NIH Report on Phase 2 Clinical Trial of BiondVax's M-001 Universal Influenza Vaccine Candidate Concludes Both Primary Endpoints Achieved
PR Newswire PR Newswire•June 10, 2020
JERUSALEM, June 10, 2020 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) today announced the completion of the clinical study report (CSR) of a Phase 2 clinical trial of the Company's M-001 universal influenza vaccine candidate. The trial in 120 adult volunteers was supported by the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
As indicated when the preliminary trial data was published earlier this year, both primary objectives of the trial, to assess the safety and T cell immune responses to M–001, were achieved. The CSR concludes that "M-001 was safe in this study" and that "M-001 induced significant polyfunctional T cell responses."
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. We also are grateful to the investigators and their teams, and to the 120 volunteers who participated in this trial. It is exciting that data from this Phase 2 trial conducted in the U.S. confirm safety and cellular immune response results, as have six previously completed clinical trials of M-001."
The NIAID-supported Phase 2 trial was conducted under an FDA Investigational New Drug application (IND), and NIAID's Division of Microbiology and Infectious Diseases (DMID) has submitted the final CSR to the FDA. NIAID has communicated to BiondVax that the study's lead investigator may prepare a manuscript for publication sometime in the future.
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 is ongoing. The trial, which is assessing M-001's ability to provide clinical protection from circulating influenza strains, is being conducted in more than 12,400 volunteers aged 50+ (with half aged 65+) over two flu seasons in seven countries. Results of the pivotal Phase 3 trial are expected by the end of 2020. https://finance.yahoo.com/news/nih-report-phase-2-clinical-110000023.html