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Osivax Announces First Participant Vaccinated in Phase 2a Clinical Booster Trial

18 Nov 2024
Admin
News Article

Osivax Announces First Participant Vaccinated in Phase 2a Clinical Booster Trial

Osivax announces first participant vaccinated in phase 2a clinical booster trial of influenza vaccine candidate OVX836

Overview

Osivax, a biopharmaceutical company developing vaccines to provide broad-spectrum protection against highly mutating infectious viruses, announced that the first participant has been vaccinated in a phase 2a clinical trial (NCT06582277) evaluating OVX836, its broad-spectrum influenza vaccine candidate as a booster in participants previously administered with OVX836.

Safety Study for Booster Dose: OVX836

Based on the encouraging data gathered so far, Osivax launched this study to further assess the safety and immunogenicity of a booster dose of OVX836.
The booster dose will be administered to participants who were vaccinated three to five years ago in earlier Osivax studies at the same clinical site.
The study is taking place at the Center for Vaccinology (CEVAC) at Ghent University Hospital.
The topline results from the trial are expected by the end of 2025.

Words from the Ghent University

“We are pleased to support the ongoing evaluation of OVX836 through this phase 2a influenza booster study,” commented Prof. Isabel Leroux-Roels, Principal Investigator at CEVAC and Associate Professor at Ghent University.
“We anticipate important insights that could significantly impact long-term influenza prevention.”

Statement from the CMO: Osivax

“This milestone is a significant step forward in our mission to develop a truly broad-spectrum, lasting flu vaccine capable of addressing the ever-evolving threat of influenza. By studying the effects of a booster dose, we aim to deepen our understanding of OVX836’s potential to provide robust and sustained immune protection,” said Dr. Nicola Groth, CMO of Osivax.
“Osivax is committed to leveraging innovative science to develop vaccines that protect individuals and help reduce the global healthcare burden associated with seasonal flu epidemics and potential pandemics.”

About the Single-Center Trial

The single-center trial is a randomized, double-blind, phase 2a clinical study evaluating the immunogenicity and safety of one single dose of OVX836 administered intramuscularly (IM) at either 180µg or 480µg.
The study includes healthy participants ages 20-64 who previously received OVX836 (180µg to 480µg), Influvac Tetra or placebo in the OVX836-002 (NCT04192500) and OVX836-003 (NCT05060887) studies.

About the Vaccine: OVX836

OVX836 is a first-in-class influenza A 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.
Osivax’ 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.
OVX836 has been tested in 5 clinical trials with 1,200 participants so far, and has shown promising safety, immunogenicity, and efficacy read-outs.

About the Company

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 in addition to strong and sustained B-cell responses.