Osivax announced in June 2024 that it has completed enrolment for its Phase I trial of OVX033, a broad-spectrum vaccine candidate against sarbecoviruses. The study will evaluate the safety and immunogenicity of OVX033 with three dose levels (100µg, 250µg and 500µg). No safety concerns or signals have been observed at any dose level to date. The study is a single-centre, randomised, double-blind, placebo-controlled trial conducted at the Clinical Investigation Centre in Vaccinology Cochin Pasteur (CIC) in Paris.
OVX033
OVX033 is a first-in-class coronavirus vaccine candidate that targets the nucleocapsid (N), which is a “highly conserved internal antigen”. Compared to the Spike (S) surface antigen, N is “much less likely to mutate”, which offers a “broader and more universal immune response”. The goal is to induce broad-spectrum protection against all current and future variants of SARS-CoV-2 as well as future pandemic coronavirus strains.
Osivax’s oligoDOM technology “enables the design and production of a recombinant version of nucleocapsid”, which “self-assembles into a nanoparticle”. It has been “uniquely designed” to increase the T-cell immune response through a specific signal sequence targeting and activating cells from the immune system. It also triggers a strong B-cell response. OVX033 has demonstrated a preclinical proof-of-concept for cross-protective efficacy in a hamster challenge model.
Dr Nicola Groth, CMO of Osivax, suggested that “sarbecoviruses remain a threat” as we saw during the COVID-19 pandemic, which “continues to have long-term consequences for global health”.
“By completing enrolment for our Phase I trial with OVX033, we are taking a significant step forward in addressing the need for a broad-spectrum vaccine to provide protection against these rapidly mutating viruses.”
Professor Odile Launay from Paris University is the Principal Investigator of the trial and looks forward to sharing the data readout “later this year”.
“The data gathered from the Phase I trial with OVX033 will be critical to its further development as an effective and safe protective measure against various strains of sarbecoviruses.”
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