BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV) reported today the first participant enrollment in the United States in a Phase 2 clinical trial of the company’s universal flu vaccine candidate, M-001. The trial is sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Conducted under an FDA Investigational New Drug (IND), the trial marks M-001’s clinical debut in the United States.

 Initially developed in Professor Ruth Arnon‘s lab at the Weizmann Institute of Science in Israel, M-001 is comprised of nine epitopes common to influenza virus strains including both influenza Type A and B. In six completed clinical trials in Israel and Europe (two Phase 1/2 and four Phase 2), BiondVax’s universal flu vaccine candidate has been shown to be safe, well-tolerated, and immunogenic to a broad range of influenza strains.

As previously announced, a pivotal clinical efficacy Phase 3 trial is planned in Europe later this year. Co-funded by the European Union’s European Investment Bank (EIB), the trial will enroll 9,630 participants aged 50 years and older across four to six countries over a period of two flu seasons.

Dr. Ron Babecoff, BiondVax’s CEO, commented, “We are honored to be merging the world-renowned clinical and biomedical expertise of NIAID-supported researchers with BiondVax’s universal flu vaccine development efforts. We are pleased to participate in NIAID’s focus on development of novel flu vaccines to improve protection against current strains and protect against emerging seasonal and pandemic threats.

The NIAID-sponsored study, titled “A Phase II, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial to Assess the Safety, Reactogenicity and Immunogenicity of Two Doses of Multimeric-001 (M-001) Followed by Seasonal Quadrivalent Influenza Vaccine” is being conducted at three sites (University of Iowa, Cincinnati Children’s Hospital Medical Center in Ohio, and Baylor College of Medicine in Houston, Texas), with laboratory support by St. Louis University in St. Louis, Missouri. These sites are part of the NIAID-funded network of Vaccine and Treatment Evaluation Units (VTEUs).

A total of 120 participants aged 18 to 49 years will be randomly assigned to receive either two doses of M-001  or two doses of a placebo, with the doses spaced several weeks apart. A few months following the second injection, all participants will receive a currently marketed unadjuvanted quadrivalent seasonal influenza vaccine. Safety and immunogenicity will be assessed and compared between the groups receiving M-001 and placebo.