Final Participant Receives Vaccine in Osivax's Phase 2a Trial of OVX836 with QIVs

Osivax, a biopharmaceutical firm focused on developing vaccines against rapidly mutating viruses, has reported that the final participant visits for the Phase 2a clinical trial of its universal influenza A vaccine candidate, OVX836, have been concluded. The trial, which is set to deliver its primary immunogenicity and safety data in the latter half of 2024, involved 478 healthy volunteers in Australia.

The study was designed as a randomized, double-blind, and double placebo-controlled parallel-group trial, aiming to assess the safety and immunogenicity of a 480μg dose of the OVX836 vaccine when combined with Quadrivalent Influenza Vaccines (QIVs). The participants, ranging in age from 18 to 60, were monitored for 180 days after receiving the vaccine and QIVs concurrently as two separate intramuscular injections or a single administration of either the vaccine, QIVs, or a placebo.

Laboratory tests to determine the vaccine's immunogenicity were conducted at several facilities, including VisMederi in Siena, KCAS Bio in Lyon, Osivax's Quality Control lab in Angleur, and the CEVAC lab in Ghent.

Dr. Nicola Groth, Osivax's Chief Medical Officer, emphasized the significance of the Phase 2a trial data in confirming the long-lasting and enhanced protection offered by OVX836 in conjunction with QIVs. The company expressed gratitude to the volunteers and research staff for their contributions to the trial's success.

Alexandre Le Vert, Osivax's CEO and Co-Founder, highlighted the ongoing demand for improved flu vaccines and the importance of the trial's conclusion in advancing the development of OVX836 as a universal influenza vaccine. The collected data is expected to strengthen the vaccine's profile.

OVX836 is distinguished as a first-in-class influenza A vaccine candidate that targets the nucleoprotein (NP), an internal antigen that is less prone to mutation, thereby offering a broader immune response. Osivax's proprietary oligoDOM™ technology facilitates the creation of a recombinant NP that self-assembles into nanoparticles, stimulating robust T- and B-cell responses. OVX836 has undergone testing in five clinical trials with 1200 participants, demonstrating promising safety, immunogenicity, and efficacy.

Osivax is a clinical-stage biopharmaceutical company that utilizes its innovative self-assembling nanoparticle platform technology, oligoDOM™, to develop groundbreaking pan-respiratory virus vaccines that elicit superior T-cell responses alongside strong and enduring B-cell responses. The company is currently establishing proof of concept with its "universal" influenza candidate, OVX836, which is in Phase 2 clinical trials and has shown encouraging efficacy data. Osivax's goal is to develop a pan-respiratory virus vaccine capable of preventing all strains of influenza and all variants of Covid-19 in a single dose, with plans to expand into other infectious disease areas through global collaborations.