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OSE Immunotherapeutics announces additional public funding of € 10.7 million, via Bpifrance, to fund the further development of CoVepiT, its multi-target and multi-variant COVID-19 vaccine in clinical phase 1
CoVepiT is a vaccine against SARS-CoV-2 activating T cell defenses through CD8 T cell multi-epitopes. CoVepiT * epitopes are selected from 11 viral protein targets designed to cover all initial and new emerging variants of SARS-CoV-2. -generation, potentially provides long-term cellular immunity with memory T cells. NANTES, France, May 18, 2021 (GLOBE NEWSWIRE) – OSE Immunotherapeutics (ISIN: FR0012127173; Mnemo: OSE) today announced that it has secured public funding of € 10.7 million as part of the call for projects “Capacity building”, operated on behalf of the French government by Bpifrance as part of the “Future Investments Program” (PIA) and the “France Relance” plan to support the development of its program on CoVepiT, its vaccine multi-variant against COVID-19, currently in a phase 1 clinical trial. Alexis Peyroles, CEO of OSE Immunotherapeutics, comments: “We thank the French government and Bpifrance for once again showing their confidence in OSE and in us. support with additional funding that will help expand the clinical development of CoVepiT, subject to positive results from the ongoing phase 1 in Belgium, with potential extension of further clinical trials to other European countries. At the same time, we are making great progress in the industrialization of our vaccines, a critical stage in its development, notably with the manufacture of a new clinical batch to be ready in time for the launch of the next clinical phases. The ongoing Phase 1 clinical trial ** aims to evaluate the safety, reactogenicity and immunogenicity of CoVepiT in healthy adult volunteers. This study is based on the results of human preclinical and ex vivo studies (CoVepiT 1) demonstrating that CoVepiT has the potential to generate sentinel memory T cells with a long-term protective effect against COVID-19. Targeting 11 viral proteins (including Spike, M, N and several non-structural proteins), this second generation vaccine is designed to cover all initial and new variants of SARS-CoV-2. In December 2020, OSE Immunotherapeutics obtained initial funding of 5.2 million euros as part of the French State’s PSPC-COVID call for projects, operated on behalf of the State by Bpifrance in within the framework of the “Future Investments Program” (PIA). This funding was intended in particular to support the CoVepiT 1 study, the manufacture of a clinical batch according to Good Manufacturing Practices and a Phase 1 clinical trial. * T Epitope: small fragment of protein (8 and 11 amino acids in length ) recognized by the immune system. ** For more information: Clinicaltrial.gov ABOUT CoVepiTCoVepiT is a new generation multi-target, multi-variant vaccine against SARS-CoV-2. The vaccine candidate was designed using optimized epitopes selected after screening more than 67,000 global SARS-CoV-2 genomes, as well as those of previous CoV infectious to humans, SARS and MERS, to identify targets vaccine presenting the lowest risk of natural mutation. Targeting 11 viral proteins including Spike, M, N and several non-structural proteins, this second generation vaccine covers all the initial and new variants of SARS-CoV-2 identified to date in the world. In preclinical testing, CoVepiT has demonstrated the ability to activate T cell defenses through CD8 T cell multi-epitope responses for long term memory T cell immunity. ABOUT OSE ImmunotherapeuticsOSE Immunotherapeutics is an integrated biotechnology company focused on the development and partnership of therapies to control the immune system for immuno-oncology and autoimmune diseases. The company’s immunology research and development platform focuses on three areas: T-cell vaccination, immuno-oncology (focus on myeloid targets), autoimmunity and inflammation . Its first-rate balanced clinical and preclinical portfolio presents a diversified risk profile: Tedopi® vaccine platform (innovative combination of neoepitopes): the most advanced product of the company; positive results for step 1 of the phase 3 trial (Atalante 1) in the failure of the post-checkpoint inhibitor in non-small cell lung cancer In phase 2 in pancreatic cancer (TEDOPaM, sponsor GERCOR ) In phase 2 in ovarian cancer (TEDOVA, sponsor ARCAGY -GINECO) Due to the COVID-19 crisis, the accumulation of new patients in TEDOPaM is expected to restart in 2021 CoVepiT: a second generation prophylactic vaccine against COVID-19, developed using epitopes optimized for SARS-CoV-2 against several variants. Positive preclinical and human ex vivo results in August 2020. In clinical phase 1. BI 765063 immuno-oncology platform (OSE-172, anti-SIRPα mAb on the SIRPα / CD47 pathway): developed in partnership with Boehringer Ingelheim; Phase 1 myeloid checkpoint inhibitor in advanced solid tumors CLEC-1 (new myeloid checkpoint target): identification of CLEC-1 mAb antagonists blocking the ‘Don’t Eat Me’ signal that increase at both phagocytosis of tumor cells by macrophages and antigen uptake by dendritic cells.BiCKI®: bispecific fusion protein platform built on the key component of the anti-PD-1 (OSE-279) backbone combined with new immunotherapy targets; 2nd generation of PD- (L) 1 inhibitors to increase anti-tumor efficacy. Autoimmunity and inflammation platform FR104 (anti-CD28 monoclonal antibody): License partnership agreement with Veloxis in the organ transplantation market; Phase 1/2 in renal transplantation in progress (sponsored by the Nantes University Hospital); Active ready for phase 2 in a niche indication in autoimmune diseases OSE-127 / S95011 (humanized monoclonal antibody targeting the IL-7 receptor): developed in partnership with Servier; positive results of phase 1; in phase 2 in ulcerative colitis (sponsor OSE) and an independent phase 2a expected in Sjögren syndrome (sponsor Servier) OSE-230 (mAb ChemR23 agonist): first-order therapeutic agent with the potential to resolve chronic inflammation by leading affected tissues to tissue integrity. For more information: Click and follow us on Twitter and LinkedInhttps: //twitter.com/OSEIMMUNOhttps: //www.linkedin.com/company/10929673 Contacts OSE ImmunotherapeuticsSylvie Dé[email protected]+33 153 198 757 French Media: FP2COM Florence [email protected]+33 607 768 283 Media: LifeSci Communications Darren Opland, [email protected]+1 646 627 8387 and European investors Chris Maggos [email protected] +41 79 367 6254 ABOUT BPIFRANCE Bpifrance is the French national investment bank: it finances companies – at every stage of their development – through loans, guarantees, participation and export insurance. Bpifrance also offers extra-financial services (training, advice, etc.) to help entrepreneurs meet their challenges (innovation, export, etc.). For more information, visit: www.bpifrance.fr/presse.bpifrance.fr – Follow us on Twitter: @Bpifrance – @BpifrancePresse ABOUT THE “INVESTMENT PROGRAM OF THE FUTURE” (PIA) Committed for 10 years and managed by the General Secretariat for Investment with the Prime Minister, the PIA has financed innovative projects, contributing to the transformation of the country, to sustainable growth and to the creation of the jobs of tomorrow. From the emergence of an idea to the dissemination of a new product or service, the PIA supports the entire innovation life cycle, between the public and private sectors, alongside economic, academic, regional and other partners. Europeans. These investments are based on a demanding doctrine, open selective procedures and principles of co-financing or return on investment for the State. The fourth PIA (PIA4) includes 20 billion euros in commitments over the 2021-2025 period, of which 11 billion euros will support innovative projects as part of the French recovery plan. The PIA will continue to provide long-term support for innovation, in all its forms, so that France can strengthen its positions in the sectors of the future, in the service of competitiveness, ecological transition, economic independence and organizations of the country. More information on: www.gouvernement.fr/[email protected]_avenir Forward-looking statements This press release contains express or implied information and statements that may be considered as forward-looking information and statements regarding OSE Immunotherapy. They do not constitute historical facts. These information and statements include financial projections based on certain assumptions and assessments made by the management of OSE Immunotherapeutics in light of its experience and perception of historical trends, current economic and industry conditions, future developments. expected and other factors they deem appropriate. . These forward-looking statements include statements that generally use conditional verbs and contain verbs such as “expect”, “anticipate”, “believe”, “target”, “plan” or “estimate”, their declensions and conjugations and words of similar importance. Although the management of OSE Immunotherapeutics believes that the forward-looking statements and information are reasonable, the shareholders of OSE Immunotherapeutics and other investors are cautioned that the achievement of these expectations is inherently subject to various risks, known or unknown, and to difficult uncertainties. to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed or implied or projected by forward-looking statements. These risks include those discussed or identified in the public files filed by OSE Immunotherapeutics with the AMF. These forward-looking statements are not guarantees of future performance. This press release contains only summary information and should be read together with the Universal Reference Document of OSE Immunotherapeutics filed with the AMF on April 15, 2021, including the annual financial report for fiscal year 2020, available on the website from OSE Immunotherapeutics. Except as required by applicable law, OSE Immunotherapeutics is issuing this press release as of the date hereof and does not undertake any obligation to update or revise any forward-looking information or statements.