Osivax Vaccinates First Participant in Phase 2a Clinical Booster Trial for OVX836

Osivax, a biopharmaceutical company developing vaccines to provide broad-spectrum protection against highly mutating infectious viruses, announced today that the first participant has been vaccinated in a new Phase 2a clinical trial evaluating a booster dose of OVX836 in participants previously administered with the broad-spectrum influenza vaccine candidate. The randomized, double-blind, single-center trial is expected to enroll over 150 participants and is being conducted at the Center for Vaccinology (CEVAC) at Ghent University Hospital under the supervision of Isabel Leroux-Roels, Principal Investigator at CEVAC and Associate Professor at Ghent University.

Key Facts:

·       The Phase 2a clinical study will evaluate the safety and immunogenicity of a single dose of OVX0836 at two dose levels (180 µg or 480 µg) administered intramuscularly.

·       The study includes healthy participants ages 20-64 who previously received OVX836 (180 µg to 480 µg), Influvac® Tetra, or placebo in the OVX836-002 and OVX836-003 studies, respectively.

·       Top-line results from the trial are anticipated by the end of 2025, which will provide important insights into long-term influenza prevention through booster vaccination.

·       Osivax recently announced an exclusive license option agreement with KM Biologics, a leading vaccine manufacturer, to develop, manufacture, and commercialize the company’s broad-spectrum influenza vaccine candidates for the Japanese market.

·       OVX836, Osivax’ lead influenza vaccine candidate, has shown promising safety, immunogenicity, and preliminary efficacy in previous trials involving over 1,200 participants. Key findings were published in The Lancet Infectious Disease in 2023.