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LYON, France

Osivax, a biopharmaceutical company developing vaccines to provide broad-spectrum protection against highly mutating infectious viruses, today announced that the first participant has been vaccinated in its new Phase 2a clinical trial (NCT05734040) evaluating broad-spectrum influenza vaccine candidate, OVX836 in combination with Quadrivalent Influenza Vaccines (QIVs).

At the internationally-renowned 2023 World Vaccine Congress, the company presented initial data from its Phase 2a trial (NCT05284799) evaluating OVX836 in combination with a Quadrivalent Influenza Vaccine (QIV) in 180 healthy volunteers. The combination demonstrated a good safety profile and no interference on the antibody immune responses driven by the QIV was observed. Based on these encouraging data, Osivax will continue investigating the potential of OVX836 in concomitant administration with various QIVs in different age-groups by conducting this larger Phase 2a trial that is expected to enroll over 500 participants ages 18-60 across several clinical sites in Australia.

“The vaccination of the first participant in this trial is an exciting, critical step in pursuing the further clinical development of OVX836,” commented Dr. Paul Griffin, Study Lead Investigator. “By combining OVX836 with the current standard of care, we expect to bring much-needed and critical additional protection against seasonal influenza, especially for high-risk populations, including the elderly.”

“The initiation of our multicenter Phase 2a trial marks an important milestone for Osivax as we continue optimizing the development of OVX836 in combination with conventional influenza vaccines within a larger and more diverse population,” commented Alexandre Le Vert, CEO & Co-Founder of Osivax. “We are eager to build upon the promising initial data from our previous study in an effort to provide improved and broad-spectrum protection, especially for at-risk populations.”

The multicentric trial is a randomized, double-blind, double placebo-controlled, parallel-group Phase 2a clinical study designed to evaluate the safety and the immunogenicity of the concomitant administration of OVX836 with Quadrivalent Influenza Vaccines (QIVs). Topline results are expected by the end of 2023.

About OVX836

OVX836 is a first-in-class broad-spectrum 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. 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 4 clinical trials with 800 participants so far, and has shown promising safety, immunogenicity, and efficacy read-outs.

About Osivax

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. The company is establishing proof of concept with its broad-spectrum “universal” influenza candidate, OVX836, which is currently in Phase 2 clinical trials with over 1100 subjects tested and encouraging efficacy proof of concept data. Osivax’ ambition is to develop a pan-respiratory virus vaccine to prevent all strains of influenza and all variants of Covid-19 in one single shot. The company will expand into other infectious disease indications through combinations and collaborations worldwide.

For further information: www.osivax.com

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