CoVepiT Vaccine Candidate Phase 1 Study Voluntary Paused
France-based OSE Immunotherapeutics notified the Belgian Health Authorities today that the Company is voluntarily pausing its Phase 1 clinical study of the CoVepiT vaccine candidate in healthy volunteers.
This pause was decided after receiving a preliminary update by the trial’s principal investigator at the Center for Vaccinology, Ghent University, regarding a limited number of Grade 1 and one Grade 2 adverse events.
In particular, persistent nodules around injection points (subcutaneous, with no pain, no inflammation, no fever, no impact on everyday life, and without any systemic symptoms).
Out of an abundance of caution and in agreement with the independent Safety Monitoring Committee, the Company has decided to voluntarily pause dosing in its ongoing clinical study and assess the evolution of these nodules before determining the best way forward for CoVepiT stated the related press statement issued on July 19, 2021.
"As always, patient safety and wellbeing is our utmost priority, and we are working to resolve this unfortunate trial delay,” stated Alexis Peyroles, CEO of OSE Immunotherapeutics. “We will maintain an open dialogue with the SMC and with the trial’s principal investigator at the University of Ghent on the modalities to resume the clinical development of CoVepiT."
"In an ever-changing COVID-19 vaccine environment, where multiple lines of defenses could be useful, in particular, for populations at higher risk, we believe it is valuable to have a candidate targeting 11 viral proteins and designed to cover all initial and new emerging SARS-CoV-2 variants."
CoVepiT is a next-generation multi-target, multi-variant vaccine against the SARS-CoV-2 coronavirus designed to generate robust CD8 T cell responses and supported by Bpifrance.
The vaccine candidate was designed using optimized epitopes selected after screening more than 67,000 global SARS-CoV-2 genomes and previous human-infective coronaviruses, SARS, and MERS to identify vaccine targets lowest chance of natural mutation. Targeting 11 virus proteins, including Spike, M, N, and several nonstructural proteins, this second-generation vaccine covers all initial and novel SARS-CoV-2 variants identified globally to date.
OSE Immunotherapeutics is an integrated biotechnology company located in Nantes, France, focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases.