Osivax Announces Publication of Phase 1 Data on its Broad-Spectrum Influenza Vaccine Candidate OVX836 in the Journal of Infectious Diseases
Encouraging safety and cellular immune response data as well as a promising reactogenicity profile warrant further evaluation of OVX836 in Phase 2a study
Lyon, France – December 2nd, 2021 –
Osivax, a biopharmaceutical company focused on the development of universal vaccines against highly-mutating viruses, including influenza and coronaviruses, announced today the publication of results of its Phase 1 clinical trial with OVX836 titled “Phase 1 Randomized, Placebo-Controlled, Dose-Escalating Study to Evaluate OVX836, a Nucleoprotein-Based Influenza Vaccine: Intramuscular Results” in the Journal of Infectious Diseases. OVX836 is Osivax’ lead universal influenza vaccine candidate developed using the company’s proprietary oligoDOM® technology platform.
The first-in-human, randomized, placebo-controlled Phase 1 trial enrolled 36 healthy adults. Topline results demonstrated that OVX836 was safe and well-tolerated at 30, 90 and 180 µg, with a 2-dose schedule administered intramuscularly following a 1-month interval. Additionally, no significant dose-effect relationship was observed in terms of reactogenicity or safety up to the 180 µg dose. Notably, results indicate a strong T-Cell immune response specific to the Nucleoprotein, an antigen highly conserved among seasonal and pandemic influenza strains, after one vaccination, encouraging further development of OVX836 as a universal influenza vaccine.
Professor Pierre Van Damme, Head of the Center for the Evaluation of Vaccinations at the University of Antwerp, Principal Investigator, and co-author of the manuscript commented, “Not only was OVX836 safe up to the highest dosage level, but it also produced a strong immune response after only one administration in all vaccinated participants.”
“The publication of our Phase 1 data in the industry renowned Journal of Infectious Diseases is an important milestone for Osivax,” commented Alexandre Le Vert, CEO and cofounder of Osivax, “This publication further validates our approach to preventing influenza outbreaks while reinforcing oligoDOM® as a valuable, safe technology that enables strong cellular responses and acts as a complementary pathway to conventional antibody-based vaccine approaches. Building on this promising initial data, we look forward to sharing our Phase 2a result in early 2022.”
Osivax’ Phase 1 clinical trial (NCT03594890) was conducted at the Center for the Evaluation of Vaccinations in the University of Antwerp in Belgium and was supported by Bpifrance and the European Union’s Horizon 2020 Research and Innovation Program.
The full manuscript can be accessed on PubMed at: https://pubmed.ncbi.nlm.nih.gov/34653245/
Osivax lead universal influenza vaccine, OVX836 targets the nucleoprotein (NP), a highly conserved internal antigen. Unlike surface antigens, the NP is much less likely to mutate, alleviating the need for annual vaccination updates. Osivax’ oligoDOM® technology enables the transformation of the NP into a highly immunogenic antigen to trigger powerful B- and T-cell immune responses. OVX836 has shown promising safety and response data in preclinical and Phase 1 data. OVX836 is currently being evaluated in a dose-optimization Phase 2a clinical study conducted at the Center for Vaccinology of the Ghent University (CEVAC.)
OSIVAX’s mission is to develop “universal” vaccines against highly-mutating viruses. Leveraging its unique oligoDOM® technology platform, OSIVAX is developing a universal vaccine for both current and future influenza infections. The Company’s universal flu vaccine candidate, OVX836 is in Phase 2a clinical development. OSIVAX is leveraging the same platform technology for the development of a universal vaccine against all existing and emerging coronavirus infections. OSIVAX is focused on providing proof-of-concept in influenza and coronavirus, and to applying its oligoDOM® platform broadly in other infectious and immune system-associated diseases.
For further information: www.osivax.com
Alexandre LE VERT, CEO
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