- Grant supports preclinical evaluation of OVX836 providing protection against pandemic influenza strains
- OVX836 has been evaluated in multiple Phase 2 clinical trials against seasonal influenza and has initially shown broad-spectrum protection
LYON, France–(BUSINESS WIRE)–Osivax, a biopharmaceutical company developing vaccines to provide broad-spectrum protection against highly mutated infectious viruses, today announced it has received more than $1.5 million from the National Institute of Allergy and Infectious Diseases. Funded by (NIAID), part of the National Institutes of Health (NIH). This grant (Project No. 1R01AI177376) will support preclinical studies evaluating the breadth of protection and immune response of the company’s lead broad-spectrum influenza vaccine candidate, OVX836, against pandemic influenza strains.
The preclinical studies are planned at the Innovative Therapeutics Modeling of Infectious Diseases (IDMIT) unit at the French Alternative Energies and Atomic Energy Commission (CEA) site in Fontenay-Rose, France. IDMIT is highly specialized in human infectious diseases and has the facilities required to test the immunogenicity and efficacy of OVX836 as a vaccine against pandemic influenza strains in preclinical models.
OVX836 will be evaluated in preclinical models against two pandemic influenza A virus strains: pH1N1, a once-pandemic but now seasonal, and H5N1, a highly pathogenic variant with pandemic potential.
“Testing OVX836 in preclinical models will be critical to assess the breadth of protection against strains with pandemic potential. ” commented Florence Nicolas, co-founder and principal researcher at Osivax. “Importantly, these new preclinical studies will allow us to identify potential correlates of protection for further evaluation in human clinical studies.“
“Working with Osivax to evaluate OVX836 against pandemic strains is an important step in preparing for future influenza outbreaks that pose a significant risk to public health.” commented Roger Le Grand, Director and Principal Investigator, IDMIT.
“Receiving this grant from NIAID will support our progress in developing OVX836 to provide broad-spectrum protection against influenza, which remains a long-standing pandemic threat.“ commented Alexandre Le Vert, Co-Founder and CEO, Osivax. “We believe that by generating these additional data against pandemic influenza strains, we will be able to enhance the positive results produced by OVX836 against seasonal strains, putting us on a strategic path toward future regulatory approval.“
OVX836 has shown encouraging safety, immunogenicity and efficacy data in preclinical and clinical trials (Phase 1 and Phase 2a). It is being evaluated in other ongoing clinical trials: two studies in Australia co-administering OVX836 with a quadrivalent inactivated influenza virus (QIV) vaccine (OVX836-004 and OVX836-006). Osivax also recently published results from a Phase 2a dose optimization study (OVX836-003) The Lancet Infectious Diseases Shows efficacy in humans against seasonal strains.
OVX836 is a first-in-class influenza vaccine candidate targeting nucleoprotein (NP), a highly conserved internal antigen. Unlike surface antigens, NPs are much less likely to mutate, providing a broader and more general immune response. Osivax’oligoDOM® Technology enables the design and production of recombinant versions of NPs that can self-assemble into nanoparticles, thereby eliciting powerful T-cell and B-cell immune responses. To date, OVX836 has been tested in 5 clinical trials involving 1,200 participants and has shown promising safety, immunogenicity and efficacy readouts.
Osivax is a clinical-stage biopharmaceutical company leveraging its novel self-assembling nanoparticle platform technology oligoDOM®, to develop a revolutionary, first-in-class pan-respiratory virus vaccine that generates a superior T-cell response in addition to a strong and sustained B-cell response. The company is conducting a proof-of-concept with its broad-spectrum, “universal” influenza drug candidate OVX836, which is currently in Phase 2 clinical trials and has been tested in more than 1,200 subjects with encouraging proof-of-concept data. Osivax aims to develop a pan-respiratory virus vaccine that would protect against all influenza strains and all sarbecovirus variants in one shot. The company will expand into other infectious disease indications through alliances and collaborations globally.
For more information: https://osivax.com/
Alexander LeVert, Chief Executive Officer
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