Osivax Finishes Enrollment for Phase 1 Trial of Broad-Spectrum Sarbecovirus Vaccine OVX033

Osivax, a biopharmaceutical firm focused on creating vaccines for broad-spectrum protection against mutating respiratory viruses, has successfully enrolled 48 healthy volunteers in its Phase 1 trial of OVX033. This vaccine candidate aims to combat sarbecoviruses, a group that includes SARS-CoV-2, responsible for COVID-19. Topline data from this trial is anticipated by the fourth quarter of 2024.

The Phase 1 clinical trial (NCT06128382) is structured to assess both the safety and immunogenicity of OVX033 at varying dose levels—100µg, 250µg, and 500µg. So far, no safety issues have emerged, allowing the escalation to the highest dose level of 500µg. The single-center study is randomized, double-blind, and placebo-controlled, taking place at the Clinical Investigation Center in Vaccinology Cochin Pasteur (CIC) located in Cochin Hospital in Paris, France.

Dr. Nicola Groth, Chief Medical Officer of Osivax, emphasized the importance of this trial, considering the persistent threat posed by sarbecoviruses, as demonstrated by the ongoing COVID-19 pandemic. The successful enrollment marks a crucial step in developing a vaccine that offers broad-spectrum protection against these rapidly mutating viruses.

Professor Odile Launay, the Principal Investigator and a professor at Paris Cité University, highlighted that the data from this trial will be pivotal for the continued development of OVX033. The goal is to establish OVX033 as a safe and effective protective measure against various sarbecovirus strains. She expressed anticipation in sharing the trial results later in the year and extended gratitude to the volunteers participating in the study.

OVX033, a first-in-class coronavirus vaccine candidate, targets the nucleocapsid (N) protein, an internal antigen that is highly conserved and less prone to mutations compared to surface proteins like Spike (S). This targeting aims to elicit a more universal immune response, potentially providing protection against all existing and future variants of SARS-CoV-2, as well as other pandemic coronaviruses. Osivax employs its oligoDOMTM technology to design and produce a recombinant version of the nucleocapsid, which self-assembles into a nanoparticle. This nanoparticle effectively stimulates strong T-cell and B-cell immune responses. OVX033 has already shown cross-protective efficacy in preclinical hamster studies, a concept validated in a publication in "Frontiers in Immunology." Further preclinical studies and this first-in-human clinical trial are ongoing.

The project is financially backed by the French government under the France 2030 initiative, “Programme Investissements d’Avenir,” managed by Bpifrance.

Osivax is a clinical-stage biopharmaceutical company that leverages its innovative self-assembling nanoparticle platform technology, oligoDOMTM, to develop first-in-class vaccines against a range of respiratory viruses. This technology aims to generate potent T-cell responses along with robust and durable B-cell responses. The company is also working on a universal influenza vaccine candidate, OVX836, which is in Phase 2 clinical trials with over 1,200 volunteers, showing promising efficacy data. Osivax's broader mission is to create a pan-respiratory virus vaccine capable of preventing all strains of influenza and all variants of COVID-19 in a single shot. The company plans to extend its efforts to other infectious diseases through strategic partnerships and collaborations globally.