OSE Immunotherapeutics Receives Authorization for Phase 1 Clinical Trial of its Multi-Target Multi-Variant COVID-19 Vaccine

Regulatory News:

OSE Immunotherapeutics (ISIN: FR0012127173; Mnemo: OSE) today announced that the Belgian Federal Agency for Medicines and Health Products (Agence Fédérale des Médicaments et des Produits de Santé - AFMPS) and the Belgian Ethics Committee approved the Phase 1 trial evaluating its COVID-19 vaccine, named CoVepiT, on 48 healthy volunteers. First subjects are expected to be enrolled shortly.

Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics, comments: “The last year has demonstrated that the COVID-19 is a fast-mutating virus and that vaccination with broader coverage will be needed in the coming months and years, in particular in vulnerable populations. CoVepiT is based on the identification of multiple immuno-dominant epitopes that generate a T memory lymphocyte response and combining them in the vaccine. These epitopes target 11 viral proteins including Spike protein. These epitopes are selected in the protein domains of the virus with a very low level of mutations, and as such, cover the initial and all novel SARS-CoV-2 variants identified to date, potentially providing people with broad, long-term protection against COVID-19, even if it continues to mutate. The objective of the clinical development for our next-generation vaccine CoVepiT is to evaluate its safety and benefit, particularly for people at risk, i.e., vulnerable populations.”

This Phase 1 clinical trial will evaluate the safety, reactogenicity and immunogenicity of CoVepiT in healthy adult volunteers.

Professor Isabel Leroux-Roels, at the Center for Vaccinology, Ghent University and Hospital, Ghent, Belgium, will serve as the trial’s Principal Investigator.

* T Epitope: small fragment of protein (8 and 11 amino acids in length) recognized by the immune system.

ABOUT CoVepiT
CoVepiT is a next-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 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.