CyanVac Wins BARDA Grant for Phase 2b Study of Intranasal COVID-19 Vaccine

CyanVac LLC, a clinical-stage biotechnology company, has announced the receipt of federal Project NextGen funding to support a Phase 2b study of its PIV5-based intranasal vaccine candidate, CVXGA. This vaccine is designed to protect against COVID-19 and will be tested against a commercial COVID-19 vaccine in a study involving 10,000 participants.

Project NextGen, an initiative by the U.S. Department of Health and Human Services (HHS), aims to advance new vaccines and therapeutics that offer broader and more durable protection against COVID-19. This funding comes through the Rapid Response Partnership Vehicle, a consortium supported by the Biomedical Advanced Research and Development Authority (BARDA) under the Administration for Strategic Preparedness and Response (ASPR). The goal is to accelerate the development of innovative products and technologies.

The Phase 2b study will be conducted using BARDA’s Clinical Studies Network. CyanVac’s founder and CEO, Dr. Biao He, highlighted the significance of this award, stating that it will expedite the development of their PIV5-based intranasal COVID-19 vaccine. The PIV5 vector has shown promise in clinical trials, replicating safely in humans and stimulating all three pillars of immunity—cellular, mucosal, and humoral—while causing minimal side effects. If successful, this intranasal vaccine could demonstrate the capabilities of the PIV5 platform and support the development of vaccines for other emerging infectious diseases.

CyanVac will sponsor the study, which will involve a randomized, double-blinded trial comparing the efficacy, safety, and immunogenicity of CVXGA with an FDA-approved mRNA-based COVID-19 vaccine. The study aims to include participants at higher risk of severe disease and is expected to begin in the fall of 2024. It will assess the vaccine's effectiveness in preventing both severe and asymptomatic COVID-19 infections.

Dr. Henry Radziewicz, Chief Medical Officer of CyanVac, emphasized the importance of developing vaccines that can prevent the transmission of pathogens. He noted that many existing vaccines, including those for COVID-19, are effective at preventing serious illness and death but do not necessarily block pathogen transmission. Their intranasal vaccine targets mucosal surfaces, a key area of focus for Project NextGen, with the potential to reduce disease spread.

Dr. He expressed enthusiasm for the collaboration with BARDA and gratitude for their support, noting the significance of this large-scale trial for advancing their vaccine development efforts.

The development of CVXGA involves a proprietary parainfluenza virus 5 (PIV5) vector that encodes the spike protein of SARS-CoV-2. This PIV5 vector, developed at the University of Georgia, is based on a respiratory virus commonly administered to dogs as part of combination vaccines for decades, and it is not known to cause disease in humans. CyanVac and its affiliate, Blue Lake Biotechnology, are developing CVXGA as a single-dose, intranasal vaccine to prevent SARS-CoV-2 infection and related complications. Preclinical studies have shown that CVXGA is both immunogenic and protective, preventing the transmission of SARS-CoV-2. Phase 1 data indicated robust mucosal, cellular, and humoral immune responses in subjects, with limited or no reactogenicity and no serious vaccine-related events.

CyanVac LLC and Blue Lake Biotechnology are focused on developing intranasal vaccines that leverage the full spectrum of the immune system to prevent serious infectious diseases and protect vulnerable populations. Their platform uses a proprietary PIV5 vector to introduce a foreign gene from a targeted pathogen, aiming to overcome the limitations of existing vaccine technologies. Their lead product candidates have shown potential for high efficacy and durability with minimal side effects.