Centivax Doses First Participants in Phase 1A Universal Flu Vaccine Trial

California-based biotechnology firm Centivax has dosed the first participants in a Phase 1A clinical trial evaluating Centi-Flu 01, a pan-influenza universal flu vaccine candidate, marking the company's transition into clinical-stage development. The randomized, double-blind, placebo-controlled, dose escalation study includes an open-label, active-controlled phase and involves healthy adults aged 18-64 years and those 65 and older.

Unlike conventional seasonal influenza vaccines, which must be reformulated annually to attempt to match predicted circulating strains, Centi-Flu 01 is designed to focus both antibody and cellular immune responses on conserved regions of the influenza virus that cannot mutate and are shared across strains and distance subtypes. This approach aims to generate broad, consistent, and durable immunity against both seasonal and pandemic influenza.

The study will assess the safety and immunogenicity, as well as efficacy, using established correlates of protection. The gold-standard hemagglutination inhibition (HAI) assay will be utilized to compare immune responses against a panel of more than 20 flu strains. These include historical mismatch, current circulating, pandemic strains, and seasonal guidance, directly against existing standard-of-care flu vaccines. Because the HAI assay is the same correlate-of-protection used to license seasonal flu vaccines, positive data will provide a clear benchmark demonstrating the candidate's ability to deliver broad protection with a single vaccine.

Initial data from approximately 180 participants is expected within the year. The Phase 1A represents a key value-inflection point for the company because it will show very quickly whether the vaccine and the universal immunity platform is working and if it outperforms standard of care. This accelerates the company towards the very large $7 billion a year flu market and the unmet medical need of consistent immune protection against flu.

Beyond its flagship universal flu program, Centivax's epitope-focusing platform is advancing a growing pipeline spanning a pan-herpes Alzheimer's preventative, a broad oncology treatment, a malaria vaccine, and a universal antivenom recently published in Cell. Collectively, these programs underscore the universal immunity platform's broad potential to tackle diverse medical threats.

The Centivax universal immunity mission has been supported by a broad coalition of investors, strategic partners, philanthropic organizations, and U.S. government entities dedicated to advancing next-generation immunology and strengthening global pandemic preparedness. This includes over $26 million in non-dilutive financing from groups such as the Bill & Melinda Gates Foundation, the Coalition for Epidemic Preparedness Innovations, the National Institutes of Health, the United States Department of Agriculture, the Military Infectious Diseases Research Program, the U.S. Naval Medical Research Command, the Department of Defense and others. Centivax investors include Future Ventures, NFX, Global Health Investment Corporation, BOLD Capital Partners, Base4 Capital, Kendall Capital Partners, Amplify Partners, and others.

The global influenza vaccine market is estimated at more than $7 billion annually. Centivax is headquartered in South San Francisco, California.