BiondVax Pharmaceuticals Ltd., a clinical phase biopharmaceutical company, announced that the Israel Investment Center, a unit of the Government of Israel’s Ministry of Economy and Industry, approved a grant representing 20% of a NIS 20M budget to be utilized towards the construction of a factory for the production of phase 3 and commercial batches of BiondVax’s universal flu vaccine candidate M-001. The grant is subject to certain terms and conditions including those outlined under the Encouragement of Capital Investment Law 1959.
BiondVax plans to build the mid-sized factory in Jerusalem, with potential capacity to annually produce up to tens of millions of doses of M-001. M-001 is designed to provide protection against current and future seasonal and pandemic flu strains. Five completed phase 1/2 and phase 2 human clinical trials have shown the vaccine to be safe and immunogenic to multiple flu strains.
Dr. Ron Babecoff, BiondVax’s CEO, commented, “This significant milestone signifies the evolution of BiondVax from a biotech start-up to a pharmaceutical company positioned for significant growth and contributions to society. I would like to thank the Ministry of Economy and Industry for helping translate BiondVax’s vision to reality.”
Dr. Shimon Hassin, BiondVax’s COO noted, “In the past few years BiondVax focused on establishing a small scale GMP facility, one that was approved by the European Union. Our current facility laid the foundation for manufacturing quality excellence that will be implemented in the new factory.”
An ongoing phase 2b trial is being conducted in collaboration with the UNISEC consortium. The research has received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement n°602012. Positive preliminary safety results were announced [http://www.biondvax.com/2016/11/ biondvax-phase-2b-trial-preliminary-safety-results-the-universal-flu-vaccine-candidate-is-safe-and-well-tolerated/] in November 2016. BiondVax’s consortium partners are continuing to analyze study samples. BiondVax expects the consortium will finalize and release results in Q2 2017.
BiondVax is a clinical phase biopharmaceutical company developing a universal flu vaccine. The vaccine is designed to provide multi-season protection against most seasonal and pandemic human influenza virus strains.