BiondVax announces patent covering M-001 production processes
BiondVax announced that a patent covering production processes of the company's M-001 universal influenza vaccine candidate was allowed in the USA and Japan. The patent, which is pending in Europe, covers the 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. BiondVax is currently conducting a 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.