Osivax Announces Clinical and Preclinical Vaccine Data Presentations at Upcoming Global Influenza Conferences

• Influenza vaccine candidate OVX836 safety profile and efficacy signals from Phase 2a dose-optimization study to be presented at UIV 2022
• Preclinical proof of cross-protection against SARS-COV-2 with OVX033 in hamster challenge model to be presented at Options XI
• Additional results on the synergy of co-administering T-cell based vaccine candidate OVX836 with traditional antibody-based flu vaccines will be presented in a poster session during Options XI

LYON, France--(BUSINESS WIRE)-- Osivax, a biopharmaceutical company developing vaccines to provide broad-spectrum protection against highly mutating infectious viruses and diseases, today announced upcoming oral presentations at the Universal Influenza Vaccines (UIV) 2022 event held September 5-7 in Oxford, UK and the Options XI for the Control of Influenza conference, held September 26-29 in Belfast, UK. Osivax’ Chief Business Development Officer, Delphine Guyon-Gellin, will present the most recent clinical and preclinical data for the company’s lead programs, OVX836, a broad-spectrum influenza vaccine, and OVX033 a broad-spectrum coronavirus vaccine. Additionally, two poster presentations providing further clinical and preclinical data for OVX836 will be presented at Options XI.

The oral presentation at the UIV conference will take place on September 7^th and will include the latest results from the Phase 2a dose-optimization study (OVX836-003), an ongoing trial evaluating OVX836 in healthy adults at 180µg, 300µg and 480µg. OVX836 maintained an excellent safety profile at all dose levels and provided protective efficacy in reducing PCR-confirmed influenza-like-illnesses by 78%. The trial represents the second time OVX836 has demonstrated positive efficacy results, demonstrating further evidence of its potential to deliver broad-spectrum protection against a broad range of influenza strains. Jeffrey Almond, Chairman of Osivax’ Clinical Advisory Board and professor at Oxford University will also present a review on the importance of ‘Combining T-cell and Antibody-based approaches to develop more effective influenza vaccines’ at UIV conference.

Delphine Guyon-Gellin will present OVX033 preclinical results at the Options XI conference on September 29^th. The vaccine candidate, which targets the nucleocapsid, an integral and invariant antigen contained within the coronavirus, was injected twice over 28 days in hamsters challenged with the Europe B.1, Delta or Omicron strains. The study results have shown protective efficacy against weight loss, lung viral load and pneumonia caused by SARS-CoV-2. Positive signs of an increased immune response warrant further evaluation of OVX033’s ability to provide a broad level of protection against current and future variants of SARS-COV-2 and reinforce the rationale for testing the vaccine candidate against other Sarbecoviruses.

Osivax will present two posters covering additional OVX836 clinical and preclinical results at the Options XI conference. The first poster describes preclinical results demonstrating the potential for higher and broader protection against influenza by co-administering OVX836 with a conventional flu vaccine. Osivax is currently conducting a Phase 2a combination trial (OVX836-004) with OVX836 and a quadrivalent inactivated influenza vaccine (QIV) in Australia, with safety results from the trial included in this poster. The second poster will share the safety profile and signals of efficacy obtained with OVX836 in the Phase 2a Dose-Optimization Study (OVX836-003).

Universal Influenza Vaccines 2022 – 5^th to 7^th of September 2022

Oral Presentation on Monday, September 5, 2022 – Jeffrey Almond

• Combining T-cell and antibody-based approaches to develop more effective influenza vaccines

Oral Presentation on Wednesday, September 7, 2022 – Delphine Guyon-Gellin

• Results of a Phase 2a study with OVX836 suggest effectiveness in preventing Influenza-Like-Illness and confirm good safety profile

Options XI – 26^th to 29^th of September 2022

Oral Presentation on Thursday, September 29, 2022 – Delphine Guyon-Gellin

• OVX033, T-cell based vaccine targeting the Nucleocapsid provides broad-spectrum protection against SARS-COV-2 VoC in hamster challenge model

Poster Presentations

• How to drastically improve influenza prevention: the addition of a T-cell component to increase current vaccine efficacy, preclinical and early clinical results
• Results of a Phase 2 study with OVX836 suggest effectiveness in preventing Influenza-Like Illness and confirm good safety profile

About OVX836
Osivax’ influenza vaccine candidate, OVX836, targets the nucleoprotein (NP), a highly conserved internal antigen. Unlike surface antigens, NP is much less likely to mutate, providing a broader and more universal immune response. Osivax’ oligoDOM

technology enables the design and production of recombinant version of the NP which self-assembles into a nanoparticle, thus triggering powerful T-and B-cell immune responses. OVX836 has shown promising safety, immunogenicity, and efficacy in preclinical and clinical trials (Phase 1 and Phase 2a) and continues to be evaluated in additional studies.

About OVX033
Osivax’ coronavirus vaccine candidate, OVX033, targets the nucleocapsid, an internal and invariant coronavirus antigen. The target is transformed into a highly immunogenic antigen through the application of oligoDOM^® technology and is expected to provide broad-spectrum protection against all current and future variants of SARS-COV-2 as well as against future pandemic Sarbecoviruses. OVX033 has demonstrated a first preclinical Proof of Concept for cross-protective efficacy in a hamster challenge model. Further preclinical studies are on-going, and a first-in-human clinical trial is expected to start in 2023.

About Osivax
Osivax is a biopharmaceutical company leveraging its novel, self-assembling nanoparticle platform technology, oligoDOM^®, to transform current and new vaccines by generating superior T-cell responses in addition to strong and sustained B cell responses against highly mutating viruses. The company is establishing proof of concept with its highly validated lead influenza candidate, OVX836, which is currently in Phase 2 testing with over 800 subjects tested. Osivax is also exploring the broader application of its technology in a variety of indications. The company will expand into other infectious disease indications through combinations and collaborations worldwide.

For further information: www.osivax.com

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