BiondVax Pharmaceuticals, an Israeli developer of the Universal Flu Vaccine candidate M-001, announced today 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 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.
The name of the European-headquartered contract research organisation which will collaborate with BiondVax on clinical trial is not mentioned.
BiondVax is an advanced clinical stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is designed to provide multi-season protection against current and future, seasonal and pandemic influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common influenza virus peptides, activating both arms of the immune system for a cross-protecting and long-lasting effect.