secured a grant from the Israel Investment Center, a unit of the Government of Israel's Ministry of Economy and Industry, to build a manufacturing facility for the production of Phase 3 and commercial batches of its universal flu vaccine, M-001. The grant represents 20% of a 20 million Israeli New Shekel budget. (See also, Glaxo Flu Drug Fluarix Seeks Label Expansion.)
Influenza viruses often undergo changes to certain surface proteins which results in development of new virus strains that are unfamiliar to the human body immune system. The bigger the surface protein change, the lower the possibility of body’s immune system to fight against the disease.
BiondVax builds a combination of conserved epitopes, the part of an antigen molecule to which an antibody attaches itself, that is derived from the flu virus to form a vaccine. Such epitopes are common to most human flu virus strains regardless of their antigenic changes, resulting in development of a better vaccine against the flu.
The company’s flu vaccine candidate, M-001, is built to offer protection against current and future seasonal and pandemic flu strains. The drug has been successful in five different early-stage and mid-stage trials, which demonstrated that the vaccine is safe and immunogenic to multiple flu strains.
The drug is being assessed in an ongoing Phase 2b study which is being conducted in collaboration with the UNISEC consortium, and the study results are expected by second quarter of this year.
The Israel-based BiondVax plans to build the factory in Jerusalem, which will be used for bulk production of M-001 vaccine for both clinical and commercial use.
"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," said Dr. Ron Babecoff, BiondVax's Chief Executive Officer.
Following the update, BiondVax's stock price spiked 36%, to hit a 52-week high of $7.87 per share on Thursday morning. (See also, The Cost Of Getting The Flu.)
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