Pharma Focus Europe

Osivax Initiates First-in-Human Trial for Sarbecovirus Vaccine Candidate OVX033 with First Participant Vaccination

Friday, February 16, 2024

Osivax, a company specializing in biopharmaceuticals, has launched its Phase 1 trial (NCT06128382) for OVX033, a broad-spectrum sarbecovirus vaccine candidate. The trial marks a significant step forward as the first participant receives the vaccination.

Recent research published in Frontiers in Immunology has shown that OVX033 offers cross-protection against three concerning variants of SARS-CoV-2. Additionally, in a rabbit toxicology study, the vaccine demonstrated a positive safety and tolerance profile following intramuscular administration. This important study is being conducted at the Clinical Investigation Center in Vaccinology Cochin Pasteur (CIC) at Cochin Hospital in Paris, under the supervision of Prof. Odile Launay, MD, PhD, from Paris Cité University.

Prof. Odile Launay, the Principal Investigator, stated, "OVX033 has demonstrated its efficacy in preclinical models, offering broad protection against various coronavirus strains. We're excited to assess its potential in preventing the widespread transmission of current and future SARS-CoV-2 variants."

Alexandre Le Vert, CEO & Co-Founder of Osivax, emphasized the significance of this milestone, stating, "Initiating the Phase 1 trial for OVX033 marks another milestone in validating our self-assembling nanoparticle platform, OligoDOMTM. This places us at the forefront of developing a new class of vaccines capable of combatting a range of infectious threats."

The Phase 1 trial, conducted at a single center, is a randomized, double-blind, placebo-controlled study assessing the safety and immunogenicity of OVX033 across three dose levels (100 µg, 250 µg, and 500 µg). Forty-eight healthy subjects aged 18-49 will receive either a single dose of the OVX033 vaccine or a placebo intramuscularly.

OVX033, utilizing Osivax's innovative technology, OligoDOMTM, targets the nucleocapsid (N), an internal antigen with high conservation. This design aims to elicit a broader and more universal immune response compared to surface antigens like Spike (S). The vaccine's recombinant nucleocapsid self-assembles into nanoparticles, triggering robust T- and B-cell immune responses. OVX033 has demonstrated promising preclinical cross-protective efficacy in a hamster challenge model.



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