The Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services (HHS), announced that it has awarded approximately $40 million to CyanVac and approximately $34 million to CastleVax to support Phase 2b clinical trials of the companies’ intranasal COVID-19 vaccine candidates. Each of the Phase 2b trials will enroll 10,000 participants and will compare the vaccine candidate to a currently approved COVID-19 vaccine. The funding comes from Project NextGen, which has also supported development of Codagenix‘s CoviLiv intranasal vaccine.
CyanVac and subsidiary Blue Lake Biotechnology conducted a Phase 1 trial of CVXGA (BLB101), which is based on an attenuated strain of canine parainfluenza virus (PIV5), in 2021 and say that a Phase 2a trial is underway. CastleVax was formed in 2022 to develop the Newcastle disease virus (NDV) vaccine platform developed by the Mount Sinai Health System. According to the CastleVax web site, both systemic and intranasal formulations of CVAX-01 are in development.
BARDA is part of HHS’s Administration for Strategic Preparedness and Response (ASPR). Assistant Secretary for Preparedness and Response Dawn O’Connell commented, “At ASPR, we are working to unlock technology that will better protect Americans from viruses like COVID-19. The next generation vaccines that BARDA is investing in may bolster our protection against COVID-19 and be easier to administer through intranasal or oral delivery.”
CyanVac CEO Biao He said, “This award will accelerate the development of our PIV5-based intranasal COVID-19 vaccine, building on our very promising Phase 1 and preliminary Phase 2a clinical trial results. PIV5 is a novel intranasal vaccine vector that has been shown to replicate safely in humans in clinical trials and stimulates all three pillars of immunity – cellular, mucosal, and humoral – with minimal uncomfortable side effects. The successful development of an intranasal COVID-19 vaccine using this new vector will demonstrate the capabilities of our PIV5 platform and benefit the development of PIV5-based vaccines for other emerging infectious diseases.”
Read the BARDA press release.
Read the CyanVac press release.
