BiondVax Pharmaceuticals Ltd. (NASDAQ:BVXV) announced today that preliminary data from the Phase 2 clinical trial of BiondVax's M-001 universal influenza vaccine candidate have been published. The trial was supported by the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The primary objectives of the trial were to assess safety and T-cell responses to M‑001. The data, which are consistent with results of previous clinical trials of M-001, indicate that both primary objectives were achieved. Analysis of the data is ongoing, and the clinical study report (CSR) is expected in Q2 2020.
Dr. Tamar Ben-Yedidia, BiondVax's Chief Scientific Officer, commented, "We are grateful for the opportunity to collaborate with NIAID and thank them for their professionalism and partnership. This was M-001's first clinical trial in the US under the FDA's Investigational New Drug program (IND). Data from this Phase 2 trial confirm results from six previously completed clinical trials of M-001. BiondVax's universal flu vaccine candidate was found to be safe, well tolerated and induce statistically significant cellular immune responses."
The Phase 2 clinical trial was conducted by NIAID-funded Vaccine and Treatment Evaluation Units (VTEUs). The trial enrolled 120 participants aged 18 to 49 years at the following VTEU sites: Baylor College of Medicine in Houston, Texas; the University of Iowa in Iowa City, Iowa; and Cincinnati Children's Hospital Medical Center in Cincinnati, Ohio. Individuals were randomly assigned to receive either two doses of M-001 or two doses of a placebo, with the doses spaced three weeks apart. Later, near the beginning of the 2018/19 flu season, all participants were immunized with a currently marketed quadrivalent seasonal influenza vaccine. Laboratory analyses of vaccine immunogenicity were performed at the Baylor College of Medicine and Saint Louis University (St. Louis, Missouri) VTEU sites and at BiondVax Pharmaceuticals.
The published data are available at https://clinicaltrials.gov/ct2/show/NCT03058692. The trial was supported through NIAID awards #HHSN272201300016I, HHSN272201300015I, HHSN272201300020I, and HHSN272201300021I.
In parallel, BiondVax's pivotal, clinical efficacy, Phase 3 trial in Europe, involving 12,463 older adults, is ongoing. Results of that trial are expected by the end of 2020.