Appoints Cytovance Biologics for the production of clinical batches of M-001
Nes Ziona, Israel – October 1, 2015 – BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV) announced today that it has entered into a Development and Manufacturing Agreement for the production of clinical batches of its universal flu vaccine, M-001, with Cytovance Biologics Inc., a Contract Manufacturing Organization (CMO), based in Oklahoma, USA.
Under the terms of the Agreement, Cytovance Biologics will scale up and optimize the small-scale cGMP manufacturing process of M-001, previously developed by BiondVax and audited by a European Qualifying Person (QP). The technology transfer will start immediately, with the initial clinical batches expected to be manufactured by the fourth quarter of 2016. The clinical grade M-001 batch is intended to be used by BiondVax for its phase III trial, planned for the 2017/18 timeframe, which is a critical step towards commercialization of M-001 in the US, Europe and the rest of the world.
Shimon Hassin, COO of BiondVax commented: “This new strategic relationship with Cytovance Biologics, a U.S. leader in contract manufacturing with a significant track record in the production of clinical materials, is a key development for BiondVax. Their expertise will play a major role in accelerating the clinical development and large scale manufacture of our universal flu vaccine, M-001, that will hopefully improve the lives of the millions of individuals who suffer, and some of which die, every year from Influenza and its complications.”