In June 2024 CyanVac announced that it has received a funding award under Project NextGen to support a Phase IIb study of CVXGA, the company’s PIV5-based vaccine candidate for protection against COVID-19. This is one of the first awards made through the Rapid Response Partnership Vehicle. The Phase IIb study of the intranasal vaccine will be conducted within BARDA’s clinical studies network.
The technology
CyanVac’s proprietary vaccines are based on parainfluenza virus 5 (PIV5). The company reports successful induction of three forms of immunity in preclinical studies:
- Cellular immunity – the vaccines “regularly” generate “robust” cytotoxic T-cell responses.
- Humoral immunity – the vaccines produce a “strong” antibody response with a single dose.
- Mucosal immunity – intranasal vaccines are introduced through the nasal mucosa, generating mucosal immunity.
“PIV5 is a respiratory virus, so our vaccines are “born intranasal”. Delivered as a spray in the nose, without injections, our vaccines will facilitate broad delivery not only to paediatric and other needle-hesitant populations, but also in parts of the world where healthcare professionals are scarce.”
The award
Through the award, CyanVac will sponsor a 10,000 participant, randomised, double-blinded study to compare the efficacy, safety, and immunogenicity of the vaccine candidate to a US FDA-approved mRNA-based COVID-19 vaccine. The study will evaluate the vaccine among participants at higher risk of severe disease and will evaluate CVXGA’s efficacy in preventing both severe COVID-19 infections and asymptomatic infections. It is expected to start in the autumn of 2024.
Dr Biao He, founder and CEO of CyanVac, looks forward to “building on our very promising Phase I and preliminary Phase IIa clinical trial results” through the award.
“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.”
Dr He hopes to “demonstrate the capabilities” of the platform and “benefit the development of PIV5-based vaccines for other emerging infectious diseases”.
“We are excited to work with BARDA on this large-scale trial and are grateful for their support.”
Dr Henry Radziewicz, Chief Medical Officer at CyanVac, identifies a “need for vaccines that can also block transmission of a pathogen to other people”.
“Our intranasal vaccine is delivered to mucosal surfaces, a key focus area for Project NextGen by BARDA because such vaccines have the potential to reduce the spread of disease.”
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