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LYON, France

Osivax, a biopharmaceutical company developing vaccines to provide broad-spectrum protection against highly mutating viruses, today announced that all participants have completed their final visit in the Phase 2a clinical trial (NCT05734040) evaluating OVX836, Osivax’ broad-spectrum influenza A vaccine candidate, in combination with Quadrivalent Influenza Vaccines (QIVs). Topline results from this study are expected in the second half of 2024.

The randomized, double-blind, double placebo-controlled, parallel-group, multicentric clinical trial evaluated the safety and immunogenicity of a 480μg dose of the OVX836 vaccine with licensed QIVs and placebo in healthy participants across Australia. The enrolled 478 healthy volunteers from 18 to 60 years old were observed over a period of 180 days following the concomitant administration of the OVX836 vaccine with licensed QIVs, as two separate intramuscular injections into opposite arms, compared to one administration of OVX836, QIVs or placebo.

Laboratory analyses of the vaccine immunogenicity are being performed at VisMederi – Siena, KCAS Bio – Lyon, Osivax Quality Control lab – Angleur, and the CEVAC lab – Ghent.

“The data gathered from this Phase 2a trial is a necessary step in demonstrating OVX836’s ability to provide long-lasting, improved protection in combination with QIVs. We look forward to analyzing the data to confirm the promising results we have observed with OVX836 to date,” commented Dr. Nicola Groth, CMO of Osivax. “We would like to thank the volunteers and dedicated staff of researchers and clinicians whose contributions have ensured the trial’s successful completion.”

“The need for more effective and safe flu vaccines remains high and the conclusion of our trial which evaluates OVX836 in combination with QIVs brings us one step closer to providing improved protection,” said Alexandre Le Vert, CEO & Co-Founder of Osivax. “The data collected from this trial will bolster our development of OVX836 as a broad-spectrum influenza vaccine.”

About 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 1200 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 1,200 volunteers 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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