A Phase 2 trial supported by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) concluded that BiondVax Pharmaceuticals’ (NASDAQ:BVXV) M-001 universal influenza vaccine candidate achieved safety and significant polyfunctional T-cell immune responses.
The NIAID-supported Phase 2 trial in 120 healthy volunteers was conducted under an IND. The NIAID’s division of Microbiology and Infectious Diseases has submitted a final study report to the FDA. The NIAID also has indicated that the study’s lead investigator may prepare a manuscript for publication sometime in the future.
In a statement, Dr. Tamar Ben-Yedidia, BiondVax’s CSO, said data from the Phase 2 trial confirmed safety and cellular immune response results, as have six previously completed clinical trials of M-001.
BiondVax’s pivotal Phase 3 trial in Europe is assessing M-001’s ability to provide clinical protection from circulating influenza strains. The trial is being conducted in more than 12,400 volunteers aged 50-plus, with half aged 65-plus, during two flu seasons in seven countries. Results are expected by the end of 2020.
