research (AACR) Virtual Annual Meeting II, to be held on June 22-24, 2020.Nicolas Poirier, Chief Scientific Officer of OSE Immunotherapeutics, comments: “These data indicate that the myeloid checkpoint CLEC-1 is a new therapeutic target in immuno-oncology and that antagonists of the CLEC-1 pathway constitute an innovative cancer immunotherapy approach synergistic with chemotherapy or tumor-targeting antibodies. The identification of CLEC-1 and its antagonists continue to reinforce our presence in the highly attractive field of myeloid cells and macrophages, identified as poor prognostic factors in oncology and in immune escape mechanisms of cancer immunotherapies.” These findings come from a research program conducted by OSE's R&D team in collaboration with Dr Elise Chiffoleau (Center for Research in Transplantation and Immunology, UMR - INSERM 1064, Nantes University Hospital). This program is focused on the development of a cancer immunotherapy targeting a newly identified C-type lectin receptor, CLEC-1, to block suppressive functions of myeloid cells and to restore anti-tumor response of T-lymphocytes. Suppressive myeloid cells have the ability to accumulate in the tumor microenvironment and to deregulate the immune activation of T-lymphocytes.This research has demonstrated that novel myeloid immune checkpoint CLEC-1 is a new therapeutic target of interest in immuno-oncology. The main findings being presented at AACR are: * CLEC-1 is a novel “Don’t eat me” signal (similar to the SIRPα-CD47 axis) and CLEC-1 antagonist antibodies developed by OSE Immunotherapeutics restore the phagocytosis function of macrophages and dendritic cells in synergy with tumor-targeting antibodies. * CLEC-1 acts as a “sensor of death” by recognizing stress conditions and cell necrosis of tumor cells. * CLEC-1 genetically deficient mice more efficiently eradicate tumor cells, in particular when combined with cytotoxic and immunogenic chemotherapy that induces cell stress conditions. * CLEC-1 is expressed by specific subtypes of dendritic cells specialized in antigen presentation in the tumor; in vivo the receptor inhibits T lymphocytes cross-priming and dampens adaptative memory immune response. The absence of CLEC-1 favors the generation of adaptive memory immune responses. (1) AACR Virtual Annual Meeting II presentation details        CLEC-1 is a novel myeloid immune checkpoint for cancer immunotherapy controlling damaged and tumor cells phagocytosis. Gauttier V*, Drouin M*, Saenz J,  Evrard B, Mary C,, Teppaz G, Desalle A, Thépenier V, Wilhelm E , Poirier N*, Chiffoleau E* *authors contribute equally to this workCLEC-1 suppress dendritic cell antigen presentation and is a novel myeloid immune checkpoint target for cancer immunotherapy. Drouin M*, Saenz J*, Evrard B, Gauttier V, Teppaz G, Lopez-Robles MD, Louvet C, Poirier N*, Chiffoleau E* *authors contribute equally to this workABOUT OSE ImmunotherapeuticsOSE Immunotherapeutics is a clinical-stage biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases. The company has several scientific and technological platforms including neoepitopes and agonist or antagonist monoclonal antibodies, all ideally positioned to fight cancer and autoimmune diseases. Its first-in-class clinical and preclinical portfolio has a diversified risk profile: * Tedopi® (innovative combination of neoepitopes) : the company’s most advanced product ; positive results for Step-1 of the Phase 3 trial (Atalante 1) in Non-Small Cell Lung Cancer post checkpoint inhibitor failure; due to Covid-19, voluntary definitive suspension of new patient accrual in the Step-2 initially planned in the trial. In Phase 2 in pancreatic cancer (TEDOPaM, sponsor GERCOR) in combination with checkpoint inhibitor Opdivo®. * BI 765063 (OSE-172, anti-SIRPα monoclonal antibody): developed in partnership with Boehringer Ingelheim; myeloid checkpoint inhibitor in Phase 1 in advanced solid tumors. * FR104 (anti-CD28 monoclonal antibody): positive Phase 1 results; Phase 2-ready asset in autoimmune diseases or in transplantation. * OSE-127 (humanized monoclonal antibody targeting IL-7 receptor): developed in partnership with Servier; positive Phase 1 results; two independent Phase 2 planned in ulcerative colitis (OSE sponsor) and in Sjögren’s syndrome (Servier sponsor) to start in 2020. * BiCKI®: bispecific fusion protein platform built on the key backbone component anti-PD-1 (OSE-279) combined with new immunotherapy targets; 2nd generation of PD-(L)1 inhibitors to increase antitumor efficacity. Additional innovative research programs. * CoVepiT: a prophylactic vaccine against COVID-19, developed using SARS-CoV-2 optimized neo-epitopes. First preclinical results expected start of H2 2020, possible clinical trial by year end. Due to the COVID-19 crisis, accrual of new patients in the clinical trials TEDOPaM and BI 765063 is temporarily suspended and initiation timelines for both Phase 2 trials of OSE-127 could be impacted during the coming months.For more information: https://ose-immuno.com/en/ Click and follow us on Twitter and LinkedIn https://twitter.com/OSEIMMUNO https://www.linkedin.com/company/10929673ContactsOSE Immunotherapeutics Sylvie Détry Sylvie.detry@ose-immuno.com +33 153 198 757 French Media: FP2COM Florence Portejoie fportejoie@fp2com.fr +33 607 768 283U.S. Media: LifeSci Public Relations Darren Opland, Ph.D. darren@lifescipublicrelations.com +1 646 627 8387 U.S. and European Investors Chris Maggos chris@lifesciadvisors.com +41 79 367 6254 Forward-looking statements This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate. These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Universal Registration Document filed with the AMF on 15 April 2020, including the annual financial report for the fiscal year 2019, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.

  • Globe Newswire

    OSE Immunotherapeutics Announces COVID-19 Prophylactic Vaccine Program

    * Vaccine leverages expertise in peptide selection and optimization and proprietary Memopi® technology to explore a T lymphocyte immune response for COVID-19 * Uses artificial intelligence algorithm from MAbSilico to accelerate optimization of epitopes able to induce a robust cell memory immunity * First preclinical results expected start of H2 2020, possible clinical trial by year endNANTES, France, May 05, 2020 (GLOBE NEWSWIRE) -- OSE Immunotherapeutics (ISIN: FR0012127173; Mnémo: OSE) today announced that the Company is committed to the fight against COVID-19. Its team of immunologists is actively working on the development of a prophylactic vaccine against the pandemic virus SARS-CoV-2.To conduct this program, OSE Immunotherapeutics leverages its expertise in the selection and optimization of peptides of interest and their GMP (Good Manufacturing Practices) formulation for a specific type of combination of multiple peptides. The Company uses the know-how from its Memopi® epitope (neo-epitope) optimization technology, recently successfully validated in the first step of a Phase 3 clinical testing for Tedopi®, a combination of antitumor neo-epitopes, to increase the memory immune response of T lymphocytes against specific antigens.Using bioinformatics approaches and algorithms for predicting immunogenicity in the virus genome, OSE Immunotherapeutics’ R&D team has screened a large number of peptides derived from different proteins of SARS-CoV-2, SARS-CoV (virus responsible for SARS disease) and MERS-CoV (coronavirus of the Middle East respiratory syndrome) and selected the immuno-dominant epitopes from 4 major proteins of coronaviruses. OSE Immunotherapeutics is collaborating with deeptech company MAbSilico to benefit from its know-how and versatile solutions in artificial intelligence algorithms to accelerate optimization of these neo-epitopes and increase their immunogenicity capacity to induce robust T cell memory immunity.To date, more than 20,000 SARS-CoV-2 neo-epitopes and as many peptide / HLA structural models have been evaluated. OSE Immunotherapeutics has selected the most specific epitopes with high potential for immunogenicity to move into preclinical testing and validate efficacy of the vaccine.Nicolas Poirier, Chief Scientific Officer of OSE Immunotherapeutics, comments: “Our COVEPIT vaccine technology, developed using SARS-CoV-2 optimized neo-epitopes, is complementary to conventional approaches targeting antibodies and could significantly contribute to fight COVID-19 by promoting prophylactic vaccine research focused on memory T cells. Research on COVID-19 has shown the potential of antibodies in the fight against the virus, but several studies on SARS-CoV or SARS-CoV-2(1, 2 ,3, 4) have shown that the antibody response is highly variable, not always neutralizing and generally quite limited in time. The advantage of a T lymphocyte response is that it can last over time, which is necessary to eliminate infected cells and avoid developing serious forms. This is why we are applying our scientific rationale and validated know-how to participate in the fight against COVID-19."Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics, concludes: "OSE Immunotherapeutics wants to contribute to the fight against the COVID-19 pandemic and participate in the collective effort by developing a vaccine against this virus as soon as possible. Our objective is to use our scientific expertise in immunotherapy, and in particular our Memopi® technology, to develop a COVID-19 vaccine based on peptides. This same technology has been applied to develop Tedopi®, our neo-epitope-based vaccine in advanced lung cancer, which has shown efficacy and good tolerance in this indication. We expect the first preclinical results at the start of the second half of 2020 and, if possible, to launch a clinical trial before the end of the year." 1. Wu et al. Neutralizing antibody responses to SARS-CoV-2 in a COVID-19 recovered 2 patient cohort and their implications MedRxiv April 6, 2020  2. Huang et al. A systematic review of antibody mediated immunity to coronaviruses: antibody kinetics, correlates of protection, and association of antibody responses with severity of disease. MedRxiv April 17, 2020 3. Tang et al. Lack Peripheral Memory B Cell Responses in Recovered Patients with Severe Acute Respiratory Syndrome: A Six-Year Follow-Up Study. Journal of Immunology 2011  4. Ho et al. Neutralizing Antibody Response and SARS Severity. Emerg Infect Dis. 2005ABOUT OSE Immunotherapeutics OSE Immunotherapeutics is a clinical-stage biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases. The company has several scientific and technological platforms including neoepitopes and agonist or antagonist monoclonal antibodies, all ideally positioned to fight cancer and autoimmune diseases. Its first-in-class clinical and preclinical portfolio has a diversified risk profile: * Tedopi® (innovative combination of neoepitopes) : the company’s most advanced product ; positive results for Step-1 of the Phase 3 trial (Atalante 1) in Non-Small Cell Lung Cancer post checkpoint inhibitor failure; due to COVID-19, voluntary definitive suspension of new patient accrual in the Step-2 initially planned in the trial. In Phase 2 in pancreatic cancer (TEDOPaM, sponsor GERCOR) in combination with checkpoint inhibitor Opdivo®. * BI 765063 (OSE-172, anti-SIRPα monoclonal antibody): developed in partnership with Boehringer Ingelheim; myeloid checkpoint inhibitor in Phase 1 in advanced solid tumors. * FR104 (anti-CD28 monoclonal antibody): positive Phase 1 results; Phase 2-ready asset in autoimmune diseases or in transplantation. * OSE-127 (humanized monoclonal antibody targeting IL-7 receptor): developed in partnership with Servier; positive Phase 1 results; two independent Phase 2 planned in ulcerative colitis (OSE sponsor) and in Sjögren’s syndrome (Servier sponsor) to start in 2020. * BiCKI®: bispecific fusion protein platform built on the key backbone component anti-PD-1 (OSE-279) combined with new immunotherapy targets; 2nd generation of PD-(L)1 inhibitors to increase antitumor efficacity. Additional innovative research programs.Due to the COVID-19 crisis, accrual of new patients in the clinical trials TEDOPaM and BI 765063 is temporally suspended and initiation timelines for both Phases 2 OSE-127 may be impacted during the coming months.For more information: https://ose-immuno.com/en/Click and follow us on Twitter and Linkedln https://twitter.com/OSEIMMUNO https://www.linkedin.com/company/10929673   Contacts  OSE Immunotherapeutics Sylvie Détry Sylvie.detry@ose-immuno.com +33 153 198 757U.S. Media: LifeSci Public Relations Darren Opland, Ph.D. darren@lifescipublicrelations.com +1 646 627 8387    French Media: FP2COM Florence Portejoie fportejoie@fp2com.fr +33 607 768 283U.S. and European Investors Chris Maggos chris@lifesciadvisors.com +41 79 367 6254 Forward-looking statements This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate. These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics’ Universal Registration Document filed with the AMF on 15 April 2020, including the annual financial report for the fiscal year 2019, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.

  • Globe Newswire

    Phase 3 Clinical Trial of Tedopi®: OSE Immunotherapeutics Announces Positive Top-Line Results for Step-1 of its trial ‘Atalante 1’ in Non-Small Cell Lung Cancer

    * Step-1 primary endpoint met: 12-month survival rate in Tedopi® treated patients;     * Complete analysis of Step-1 results and further discussions with regulatory agencies will determine the best options for additional clinical development of Tedopi® and potential partnership plans;   * Due to the current COVID-19 outbreak and its potential impact on Step-2 of Atalante 1, voluntary definitive suspension of recruitment motivated by the risks for the patients and on the data integrity of this now cancelled Step-2.NANTES, France, April 01, 2020 (GLOBE NEWSWIRE) -- OSE Immunotherapeutics (ISIN: FR0012127173; Mnémo: OSE) today announced that the primary endpoint was met in the predefined Step-1 analysis of its Phase 3 clinical trial of investigational product Tedopi®, called Atalante 1, in HLA-A2 positive non-small cell lung cancer (NSCLC) patients after failure from immune checkpoint inhibitors (PD-1/PD-L1). Considering the population of the treated patients in both trial arms randomized at least 12 months before the time of the Step-1 analysis (N=99), the primary objective of Step-1 of the Atalante 1 trial planned in the protocol was met:In the Phase 3 Step-1 analysis, the statistically positive preliminary results show at least 12-month survival for 29 patients out of 63 patients in the Tedopi® arm, corresponding to a 12-month survival rate of 46% with the lower limit (33%) of the 95% confidence interval* [33% - 59%], above the pre-specified futility boundary of 25%.The observed rate of 46% is also above the assumption of a survival rate of 40% specified for the alternative efficacy hypothesis in the protocol.In the chemotherapy control arm the results show at least 12-month survival for 13 patients out of 36 patients, corresponding to a 12-month survival rate of 36%.Alexis Peyroles, CEO of OSE Immunotherapeutics, said: “We are very pleased with these positive results for Tedopi in Step-1 and with a 10% absolute difference in 12-month survival rate versus chemotherapy in NSCLC patients after failure of checkpoint inhibitor treated in Atalante 1 Step-1 trial. This outcome confirms the therapeutic value of our neoepitope product in a patient population for whom there are no registered product today and who needs new therapeutic options. Based on these positive results, we are now eager to engage in discussions with regulatory authorities to evaluate Tedopi’s current clinical results and agree upon the best options for further development to maximize on the product’s positive data in terms of benefit/risk ratio. In parallel, given the significant value added by positive Step-1 results, we continue exploring potential partnership opportunities for Tedopi.”As explained in the recent press release from March 26, 2020, the Company together with the Independent Data Monitoring Committee (IDMC) and the Steering Committee of the trial have reviewed the potential impact of the COVID-19 outbreak on the Atalante 1 trial. As of today, there is ongoing concern that trial data may be markedly impacted given the current worldwide COVID-19 pandemic and the increased risk for patients with NSCLC as COVID-19 can cause serious pulmonary complications in this immunocompromised patient population. In addition, recommendations from several medical societies include voluntary holds on recruitment of new patients in oncology trials for the time being, due to patient safety concerns.Consequently, following the recommendation from both IDMC and Steering Committee of Atalante 1, OSE Immunotherapeutics voluntarily decided to terminate patient screening and accrual in the initially planned and now cancelled Step-2. Further analysis of the positive Step-1 data will commence while engaging with regulatory agencies on the best development path forward for the product given the significant unmet medical need in the NSCLC patient population post-checkpoint inhibitor therapy failure.*The 95% confidence interval (CI) is a range of values ​​which has a 95% chance of containing the true value of the estimated parameter. With less rigor, it can be said that the CI represents the range of values ​​within which it is 95% certain to find the true value sought. It provides a visualization of the uncertainty of the estimate.ABOUT OSE Immunotherapeutics OSE Immunotherapeutics is a clinical-stage biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases. The company has a diversified first-in-class clinical portfolio consisting of several scientific and technological platforms including neoepitopes and agonist or antagonist monoclonal antibodies, all ideally positioned to fight cancer and autoimmune diseases. The most advanced therapeutic-candidate, Tedopi®, is a proprietary combination of 10 neo-epitopes aimed at stimulating T-lymphocytes: positive results for Step-1 of the ongoing Phase 3 trial (Atalante 1) in Non-Small Cell Lung Cancer post checkpoint inhibitor failure; voluntary definitive suspension of new patient accrual (cancellation of Step-2 initially planned in the clinical trial) due to Covid-19. Tedopi® is also in Phase 2 testing in pancreatic cancer in combination with checkpoint inhibitor Opdivo®; continuation of screening but temporary pause of patient accrual in the study by the GERCOR, study sponsor. BI 765063 (OSE-172) (anti-SIRPa monoclonal antibody) is under a license and collaboration agreement with Boehringer Ingelheim; this checkpoint inhibitor is currently under Phase 1 clinical trial in advanced solid tumor; due to the COVID-19 crisis, temporary suspension of new screening and new inclusions in the study. BiCKI® is a bispecific fusion protein platform built on the key backbone component anti-PD-1 (OSE-279) and targeting innovative targets. FR104 (an anti-CD28 mAb) has successfully completed Phase 1 testing and has potential to treat autoimmune diseases. OSE-127 (monoclonal antibody targeting the CD127 receptor, the alpha chain of the interleukin-7 receptor) is partnered with Servier under a two-step license option agreement. The Phase 1 clinical phase of OSE-127 is completed and has shown positive results; two independent Phase 2 studies planned in ulcerative colitis (OSE sponsor) and Sjögren’s syndrome (Servier sponsor) to start in 2020; subject to the evolution of the COVID-19 situation.For more information: https://ose-immuno.com/en/Click and follow us on Twitter and LinkedInhttps://twitter.com/OSEIMMUNO https://www.linkedin.com/company/10929673ContactsOSE ImmunotherapeuticsU.S. Media: LifeSci Public Relations Sylvie DétryDarren Opland, Ph.D. Sylvie.detry@ose-immuno.com darren@lifescipublicrelations.com  +33 153 198 757+1 646 627 8387    French Media: FP2COMU.S. and European Investors Florence PortejoieChris Maggos  fportejoie@fp2com.fr chris@lifesciadvisors.com  +33 607 768 283+41 79 367 6254 Forward-looking statements This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate. These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Reference Document filed with the AMF on 26 April 2019, including the annual financial report for the fiscal year 2018, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.

  • Globe Newswire

    OSE Immunotherapeutics Reports 2019 Financial Results and Provides Business Update Expectations for Potential Impact of COVID-19 on the Company’s Clinical Development Activities

    * Strong clinical progress in lead assets Tedopi®, OSE-127 and BI 765063 * Bispecific antibody platform BiCKI®: First project selected, cytokine IL-7 to be paired with anti-PD-1  * €5 million milestone payment from Servier accelerated and now expected by the start of a Phase 2 with OSE-127 in Sjögren's syndrome  * FY 2019 turnover of €26 million * 2019 year-end cash position of €25.8 million * Expected €3 million research tax credit and Servier milestone to provide funding until Q1 2021NANTES, France, March 26, 2020 (GLOBE NEWSWIRE) -- OSE Immunotherapeutics (ISIN: FR0012127173; Mnémo: OSE) today reported its consolidated annual financial results for 2019 and provided an update on key achievements, as well as the company’s outlook for its agonist and antagonist immunotherapies for cancers and autoimmune diseases.Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics, said: “The current COVID-19 situation is a major public health concern and also an important factor impacting our ongoing and upcoming clinical trials. Health agencies and expert groups have said in the past few days that the continuation of clinical trials in hospitals would be very disrupted due to the mobilization of medical teams, containment and the potential risks associated with the epidemic of COVID-19 for fragile patients. Our short-term priority is to do our part to ensure healthcare systems have the resources to fight COVID-19 and to reduce the demands on healthcare professionals, while safeguarding patients currently taking part in our clinical trials.“OSE Immunotherapeutics made significant clinical progress with our lead assets in immuno-oncology and auto-immune diseases in 2019 and early 2020.“In 2019, our drug candidates being developed with partners Boehringer Ingelheim and Servier generated €25 million in milestone payments and both achieved key clinical milestones: initiation of the ongoing Phase 1 trial of myeloid checkpoint inhibitor BI 765063 in advanced solid tumors and completion of Phase 1 trial of anti-IL-7 receptor antagonist OSE-127 with positive results. Based on these results, two Phase 2 studies with OSE-127 are planned to start in 2020. Furthermore, a recent amendment to our license option agreement with Servier on OSE-127 confirms our partner’s commitment and strong belief in the potential of the product.“In 2020, we plan to continue the company’s value creation by advancing our clinical and preclinical programs while adapting our organization to the COVID-19 crisis. In line with our business model, we will continue to secure financial resources to invest in R&D to discover and develop novel therapeutics for patients. In particular, the milestone payment associated with the recently-amended agreement with Servier on OSE-127 will reinforce our cash position and flexibility to progress on our development strategy. With these considerations in mind, we have provided expectations for the impact that COVID-19 could have on our clinical programs, given the current assessment of the situation. We continue to monitor the situation and will provide updates on any changes in timelines as they arise."2019 KEY ACHIEVEMENTSMajor clinical progress with four differentiated therapeutic programs in immuno-oncology and autoimmune diseasesTedopi®, a combination of 10 neoepitopes intended to induce specific T-lymphocyte activation, is OSE Immunotherapeutics’ most advanced drug candidate and is currently in a Phase 3 pivotal clinical trial, called Atalante 1, to treat non-small cell lung cancer (NSCLC) following failure of immune checkpoint inhibitor treatment (PD-1/PD-L1). Due to the COVID-19 outbreak situation and associated considerations of the safety of trial participants, compliance with good clinical practice (GCP), and risks to trial integrity during the COVID-19 pandemic following the specific guidelines of regulatory agencies, OSE Immunotherapeutics is reviewing the potential impact of this outbreak on the Atalante 1 trial. The Company will provide an update on the status of this review and on the results of the trial’s pre-defined step 1 as soon as possible in the coming next weeks.Tedopi® also is in Phase 2 development in combination with Opdivo® (nivolumab) in patients with pancreatic cancer, called TEDOPaM, a trial sponsored by the GERCOR cooperative group in oncology and supported by Bristol Myers Squibb. Patients screening and accrual in the TEDOPaM study are expected to be impacted by the COVID-19 situation in the coming months.The Company will maintain an open dialogue with updates to these and other trials as more clarity arises on the overall impact this public health crisis has on expected timelines. * Tedopi®’s intellectual property in immuno-oncology in HLA-A2 positive patients has been further strengthened and extended by notice of allowance in Japan and in the U.S. for a new patent family related to Tedopi® for use in the treatment of brain metastasis originating from cancers, including NSCLC. It was also strengthened by issuance in Japan of a new patent family protecting the product’s method for inducing early T-lymphocyte memory response for use in the treatment of cancer. * A new licensing deal was signed with Chong Kun Dang (CKD) Pharmaceutical Corporation for potential registration and commercialization of Tedopi® in South Korea. Financial terms of the contract include both upfront and short-term milestone payments of €1.2 million with total milestone payments of €4.3 million, as well as royalties on sales and transfer price in the high twenties percentage. * OSE Immunotherapeutics and HalioDx, an immuno-oncology diagnostic company, have initiated a collaboration to conduct a translational investigation of immune biomarkers as part of the ongoing Phase 3 clinical trial of Tedopi® in NSCLC patients. This investigation is focused on identifying potential immune biomarkers in NSCLC. Based on the data generated, the collaboration aims at defining the profile of responder patients to Tedopi® treatment in advanced lung cancer.BI 765063 (formerly OSE-172), a myeloid checkpoint inhibitor and SIRPα antagonist, being developed in partnership with Boehringer Ingelheim, is in Phase 1 trial in advanced solid tumors. * The first patient was enrolled and dosed in June 2019 in the first-in-human Phase 1 trial, a dose finding study of BI 765063 administered as a single agent and in combination with Boehringer Ingelheim’s monoclonal antibody PD-1 antagonist BI 754091. The trial aims to characterize safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of the immunotherapy in patients with advanced solid tumors. The trial is expected to be impacted by the COVID-19 situation with regard to the screening and accrual of new patients in Q2 2020. Further updates will be made when available * OSE Immunotherapeutics received a €5.4 million payment from Bpifrance triggered by the successful completion of development milestones related to its collaborative program, called EFFI-CLIN, focused on evaluating BI 765063.OSE-127 is a monoclonal antibody antagonist of the interleukin-7 receptor (IL-7R) being developed in partnership with Servier. * The United States Patent and Trademark Office (USPTO) issued a first notice of allowance for a patent application covering OSE-127 and protecting the product until at least 2035. This new patent validates the product’s novel and differentiated mechanism of action as the only full-antagonist of IL-7R in clinical development, a target which has been shown to induce a powerful antagonistic effect on effector T-lymphocytes responsible for causing autoimmune pathologies. * The Phase 1 clinical study of OSE-127 was completed end of 2019 with positive results showing a good safety and tolerability profile for the product. All pharmacokinetic and pharmacodynamic parameters were consistent and demonstrated a dose-proportionality across the several dose-levels up to 10 mg/kg. Based on these positive data, two Phase 2 trials are planned to start in 2020: in ulcerative colitis (OSE sponsored) and Sjögren’s syndrome (Servier sponsored). * In March 2020, OSE Immunotherapeutics and Servier signed an amendment to the two-step global licensing option agreement for OSE-127. Under this amendment, both companies have agreed to modify the provisions regarding the potential exercise of the option, amending step 2 of the option agreement, making OSE eligible to receive a €5 million milestone payment from Servier upon the enrollment of the first patient in the Phase 2a clinical study in Sjögren’s syndrome and the remaining €15 million payment upon exercise of an option at the completion of both Phase 2 clinical trials, and in priority upon completion of the Phase 2a clinical study in Sjögren’s syndrome. The previous version of the agreement had the full €20 million milestone payment due upon completion of Phase 2 clinical study in ulcerative colitis. The initiation of both Phase 2 clinical trials planned in 2020 is subject to the evolution of the COVID-19 situation and will take place once all preparatory steps are achieved and once hospitals and healthcare professionals are able to ensure safe practices during clinical research and patients’ care.FR104, a monoclonal antibody antagonist of CD28, is a Phase-2 ready asset with potential to be developed in either autoimmune disease or in transplantation. * The Canadian Intellectual Property Office granted a patent that covers the product and its therapeutic applications in T-lymphocyte-mediated autoimmune diseases, chronic inflammatory diseases and graft applications. At the same time, the USPTO issued a notice of allowance providing additional protection covering the use of FR104 in the treatment of T-lymphocyte-mediated chronic inflammatory diseases. Therapeutic applications of FR104 are thus covered through 2031.A dynamic partnership business model based on innovative products to generate revenues to broaden R&D programs * OSE Immunotherapeutics received €25 million in milestone payments during H1 2019 (€10 million payment from Servier upon exercise of first of two steps of a global licensing option agreement for OSE-127; €15 million in payments from Boehringer Ingelheim upon Clinical Trial Authorization and first dosing of a patient in the Phase 1 clinical trial of BI 765063). * OSE Immunotherapeutics is evaluating the best options for continuing sustainable development of FR104, a Phase 2-ready asset, in autoimmune diseases or in transplantation, including worldwide partnering opportunities. Furthermore, the Company is exploring global partnership opportunities for Tedopi®, currently in Phase 3 in NSCLC and in Phase 2 in pancreatic cancer.Research & Development Focused on novel target discovery to generate innovative agonists or antagonists of the immune response, the Company is pursuing advancement of new innovative research programs. * The Company disclosed its novel bispecific checkpoint inhibitor (BiCKI®) platform built on the key backbone component anti-PD-1 (OSE-279) and targeting innovative targets. BiCKI® represents the second generation of PD-(L)1 inhibitors that have been used to increase antitumor efficacy in hard to treat cancers by addressing untapped immune evasion mechanisms. The first cytokine selected to be paired with the anti-PD-1 in the bispecific antibody is Interleukin-7 (IL-7), which has been shown to improve immune functions and cancer immunotherapy efficacy. * A new research collaboration agreement was concluded with premier cancer research hospital Léon Bérard Cancer Center in Lyon, France, to use artificial intelligence-based bioanalysis and bioinformatics to analyze gene expression in the human tumor microenvironment and the composition of tumor infiltrates. The findings from this collaboration will be used for the selection and validation of innovative targets for early development of new drug candidates from the platform of bispecific fusion proteins targeting PD-1 and innovative targets (BiCKI). * OSE Immunotherapeutics’ “DC-Target” project was selected by the French National Research Agency to be awarded a grant of up to €800,000 as part of the “AAPG 2019” call for proposals. This research program, coordinated by the Léon Bérard Cancer Center, aims to identify new targets of therapeutic interest expressed by myeloid cells through in-depth characterization of the role of each cell by single cell RNAseq (scRNAseq - Cellenion) and gene editing. * Early 2020, the Company signed a drug development collaboration with innovative deep technology French start-up MAbSilico to use artificial intelligence-based solution for the development of monoclonal antibodies, including novel bispecific antibodies (BiCKI® platform).Governance * Nicolas Poirier, Ph.D., Chief Scientific Officer of OSE Immunotherapeutics, was additionally appointed as Director, representing the employee shareholders. * Walter Flamenbaum resigned from the Company’s Board of Directors on February 19, 2020.2019 RESULTSA meeting of the Board of Directors of OSE Immunotherapeutics was held on March 26, 2020 according to the ordinance n° 2020-321. Following the opinion of the Audit Committee, the Board approved the annual and consolidated financial statements prepared under IFRS at 31 December 2019.The key figures of the 2019 consolidated annual results are reported below (and presented in the attached tables):In k€December 31, 2019December 31, 2018 Current operating result(1 469)4 974 Operating result(1 472)4 847 Net result(4 652)5 490 Available cash*25 84212 433 Consolidated balance sheet88 93376 903 As of December 31, 2019, the Company’s available cash* amounted to €25.8 million, giving financial visibility until Q1 2021, taking into account €3 million from research tax credit and an additional planned milestone payment of €5 million from Servier, following amendment to the global license option agreement on OSE-127, and expected at the start of a Phase 2 in Sjögren's syndrome.During 2019, additional cash influx of €25 million has been generated by milestone payments related to partnerships (€15 million from Boehringer Ingelheim upon CTA for the Phase 1 trial with BI 765063 and upcoming first patient dosed and €10 million from Servier upon exercising of the first option under the two-step option within global license agreement). Moreover, the Company received a €5.4 million payment from Bpifrance triggered by the successful completion of development milestones related to its collaborative program EFFI-CLIN, program focused on evaluating BI 765063.This available cash will enable the Company to finance its clinical development costs and R&D costs on earlier stage products until Q1 2021 at least. If there are significant delays or clinical trial holds as a result of COVID-19, our cash runway will be extended beyond the current Q1 2021 projection, given that the bulk of our expenses are mainly related to clinical development expenditures.The turnover amounted to €26 million due to the milestone payments from the collaboration agreement with Boehringer Ingelheim and Servier. During 2019, the Company recorded a consolidated operating loss of (€1.5) million.Current operating expenses were €27.4 million (€19.5 million in 2018) of which 81% related to R&D. Among R&D expenses of €21.6 million, 85% are dedicated to the Company’s ongoing clinical projects, in line with the broadening and progress of its pipeline.*Available cash and cash equivalents and current financial assetsAbout OSE Immunotherapeutics OSE Immunotherapeutics is a clinical-stage biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases. The company has a diversified first-in-class clinical portfolio consisting of several scientific and technological platforms including neoepitopes and agonist or antagonist monoclonal antibodies, all ideally positioned to fight cancer and autoimmune diseases. The most advanced therapeutic-candidate, Tedopi®, is a proprietary combination of 10 neo-epitopes aimed at stimulating T-lymphocytes and is currently in Phase 3 development in non-small cell lung cancer (NSCLC) in patients in failure after checkpoint inhibitor treatment (anti PD-1 and anti PD-L1) and in Phase 2 testing in pancreatic cancer in combination with checkpoint inhibitor Opdivo®. BI 765063 (OSE-172) (anti-SIRPα monoclonal antibody) is under a license and collaboration agreement with Boehringer Ingelheim; this checkpoint inhibitor is currently under Phase 1 clinical trial in advanced solid tumors. BiCKI® is a bispecific fusion protein platform built on the key backbone component anti-PD-1 (OSE-279) and targeting innovative targets. FR104 (an anti-CD28 mAb) has successfully completed Phase 1 testing and has potential to treat autoimmune diseases. OSE-127 (monoclonal antibody targeting the CD127 receptor, the alpha chain of the interleukin-7 receptor) is partnered with Servier under a two-step licensing option agreement. The Phase 1 clinical phase of OSE-127 is completed and has shown positive results; two independent Phase 2 studies planned in ulcerative colitis (OSE sponsor) and Sjögren’s syndrome (Servier sponsor) to start in 2020, subject to the evolution of the COVID-19 situation.For more information: https://ose-immuno.com/en/Click and follow us on Twitter and LinkedIn https://twitter.com/OSEIMMUNO https://www.linkedin.com/company/10929673Contacts   OSE Immunotherapeutics Sylvie Détry Sylvie.detry@ose-immuno.com +33 153 198 757 U.S. Media: LifeSci Communications Darren Opland, Ph.D. darren@lifescicomms.com +1 646 627 8387       French Media: FP2COM Florence Portejoie fportejoie@fp2com.fr +33 607 768 283U.S. and European Investors Guillaume van Renterghem gvanrenterghem@lifesciadvisors.com  Forward-looking statements This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate.These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Reference Document filed with the AMF on 26 April 2019, including the annual financial report for the fiscal year 2018, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.    APPENDICES   CONSOLIDATED PROFIT & LOSS     P&L IN K€December 31, 2019 December 31, 2018  Turnover25 952 24 456  Other operating income0 0  Total Revenues25 952 24 456  Research and development expenses(21 655)(15 057) Overhead expenses(3 898)(3 448) Expenses related to shares payments(1 868)(977) OPERATING PROFIT/LOSS - CURRENT(1 469)4 974  Other operating products (badwill)0 0  Other operating expenses(2)(127) OPERATING PROFIT/LOSS(1 472)4 847  Financial products221 86  Financial expenses(213)(227) PROFIT/LOSS BEFORE TAX(1 464)4 707  Income Tax(3 188)783  NET PROFIT/LOSS(4 652)5 490  Of which consolidated net result attributable to shareholders(4 652)5 490  Net earnings attributable to shareholders    Weighted average number of shares outstanding14 892 496 14 634 760  Basic earnings per share(0,31)0,38  Diluted earnings per share(0,31)0,35  IN K€2019 2018 NET RESULT(4 652)5 490  Amounts to be recycled in the income statement:   Unrealized gains on securities available for sale, net of tax   Currency conversion difference(43)(42)     Amounts not to be recycled in the income statement:(37)12  Actuarial gains and losses on post-employment benefits    Other comprehensive income in the period(80)(30) GLOBAL PROFIT/LOSS (4 732)5 460         CONSOLIDATED BALANCE SHEET   ASSETS IN K€December 31, 2019December 31, 2018 Intangible assets52 600 52 600  Tangible assets1 009 904  Right-of-use assets1 692 0  Financial assets287 103  Differed tax assets283 272  TOTAL NON CURRENT ASSETS55 871 53 879  Trade receivables747 2 253  Other current assets6 474 3 834  Tax accounts receivables0 4 504  Current financial assets0 2 861  Cash and cash equivalents25 842 9 573  TOTAL CURRENT ASSETS33 062 23 024  TOTAL ASSETS88 933 76 903        EQUITY & LIABILITIES in K€ December 31, 2019December 31, 2018     SHAREHOLDERS’ EQUITY    Stated capital3 001 2 963  Share premium21 670 21 708  Merger premium26 827 26 827  Treasury stock(148)(168) Reserves and retained earnings11 838 4 934  Consolidated result(4 652)5 490  TOTAL SHAREHOLDERS’ EQUITY 58 536 61 754  NON-CURRENT DEBTS   Non-current financial liabilities9 211 3 832  Non-current lease liabilities1 413 0  Non-current deferred tax liabilities 5 066 2 010  Non-current provisions 377 233  TOTAL NON-CURRENT DEBTS 16 067 6 074  CURRENT DEBTS   Current financial liabilities548 628  Current lease liabilities309 0  Trade payables6 918 6 555  Corporate income tax liabilities20 86  Social and tax payables1 723 1 231  Other debts and accruals 4 812 575  TOTAL CURRENT DEBTS14 330 9 075  TOTAL LIABILITIES88 933 76 903      CONSOLIDATED CASH FLOW STATEMENT In K€December 31, 2019December 31, 2018  CONSOLIDATED RESULT(4 652 )5 490  +/-Depreciation, amortization and provision expenses323 116  +Amortization on "right-of-use"251 0  +/-Shares based payments (1)1 511 845   CASH FLOW BEFORE TAX(2 568 )6 450  +Financial charges30 (783) -Income tax expenses3 188 0  -Tax paid(70)0  +/-Working capital variation (2)8 555 (4 590)  CASH FLOW FROM OPERATING ACTIVITIES (A)9 135   1 077  -Tangible assets increase(336)(593) +/-Financial assets variation2 861 40  +/-Mutual finds units accounted in current financial assets34 22  +/-Loans and advances variation(184)(27)  CASH FLOW FROM INVESTING ACTIVITIES (B)  2 375 (558 ) +Capital increase (including share premium)0 23  +/-Own shares transactions0 (67) +Warrant subscription0 7  +Loans subscription5 628 0  -Loans repayment(455)(485) -Lease debt repayment (3)(251)0  -Financial charges164 (71)  CASH FLOW FROM FINANCING ACTIVITIES (C)4 759 (592 ) +/-Currency translation transactions (D)0 0   CASH VARIATION E = (A + B + C + D)  16 269 (73 )  CASH OPENING BALANCE (F)9 573 9 646   CASH CLOSING BALANCE (G)25 842 9 573   DIFFERENCE: E (G-F)0 0     (1)  Warrants and free shares awards granted in 2019 and valuated for 1 511 K€    (2)  Mainly explained by:           -   Decrease of trade receivable for 1 506 K€           -   Decrease of other current assets for 1 864 K€           -   Increase of trade accounts payable for 363 K€           -   Increase of social and tax payable for 493 K€           -   Increase of other debts for 4 237 K€    (3)  Explained by IFRS16 application, which corresponds to reimbursement of lease debt for 251 K€    As of December 31, 2019, the available cash is as follows: In K€December 31, 2019December 31, 2018 Cash & equivalents according to IAS 725 8429 573 Current financial assets02 861 AVAILABLE CASH25 84212 433

  • Globe Newswire

    OSE Immunotherapeutics and Servier Amend the Global Licensing Option Agreement for IL-7R Antagonist OSE-127 in Autoimmune Diseases

    * Under this amendment, OSE Immunotherapeutics will receive a €5 million milestone payment at the start of the Sjögren’s Phase 2 study sponsored by Servier, originally scheduled to be part of a post-Phase 2 option exercise milestone.NANTES, France, March 17, 2020 (GLOBE NEWSWIRE) -- OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnémo: OSE) and Servier today announced the execution of an amendment to the two-step global licensing option agreement for exclusive global rights to interleukin-7 receptor (IL-7R) antagonist OSE-127. In particular, the amendment modifies the provisions regarding the option exercise modalities and associated financial conditions.Under this amendment, OSE Immunotherapeutics and Servier have agreed to modify the provisions regarding the potential exercise of the option, amending step 2 of the option agreement, making OSE eligible to receive a €5 million milestone payment from Servier upon the enrollment of the first patient in the Phase 2a clinical study in Sjögren’s syndrome and an additional €15 million payment upon exercise option completion of both Phase 2 clinical trials, and in priority upon completion of the Phase 2a clinical study in Sjögren’s syndrome. The previous version of the agreement had the full €20 million milestone payment due upon completion of Phase 2 clinical study in Ulcerative colitis.Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics, said: “We are very pleased with the terms of this amendment, further demonstrating Servier’s commitment and strong belief in the potential of OSE-127, as a potential best-in-class treatment for autoimmune conditions. This milestone payment associated with this amendment, in line with our business model, will reinforce our cash position. The encouraging Phase 1 results with OSE-127 showing a good safety and tolerability profile for the product, together with a novel and differentiated mechanism of action as the only full-antagonist of IL-7R, support the potential of this compound to be an important therapy for patients suffering from Sjögren's syndrome or ulcerative colitis, both debilitating autoimmune diseases. We look forward to evaluating the product’s efficacy in these indications through the two independent Phase 2 studies expected to be initiated this year.”Claude Bertrand, Executive Vice-President Research & Development at Servier, said: “We are very pleased with the progress already achieved on OSE-127’s program. Having two Phase 2 clinical trials to start this year is a significant milestone in R&D. Our collaboration with OSE will contribute to the acceleration of the development of therapeutic solutions for patients suffering from auto-inflammatory diseases with very strong medical needs.”   Under the terms of the initial agreement signed in December 2016, OSE Immunotherapeutics granted Servier a two-step option agreement to acquire the exclusive worldwide license to develop and commercialize OSE-127 until the completion of a Phase 2 clinical trial planned in ulcerative colitis, an autoimmune bowel disease. OSE is eligible to receive up to a total of €272 million in development, regulatory and sales milestones. The €272 million include the upfront payment of €10.25 million, received in early 2017, and additional payments of up to €30 million to be paid upon the exercise of the initial two-step option, including €10 million paid upon exercise of the first option step and received in early 2019. Based on the positive Phase 1 results with OSE-127, two independent Phase 2 clinical studies are expected to start in 2020: in Sjögren’s syndrome, under Servier sponsorship, and in ulcerative colitis, under OSE sponsorship. Under the current amendment, the second option provides a €5 million milestone payment upon enrollment of the first patient in the Phase 2a clinical study in Sjögren’s syndrome and a €15 million milestone payment upon completion of both Phase 2 clinical studies and exercise of the option, in priority upon successful completion of the Phase 2 in Sjögren’s syndrome.About Servier Servier is an international pharmaceutical company governed by a non-profit foundation, with its headquarters in France (Suresnes). With a strong international presence in 149 countries and a total revenue of 4.6 billion euros in 2019, Servier employs 22,000 people worldwide. Entirely independent, the Group invests on average 25% of its total revenue (excluding generics) every year in research and development and uses all its profits for its development. Corporate growth is driven by Servier’s constant search for innovation in five areas of excellence: cardiovascular, immune-inflammatory, and neurodegenerative diseases, cancer and diabetes, as well as by its activities in high-quality generic drugs. Servier also offers eHealth solutions beyond drug development.Becoming a key player in the fight against immune-inflammatory disease is part of Servier’s long-term strategy. Servier wishes to bring innovative therapeutic solutions to patients suffering from these often highly debilitating pathologies. Its research focuses on lupus, Gougerot-Sjögren syndrome and scleroderma, for which no cure exists. This goal will be reached by establishing partnerships all over the world, to accelerate the marketing of innovative drugs with high added value for patients.More information: www.servier.comFollow us on Social Media:  https://www.linkedin.com/company/servier/ https://www.facebook.com/Servier/ https://twitter.com/servier?lang=frPress contacts: Sonia Marques : presse@servier.com – Tel. +33 (0)1 55 72 40 21 / + 33 (0) 7 84 28 76 13 Jean-Clément Vergeau : presse@servier.com – Tel. +33 (0)1 55 46 16 / +33 6 79 56 75 96About OSE Immunotherapeutics OSE Immunotherapeutics is a clinical-stage biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases. The company has a diversified first-in-class clinical portfolio consisting of several scientific and technological platforms including neoepitopes and agonist or antagonist monoclonal antibodies, all ideally positioned to fight cancer and autoimmune diseases. The most advanced therapeutic-candidate, Tedopi®, is a proprietary combination of 10 neo-epitopes aimed at stimulating T-lymphocytes and is currently in Phase 3 development in non-small cell lung cancer (NSCLC) in patients in failure after checkpoint inhibitor treatment (anti PD-1 and anti PD-L1) and in Phase 2 testing in pancreatic cancer in combination with checkpoint inhibitor Opdivo®. BI 765063 (OSE-172) (anti-SIRPa monoclonal antibody) is under a license and collaboration agreement with Boehringer Ingelheim; this checkpoint inhibitor is currently under Phase 1 clinical trial in advanced solid tumors. BiCKI® is a bispecific fusion protein platform built on the key backbone component anti-PD-1 (OSE-279) and targeting innovative targets. FR104 (an anti-CD28 mAb) has successfully completed Phase 1 testing and has potential to treat autoimmune diseases. OSE-127 (monoclonal antibody targeting the CD127 receptor, the alpha chain of the interleukin-7 receptor) is partnered with Servier under an option agreement up to the completion of a Phase 2 clinical trial planned in autoimmune bowel diseases; in parallel, Servier plans a development in the Sjögren syndrome. The Phase 1 clinical phase of OSE-127 is completed and has shown positive results; planned Phase 2 studies in ulcerative colitis and Sjögren’s syndrome to start in 2020.For more information: https://ose-immuno.com/en/Click and follow us on Twitter and LinkedIn https://twitter.com/OSEIMMUNO https://www.linkedin.com/company/10929673ContactsOSE Immunotherapeutics Sylvie Détry Sylvie.detry@ose-immuno.com +33 153 198 757 French Media: FP2COM Florence Portejoie fportejoie@fp2com.fr +33 607 768 283U.S. Media: LifeSci Public Relations Darren Opland, Ph.D. darren@lifescipublicrelations.com +1 646 627 8387 U.S. and European Investors Chris Maggos chris@lifesciadvisors.com +41 79 367 6254 Forward-looking statements This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate. These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Reference Document filed with the AMF on 26 April 2019, including the annual financial report for the fiscal year 2018, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.

  • Globe Newswire

    OSE Immunotherapeutics Announces Artificial Intelligence Antibody Drug Development Collaboration with MAbSilico

    * Agreement capitalizes on artificial intelligence and deep learning to develop therapeutic monoclonal antibodies, including novel bispecific antibodies (BiCKI® platform) * Collaboration runs for 3 years and will be used for 6 antibody programsNANTES, France, Feb. 12, 2020 (GLOBE NEWSWIRE) -- OSE Immunotherapeutics (ISIN: FR0012127173; Mnémo: OSE), today announced a new collaboration agreement with deep technology innovative start-up MAbSilico, located in Tours, France, to use artificial intelligence (AI)-based solutions for therapeutic antibody drug development.OSE Immunotherapeutics plans to incorporate innovative problem-solving solutions like AI for the development of new monoclonal antibodies. MAbSilico solutions have already been tested and validated by OSE Immunotherapeutics and will be used for six antibody programs, including novel bispecific antibodies. AI and numerical simulation can guide therapeutic antibody discovery, help reduce the risk of failure and accelerate the pre-clinical development process of these drug candidates before clinical tests.Nicolas Poirier, Chief Scientific Officer of OSE Immunotherapeutics, stated: “We are delighted with this collaboration, we constantly strive to introduce innovative technologies to develop first-in-class products in immuno-oncology and autoimmune diseases. Due to the devastating nature of these diseases, our development strategies need to be accelerated and artificial intelligence solutions for drug discovery offered by MAbSilico can be a great asset to achieve this goal.”While all MAbSilico’s commercialized solutions are included in this three-year agreement, OSE Immunotherapeutics also gains early access to MAbSilico’s SaaS (Software as a Service) and technologies in development including those for the conception of therapeutic antibodies optimized for bioproduction. OSE provides internal data to MAbSilico in order to feed their algorithms in development and deliver new technology faster.Vincent Puard, Chief Executive Officer of MAbSilico, stated: “It is a pleasure to start this collaboration with one of the top French Biotech. This partnership demonstrates the need to fasten new AI-based solutions for antibody drug discovery. We believe that with the trust and collaboration of OSE, we will accelerate the release of our software and new technologies.”ABOUT OSE ImmunotherapeuticsOSE Immunotherapeutics is a clinical-stage biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases. The company has a diversified first-in-class clinical portfolio consisting of several scientific and technological platforms including neoepitopes and agonist or antagonist monoclonal antibodies, all ideally positioned to fight cancer and autoimmune diseases. The most advanced therapeutic-candidate, Tedopi®, is a proprietary combination of 10 neo-epitopes aimed at stimulating T-lymphocytes and is currently in Phase 3 development in non-small cell lung cancer (NSCLC) in patients in failure after checkpoint inhibitor treatment (anti PD-1 and anti PD-L1) and inPhase 2 testing in pancreatic cancer in combination with checkpoint inhibitor Opdivo®. BI 765063 (OSE-172) (anti-SIRPa monoclonal antibody) is under a license and collaboration agreement with Boehringer Ingelheim; this checkpoint inhibitor is currently under Phase 1 clinical trial in advanced solid tumors. BiCKI® is a bispecific fusion protein platform built on the key backbone component anti-PD-1 (OSE-279) and targeting innovative targets. FR104 (an anti-CD28 mAb) has successfully completed Phase 1 testing and has potential to treat autoimmune diseases. OSE-127 (monoclonal antibody targeting the CD127 receptor, the alpha chain of the interleukin-7 receptor) is partnered with Servier under an option agreement up to the completion of a Phase 2 clinical trial planned in autoimmune bowel diseases; in parallel, Servier plans a development in the Sjögren syndrome. The Phase 1 clinical phase of OSE-127 is completed and has shown positive results; planned Phase 2 studies in ulcerative colitis and Sjögren’s syndrome to start in 2020.For more information: https://ose-immuno.com/en/Click and follow us on Twitter and LinkedInhttps://twitter.com/OSEIMMUNO https://www.linkedin.com/company/10929673ContactsOSE Immunotherapeutics Sylvie Détry Sylvie.detry@ose-immuno.com +33 153 198 757U.S. Media: LifeSci Public Relations Darren Opland, Ph.D. darren@lifescipublicrelations.com +1 646 627 8387    French Media: FP2COM Florence Portejoie fportejoie@fp2com.fr +33 607 768 283U.S. and European Investors Chris Maggos chris@lifesciadvisors.com  +41 79 367 6254 About MAbSilico MAbSilico is a deeptech company, founded in September 2017, which implements computational solutions for the development of therapeutic antibodies, bio-drugs used in an increasing number of pathologies, including oncology.MAbSilico’s objective is to propose a software suite that creates a formal approach of antibody development, reducing the risks of failure and the duration of pre-clinical steps, as well as strengthening intellectual protection. Conventional approaches for the discovery and pre-clinical development take two to three years, MAbSilico technologies allow shrinking this time to a few weeks.The technology developed by MAbSilico is the result of more than twenty years of French scientific research, in laboratories affiliated to INRA and CNRS. It is based on artificial intelligence (AI), machine learning (ML), and has partly been funded by the Loire-Valley Region and the MAbImprove Labex. MAbSilico tools have been the subjects of more than ten scientific publications and are covered by an international patent.The MAbSilico team consists in five persons, including three co-founders and co-inventors of the methods. It is located on the INRA Loire-Valley site.Since 2018, MAbSilico has been commercializing its tools in France, Europe and USA, with more than 20 clients: academics, startups and biotechs.MAbSilico is looking forward to extending its commercial effort in Europe and to hire ten persons in Tours for positions in software development, data science, bioinformatics, biology and business development. The implementation of our solutions will be made in close link with our clients to best meet their needs.More information at www.mabsilico.comClick and follow us on Twitter and LinkedInhttps://twitter.com/mabsilico https://www.linkedin.com/company/18152652 ContactsMAbSilico Vincent Puard vincent.puard@mabsilico.comForward-looking statements This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate.These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Reference Document filed with the AMF on 26 April 2019, including the annual financial report for the fiscal year 2018, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.

  • Globe Newswire

    OSE Immunotherapeutics Announces Issuance of a New Patent in Japan for Tedopi® on Inducing Early T-Lymphocyte Memory Response

    Further Strengthens Global Intellectual Property Portfolio for Tedopi® in Immuno-OncologyNANTES, France, Jan. 14, 2020 (GLOBE NEWSWIRE) -- OSE Immunotherapeutics (ISIN: FR0012127173; Mnémo: OSE) today announced that the Japanese Patent Office has issued a new patent family related to Tedopi®, a combination of neoepitopes, protecting the product’s method for inducing early T-lymphocyte memory response for use in the treatment of cancer in HLA-A2 positive patients. This patent provides a protection until 2035. Tedopi is a combination of 10 neo-epitopes, selected and optimized from five tumor-associated antigens inducing a specific immune response in positive HLA-A2 patients. In association with T helper cells, the memory T lymphocytes recognize specifically at least one of these tumor-associated antigens expressed by the tumor cells and generate a specific cytotoxic response against them.Due to this specific mechanism of action, activated specific T memory lymphocytes are key cells in cancer treatment and immunosurveillance. “This new patent family, granted in Japan, further expands the patent protection for Tedopi® and strengthens our immuno-oncology portfolio. This allowance further validates a specific mechanism of action inducing an early T lymphocyte memory response in HLA-A2 positive patients, which represent 45% of the population, and covering all cancers. Moreover, with more than one million new cancer cases in Japan in 2018*, and a growing oncology drug market in this country and across the world, Tedopi® is positioned as a leading asset in multiple oncology indications in a broad population of patients,” said Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics.Tedopi® is currently being evaluated in a Phase 3 trial, called Atalante 1, in advanced non-small cell lung cancer (NSCLC) for HLA-A2 positive patients after failure from previous treatment with PD-1/PD-L1 checkpoint inhibitors. Even with recent advances in treatment options, the majority of NSCLC patients still fail to respond to checkpoint inhibitor therapy**, creating a great need for an effective new option for these patients. Results from the first step of this ongoing Phase 3 trial are expected by the end of Q1 2020. Tedopi® is also being studied in an ongoing Phase 2 trial in patients with pancreatic cancer.* Shibata et al., Japan oncology market overview: Current and future perspectives; Journal of Generic Medicines, 2019 ** Haslam et al., Estimation of the Percentage of US Patients With Cancer Who Are Eligible for and Respond to Checkpoint Inhibitor Immunotherapy Drugs; JAMA Netw Open. 2019;2(5):e192535.ABOUT OSE Immunotherapeutics OSE Immunotherapeutics is a clinical-stage biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases. The company has a diversified first-in-class clinical portfolio consisting of several scientific and technological platforms including neoepitopes and agonist or antagonist monoclonal antibodies, all ideally positioned to fight cancer and autoimmune diseases. The most advanced therapeutic-candidate, Tedopi®, is a proprietary combination of 10 neo-epitopes aimed at stimulating T-lymphocytes and is currently in Phase 3 development in non-small cell lung cancer (NSCLC)  in patients in failure after checkpoint inhibitor treatment (anti PD-1 and anti PD-L1) and in Phase 2 testing in pancreatic cancer in combination with checkpoint inhibitor Opdivo®. BI 765063 (OSE-172) (anti-SIRPa monoclonal antibody) is under a license and collaboration agreement with Boehringer Ingelheim; this checkpoint inhibitor is currently under Phase 1 clinical trial in advanced solid tumors. BiCKI® is a bispecific fusion protein platform built on the key backbone component anti-PD-1 (OSE-279) and targeting innovative targets. FR104 (an anti-CD28 mAb) has successfully completed Phase 1 testing and has potential to treat autoimmune diseases. OSE-127 (monoclonal antibody targeting the CD127 receptor, the alpha chain of the interleukin-7 receptor) is partnered with Servier under an option agreement up to the completion of a Phase 2 clinical trial planned in autoimmune bowel diseases; in parallel, Servier plans a development in the Sjögren syndrome. The Phase 1 clinical phase of OSE-127 is completed and has shown positive results; planned Phase 2 studies in ulcerative colitis and Sjögren’s syndrome to start in 2020.For more information: https://ose-immuno.com/en/Click and follow us on Twitter and LinkedIn https://twitter.com/OSEIMMUNO https://www.linkedin.com/company/10929673Contacts  OSE Immunotherapeutics Sylvie Détry Sylvie.detry@ose-immuno.com +33 153 198 757U.S. Media: LifeSci Public Relations Darren Opland, Ph.D. darren@lifescipublicrelations.com +1 646 627 8387    French Media: FP2COM Florence Portejoie fportejoie@fp2com.fr +33 607 768 283U.S. and European Investors Chris Maggos chris@lifesciadvisors.com  +41 79 367 6254 Forward-looking statements This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate. These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Reference Document filed with the AMF on 26 April 2019, including the annual financial report for the fiscal year 2018, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.

  • Globe Newswire

    OSE Immunotherapeutics Announces Positive Results from Phase 1 Clinical Study of Anti-IL-7 Receptor Antagonist OSE-127

    * Planned Phase 2 Studies in Ulcerative Colitis and Sjögren's Syndrome to Start in 2020 NANTES, France, Dec. 02, 2019 (GLOBE NEWSWIRE) -- OSE Immunotherapeutics (ISIN: FR0012127173; Mnémo: OSE) today announced completion and positive results from the Phase 1 study of OSE-127, a humanized monoclonal antibody with a differentiated mechanism of action as a full-antagonist of the CD127 receptor, the alpha chain of the interleukin-7 receptor (IL-7R). OSE-127 has been shown in previous studies to induce a powerful antagonistic effect on effector T lymphocytes responsible for causing autoimmune diseases.The Phase 1 study results show a good safety and tolerability profile for OSE-127. All pharmacokinetic and pharmacodynamic parameters are consistent and demonstrate a dose-proportionality across the several dose-levels up to 10 mg/kg. These findings will help determine the dosing and administration schedule for the two planned Phase 2 trials in ulcerative colitis and Sjögren’s syndrome. Both trial initiations are expected in 2020.“These encouraging Phase 1 findings, together with the novel and differentiated mechanism of action of OSE-127, the only full-antagonist of IL-7R, provide a firm foundation for further clinical development. These data support the potential of this compound to be a relevant therapy in ulcerative colitis, a chronic inflammatory bowel disease, representing 12.2 per 100,000 people by year* and Sjögren's syndrome, representing 7 per 100,000 people by year**. We look forward to evaluating the product’s efficacy in both indications through two independent Phase 2 studies expected to be initiated in 2020,” said Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics.This study was a first-in-human dose-escalation, randomized, double-blind, placebo-controlled Phase 1 trial, aimed to evaluate the safety and tolerability of single- and multiple-ascending intravenous and subcutaneous doses of OSE-127 in 63 healthy volunteers. Secondary endpoints included measures of pharmacokinetics, pharmacodynamics and immunogenicity to help assess and understand how the drug is absorbed and metabolized.OSE-127 is being developed in partnership with Servier¹ under an option agreement up to the completion of a Phase 2 clinical trial planned in autoimmune bowel diseases. In parallel, Servier plans to develop OSE-127 in Sjögren’s syndrome.¹ Servier is an independent international pharmaceutical company, governed by a non-profit foundation, with headquarters based in France. * Loftus EV, Jr., Shivashankar R, Tremaine WJ, Harmsen WS, Zinsmeiseter AR. Updated Incidence and Prevalence of Crohn’s Disease and Ulcerative Colitis in Olmsted County, Minnesota (1970-2011). ACG 2014 Annual Scientific Meeting. October 2014 ** Qin B. et al; Epidemiology of primary Sjögren’s syndrome: a systematic review and meta-analysis Ann Rheum Dis 2014ABOUT OSE-127 OSE-127 is a monoclonal immunomodulatory antibody targeting the CD127 receptor, the alpha chain of the interleukin-7 receptor (IL-7R) that induces a powerful antagonist effect on effector T lymphocytes. Interleukin-7 is a cytokine which specifically regulates the tissue migration of human effector T lymphocytes, especially in the gut. The blockage of IL-7R prevents the migration of pathogenic T lymphocytes while preserving regulator T lymphocytes which have a positive impact in autoimmune diseases.ABOUT OSE Immunotherapeutics OSE Immunotherapeutics is a clinical-stage biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases. The company has a diversified first-in-class clinical portfolio consisting of several scientific and technological platforms including neoepitopes and agonist or antagonist monoclonal antibodies, all ideally positioned to fight cancer and autoimmune diseases. The most advanced therapeutic-candidate, Tedopi®, is a proprietary combination of 10 neo-epitopes aimed at stimulating T-lymphocytes and is currently in Phase 3 development in non-small cell lung cancer (NSCLC) in patients in failure after checkpoint inhibitor treatment (anti PD-1 and anti PD-L1) and in Phase 2 testing in pancreatic cancer in combination with checkpoint inhibitor Opdivo®. BI 765063 (OSE-172) (anti-SIRPa monoclonal antibody) is under a license and collaboration agreement with Boehringer Ingelheim; this checkpoint inhibitor is currently under Phase 1 clinical trial in advanced solid tumors. BiCKI® is a bispecific fusion protein platform built on the key backbone component anti-PD-1 (OSE-279) and targeting innovative targets. FR104 (an anti-CD28 mAb) has successfully completed Phase 1 testing and has potential to treat autoimmune diseases. OSE-127 (monoclonal antibody targeting the CD127 receptor, the alpha chain of the interleukin-7 receptor) is partnered with Servier under an option agreement up to the completion of a Phase 2 clinical trial planned in autoimmune bowel diseases; in parallel, Servier plans a development in the Sjögren’s syndrome. The Phase 1 clinical phase of OSE-127 is completed and has shown positive results; planned Phase 2 studies in ulcerative colitis and Sjögren’s syndrome to start in 2020.For more information: https://ose-immuno.com/en/Click and follow us on Twitter and LinkedIn.Contacts  OSE Immunotherapeutics Sylvie Détry Sylvie.detry@ose-immuno.com +33 153 198 757  French Media: FP2COM Florence Portejoie fportejoie@fp2com.fr +33 607 768 283U.S. Media: LifeSci Public Relations Darren Opland, Ph.D. darren@lifescipublicrelations.com +1 646 627 8387  U.S. and European Investors Chris Maggos chris@lifesciadvisors.com +41 79 367 6254 Forward-looking statements This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate. These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Reference Document filed with the AMF on 26 April 2019, including the annual financial report for the fiscal year 2018, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.

  • Globe Newswire

    OSE Immunotherapeutics and HalioDx Collaborate to Perform Immune Biomarker Exploratory Work during Atalante 1 Phase 3 Clinical Trial of Tedopi® in Non-Small Cell Lung Cancer

    NANTES, France and MARSEILLE, France, Nov. 27, 2019 (GLOBE NEWSWIRE) -- OSE Immunotherapeutics (ISIN: FR0012127173; Mnémo: OSE), a clinical-stage biotechnology company focused on developing innovative immunotherapies, and HalioDx, the immuno-oncology diagnostic company, today announced a collaboration to conduct a translational investigation of immune biomarkers as part of the ongoing Phase 3 clinical trial of neoepitope combination Tedopi® in non-small cell lung cancer (NSCLC) patients.The collaboration will focus on the testing and analysis of clinical biopsy tissue samples from patients participating in the ongoing Phase 3 Atalante 1 clinical trial. HalioDx will leverage its expertise in proprietary technology immuno-oncology diagnostic platforms to perform immune biomarker exploratory work as part of the clinical trial objectives.  “We look forward to combining our companies’ innovative approaches, OSE's neoepitope combination Tedopi® and HalioDx’s pioneering diagnostic applications such as Immunoscore® and Immunosign®, to conduct a translational investigation focused on identifying potential immune biomarkers in NSCLC. Based on the data generated, we aim at defining the profile of responder patients to Tedopi® treatment in advanced lung cancer,” said Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics.“Relapse of NSCLC patients after treatment with PD-1/PD-L1 checkpoint inhibitors (ICI) is today a critical issue to solve. Tedopi® is an exciting and promising approach to overcome ICI resistance. We are delighted to work together with the OSE team to execute this comprehensive biomarker program with the objective to map the immune contexture and identify the responders,” added Vincent Fert, Chief Executive Officer of HalioDx.Tedopi® is currently being evaluated in a Phase 3 trial, called Atalante 1, in advanced NSCLC for HLA-A2 positive patients after failure from previous treatment with PD-1/PD-L1 checkpoint inhibitors. Results from the first step of this ongoing Phase 3 trial are expected by the end of Q1 2020. Tedopi® is also being studied in an ongoing Phase 2 trial in patients with pancreatic cancer.About HalioDxThe Immune Response to Cancer DiagnosticsHalioDx is an immuno-oncology diagnostic company providing oncologists and Biopharma with first-in-class Immune-based diagnostic products and services to guide cancer care and contribute to precision medicine in the era of immuno-oncology and combination therapies. Immunoscore® proprietary technology, pioneered by Jérôme Galon at the Cordeliers Research Center, Paris, France, integrates immunohistochemistry combined with sophisticated algorithm and advanced imaging analysis enabling extraction of spatially organized tissue molecular information. Immunoscore® is a platform for many cancers, as immune response to tumor is a key hallmark of disease progression. HalioDx collaborates with renowned international clinical groups to support clinical utility and ensure rigorous performance validation of its assays in selected cancer indications. HalioDx has an experienced team of more than 165 employees, CLIA-certified laboratories and compliant facilities in Europe and in the US to develop, manufacture, register and market in vitro diagnostic (IVD) products. HalioDx executes biomarker studies and companion diagnostic assay development in conformity with regulations and in partnership with biopharmaceutical companies. The company co-founded the European immunology cluster Marseille Immunopôle (MI).For more information, please visit our websites www.haliodx.com and www.immunoscore-colon.com and follow the company on Twitter @HalioDx and Linkedin https://www.linkedin.com/company/haliodx/.HalioDx® and Immunoscore® are registered trademarks of HalioDx.ABOUT OSE ImmunotherapeuticsOSE Immunotherapeutics is a clinical-stage biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases. The company has a diversified first-in-class clinical portfolio consisting of several scientific and technological platforms including neoepitopes and agonist or antagonist monoclonal antibodies, all ideally positioned to fight cancer and autoimmune diseases. The most advanced therapeutic-candidate, Tedopi®, is a proprietary combination of 10 neo-epitopes aimed at stimulating T-lymphocytes and is currently in Phase 3 development in non-small cell lung cancer (NSCLC)  in patients in failure after checkpoint inhibitor treatment (anti PD-1 and anti PD-L1) and in Phase 2 testing in pancreatic cancer in combination with checkpoint inhibitor Opdivo®. BI 765063 (OSE-172) (anti-SIRPa monoclonal antibody) is under a license and collaboration agreement with Boehringer Ingelheim; this checkpoint inhibitor is currently under Phase 1 clinical trial in advanced solid tumors. BiCKI® is a bispecific fusion protein platform built on the key backbone component anti-PD-1 (OSE-279) and targeting innovative targets. FR104 (an anti-CD28 mAb) has successfully completed Phase 1 testing and has potential to treat autoimmune diseases. OSE-127 (monoclonal antibody targeting the CD127 receptor, the alpha chain of the interleukin-7 receptor) is partnered with Servier under an option agreement up to the completion of a Phase 2 clinical trial planned in autoimmune bowel diseases; in parallel, Servier plans a development in the Sjögren syndrome. OSE-127 is currently under Phase 1 clinical trial.Click and follow us on Twitter and LinkedInhttps://twitter.com/OSEIMMUNO https://www.linkedin.com/company/10929673   Contacts  OSE Immunotherapeutics Sylvie Détry Sylvie.detry@ose-immuno.com +33 153 198 757 U.S. Media: LifeSci Public Relations Darren Opland, Ph.D. darren@lifescipublicrelations.com +1 646 627 8387    French Media: FP2COM Florence Portejoie fportejoie@fp2com.fr  +33 607 768 283U.S. and European Investors Chris Maggos chris@lifesciadvisors.com  +41 79 367 6254    HalioDx SAS Vincent Fert President and CEO \+ 33 (0)4 91 29 30 90 vincent.fert@haliodx.com  ATCG Press Marie Puvieux (France) +33 981 87 46 72 Céline Voisin (ROW) +33 662 12 53 39 haliodx@atcg-partners.com  Forward-looking statements This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate. These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Reference Document filed with the AMF on 26 April 2019, including the annual financial report for the fiscal year 2018, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.

  • Globe Newswire

    OSE Immunotherapeutics Presented Positive Correlation Between Neoepitope Response and Increased Survival for NSCLC Patients Treated with Tedopi®

    At the 34th SITC Annual MeetingNANTES, France, Nov. 11, 2019 (GLOBE NEWSWIRE) -- OSE Immunotherapeutics (ISIN: FR0012127173; Mnémo: OSE), today announced that new clinical and preclinical data on its products in immuno-oncology - Tedopi®, BI 765063 (OSE-172) and the BiCKI® platform - were presented at the 2019 Society for Immunotherapy of Cancer (SITC) Annual Meeting, held November 6 – 10, 2019 in National Harbor, Maryland, USA. The poster (P339), entitled “Survival is improved by antigen-specific cytotoxic T lymphocytes (CTL) responses after treatment with the neoepitope-based vaccine Tedopi® in HLA-A2 positive advanced non-small cell lung cancer (NSCLC) patients,”* reported on immunogenicity assays that have been conducted to explore the predictive effect of the type and number of neoepitopes on overall survival. The results presented demonstrated that in advanced non-small cell lung cancer (NSCLC) patients, survival was significantly prolonged in patients immunized with the combination of neoepitopes used in Tedopi®."The new exploratory data from translational analysis demonstrate that neoepitope combination Tedopi® increases the recognition of cancer cells by antigen-specific CD8 T cells with a favorable correlation with patients’ survival. This supports the mechanism of action of Tedopi® of increasing the tumor antigen presentation and activation of T-cell priming, leading to an anti-tumoral effect and potentially combatting the main resistance mechanisms to immune checkpoint inhibitors. We are encouraged by these findings and look forward to confirming the correlation between neoepitope response and survival in further translational investigations," said Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics.Tedopi®, a combination of neoepitopes, is currently being evaluated in an open-label Phase 3 trial in advanced NSCLC for HLA-A2 positive patients who failed previous treatments with checkpoint inhibitors. Tedopi® is also being studied in an ongoing Phase 2 trial in patients with pancreatic cancer.The second poster (P428) presented was a BI 765063 Phase 1 trial-in-progress presentation entitled: “A phase 1 study evaluating BI 765063, a first in class selective myeloid SIRPα inhibitor, as stand-alone and in combination with BI 754091, a PD-1 inhibitor, in patients with advanced solid tumours.”** BI 765063, a first-in-class monoclonal antibody antagonist targeting the SIRPa receptor expressed on myeloid pro-tumor suppressive cells, is being developed in partnership with Boehringer Ingelheim. The ongoing Phase 1 trial conducted in patients with advanced solid tumors is a dose finding study of BI 765063 administered as a single agent and in combination with Boehringer Ingelheim’s monoclonal antibody PD-1 antagonist BI 754091, a T-lymphocyte checkpoint inhibitor.The third poster (P256), entitled “A novel bifunctional anti-PD-1 / IL-7 fusion protein potentiates effector function of exhausted T cell and disarms Treg suppressive activity,” *** focuses on OSE's proprietary bispecific checkpoint inhibitor (BiCKI®) platform. BiCKI® antibodies are based on anti-PD-1 backbone (OSE-279) selected based on optimized bioproduction capacity. The first cytokine selected to be paired with the anti-PD-1 in the bispecific antibody is interleukin-7 (IL-7), which has been shown to improve immune functions and cancer immunotherapy efficacy. The poster reports preclinical evidence that OSE’s bifunctional anti-PD1/IL-7 favors the T cell effector over regulatory immune balance by stimulating effector T cell functions while disarming regulatory T cells.* Benjamin Besse, Enriqueta Felip, Giuseppe Giaccone, Rafal Dziadziuszko, Elisabeth Quoix, Werner Hilgers, Federico Cappuzzo, Christophe Borg, Jordi Remon, Nicolas Poirier, Dominique Costantini, Bérangère Vasseur, Santiago Viteri**Nuria Kotecki, Philippe Cassier, Jean Pierre Delord, Stéphane Champiat, Christiane Jungels, Armelle Vinceneux, Iphigenie Korakis, Richard Huhn, Nicolas Poirier, Dominique Costantini, Bérangère Vasseur, Aurélien Marabelle*** Aurore Morello, Justine Durand, Caroline Mary, Virginie Thepenier, Margaux Seite, Géraldine Teppaz, Nicolas PoirierABOUT OSE ImmunotherapeuticsOSE Immunotherapeutics is a clinical-stage biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases. The company has a diversified first-in-class clinical portfolio consisting of several scientific and technological platforms including neoepitopes and agonist or antagonist monoclonal antibodies, all ideally positioned to fight cancer and autoimmune diseases. The most advanced therapeutic-candidate, Tedopi®, is a proprietary combination of 10 neo-epitopes aimed at stimulating T-lymphocytes and is currently in Phase 3 development in non-small cell lung cancer (NSCLC)  in patients in failure after checkpoint inhibitor treatment (anti PD-1 and anti PD-L1) and in Phase 2 testing in pancreatic cancer in combination with checkpoint inhibitor Opdivo®. BI 765063 (OSE-172) (anti-SIRPa monoclonal antibody) is under a license and collaboration agreement with Boehringer Ingelheim; this checkpoint inhibitor is currently under Phase 1 clinical trial in advanced solid tumors. BiCKI® is a bispecific fusion protein platform built on the key backbone component anti-PD-1 (OSE-279) and targeting innovative targets. FR104 (an anti-CD28 mAb) has successfully completed Phase 1 testing and has potential to treat autoimmune diseases. OSE-127 (monoclonal antibody targeting the CD127 receptor, the alpha chain of the interleukin-7 receptor) is partnered with Servier under an option agreement up to the completion of a Phase 2 clinical trial planned in autoimmune bowel diseases; in parallel, Servier plans a development in the Sjögren syndrome. OSE-127 is currently under Phase 1 clinical trial.Click and follow us on Twitter and LinkedInhttps://twitter.com/OSEIMMUNO https://www.linkedin.com/company/10929673ContactsOSE Immunotherapeutics Sylvie Détry Sylvie.detry@ose-immuno.com +33 153 198 757   French Media: FP2COM Florence Portejoie fportejoie@fp2com.fr +33 607 768 283U.S. Media: LifeSci Public Relations Darren Opland, Ph.D. darren@lifescipublicrelations.com +1 646 627 8387   U.S. and European Investors Chris Maggos chris@lifesciadvisors.com  +41 79 367 6254 Forward-looking statements This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate.These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Reference Document filed with the AMF on 26 April 2019, including the annual financial report for the fiscal year 2018, available on the OSE Immunotherapeutics’ website.Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.

  • Globe Newswire

    OSE Immunotherapeutics Announces Licensing Deal for Neoepitope Combination Tedopi® in Korea with Chong Kun Dang Pharmaceutical Corporation

    NANTES, France, Nov. 07, 2019 (GLOBE NEWSWIRE) -- OSE Immunotherapeutics (ISIN: FR0012127173; Mnémo: OSE), today announced a new licensing deal with Chong Kun Dang (CKD) Pharmaceutical Corporation for Tedopi®, a combination of neoepitopes selected and optimized from five tumor antigens shown to generate a specific response of cytotoxic T cells versus cancer cells expressing at least one of these tumor associated antigens and an associated T-helper cell response, for potential registration and commercialization in Korea. "We are pleased to announce the licensing of Tedopi® to such a strong partner as CKD, one of the industry leaders in Korea," said Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics. "This partnership allows us to make a difference for Korean non-small cell lung cancer patients after previous checkpoint inhibitor treatment failure, a population for which there is great unmet medical need. This licensing agreement is an example of our commitment to making Tedopi® available to the broadest audience globally and maximizing its potential."Financial terms of the contract include both upfront and short-term milestone payments of €1.2 million with total milestones payments of €4.3 million, as well as royalties on sales and transfer price in the high twenties. The deal applies specifically to development and licensing of Tedopi® in the Korean market which accounts for approximately 1% of the total global oncology market."It is indeed interesting times as cancer immunotherapies are dramatically transforming the landscape of cancer treatment. However, there is a large population still devastated from checkpoint inhibitor failures,” said Young-Joo Kim, Chief Executive Officer of Chong Kun Dang Pharmaceutical Corp. "We are excited to add a promising product to help an underserved patient population to our portfolio and look forward to working with the outstanding team at OSE to help bring Tedopi® to the Korean market.”Tedopi® is currently being evaluated in an open-label Phase 3 trial (called Atalante 1) in advanced non-small cell lung cancer (NSCLC) for HLA-A2 positive patients after failure from previous treatment with PD-1/PD-L1 checkpoint inhibitors. Results from the first step of this ongoing Tedopi® Phase 3 trial in NSCLC are expected end of Q1 2020.Tedopi® is also being studied in an ongoing Phase 2 trial in patients with pancreatic cancer.ABOUT CHONG KUN DANG PHARMACEUTICAL CORPORATION Chong Kun Dang Pharmaceutical Corporation (CKD) is a South Korea-based healthcare company founded in 1941. According to IQVIA, Chong Kun Dang is leading the market among local pharmaceutical companies for five consecutive years. The core business consists of primary & specialty care, consumer health, healthcare supplements, and contract manufacturing of active pharmaceutical ingredients. Over the last decade, Chong Kun Dang has formed partnerships with MNCs such as Bayer, Roche, Allergan, Pfizer, MSD, Amgen, Eisai, Lilly and Alvogen. As a result, Chong Kun Dang has an unrivalled leadership in the local market enhanced by its robust product portfolio which now covers a broad range of therapeutic classes. Chong Kun Dang continues to strengthen its major therapeutic area by its R&D capability and licensing-in innovative drugs from business partners worldwide. For more information, visit www.ckdpharm.com/eng.ABOUT OSE Immunotherapeutics OSE Immunotherapeutics is a clinical-stage biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases. The company has a diversified first-in-class clinical portfolio consisting of several scientific and technological platforms including neoepitopes and agonist or antagonist monoclonal antibodies, all ideally positioned to fight cancer and autoimmune diseases. The most advanced therapeutic-candidate, Tedopi®, is a proprietary combination of 10 neoepitopes aimed at stimulating T-lymphocytes and is currently in Phase 3 development in non-small cell lung cancer (NSCLC)  in patients in failure after checkpoint inhibitor treatment (anti PD-1 and anti PD-L1) and in Phase 2 testing in pancreatic cancer in combination with checkpoint inhibitor Opdivo®. BI 765063 (OSE-172) (anti-SIRPa monoclonal antibody) is under a license and collaboration agreement with Boehringer Ingelheim; this checkpoint inhibitor is currently under Phase 1 clinical trial in advanced solid tumors. BiCKI® is a bispecific fusion protein platform built on the key backbone component anti-PD-1 (OSE-279) and targeting innovative targets. FR104 (an anti-CD28 mAb) has successfully completed Phase 1 testing and has potential to treat autoimmune diseases. OSE-127 (monoclonal antibody targeting the CD127 receptor, the alpha chain of the interleukin-7 receptor) is partnered with Servier under an option agreement up to the completion of a Phase 2 clinical trial planned in autoimmune bowel diseases; in parallel, Servier plans a development in the Sjögren syndrome. OSE-127 is currently under Phase 1 clinical trial.Click and follow us on Twitter and LinkedInhttps://twitter.com/OSEIMMUNO https://www.linkedin.com/company/10929673ContactsOSE Immunotherapeutics Sylvie Détry Sylvie.detry@ose-immuno.com +33 153 198 757 French Media: FP2COM Florence Portejoie fportejoie@fp2com.fr +33 607 768 283U.S. Media: LifeSci Public Relations Darren Opland, Ph.D. darren@lifescipublicrelations.com +1 646 627 8387 U.S. and European Investors Chris Maggos chris@lifesciadvisors.com +41 79 367 6254  Forward-looking statements This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate. These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Reference Document filed with the AMF on 26 April 2019, including the annual financial report for the fiscal year 2018, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.

  • Globe Newswire

    OSE Immunotherapeutics Presents New Preclinical Data on its Novel Bispecific Checkpoint Inhibitor (BiCKI®) Platform Targeting PD-1 and Cytokines to Overcome Tumor Resistance to Checkpoint Inhibitor Blockade

    New data presented at the International Cancer Immunotherapy Conference (CICON)NANTES, France, Sept. 30, 2019 (GLOBE NEWSWIRE) -- OSE Immunotherapeutics (ISIN: FR0012127173; Euronext: OSE) presented new data on its BiCKI® platform at the International Cancer Immunotherapy Conference (CICON) being held September 25-28, 2019, in Paris, France. The presentation focused on a novel bispecific antibody therapy being developed by the Company to fight primary and secondary resistance mechanisms developed by cancers to evade checkpoint inhibitor therapies. BiCKI® antibodies are based on anti-PD-1 backbone (OSE-279) selected on optimized bioproduction capacity. The first cytokine selected to be paired with the anti-PD-1 in the bispecific antibody is Interleukin-7 (IL-7), which has been shown to improve immune functions and cancer immunotherapy efficacy. “Our data validates the therapeutic potential of a novel bispecific therapy combining anti-PD-1 and IL-7 cytokine to fight primary and secondary resistance mechanisms to checkpoint inhibitors. Along with Tedopi®, OSE's neoepitope product currently in a Phase 3 trial in NSCLC, BiCKI®IL-7 addresses a patient population in immune escape from checkpoint inhibitor treatment for whom the clinical need is extremely high,” said Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics.The poster, entitled “A novel bifunctional anti-PD-1 / IL-7 fusion protein potentiates effector function of exhausted T cell and disarms Treg suppressive activity” * reports that OSE’s bifunctional anti-PD1/IL-7 favors the T cell effector over regulatory immune balance by stimulating effector T cell functions while disarming regulatory T cells.Immune checkpoint inhibitors are now considered a new standard of care against a wide range of cancers. However, these therapies are ineffective in a significant percentage of patients, and some initial responders eventually develop resistance to these therapies with relapsed disease**. Sustained tumor antigen stimulation may result in a state of functional impairment referred to as exhaustion of tumor T lymphocytes. Disarming T regulatory cells (Tregs) is also important as Tregs contribute to dampening anti-tumor response.* Poster authors: Aurore Morello, Justine Durand, Virginie Thepenier, Géraldine Teppaz, Sabrina Pengam, Caroline Mary, Nicolas Poirier**Cancer J.; available in PMC 2019 Jan 1.; Mechanisms of Resistance to PD-1 and PD-L1 blockade Theodore S. Nowicki et al.ABOUT THE CONFERENCEThe Cancer Research Institute (CRI), the Association for Cancer lmmunotherapy (CIMT), the European Academy of Tumor Immunology (EATI), and the American Association for Cancer Research (AACR) are proud to present the Fifth International Cancer lmmunotherapy Conference.The 2019 meeting is focused on "Translating Science into Survival," and features talks from more than 50 leaders in the field covering all areas of inquiry in cancer immunology and immunotherapy, including: regulating T cells and their response to cancer, tumor microenvironment, genetically engineered T cells, maintenance of immune balance, novel vaccine platforms and combinations, mutational analysis and predicting response to immunotherapy, convergence of technology and cancer immunotherapy, microbiome, and metabolism. This meeting provides an unparalleled opportunity for teaching, learning, and networking among all stakeholders in the field: scientists, clinicians, regulators, drug developers, and patient advocates.ABOUT OSE ImmunotherapeuticsOSE Immunotherapeutics is a clinical-stage biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases. The company has a diversified first-in-class clinical portfolio consisting of several scientific and technological platforms including neoepitopes and agonist or antagonist monoclonal antibodies, all ideally positioned to fight cancer and autoimmune diseases. The most advanced therapeutic-candidate, Tedopi®, is a proprietary combination of 10 neo-epitopes aimed at stimulating T-lymphocytes and is currently in Phase 3 development in non-small cell lung cancer (NSCLC)  in patients in failure after checkpoint inhibitor treatment (anti PD-1 and anti PD-L1) and in Phase 2 testing in pancreatic cancer in combination with checkpoint inhibitor Opdivo®. BI 765063 (OSE-172) (anti-SIRPa monoclonal antibody) is under a license and collaboration agreement with Boehringer Ingelheim; this checkpoint inhibitor is currently under Phase 1 clinical trial in advanced solid tumors. BiCKI® is a bispecific fusion protein platform built on the key backbone component anti-PD-1 (OSE-279) and targeting innovative targets. FR104 (an anti-CD28 mAb) has successfully completed Phase 1 testing and has potential to treat autoimmune diseases. OSE-127 (monoclonal antibody targeting the CD127 receptor, the alpha chain of the interleukin-7 receptor) is partnered with Servier under an option agreement up to the completion of a Phase 2 clinical trial planned in autoimmune bowel diseases; in parallel, Servier plans a development in the Sjögren syndrome. OSE-127 is currently under Phase 1 clinical trial.Click and follow us on Twitter and LinkedInhttps://twitter.com/OSEIMMUNO https://www.linkedin.com/company/10929673ContactsOSE Immunotherapeutics Sylvie Détry Sylvie.detry@ose-immuno.com +33 153 198 757 French Media: FP2COM Florence Portejoie fportejoie@fp2com.fr +33 607 768 283U.S. Media: LifeSci Public Relations Darren Opland, Ph.D. darren@lifescipublicrelations.com +1 646 627 8387 U.S. and European Investors Chris Maggos chris@lifesciadvisors.com  +41 79 367 6254 Forward-looking statements This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate.These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Reference Document filed with the AMF on 26 April 2019, including the annual financial report for the fiscal year 2018, available on the OSE Immunotherapeutics’ website.Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.

  • Globe Newswire

    OSE Immunotherapeutics Receives a Milestone Payment of €5.4 Million From Bpifrance for SIRPα-Antagonist Monoclonal Antibody BI 765063

    * First-in-Class Myeloid Checkpoint Inhibitor BI 765063* is Currently in Phase 1 Clinical Development in Advanced Solid Tumors in Partnership with Boehringer Ingelheim * Milestone Endorses OSE’s Business Model and Marks Continued Progress as PlannedNANTES, France, Sept. 18, 2019 (GLOBE NEWSWIRE) -- OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnémo: OSE) announces today that the Company received a €5.4 million payment from Bpifrance triggered by the successful completion of development milestones related to its collaborative program EFFI-CLIN. This program is focused on evaluating BI 765063*, a SIRPa-antagonist and myeloid checkpoint inhibitor.“This milestone payment reflects the significant progress made with BI 765063, which is currently in clinical development in collaboration with Boehringer Ingelheim. We view today's announcement as an endorsement of the Company’s partnership and collaboration business model based on innovative products candidates for partnerships and public-private collaborative projects generating significant non-dilutive financing. Since early 2019, in addition to this €5.4 million payment, the Company has received a €15 million in payment from BI upon clinical trial authorization and first patient dosed in the Phase 1. Our business model has allowed OSE to successfully advance its research and clinical development projects without the need for dilutive funding since 2015. With four clinical stage products and financial visibility until end of 2020, OSE is today ideally positioned to become one of the leaders of Immunotherapy in Europe,” commented Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics.This first milestone of €5.4 million, as part of the EFFI-CLIN “Invest in the Future Program” for BI 765063, was triggered by reaching several steps including initiation of studies characterizing the SIRPa/CD47 axis and determining preclinical efficacy, completion of regulatory preclinical toxicology studies, manufacturing of GMP compliant batches and development of a tool used to characterize the immune profile and biomarkers found in patients.BI 765063, being developed in partnership with Boehringer Ingelheim, is in Phase 1 testing in advanced solid tumors and the first patient was enrolled and dosed in June, 2019. This first-in-human Phase 1 trial is a dose finding study of BI 765063 administered as a single agent and in combination with Boehringer Ingelheim’s monoclonal antibody PD-1 antagonist BI 754091, a T-lymphocyte checkpoint inhibitor. The trial aims to characterize safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of the immunotherapy in patients with advanced solid tumors.* BI 765063, previously OSE-172ABOUT THE EFFI-CLIN PROGRAM OSE Immunotherapeutics is the leader of the EFFI-CLIN program consortium which also includes the European Center for Transplantation and Immunotherapy (CESTI), a public organization based in Nantes, and HISTALIM, a SME based in Montpellier. This project has total funding of €9.2 million for OSE Immunotherapeutics to evaluate the safety and the clinical efficacy of new cancer immunotherapy candidate BI 765063 as a monotherapy and in combination in various indications where myeloid cells represent a poor prognosis factor. The project’s scope includes the product manufacturing, which is to be compliant with pharmaceutical standards, translational studies conducted from tumor tissues to measure the presence of immunological targets including SIRPa, a clinical program planned until Phase 2, as well as other exploratory research under the SIRP family.ABOUT Bpifrance Bpifrance, a subsidiary of Caisse des Dépôts and the French State, is a trusted partner of entrepreneurs which provides companies with credit, collateral and equity financing support from start up through to stock exchange listing. Bpifrance also provides guidance services and enhanced support for innovation, external growth and export, in partnership with Business France. Bpifrance offers companies a continuum of financing for each key stage of their development and an offer adapted to specific regional features. With 47 regional offices (90% of decisions are made regionally), Bpifrance offers entrepreneurs a tool for economic competitiveness. Bpifrance works in support of the public policies pursued nationally and regionally by the French government, to meet three objectives: * support the growth of businesses; * prepare for future competitiveness; * contribute to the development of a favorable ecosystem for entrepreneurship. With Bpifrance, companies have a strong and effective local contact to meet all their financial, innovation and investment needs. For more information, please visit: www.bpifrance.fr–http://investissementsdavenir.bpifrance.fr/–Twitter: @bpifranceABOUT OSE Immunotherapeutics OSE Immunotherapeutics is a clinical-stage biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases. The company has a diversified first-in-class clinical portfolio consisting of several scientific and technological platforms including neoepitopes and agonist or antagonist monoclonal antibodies, all ideally positioned to fight cancer and autoimmune diseases. The most advanced therapeutic-candidate, Tedopi®, is a proprietary combination of 10 neo-epitopes aimed at stimulating T-lymphocytes and is currently in Phase 3 development in non-small cell lung cancer (NSCLC) in patients in failure after checkpoint inhibitor treatment (anti PD-1 and anti PD-L1) and in Phase 2 testing in pancreatic cancer in combination with checkpoint inhibitor Opdivo®. BI 765063 (OSE-172) (anti-SIRPa monoclonal antibody) is under a license and collaboration agreement with Boehringer Ingelheim; this checkpoint inhibitor is currently under Phase 1 clinical trial in advanced solid tumors. BiCKI® is a bispecific fusion protein platform built on the key backbone component anti-PD-1 (OSE-279) and targeting innovative targets. FR104 (an anti-CD28 mAb) has successfully completed Phase 1 testing and has potential to treat autoimmune diseases. OSE-127 (monoclonal antibody targeting the CD127 receptor, the alpha chain of the interleukin-7 receptor) is partnered with Servier under an option agreement up to the completion of a Phase 2 clinical trial planned in autoimmune bowel diseases; in parallel, Servier plans a development in the Sjögren syndrome. OSE-127 is currently under Phase 1 clinical trial.Click and follow us on Twitter and Linkedln https://twitter.com/OSEIMMUNO https://www.linkedin.com/company/10929673ContactsOSE Immunotherapeutics Sylvie Détry Sylvie.detry@ose-immuno.com +33 153 198 757 French Media: FP2COM Florence Portejoie fportejoie@fp2com.fr +33 607 768 283U.S. Media: LifeSci Public Relations Darren Opland, Ph.D. darren@lifescipublicrelations.com +1 646 627 8387 U.S. and European Investors Chris Maggos chris@lifesciadvisors.com  +41 79 367 6254 Forward-looking statements This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate. These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Reference Document filed with the AMF on 26 April 2019, including the annual financial report for the fiscal year 2018, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.

  • Globe Newswire

    OSE Immunotherapeutics Reports First Half 2019 Results and Provides a Corporate Update

    * Major clinical progress with four differentiated therapeutic programs in immuno-oncology and autoimmune diseases; * Received €25 M in milestones from collaborations with Servier and Boehringer Ingelheim * €16 M turnover and €26.5 M available cash as of June 30, 2019 covering financial needs until the end of 2020; * Continued success as a result of dynamic partnership business model based on innovative products that generates non-dilutive revenues and finances R&D programs.NANTES, France, Sept. 05, 2019 (GLOBE NEWSWIRE) -- OSE Immunotherapeutics (ISIN: FR0012127173; Euronext: OSE) today reported its consolidated half-year financial results as of June 30, 2019 and provided an update on the key milestones reached during H1 2019.“Over the past 18 months, the Company has shown positive turnover and financial results, providing a solid financial position. H1 2019 has seen continued execution of our partnership-focused business model with a number of key milestones achieved on our innovative portfolio in immuno-oncology and autoimmune diseases. We are very pleased with the progress of our products developed in collaboration with Boehringer Ingelheim (BI 765063) and with Servier (OSE-127) which generated an additional €25 million in milestone payments during H1 2019. We are actively pursuing our clinical advances with Tedopi®, in Phase 3 in non-small cell lung cancer after failure to previous immune checkpoint inhibitors and in Phase 2 in combination with Opdivo® in pancreatic cancer, and continue to explore partnership opportunities for FR104, ready to enter Phase 2 in autoimmune diseases or in transplantation. These achievements, along with multiple ongoing clinical studies aim to demonstrate the potential value of  OSE assets in multiple indications, clearly positioning OSE Immunotherapeutics as an emerging leader in the immuno-oncology and autoimmune spaces,” said Alexis Peyroles, chief executive officer of OSE Immunotherapeutics.  Major clinical progress with four differentiated therapeutic programs in immuno-oncology and autoimmune diseasesTedopi®, a combination of 10 neoepitopes intended to induce specific T lymphocyte activation, is OSE’s most advanced product and is currently in Phase 3 in non-small cell lung cancer (NSCLC) following failure on immune checkpoint inhibitor treatment (PD-1/PD-L1), called Atalante 1. Tedopi® is also in Phase 2 in combination with Opdivo® (nivolumab) in patients with pancreatic cancer, a trial sponsored by the GERCOR cooperative group in oncology and supported by Bristol-Myers Squibb. * On June 20, 2019, the Independent Data Monitoring Committee (IDMC) reviewed safety data from the Atalante 1 Phase 3 trial in NSCLC and recommended the continuation of patient recruitment, without any modifications. NSCLC is a large patient population with no currently approved therapeutic option, and with strong clinical need. * The Japanese Patent Office and the United States Patent and Trademark Office (USPTO) have issued, respectively in January and June 2019, notice of allowance for a new patent family related to Tedopi®, for use in the treatment of brain metastasis originating from cancers, including NSCLC, in HLA-A2 positive patients. These patents will provide protection covering the use of Tedopi® in that indication until 2034, further strengthening Tedopi’s intellectual property in immuno-oncology.BI 765063 (formerly OSE-172), a myeloid checkpoint inhibitor and selective SIRPα antagonist, being developed in partnership with Boehringer Ingelheim, is in Phase 1 testing in advanced solid tumors. * In June 2019, the first patient was enrolled and dosed in the first-in-human Phase 1 trial, a dose finding study of BI 765063 administered as a single agent and in combination with Boehringer Ingelheim’s monoclonal antibody PD-1 antagonist BI 754091. The trial aims to characterize safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of the immunotherapy in patients with advanced solid tumors.OSE-127, a monoclonal antibody antagonist of the interleukin-7 (IL-7) receptor being developed in partnership with Servier, is in Phase 1 for the treatment of autoimmune diseases. This first-in-human dose-escalation study aims to evaluate the safety and tolerability of single- and multiple-ascending intravenous and subcutaneous doses of OSE-127 in 63 healthy volunteers, the first of which were dosed in December 2018. * In May 2019, the USPTO issued a first notice of allowance for a patent application covering OSE-127 that will cover it until at least 2035. This new patent validates the product’s novel and differentiated mechanism of action as an IL-7R full-antagonist, which has been shown to induce a powerful antagonistic effect on effector T lymphocytes responsible for causing autoimmune pathologies.FR104, a monoclonal antibody antagonist of CD28, is a Phase-2 ready asset with potential to be developed in either autoimmune disease or in transplant surgery. * In April 2019, the Canadian Intellectual Property Office granted a patent that covers the product and its therapeutic applications in T-lymphocyte-mediated autoimmune diseases, chronic inflammatory diseases and graft applications. At the same time, the USPTO has also issued a notice of allowance providing additional protection covering the use of FR104 in the treatment of T-lymphocyte-mediated chronic inflammatory diseases. Therapeutic applications of FR104 are thus covered through 2031.A dynamic partnership business model based on innovative products to generate non-dilutive revenues and to finance its R&D programs * As a result of its partnership agreements, OSE Immunotherapeutics has received €25 million in milestone payments during H1 2019 (a €10 million payment from Servier upon exercise of first of two steps of a global licensing option agreement for OSE-127; €15 million in payments from Boehringer Ingelheim upon Clinical Trial Authorization and first dosing of a patient in the Phase 1 clinical trial of BI 765063). * OSE Immunotherapeutics is evaluating the best options for continuing sustainable development of FR104, a Phase 2-ready asset, in autoimmune diseases or in transplantation, including worldwide partnering opportunities. Furthermore, the Company is exploring partnership opportunities for its most advanced product Tedopi, in Phase 3 in NSCLC and in Phase 2 in pancreatic cancer.Research & Development Based on OSE's diverse scientific and technological platforms (neoepitopes, agonist or antagonist monoclonal antibodies), the Company is pursuing advancement of new innovative research programs. * The Company disclosed in March 2019 its novel bispecific checkpoint inhibitor (BiCKI®) platform built on the key backbone component anti-PD-1 (OSE-279) and targeting innovative targets. BiCKI represents the second generation of PD-(L)1 inhibitors that have been used to increase antitumor efficacy in hard to treat cancers by addressing untapped immune evasion mechanisms. * A new research collaboration agreement was concluded in March 2019 with premier cancer research hospital, Léon Bérard Cancer Center in Lyon, France, to use artificial intelligence-based bioanalysis and bioinformatics to analyze gene expression in the human tumor microenvironment and the composition of tumor infiltrates. The findings from this collaboration will be used for the selection and validation of innovative targets for early development of new drug candidates from the platform of bispecific fusion proteins targeting PD-1 and innovative targets (BiCKI). * OSE will participate in the “DC-Target” project, selected by the French National Research Agency in July 2019 as part of the “AAPG 2019” call for proposals. This research program, coordinated by the Léon Bérard Cancer Center, aims to identify new targets of therapeutic interest expressed by myeloid cells (tumor associated macrophages, myeloid-derived suppressive cells and dendritic cells) through in depth characterization of the role of each cell by single cell RNAseq (scRNAsed – Cellenion) and gene editing.      Scientific publications * In April 2019, an article entitled “IL-7 receptor influences anti-TNF responsiveness and T cell gut homing in inflammatory bowel disease,” was published in the Journal of Clinical Investigation (JCI), presenting data on OSE -127, the Company’s full-antagonist monoclonal antibody targeting IL-7R. The article reports on research led by the OSE Immunotherapeutics team, in collaboration with multiple international expert partners, that further supports the product’s potential for the treatment of chronic inflammatory bowel diseases and confirms the novel and differentiated mechanism of action of OSE-127, currently being investigated in an ongoing Phase 1. * In July 2019, the Company announced a first publication in the American Journal of Transplantation on the role of SIRPα, a receptor expressed by myeloid lineage cells and the target of selective SIRPα antagonist BI 765063 (OSE-172). The article, entitled "SIRPα/CD47 axis controls the maintenance of transplant tolerance sustained by myeloid‐derived suppressor cell,” describes findings showing the role of the SIRPα/CD47 axis in the induction and maintenance of acquired immune tolerance and highlights the mechanism of action of innovative myeloid checkpoint inhibitor BI 765063, currently in Phase 1 testing.General Meeting * On June 26, 2019, the Company’s shareholders approved the appointment of Nicolas Poirier, Ph.D., as director, representing the employee shareholders. Nicolas Poirier has been chief scientific officer of OSE Immunotherapeutics since 2016. His role has been to implement innovative therapeutic strategies on new targets and pathways in immunology addressing severe pathologies with high therapeutic need, thus making a robust contribution to the Company’s growth. Along with his R&D team, Dr. Poirier continues pursuing the identification of novel preclinical targets and translating them into first-class clinical-stage immunotherapies.H1 2019 ResultsThe key figures of the 2019 consolidated half-year results are reported below:In k€June 30, 2019June 30, 2018 Operating result3,91810,230 Net result5148,877     In k€June 30, 2019December 31, 2018 Available cash*26,52712,433 Consolidated balance sheet94,95076,903     As of June 30, 2019, available cash* amounted to €26.5 million, giving a financial visibility until the end of 2020. During the first semester of 2019, additional cash influx of €25 million has been generated by milestone payments related to partnerships (€15 million from Boehringer Ingelheim upon CTA for the Phase 1 trial with BI 765063 and upcoming first patient dosed and €10 million from Servier upon exercising of the first option under the two-step option within global license agreement).This available cash will enable the Company to finance its clinical development costs and R&D costs on earlier stage products.The turnover amounted to €16 million due to the upfront payment from the collaboration agreement with Boehringer Ingelheim. During the first half of 2019, the Company recorded a consolidated net result of €514 K.Current operating expenses were €12 million (versus €10.3 million for the same period of 2018) of which 84% are related to R&D. They include €9.2 million of R&D expenses, in line with the broadening and progress of OSE’s pipeline.*Available cash and cash equivalents and current financial assetsThe Board of Directors on September 5, 2019 approved the Company’s semester accounts as of June 30, 2019. The full “Semester financial report” (Regulated information) is available on: http://ose-immuno.com/en/rapports-financiers-et-document-de-reference/. The consolidated accounts have been subject to a limited review by the Statutory Auditors.ABOUT OSE Immunotherapeutics OSE Immunotherapeutics is a clinical-stage biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases. The company has a diversified first-in-class clinical portfolio consisting of several scientific and technological platforms including neoepitopes and agonist or antagonist monoclonal antibodies, all ideally positioned to fight cancer and autoimmune diseases. The most advanced therapeutic-candidate, Tedopi®, is a proprietary combination of 10 neo-epitopes aimed at stimulating T-lymphocytes and is currently in Phase 3 development in non-small cell lung cancer (NSCLC) after checkpoint inhibitor failure (anti PD-1 and anti PD-L1) and in Phase 2 testing in pancreatic cancer in combination with checkpoint inhibitor Opdivo®. BI 765063 (OSE-172) (anti-SIRPa monoclonal antibody) is under a license and collaboration agreement with Boehringer Ingelheim; this checkpoint inhibitor is currently under Phase 1 clinical trial in advanced solid tumors. BiCKI® is a bispecific fusion protein platform built on the key backbone component anti-PD-1 (OSE-279) and targeting innovative targets. FR104 (an anti-CD28 mAb) has successfully completed Phase 1 testing and has potential to treat autoimmune diseases. OSE-127 (monoclonal antibody targeting the CD127 receptor, the alpha chain of the interleukin-7 receptor) is partnered with Servier under an option agreement up to the completion of a Phase 2 clinical trial planned in autoimmune bowel diseases; in parallel, Servier plans a development in the Sjögren syndrome. OSE-127 is currently under Phase 1 clinical trial.Click and follow us on Twitter and Linkedln https://twitter.com/OSEIMMUNO https://www.linkedin.com/company/10929673Contacts  OSE Immunotherapeutics Sylvie Détry Sylvie.detry@ose-immuno.com +33 153 198 757 U.S. Media: LifeSci Public Relations Darren Opland, Ph.D. darren@lifescipublicrelations.com +1 646 627 8387    French Media: FP2COM Florence Portejoie fportejoie@fp2com.fr +33 607 768 283U.S. and European Investors Chris Maggos chris@lifesciadvisors.com +41 79 367 6254 Forward-looking statements This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate. These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Reference Document filed with the AMF on 26 April 2019, including the annual financial report for the fiscal year 2018, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.  CONSOLIDATED PROFIT & LOSS In K€H1 2019H1 2018 Turnover15,979 20,608  OPERATING INCOME - RECURRING15,979 20,608      Research & Development expenses(9,189)(7,978) Overhead expenses(2,199)(1,731) Expenses related to share-based payments(673)(542) OPERATING PROFIT/LOSS - RECURRING3,919 (10,357)     Other operating income - Badwill0 0  Other operating expenses(0)(127) OPERATING RESULT3,918 10,230      Financial income143 27  Financial expenses(74)(174) PROFIT/LOSS BEFORE TAX3,987 10,083  INCOME TAX(3,472)(1,207) CONSOLIDATED NET RESULT514 8,877  Of which consolidated net result attributable to shareholders514 8,877      Net earnings attributable to shareholders   Weighted average number of shares outstanding14,820,345 14,505,935  -  The basic and diluted result per common share (€/share)0.03  0.61   -  Diluted result per share0.03 0.57      In K€H1 2019H1 2018 NET RESULT514 8,877      Amounts to be recycled in the income statement:   Unrealized gains on securities available for sale, net of tax   Currency conversion difference(17)(13)     Amounts not to be recycled in the income statement:   Actuarial gains and losses on post-employment benefits(24)(4) Other comprehensive income in the period(41)(17) GLOBAL PROFIT/LOSS473 8,860    CONSOLIDATED BALANCE SHEET ASSETS in K€June 30, 2019December 31, 2018     NON-CURRENT ASSETS R&D expenses acquired52,600 52,600  Tangible assets993 904  Rights of use1,828  -  Financial assets141 103  Deferred tax assets276 272  TOTAL NON-CURRENT ASSETS55,838 53,879      CURRENT ASSETS   Trade receivables1,178 2,253  Other current assets6,921 3,834  Current tax receivables4,487 4,504  Current financial assets2,965 2,861  Cash and cash equivalents23,562 9,573  TOTAL CURRENT ASSETS39,112 23,024  TOTAL ASSETS94,950 76,903      EQUITY & LIABILITIES in K€June 30, 2019December 31, 2018     SHAREHOLDERS’ EQUITY   Stated capital2,993 2,963  Share premium21,678 21,708  Merger premium26,827 26,827  Treasury stock(149)(168) Reserves and retained earnings10,096 4,934  Consolidated result514 5,490  TOTAL SHAREHOLDERS’ EQUITY62,770 61,754  NON-CURRENT DEBTS   Non-current financial liabilities 4,493  3,832   Lease non-current liabilities1,551  -  Non-current deferred tax liabilities5,189 2,050  Non-current provisions291 233  TOTAL NON-CURRENT DEBTS11,523 6,074  CURRENT DEBTS   Current financial liabilities656 628  Lease current liabilities289  -  Trade payables6,247 6,555  Current tax liabilities92 86  Other payables1,281 1,231  Other debts and accruals12,092 575  TOTAL CURRENT DEBTS20,657 9,075  TOTAL LIABILITIES94,950 76,903

  • Globe Newswire

    OSE Immunotherapeutics Receives New European Patent Protection Through 2037 for OSE-703, a Cytotoxic Monoclonal Antibody Targeting IL-7R, in Cancer Patients

    NANTES, France, Sept. 03, 2019 (GLOBE NEWSWIRE) -- OSE Immunotherapeutics (ISIN: FR0012127173; Euronext: OSE) today announces the grant of a new patent from the European Patent Office (EPO) strengthening the protection covering OSE-703, a humanized monoclonal antibody directed against the extracellular domain of the alpha-chain of the receptor for interleukin-7 (CD127) making it cytotoxic for human cells expressing CD127, and its use thereof in immuno-oncology treatment. The new patent covers OSE-703 until at least 2037. This is the first patent granted in Europe for OSE-703 and represents a major step in strengthening the product’s protection. Additionally, this patent should facilitate the granting of additional patents in other major territories covered by the same patent family.“We are very pleased with this first European patent that simultaneously reinforces OSE-703 intellectual property and its position in our portfolio as an IL-7R directed immunotherapy for cancer treatment,” commented Alexis Peyroles, chief executive officer of OSE Immunotherapeutics.OSE-703 is being explored preclinically in collaboration with Memorial Sloan Kettering Cancer Center to define its efficacy profile and potential development strategy for solid tumors with non-small cell lung cancer (NSCLC) and mesothelioma as primary models. The research program is conducted by physician-scientist Prasad S. Adusumilli, M.D., FACS, an expert in tumor immunology with a focus on the development of chimeric antigen receptor T-cell (CAR T-cell) immunotherapy.ABOUT OSE-703 OSE-703 is a humanized monoclonal antibody directed against the extracellular domain of the alpha-chain of the receptor for interleukin-7, cytotoxic for human cells expressing CD127. Interleukin-7 (IL7) is an immune mediator known for its key role in the hematopoietic growth of T- and B-lymphocytes. Despite a theoretical anti-tumor effect, the aberrant expression of IL7 receptor (IL7R) in different types of cancer has been associated with poor prognosis (K. Suzuki, J Clin Oncol, 2013) and it has been demonstrated that IL7 and the presence of IL7R can have a pro-tumor effect in various cancers by decreasing cancer cell apoptosis or accelerating cell proliferation and lympho-vascular formation (J. Lin et al., Anticancer Research, 2017).ABOUT OSE Immunotherapeutics OSE Immunotherapeutics is a clinical-stage biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases. The company has a diversified first-in-class clinical portfolio consisting of several scientific and technological platforms including neoepitopes and agonist or antagonist monoclonal antibodies, all ideally positioned to fight cancer and autoimmune diseases. The most advanced therapeutic-candidate, Tedopi®, is a proprietary combination of 10 neo-epitopes aimed at stimulating T-lymphocytes and is currently in Phase 3 development in non-small cell lung cancer (NSCLC) after checkpoint inhibitor failure (anti PD-1 and anti PD-L1) and in Phase 2 testing in pancreatic cancer in combination with checkpoint inhibitor Opdivo®. BI 765063 (OSE-172) (anti-SIRPa monoclonal antibody) is under a license and collaboration agreement with Boehringer Ingelheim; this checkpoint inhibitor is currently under Phase 1 clinical trial in advanced solid tumors. BiCKI® is a bispecific fusion protein platform built on the key backbone component anti-PD-1 (OSE-279) and targeting innovative targets. FR104 (an anti-CD28 mAb) has successfully completed Phase 1 testing and has potential to treat autoimmune diseases. OSE-127 (monoclonal antibody targeting the CD127 receptor, the alpha chain of the interleukin-7 receptor) is partnered with Servier under an option agreement up to the completion of a Phase 2 clinical trial planned in autoimmune bowel diseases; in parallel, Servier plans a development in the Sjögren syndrome. OSE-127 is currently under Phase 1 clinical trial.Click and follow us on Twitter and Linkedln https://twitter.com/OSEIMMUNO https://www.linkedin.com/company/10929673ContactsOSE Immunotherapeutics Sylvie Détry Sylvie.detry@ose-immuno.com +33 153 198 757 French Media: FP2COM Florence Portejoie fportejoie@fp2com.fr +33 607 768 283U.S. Media: LifeSci Public Relations Darren Opland, Ph.D. darren@lifescipublicrelations.com +1 646 627 8387 U.S. and European Investors Chris Maggos chris@lifesciadvisors.com  +41 79 367 6254 Forward-looking statements This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate. These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Reference Document filed with the AMF on 26 April 2019, including the annual financial report for the fiscal year 2018, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.

  • Globe Newswire

    OSE Immunotherapeutics Receives a Grant from the French National Research Agency to Validate New Targets Linked to Myeloid Cells And Identify Innovative New Immunotherapies in Oncology

    * Research program coordinated by the Cancer Research Center of Lyon within the Léon Bérard Cancer Center NANTES, France, July 23, 2019 (GLOBE NEWSWIRE) -- OSE Immunotherapeutics (ISIN: FR0012127173; Mnemo: OSE) announces that its DC-TARGET project has been selected by the French National Research Agency (ANR) to be awarded a grant up to €800,000 following the “AAPG 2019” call for proposals assessment process.This research program is coordinated by Dr. Christophe Caux, a pioneer in the field of tumor immunological escape. Dr. Caux is leading a collaborative research team at the Cancer Research Center (CRCL) and Cancer Immunotherapy Laboratory of Lyon (LICL), as part of the innovation and translational research department of Léon Bérard Cancer Center, which includes several academic research centers of excellence.The aim of this program is to identify new targets of interest expressed by myeloid cells (tumor associated macrophages, myeloid-derived suppressive cells, dendritic cells). These suppressive immune cells play a major role in both tumor immune escape and in their invasive process. In order to discover new targets of therapeutic interest in the tumor microenvironment, the role of each cell will be characterized in depth by single cell RNAseq (scRNAsed – Cellenion) and gene editing.  The Bioinformatics platform, created by Gilles Thomas (1) and headed by Alain Viari(2), will be an essential tool to analyze the thousands of data points generated by the bioanalysis technologies used, and to define immunological signature deconvolution.Once the targets identified and clinically validated, OSE Immunotherapeutics will focus on translation of the research study findings through the development of specific monoclonal antibodies that are able to block the deleterious targets identified.In particular, this immuno-oncology research program will explore tissues from triple negative breast cancer (TNBC), a cancer with a high risk of progression.“This new collaboration with the Léon Bérard cancer research center, a leader in modern oncology treatments combining translational and immunological research platforms, is focused on an aggressive breast cancer with a strong need for medical innovation. OSE is already strongly involved clinically in the field of myeloid cell-based therapies for cancers,” said Alexis Peyroles, chief executive officer of OSE Immunotherapeutics.(1) Pr Gilles Thomas, worldwide recognized for his major contribution to the knowledge of genetic predispositions to cancer, created the Bioinformatics platform in 2009 as part of a senior chair of excellence of Synergy Lyon Cancer Foundation and headed it until his death, in 2014. (2) Dr Alain Viari (Gilles Thomas Bioinformatics platform, Synergy Lyon Cancer Foundation, Léon Bérard Center, Lyon): advanced expertise in bioinformatics, biostatistics, genomics, transcripto­mics and personalized medicine; strong experience in cancer research on breast cancer, prostate and gynecological carcinosarcoma as part of the International Cancer Genome Consortium (ICGC). ABOUT THE LÉON BÉRARD CENTER (CLB) The Léon Bérard Center (CLB) is developing on its site an oncology research of excellence focused on innovation. Research is one of the three essential missions of cancer centers in France and around the world, in addition to healthcare and teaching. The research conducted on its site is recognized internationally. Within the CLB, the CRCL (Cancer Research Center of Lyon – UMR Inserm 1052 CNRS 5286 Joint CLB) is an accredited research structure with a hospital partner: Hospices Civils de Lyon (HCL). With its cancer immunotherapy and translational research laboratory (LICL, Laboratoire d’Immunothérapie du Cancer), CLB has recognized scientific know-how in oncology, particularly in tumor targeting and the immune environment. His translational research is structured around research teams but also advanced technology platforms, including the platform "Innovation in Immunomonitoring and Immunotherapy" led by Christophe Caux. In clinical research, more than 200 trials are open to enrollment. As a hospital and a research center, the CLB promotes the rapprochement between practitioners and researchers, with the aim of shortening the time between scientific discoveries and the development of new treatments. For more information : www.centreleonberard.frMedia contacts: Nathalie Blanc nathalie.blanc@lyon.unicancer.fr  Julie Colomb julie.colomb@lyon.unicancer.fr  Tel: +33 4 78 78 51 43ABOUT OSE Immunotherapeutics OSE Immunotherapeutics is a clinical-stage biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases. The company has a diversified first-in-class clinical portfolio consisting of several scientific and technological platforms including neoepitopes and agonist or antagonist monoclonal antibodies, all ideally positioned to fight cancer and autoimmune diseases. The most advanced therapeutic-candidate, Tedopi®, is a proprietary combination of 10 neo-epitopes aimed at stimulating T-lymphocytes and is currently in Phase 3 development in non-small cell lung cancer (NSCLC) after checkpoint inhibitor failure (anti PD-1 and anti PD-L1) and in Phase 2 testing in pancreatic cancer in combination with checkpoint inhibitor Opdivo®. BI 765063 (OSE-172) (anti-SIRPa monoclonal antibody) is under a license and collaboration agreement with Boehringer Ingelheim; this checkpoint inhibitor is currently under Phase 1 clinical trial in advanced solid tumors. BiCKI® is a bispecific fusion protein platform built on the key backbone component anti-PD-1 (OSE-279) and targeting innovative targets. FR104 (an anti-CD28 mAb) has successfully completed Phase 1 testing and has potential to treat autoimmune diseases. OSE-127 (monoclonal antibody targeting the CD127 receptor, the alpha chain of the interleukin-7 receptor) is partnered with Servier under an option agreement up to the completion of a Phase 2 clinical trial planned in autoimmune bowel diseases; in parallel, Servier plans a development in the Sjögren syndrome. OSE-127 is currently under Phase 1 clinical trial. For more information: https://ose-immuno.com/en/Click and follow us on Twitter and Linkedlnhttps://twitter.com/OSEIMMUNO https://www.linkedin.com/company/10929673ContactsOSE Immunotherapeutics Sylvie Détry Sylvie.detry@ose-immuno.com  +33 153 198 757U.S. Media: LifeSci Public Relations Darren Opland, Ph.D. darren@lifescipublicrelations.com  +1 646 627 8387    French Media: FP2COM Florence Portejoie fportejoie@fp2com.fr  +33 607 768 283U.S. and European Investors Chris Maggos  chris@lifesciadvisors.com  +41 79 367 6254 Forward-looking statements This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate. These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Reference Document filed with the AMF on 26 April 2019, including the annual financial report for the fiscal year 2018, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.

  • Globe Newswire

    First Publication from OSE Immunotherapeutics on the Role of SIRPα in the Induction and Maintenance of Immune Tolerance in the American Journal of Transplantation

    * Findings show the role of the SIRPα/CD47 axis in the maintenance of acquired immune tolerance * Highlights the differentiated mechanism of action of OSE's innovative myeloid checkpoint inhibitor BI 765063 (OSE-172), a selective SIRPα antagonist, currently in Phase 1 clinical testingNANTES, France, July 17, 2019 (GLOBE NEWSWIRE) -- OSE Immunotherapeutics (ISIN: FR0012127173; Mnemo: OSE) announces a scientific publication in the American Journal of Transplantation(1). This publication is the first from the Company’s R&D team on SIRPα, a receptor expressed by myeloid lineage cells, and the target of its immuno-oncology program asset BI 765063 (OSE-172).This article, entitled "SIRPα/CD47 axis controls the maintenance of transplant tolerance sustained by myeloid‐derived suppressor cells" describes the important role of the SIRPα/CD47 axis in the induction and maintenance of acquired immune tolerance. Based on a transplant model, the OSE R&D team demonstrated that blockade of the inhibitory SIRPα molecule breaks allograft immune tolerance, in part by modifying both the phenotype and the function of regulatory MDSC (myeloid-derived suppressive cells) and the macrophage response.MDSC and macrophages being key cells in the tumor microenvironment and as a result, the OSE team first evaluated the role of SIRPα myeloid checkpoint blockade in breaking abnormal tolerance to cancer cells. These findings subsequently helped guide development of myeloid checkpoint inhibitor BI 765063, a selective SIRPα antagonist.BI 765063 is currently in a Phase 1 clinical trial initiated in March 2019. This first-in-class checkpoint inhibitor is being evaluated as a single agent and in combination with Boehringer Ingelheim’s monoclonal antibody PD-1 antagonist BI 754091, a lymphocyte T checkpoint inhibitor, in patients with advanced solid tumors. The trial aims to characterize safety, pharmacokinetics, pharmacodynamics and preliminary efficacy in this patient population. The study is conducted by OSE Immunotherapeutics as part of a collaboration and license agreement with Boehringer Ingelheim under which Boehringer Ingelheim obtained exclusive rights to BI 765063, signed in April 2018.“OSE’s expertise in preclinical research capitalizes on our strong knowledge of the pathways controlling immune activation and regulation, which have been leveraged to develop technologies that target master switch receptors of immune cells. Our findings, initially from transplantation immunology, and our discoveries on mechanisms regulating or reinforcing immune tolerance could be directly translated oppositely to applications in immuno-oncology to reinstate efficient immune responses. This highlights a differentiated and innovative R&D model of thinking implemented by OSE, which has provided a number of first-in-class developmental products in immuno-oncology and autoimmune diseases,” said Nicolas Poirier, chief scientific officer of OSE Immunotherapeutics.  “First-in-class BI 765063 myeloid checkpoint inhibitor illustrates this original research approach in the very attractive and competitive field of myeloid suppressive cells and tumor associated macrophages. That is how the development of selective SIRPα antagonist BI 765063 has progressed until the ongoing Phase 1 clinical study in advanced solid tumors, conducted in collaboration with partner Boehringer Ingelheim.”(1)SIRPα/CD47 axis controls the maintenance of transplant tolerance sustained by myeloid‐derived suppressor cells Sabrina Pengam1 | Justine Durand1,2 | Claire Usal2 | Vanessa Gauttier1 | Nahzli Dilek1,2 | Bernard Martinet2 | Véronique Daguin2 | Caroline Mary1 | Virginie Thepenier1 | Géraldine Teppaz1 | Karine Renaudin3 | Gilles Blancho2,3 | Bernard Vanhove1 | Nicolas Poirier1 1OSE Immunotherapeutics, Nantes, France ; 2Centre de Recherche en Transplantation et Immunologie (CRTI), UMR 1064, Inserm, Université de Nantes, Nantes, France ; 3Institut de Transplantation Urologie Néphrologie (ITUN), CHU Nantes, Nantes, FranceABOUT OSE Immunotherapeutics OSE Immunotherapeutics is a clinical-stage biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases. The company has a diversified first-in-class clinical portfolio consisting of several scientific and technological platforms including neoepitopes and agonist or antagonist monoclonal antibodies, all ideally positioned to fight cancer and autoimmune diseases. The most advanced therapeutic-candidate, Tedopi®, is a proprietary combination of 10 neo-epitopes aimed at stimulating T-lymphocytes and is currently in Phase 3 development in non-small cell lung cancer (NSCLC) after checkpoint inhibitor failure (anti PD-1 and anti PD-L1) and in Phase 2 testing in pancreatic cancer in combination with checkpoint inhibitor Opdivo®. BI 765063 (OSE-172) (anti-SIRPa monoclonal antibody) is under a license and collaboration agreement with Boehringer Ingelheim; this checkpoint inhibitor is currently under Phase 1 clinical trial in advanced solid tumors. BiCKI® is a bispecific fusion protein platform built on the key backbone component anti-PD-1 (OSE-279) and targeting innovative targets. FR104 (an anti-CD28 mAb) has successfully completed Phase 1 testing and has potential to treat autoimmune diseases. OSE-127 (monoclonal antibody targeting the CD127 receptor, the alpha chain of the interleukin-7 receptor) is partnered with Servier under an option agreement up to the completion of a Phase 2 clinical trial planned in autoimmune bowel diseases; in parallel, Servier plans a development in the Sjögren syndrome. OSE-127 is currently under Phase 1 clinical trial.Click and follow us on Twitter and Linkedln https://twitter.com/OSEIMMUNO https://www.linkedin.com/company/10929673ContactsOSE Immunotherapeutics Sylvie Détry Sylvie.detry@ose-immuno.com +33 153 198 757 French Media: FP2COM Florence Portejoie fportejoie@fp2com.fr +33 607 768 283U.S. Media: LifeSci Public Relations Darren Opland, Ph.D. darren@lifescipublicrelations.com +1 646 627 8387 U.S. and European Investors Chris Maggos chris@lifesciadvisors.com +41 79 367 6254    Forward-looking statements This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate.These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Reference Document filed with the AMF on 26 April 2019, including the annual financial report for the fiscal year 2018, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.

  • Globe Newswire

    OSE Immunotherapeutics Receives Special Recognition for European Growth, Healthcare Enterprise and Women Entrepreneurship

    Awarded by Forbes, PME Finance – Europe Entrepreneurs and their PartnersNANTES, France, July 10, 2019 (GLOBE NEWSWIRE) -- OSE Immunotherapeutics (ISIN: FR0012127173; Mnemo: OSE) announces that it received special recognition for European growth, healthcare enterprise and women entrepreneurship during the 6th Futur40 Prize ceremony, a Forbes, PME Finance-Europe Entrepreneurs and their partners ranking event. Awarded each year, these prizes honor the top 40 listed companies eligible for the French PEA-PME equity savings plan, based on their growth over the last three years.  Using an objective methodology based on verifiable and precise data, the ranking – created in 2014 by SME Finance-Europe Entrepreneurs – takes an alternative look at the valuation of French companies and detects those in full evolution and destined to become the future  exemplars of the French and European economic model.Dominique Costantini, president and director of early development for OSE Immunotherapeutics, and Maryvonne Hiance, vice president and director of public affairs, received the awards at the 6th Futur40 Prize ceremony, held on July 9th in Paris.“We are honored and proud to receive these prestigious prizes, ranking OSE Immunotherapeutics as one of fastest growing European companies involved in innovative projects in immunotherapy. These awards recognize a dramatic growth due to our dynamic business model, based on an original partnership strategy with pharmaceutical leaders supported by an innovative portfolio in immuno-oncology and autoimmune diseases. The awards reward the hard work and expertise of our teams, who continue to show deep commitment and dedication to the continuous growth and strength of the company," commented Alexis Peyroles, chief executive officer of OSE Immunotherapeutics.ABOUT THE Futur40 PRIZE An objective methodology based on the last three yearsThe Futur40 is the only list that relies on an objective methodology based on verifiable precise data. Different stages mark the selection:1 - The Morningstar rating agency reviews the activity reports of some 500 listed companies on the basis of the following objective criteria: * Cumulative growth of turnover above 15% over the last three years; * € 5 million minimum turnover; * A company listed in Paris with a minimum market footprint (floating, volumes traded) in order to obtain certified public data; * Listed financial and holding companies are excluded.On the other hand, for some companies, these criteria alone are not enough. For some industrial ETIs in particular, as turnover increases, growth tends to slow down. It is therefore necessary to take into account the growth in profitability.Morningstar thus establishes a ranking of listed companies, posting the highest growth rates, on the basis of an annual average rate calculated over the last 3 financial years (from 2016 to 2018).2 - A steering committee, made up of professionals from Euronext, RSM, Morningstar, Paris Europlace and F2IC, examines the selected financial data in order to detect any erroneous data.3 - On the basis of the consolidated ranking, the top 40 companies are distinguished for the growth of their turnover and the originality of their model.The extra-financial rating agency Sustainalytics has validated that each of the prize-winning companies has not had any controversy in the last 3 years.ABOUT OSE Immunotherapeutics  OSE Immunotherapeutics is a clinical-stage biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases. The company has a diversified first-in-class clinical portfolio consisting of several scientific and technological platforms including neoepitopes and agonist or antagonist monoclonal antibodies, all ideally positioned to fight cancer and autoimmune diseases. The most advanced therapeutic-candidate, Tedopi®, is a proprietary combination of 10 neo-epitopes aimed at stimulating T-lymphocytes and is currently in Phase 3 development in non-small cell lung cancer (NSCLC) after checkpoint inhibitor failure (anti PD-1 and anti PD-L1) and in Phase 2 testing in pancreatic cancer in combination with checkpoint inhibitor Opdivo®. BI 765063 (OSE-172) (anti-SIRPa monoclonal antibody) is under a license and collaboration agreement with Boehringer Ingelheim; this checkpoint inhibitor is currently under Phase 1 clinical trial in advanced solid tumors. BiCKI® is a bispecific fusion protein platform built on the key backbone component anti-PD-1 (OSE-279) and targeting innovative targets. FR104 (an anti-CD28 mAb) has successfully completed Phase 1 testing and has potential to treat autoimmune diseases. OSE-127 (monoclonal antibody targeting the CD127 receptor, the alpha chain of the interleukin-7 receptor) is partnered with Servier under an option agreement up to the completion of a Phase 2 clinical trial planned in autoimmune bowel diseases; in parallel, Servier plans a development in the Sjögren syndrome. OSE-127 is currently under Phase 1 clinical trial.Click and follow us on Twitter and Linkedlnhttps://twitter.com/OSEIMMUNO https://www.linkedin.com/company/10929673ContactsOSE ImmunotherapeuticsU.S. Media: LifeSci Public Relations Sylvie DétryDarren Opland, Ph.D. Sylvie.detry@ose-immuno.com darren@lifescipublicrelations.com  +33 153 198 757+1 646 627 8387    French Media: FP2COMU.S. and European Investors Florence PortejoieChris Maggos fportejoie@fp2com.fr chris@lifesciadvisors.com  +33 607 768 283+41 79 367 6254 Forward-looking statements This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate.These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Reference Document filed with the AMF on 26 April 2019, including the annual financial report for the fiscal year 2018, available on the OSE Immunotherapeutics’ website.Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.

  • Globe Newswire

    OSE Immunotherapeutics Receives U.S. Patent Notice of Allowance for Use of Tedopi® to Treat Brain Metastasis

    NANTES, France, June 11, 2019 (GLOBE NEWSWIRE) -- OSE Immunotherapeutics (ISIN: FR0012127173; Mnémo: OSE) today announced that the United States Patent and Trademark Office (USPTO) has issued the notice of allowance for a new patent family related to Tedopi®, for use in the treatment of brain metastasis originating from cancers, including non-small cell lung cancer (NSCLC), in HLA-A2 positive patients. This patent will provide a protection covering the use of Tedopi®, a combination of neoepitopes, in the treatment of brain metastasis until 2034. Brain metastasis is associated with poor prognosis as well as significant morbidity, creating a large unmet medical need. The U.S. Tedopi® patent originated from Phase 2 results conducted in NSCLC patients. In the study, patients with brain metastasis showed longer than expected overall survival as well as longer time without disease progression(1), considering the advanced stage and the poor prognosis of these brain metastasis patients heavily previously treated. The long overall survival observed was correlated with immune T lymphocyte response to neoepitopes.“The expansion of this new patent family to the United States gives Tedopi®, first granted in Japan early 2019, significantly consolidated intellectual property and value. Given the devastating nature of both advanced NSCLC and brain metastatic cancer, there is a great need for new treatment options for patients,” said Alexis Peyroles, chief executive officer of OSE Immunotherapeutics. “The two ongoing clinical trials with Tedopi® reflect our commitment to building on strong Phase 2 and preclinical evidence supporting the potential of this developmental therapy.”Tedopi® is OSE’s most advanced product, currently in Phase 3 in NSCLC patients who have failed previous immune checkpoint inhibitor therapy, a patient population with no currently approved therapeutic option. Tedopi® is also being evaluated in combination with Opdivo®, an anti-PD-1 checkpoint inhibitor, in a Phase 2 trial in pancreatic cancer sponsored by the GERCOR cooperative group in oncology. A recent key opinion leader event (click here for webcast replay) covered the history and current state of treatment for these patient populations.Tedopi® is a combination of 10 neoepitopes selected and optimized from five tumor associated antigens able to generate a specific response against cytotoxic T-cells expressing at least one of these tumor associated antigens and an associated helper T-cell response.  (1) J. Nemunaitis et al, Denver IASLC 2015ABOUT OSE Immunotherapeutics OSE Immunotherapeutics is a clinical-stage biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases. The company has a diversified first-in-class clinical portfolio consisting of several scientific and technological platforms including neoepitopes and agonist or antagonist monoclonal antibodies, all ideally positioned to fight cancer and autoimmune diseases. The most advanced therapeutic-candidate, Tedopi®, is a proprietary combination of 10 neoepitopes aimed at stimulating T-lymphocytes and is currently in Phase 3 development in non-small cell lung cancer (NSCLC) after checkpoint inhibitor failure (anti PD-1 and anti PD-L1) and in Phase 2 testing in pancreatic cancer in combination with checkpoint inhibitor Opdivo®. BI 765063 (OSE-172) (anti-SIRPa monoclonal antibody) is under a license and collaboration agreement with Boehringer Ingelheim ; this checkpoint inhibitor has received CTA from French and Belgian health authorities for a Phase 1 clinical trial in multiple cancer indications. BiCKI® is a bispecific fusion protein platform built on the key backbone component anti-PD-1 (OSE-279) and targeting innovative targets. FR104 (an anti-CD28 mAb) has successfully completed Phase 1 testing and has potential to treat autoimmune diseases. OSE-127 (monoclonal antibody targeting the CD127 receptor, the alpha chain of the interleukin-7 receptor) is partnered with Servier under an option agreement up to the completion of a Phase 2 clinical trial planned in autoimmune bowel diseases; in parallel, Servier plans a development in the Sjögren syndrome. OSE-127 is currently under Phase 1 clinical trial.Click and follow us on Twitter and Linkedln https://twitter.com/OSEIMMUNO https://www.linkedin.com/company/10929673Contacts  OSE Immunotherapeutics Sylvie Détry Sylvie.detry@ose-immuno.com +33 153 198 757 French Media: FP2COM Florence Portejoie fportejoie@fp2com.fr +33 607 768 283U.S. Media: LifeSci Public Relations Darren Opland, Ph.D. darren@lifescipublicrelations.com +1 646 627 8387   U.S. and European Investors Chris Maggos chris@lifesciadvisors.com  +41 79 367 6254 Forward-looking statements This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate.These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Reference Document filed with the AMF on 26 April 2019, including the annual financial report for the fiscal year 2018 , available on the OSE Immunotherapeutics’ website.Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.

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