CyanVac LLC, a biotechnology firm focused on clinical-stage development, has secured funding through Project NextGen to advance a Phase 2b clinical trial of its COVID-19 vaccine candidate, CVXGA. This vaccine utilizes a novel vector based on parainfluenza virus 5 (PIV5), aimed at delivering effective protection against COVID-19.

Project NextGen, an initiative under the U.S. Department of Health and Human Services (HHS), is dedicated to developing new vaccines and therapeutics that offer broader and longer-lasting immunity against COVID-19. The financial support provided is part of the Rapid Response Partnership Vehicle, a collaboration backed by the Biomedical Advanced Research and Development Authority (BARDA) under HHS’s Administration for Strategic Preparedness and Response (ASPR), intended to speed up the development of products and technologies.

The Phase 2b trial for CVXGA will involve 10,000 participants in a randomized, double-blinded format, comparing the effectiveness, safety, and immune response of CyanVac’s PIV5-based intranasal vaccine with an FDA-approved mRNA COVID-19 vaccine. This study, coordinated through BARDA's Clinical Studies Network, will concentrate on a cohort at higher risk of severe disease, with the study expected to commence in the fall of 2024. The trial will evaluate CVXGA’s efficacy in preventing both severe and mild cases of COVID-19.

CyanVac, welcomed the funding, noting the promising outcomes from earlier clinical trials. He highlighted that the PIV5 vector used in CVXGA safely induces robust immune responses across multiple fronts—cellular, mucosal, and humoral—while causing minimal side effects. Successful development of this intranasal vaccine could also facilitate the creation of other PIV5-based vaccines for emerging infectious diseases.

CyanVac, emphasized the potential of mucosal vaccines in reducing disease spread, which aligns with the goals of Project NextGen.

The study will be supported by federal funds from HHS, ASPR, BARDA, under Other Transaction (OT) number 75A50123D00005.

CVXGA is a candidate vaccine in clinical trials that employs a proprietary PIV5 vector to produce the spike (S) protein of SARS-CoV-2. Developed at the University of Georgia, this vector, based on a virus commonly used in veterinary vaccines, has shown potential in preclinical studies for its immunogenic and protective properties. Phase 1 trials have demonstrated that CVXGA induces strong immune responses with minimal adverse effects.

 

Source: businesswire.com

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