18 May 2022 - - French biopharmaceutical company Osivax, which is developing vaccines to provide broad-spectrum protection against highly mutating infectious viruses and diseases, has entered a research collaboration with the US National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, to conduct a preclinical evaluation combining Osivax' T-cell based influenza candidate, OVX836, with a range of the NIAID Vaccine Research Center 's influenza vaccine candidates, the company said.

The immune responses produced by OVX836 involve T-cells against the nucleoprotein, a highly conserved internal antigen across flu strains, and those produced by the NIAID VRC vaccine candidates involve B-cells against hemagglutinin surface antigens.

As both approaches are directed to potential pandemic influenza strains, Osivax and NIAID will evaluate potential synergies between these respective immune responses and potential additive effects in animal challenge models in an effort to create improved, broad-spectrum influenza vaccines.

Osivax' OVX836 is a nucleoprotein-targeting influenza vaccine developed using the company's proprietary oligoDOM technology.

Recently published clinical data from the company's Phase 2a trial revealed that OVX836 induced a significant increase of NP-specific cellular immune responses, including CD4+ and CD8+ T-cells, and initial efficacy signals while being safe and well-tolerated.

Osivax is pursuing the combination with the NIAID's next-generation vaccine candidates as a strategy to significantly improve the efficacy and cross-protection against existing and future pandemic influenza strains.

Under the terms of the collaboration, NIAID will provide its novel, self-assembling ferritin nanoparticles that serve as scaffolding to display multiple copies of HA protein, a protein expressed on the surface of influenza viruses, to Osivax for in vivo preclinical studies in combination with OVX836.

Preclinical data from the NIAID vaccine candidates indicate an enhanced breadth of the immune response in animal models compared to traditional seasonal vaccines, thus also offering potential protection against influenza strains not included in the vaccine.

NIAID is currently conducting Phase 1 clinical trials to assess safety and immunogenicity in humans (NCT03814720 and NCT04579250).

Osivax' influenza vaccine, OVX836 targets the nucleoprotein, 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).

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 500 subjects tested.

NIAID conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases.