OVX836 Universal Influenza Vaccine

Osivax's OVX836 is a first-in-class influenza vaccine candidate that targets the nucleoprotein (NP), a highly conserved internal antigen. Unlike surface antigens, the NP is much less likely to mutate, providing a broader and more universal immune response. As of December 2023, OVX836 has been evaluated in several Phase 2 clinical trials against seasonal influenza with initial signals of broad-spectrum protection. The company's oligoDOM® technology enables the design and production of a recombinant version of the NP, which self-assembles into a nanoparticle, thus triggering powerful T- and B-cell immune responses.

This project has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement No 961112. The French State supports this project through the Banque Publique d'Investissement France's program: Programme d'investissements d'avenir and France 2030.

A study published results from a phase 2a study on July 27, 2023, that concluded OVX836 appears to be a safe and well-tolerated candidate vaccine that elicits humoral and cellular nucleoprotein-specific immune responses (including CD8 T cells at the highest dose levels) and showed a preliminary signal of protection against influenza. Therefore, OVX836 is a promising vaccine candidate for universal influenza A prevention that warrants further trials.

Osivax is a clinical-stage biopharmaceutical company leveraging its novel, self-assembling nanoparticle platform technology, oligoDOM®, to develop transformative, first-in-class pan-respiratory virus vaccines generating superior T-cell responses and strong and sustained B-cell responses. The company is based in Swely Bâtiment C, Slam, ​70 Rue Saint Jean Dieu, 69007 Lyon, France.

OVX836 Vaccine Indication

OVX836 is being tested in healthy adults to prevent seasonal influenza.

OVX836 Vaccine Dosage

The vaccine is being administered intramuscularly or intranasally and tested at three doses in healthy adults (NCT05060887).

OVX836 Vaccine News

December 5, 2023 - Osivax announced that it received over USD 1.5M grant from the National Institute of Allergy and Infectious Diseases.

July 28, 2023 - Osivax announced that The Lancet Infectious Diseases published results from the company's OVX836-003 study under the title, "Immunogenicity, safety and preliminary efficacy evaluation of OVX836, a nucleoprotein-based universal influenza A vaccine candidate: randomized, double-blind placebo-controlled, Phase 2a trial." The research article presents the study's results evaluating the safety and immunogenicity of OVX836.

OVX836 Vaccine Clinical Trials

As of December 5, 2023, OVX836 has been tested in 5 clinical trials with 1200 participants and has shown promising safety, immunogenicity, and efficacy read-outs. OVX836 has shown promising safety, immunogenicity, and efficacy data across preclinical and clinical trials (Phase 1 and 2a). It is being evaluated in additional ongoing clinical trials: two co-administration studies conducted in Australia (OVX836-004 and OVX836-006) with OVX836 and quadrivalent inactivated influenza virus (QIV) vaccines. Osivax also recently published the results of a Phase 2a dose-optimization study (OVX836-003) in The Lancet Infectious Diseases, showing efficacy in humans against seasonal strains.