OSE Immunotherapeutics and Cenexi, a French contract development and manufacturing organization (CDMO), today announced the signature of an agreement whereby Cenexi will manufacture clinical batches of CoVepiT, OSE Immunotherapeutics’ vaccine candidate against COVID-19 currently in Phase 1 clinical trial, which will be used in the product’s development phases.
Under this agreement, Cenexi will manufacture and process the peptides, produce the sterile emulsion and package the clinical batches of CoVepiT being used in the ongoing Phase 1 clinical trial and potentially for further clinical phases, subject to positive results of the Phase 1. The manufacturing line for this product has been set up at Cenexi’s manufacturing site in Hérouville-Saint-Clair in Normandy, France, which has an available filling capacity of 40 million bottles per year.
Christophe Durand, Chief Executive Officer of Cenexi, comments: “This manufacturing collaboration with OSE is a strong symbol of our ability to meet demanding needs. The skills and flexibility of our teams allow us to adapt to innovative challenges and cutting-edge technical requirements to actively participate in industrialization of a potential future vaccine against COVID-19.”
Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics, said: “We are delighted with this collaboration with Cenexi, which benefits from the expertise and know-how required to support us on the industrial manufacturing of clinical batches, a major component through the ongoing Phase 1 and all the potential additional development phases of CoVepiT.”
CoVepiT is currently in a Phase 1 clinical trial to evaluate the safety, reactogenicity and immunogenicity of two dose regimen of the vaccine in 48 healthy adult volunteers, previously vaccinated or not by an authorized COVID-19 vaccine. This trial 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 SARSCoV-2 variants