BiondVax Pharmaceuticals (NASDAQ:BVXV) enrolled the first participant in a U.S. Phase 2 clinical trial of its universal flu vaccine candidate, M-001.
The trial is sponsored by the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, and is being conducted under an IND. The trial marks M-001’s clinical debut in the U.S.
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, the vaccine candidate was shown to be safe, well tolerated, and immunogenic to a broad range of influenza strains.
The NIAID-sponsored study is expected to enroll 120 participants aged 18-to-49. It is being conducted at three sites: University of Iowa, Cincinnati Children’s Hospital Medical Center and Baylor College of Medicine in Houston, with laboratory support by St. Louis University.
A pivotal Phase 3 trial, co-funded by the European Union’s European Investment Bank, is planned in Europe later this year. The trial will enroll 9,630 participants aged 50 years and older across four-to-six countries over a period of two flu seasons.
