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Patent Covering Manufacturing Process of M-001 Universal Flu Vaccine Allowed in USA, Japan

June 20, 2019 By americanpharmaceuticalreview

BiondVax Pharmaceuticals announced a patent covering production processes of the Company's M-001 universal influenza vaccine candidate was allowed in the USA and Japan.

Titled "Compositions of multimeric-multiepitope influenza polypeptides and their production" the patent, which is pending in Europe, covers the unique composition and manufacturing processes of M-001. Designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza, the vaccine has been shown to be safe, well-tolerated, and immunogenic to a broad range of flu strains in clinical trials.

"The USA and Japan, together with Europe, are among the largest influenza vaccine markets. We are pleased our universal flu vaccine's patent protected composition and manufacturing process is progressing as planned through its pivotal Phase 3 clinical trial,” Dr. Tamar Ben-Yedidia, BiondVax's Chief Science Officer, said. “We look forward to bringing the vaccine to the people of Japan, USA, Europe, and the rest of the world in the coming years."

BiondVax is currently conducting a pivotal, clinical efficacy, Phase 3 trial of M-001 in Europe. 4,094 participants were recruited prior to the 2018/19 flu season, and preparations are proceeding as planned towards the trial's second season of 2019/20, in which about 8,000 participants are expected to be enrolled. The placebo-controlled trial will assess safety and effectiveness of M-001 alone in reducing flu illness and severity in adults aged 50 years and older, with at least half aged 65 and older. Results are expected by the end of 2020.

In parallel, the NIAID/NIH is conducting a Phase 2 clinical trial in the USA, with results anticipated by the end of 2019.

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