BiondVax developer of the Universal Flu Vaccine candidate M-001, announced the signing of a Master Service Agreement (MSA) with a contract research organization (CRO) to conduct the first pivotal, clinical efficacy, Phase 3 trial of M-001.
Originally conceived in the lab of Professor Ruth Arnon at the Weizmann Institute of Science in Israel, M-001 is comprised of nine epitopes common to the vast majority of influenza virus strains including both influenza Type A and B. In M-001’s six successful completed clinical trials (two Phase 1/2 and four Phase 2) to-date, it has been shown to be safe, well-tolerated, and immunogenic to a broad range of influenza strains.
BiondVax’s pivotal, clinical efficacy, Phase 3 trial is planned to begin later this year, prior to the 2018/19 Northern Hemisphere flu season. 9,630 participants aged over 50 years will be enrolled across four to six countries in eastern Europe. The trial is expected to follow participants for up to two flu seasons. The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) previously reviewed BiondVax’s Phase 3 trial plan, and accepts the entire approach in general and the study design in particular, thus enabling the company to proceed.
“Having worked on our universal flu vaccine since the very beginning and ushering it through many years of R&D and clinical trials, I am particularly proud to reach this exciting milestone,” Dr. Tamar Ben-Yedidia, BiondVax’s Chief Science Officer (CSO), said. “As far as we know, this is the world’s most clinically advanced universal flu vaccine. This winter’s flu season shows us once again the urgent need for an improved flu vaccine. I hope our vaccine will contribute to significant reduction of the economic and social burden of influenza.”