Centivax announced that the first participants have been dosed in the company's phase-I(a) clinical trial evaluating Centi-Flu 01, a pan-influenza universal flu vaccine, in healthy volunteers. The study is a randomised, double-blind, placebo-controlled, dose escalation study with an open-label active-controlled phase, to evaluate the safety and immunogenicity of Centi?Flu 01 in healthy adults 18-64 years of age and 65 years 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.

"For decades, flu vaccination has been reactive. A universal influenza vaccine allows us to be proactive—moving from annual guess work to predictable durable response," said Sawsan Youssef, PhD, Founder and Chief Science Officer, Centivax.

In addition to safety, the study will evaluate efficacy based on established correlates of protection, using the gold-standard hemagglutination inhibition (HAI) assay against a panel of more than 20 flu strains—including currently circulating strains, historical mismatch strains, seasonal guidance strains and pandemic strains—in a direct head-to-head comparison with existing standard-of-care flu vaccines. Because the HAI assay is the same correlate-of-protection used to licence seasonal flu vaccines, positive data will provide a clear benchmark demonstrating the candidate's ability to deliver broad protection with a single vaccine. The first data, in 180 subjects, is expected within the year.

"We are aiming to correct the problem so many of us experience: where, despite taking a flu shot, you still get sick. The Phase-I(a) is a key value-inflection point for the company because we will see very quickly whether the vaccine—and the universal immunity platform—is working, and, if it outperforms standard of care. This accelerates us towards the very large USD 7 billion a year flu market and the unmet medical need of consistent immune protection against flu," said Jacob Glanville, PhD, Founder and Chief Executive Officer, Centivax.

Beyond its flagship universal flu programme, 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 anti-venom recently published in Cell and featured by major media. Collectively, these programmes underscore the universal immunity platform's broad potential to tackle diverse medical threats.

"Vaccines can deliver benefits well beyond preventing the initial infection, serious disease and symptom reactivation caused by pathogens. From my much earlier work helping lead the development of Zostavax, we're now seeing evidence that shingles vaccination is associated with lower risks of Alzheimer's disease and cardiovascular events. That's a glimpse of what's possible. We believe universal vaccines can take this further—expanding protection across diverse pathogens as well as protecting against the diverse long-term pathology they contribute to," said Jerry Sadoff, MD, Chief Medical Officer, Centivax.

The Centivax universal immunity mission has been supported by a broad coalition of investors, strategic partners, philanthropic organisations and US government entities dedicated to advance next-generation immunology and strengthening global pandemic preparedness. This includes over USD 26 million in non-dilutive financing from groups such as the Bill & Melinda Gates Foundation, the Coalition for Epidemic Preparedness (CEPI), the National Institutes of Health (NIH), the United States Department of Agriculture (USDA), the Military Infectious Diseases Research Programme (MIDRP), the US Naval Medical Research Command (NMRC), the Department of Defence (DOD) and others.

Centivax investors include Future Ventures, NFX, Global Health Investment Corporation (GHIC), BOLD Capital Partners, Base4 Capital, Kendall Capital Partners, Amplify Partners and others.