First Participant Enrolled in Second Phase 3 Universal Flu Vaccine Trial

BiondVax Pharmaceuticals announced the first participants in the second cohort of the pivotal, clinical efficacy, Phase 3 trial of the M-001 universal flu vaccine candidate have been successfully enrolled.

Influenza viruses mutate frequently and unpredictably, and the strains that dominate often vary in time and place. For example, according to the CDC, the first part of the 2018/19 flu season was dominated by H1 strains throughout most of the continental USA, while the south-east USA was dominated by an H3 strain. In the latter part of the flu season, a drifted H3 strain that was not included in the season's flu vaccine circulated across the country, resulting in overall flu vaccine effectiveness of only about 29%. Meanwhile, Australia's 2019 flu season has started about three months earlier than usual.

BiondVax's M-001 universal flu vaccine candidate is designed to improve upon currently marketed strain-specific vaccines in several ways. Designed as a common denominator to influenza viruses, results from six completed clinical trials indicate M-001 induces an immune response to a broad range of influenza strains. As well, M-001's single formulation enables year-round production, vaccination, and stockpiling.

"Different flu strains circulate with varying frequency across seasons and countries. The Phase 3 trial of our universal flu vaccine is being conducted for two flu seasons over a broad geographic area, and vaccination began this year in July, well before the usual onset of flu season. The current study aims to demonstrate how well M-001 protects the participants against flu illness when they are exposed to any circulating flu strain," Dr. Tamar Ben-Yedidia, BiondVax's Chief Science Officer, said.

The placebo-controlled, pivotal, clinical efficacy, Phase 3 trial will assess safety and effectiveness of the M-001 vaccine alone in reducing flu illness and severity in approximately 12,000 adults aged 50 years and older, with at least half aged 65 and older. 4,094 people were enrolled in the trial's first cohort prior to the 2018/19 flu season, and upon review of the safety profile the Data Safety Monitoring Board (DSMB) allowed the company to proceed with the trial's second cohort. About 8,000 participants are being enrolled in the trial's second cohort (2019/20 flu season) in 85 sites in seven countries in eastern Europe. Results are expected by the end of 2020.

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