OSE Immunotherapeutics Receives €5.2 M in Public Funding for the Clinical Development of CoVepiT, its Second Generation COVID-19 Vaccine

18 December 2020

• CoVepiT demonstrated generation of sentinel memory T cells with long-term protective effect against COVID-19 in preclinical and human ex vivo studies
• CoVepiT targets 11 virus proteins to prepare for potential mutations
• Clinical trial expected to start in Q1 2021
• OSE Immunotherapeutics committed to grant the French government a purchase option on doses of CoVepiT vaccine

OSE Immunotherapeutics announces that the Company has obtained funding of €5.2 million under the PSPC-COVID call for projects, operated on behalf of the French government by Bpifrance as part of the Programme d’investissements d’avenir (PIA) and led by the Secrétariat général pour l’investissement (SGPI), to support its development program on CoVepiT, its second-generation multi-target vaccine against COVID-19.

Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics, commented: “We warmly thank Bpifrance and the SGPI to support us with a funding that will help accelerate the development of CoVepiT with a clinical Phase 1/2 trial expected to start in Q1 2021. This trial is based on robust preclinical data and the recent results from CoVepiT 1, a human ex vivo study which resulted in the identification of immuno-dominant epitopes generating T memory lymphocytes that have been incorporated in the vaccine composition. These epitopes target 11 virus proteins, covering all initial and novel SARS-CoV-2 variants and potentially providing patients with broad protection against COVID-19 even if it mutates. We are looking forward to testing the vaccine candidate in partnership with the European Hospital Georges-Pompidou and the Clinical Investigation Center Cochin-Pasteur located in Cochin hospital. CoVepiT has been especially designed for people at risk including older adults or populations suffering from severe diseases.”

CoVepiT 1 was a human ex vivo clinical study, conducted in 120 convalescent COVID-19 subjects versus unexposed subjects, which enabled OSE to identify T memory immuno-dominant epitopes after infection with COVID-19, selected for their strong immunogenicity potential.

New SARS-CoV-2 mutated variants spread rapidly across Europe, some of them bearing mutations in some key targets of the virus in particular the Spike protein and Nucleoprotein. Based on new analyses of up to 226,000 different virus sequences collected around the world, the OSE bioinformatic team confirmed that mutations did not emerge in the highly stable viral genome region of the 11 targets selected by OSE. This reinforces the multi-epitope approach against these virus proteins to generate a T lymphocyte response and the CoVepiT vaccine continues to cover all previous, novel and current SARS-CoV-2 strains and variants.

The CoVepiT development program will be conducted within a consortium led by OSE Immunotherapeutics, in partnership with the teams of Prof. Eric Tartour, Head of the biological
immunology department at the European Hospital Georges-Pompidou-APHP and Professor at University of Paris, in charge of immune-monitoring, and with the teams of Prof. Odile Launay,
Professor of infectious and tropical diseases at University of Paris and Coordinator of the Clinical Investigation.

The French State’s funding, totaling €5.8 million for the entire consortium and including €5.2 million for OSE Immunotherapeutics, will in particular support the CoVepiT 1 study, the production of a clinical batch according to Good Manufacturing Practices and a Phase 1/2 clinical trial which will assess the safety and immunogenicity of CoVepiT in patients from at-risk populations.