BiondVax Pharmaceuticals Ltd., a clinical stage biopharmaceutical company focused on developing and commercializing immunomodulation therapies for infectious diseases, this week announced that its Investigational New Drug Application (IND) for its Multimeric-001 vaccine (M-001), has been accepted by the US Food and Drug Administration (FDA).
FDA acceptance of an IND provides authorization for the distribution and administration in the U.S. of medical products that have not yet been approved for commercial use for purposes of conducting clinical trials.
This IND will allow BiondVax to conduct an FDA approved Phase 2 clinical trial that will involve the administration of M-001, BiondVax’s product candidate.
“Today’s vaccines are far from ideal – they mostly protect against the strains within them, but frequent mismatches between these strains and the circulating ones lead to low vaccine effectiveness,” said Dr. Tamar Ben-Yedidia, BiondVax’s CSO. “We believe our solution, whereby one vaccine protects against each and every flu strain, will save the lives and suffering of many millions around the world each year.”
M-001 is based on a proprietary combination of conserved non-changing epitopes, or peptides, common to practically all existing and future flu virus strains, including both seasonal and pandemic flu strains such as the avian and swine flu, regardless of their antigenic drift and shifts.
The universal influenza vaccine contains a combination of 9 conserved linear epitopes from influenza virus proteins, combined in triplicate into a single recombinant protein and produced by fermentation in E.coli. The T- and B-cell epitopes were selected from Hemagglutinin (HA), Nucleoprotein (NP) and Matrix (M) proteins, therefore ensuring activation of both humoral and cellular immunity.
Source: BiondVax press release, adapted.
