OSE Immunotherapeutics Announces Dosing of the First Healthy Volunteer in Phase 1 Clinical Trial of its Multi-Variant Second-Generation COVID-19 Vaccine

Regulatory News:

OSE Immunotherapeutics (ISIN: FR0012127173; Mnemo: OSE) today announced that the first healthy volunteer has been enrolled and dosed in the Phase 1 clinical trial evaluating its COVID-19 vaccine, named CoVepiT.

This Phase 1 clinical trial is evaluating the safety, reactogenicity and immunogenicity of two dose regimen of CoVepiT in 48 healthy adult volunteers, previously vaccinated or not by an authorized COVID-19 vaccine (NCT04885361).

Alexis Peyroles, Chief Executive Officer of Immunotherapeutics, comments: “We are delighted with the progress achieved on the CoVepiT program to date with this first dosing being a significant milestone in our COVID-19 vaccine candidate’s development. We look forward to confirming our vaccine’s efficacy, providing people with broad and long-term protection against COVID-19 and its variants, particularly for more vulnerable population subgroups. The next phases of CoVepiT development are already under preparation, potentially expanding to other European countries while progressing with industrialization and manufacturing efforts. This further development is supported by a recent €10.7 million public funding from the French government via Bpifrance.”

The Phase 1 clinical trial of CoVepiT is based on the results from preclinical and human ex vivo studies demonstrating its potential to generate sentinel memory T cells with long-term protective effect against COVID-19. Targeting 11 virus proteins (including Spike, M, N and several non-structural proteins), this second-generation vaccine is designed to cover all initial and novel or upcoming SARS-CoV-2 variants.

ABOUT CoVepiT

CoVepiT is a next-generation multi-target, multi-variant vaccine against SARS-CoV-2 in clinical Phase 1. 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 human-infective CoVs, SARS and MERS, to identify vaccine targets with the lowest chance of natural mutation. Targeting 11 virus proteins including Spike, M, N and several non-structural proteins, this second-generation vaccine covers all initial and novel SARS-CoV-2 variants identified globally to date. In preclinical testing, CoVepiT demonstrated the ability to activate T cell defenses through CD8 T-cell multi-epitope responses for long-term T memory cell immunity.