The Board of Directors and Management of BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), was honored to host Mr. Ambroise Fayolle, Vice-President of the European Investment Bank (EIB), during his visit to BiondVax’s new mid-size commercial-scale manufacturing facility in Israel. During his visit, Mr. Fayolle, together with Dr. Ron Babecoff, BiondVax’s President and CEO, signed the previously announced financing agreement extension through which the EIB has supported both construction of BiondVax’s new facility and the ongoing pivotal, clinical efficacy, Phase 3 trial of M-001, BiondVax’s universal flu vaccine candidate.
Dr. Babecoff noted, “I am grateful for the EIB’s innovative financing support of BiondVax’s universal flu vaccine development. The EIB’s support has enabled us to conduct a large pivotal, clinical efficacy, Phase 3 trial in Europe, and construct a mid-size commercial-scale manufacturing facility in Jerusalem. It is an honor to host Mr. Fayolle and his colleagues.”
The transaction between EIB and BiondVax was initiated and is supported by kENUP Foundation.
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 the 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 of M-001 in the USA, with results anticipated by the end of 2019
BiondVax (NASDAQ: BVXV) is a Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. BiondVax’s proprietary technology utilizes a unique combination of conserved and common influenza virus peptides intended to stimulate both arms of the immune system for a cross-protecting and long-lasting effect. In a total of 6 completed Phase 1/2 and Phase 2 clinical trials, covering 698 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. The ongoing pivotal Phase 3 clinical trial aims to assess safety and effectiveness of M-001 in reducing flu illness and severity.