M-001 Influenza Vaccine Description
The BiondVax Pharmaceuticals Ltd. M-001 influenza vaccine candidate is a recombinant protein containing 9 conserved epitopes from Influenza A and B that are common to the vast majority of influenza viruses.
M-001 is designed to provide multi-season and multi-strain protection against all human influenza virus strains, both seasonal and pandemic. In 7 completed clinical trials the vaccine was shown to be safe, well-tolerated, and immunogenic to a broad range of flu strains.
A Phase 3 clinical phase of M-001 is currently undergoing a pivotal, clinical efficacy, in about 12,400 participants. The randomized, modified double-blind, placebo-controlled, pivotal Phase 3 trial assessed the safety and efficacy of the M‑001 vaccine candidate alone in reducing flu illness and severity in 12,463 adults aged 50 years and older, including 6,291 (50.5%) aged 65 and older. 4,042 participants were enrolled and randomized in the trial’s first cohort prior to the 2018/19 flu season, and an additional 8,421 participants were enrolled across seven Eastern European countries in the trial’s second cohort (2019/20 flu season). Each participant was monitored for one flu season.
The trial commenced in 2018 after the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) reviewed the trial design and provided feedback. The CHMP response included comments regarding various aspects of the trial design, and also stated that “It is agreed that a single pivotal efficacy trial that provides a robust demonstration of efficacy against laboratory-proven influenza-like illness (ILI) could suffice for an approval.”
Isreal based BiondVax is a Phase 3 clinical-stage biopharmaceutical company developing a universal flu vaccine.
M-001 Influenza Vaccine Indication
M-001 is a vaccine candidate designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. M-001 is intended to stimulate both arms of the immune system for a cross-protecting and long-lasting effect.
Various scientific publications are posted at this company link.
M-001 Influenza Vaccine Dosage
M-001 will be administered in this phase 3 trial as an intermuscular injection with 1mg dose of twice: Once at Day 0, and once on Day 21.
M-001 Influenza Vaccine News
October 23, 2020 - BiondVax Pharmaceuticals Ltd. announced topline data from the Company’s pivotal, phase 3 clinical trial of M-001 as a standalone universal flu vaccine candidate. Results did not demonstrate a statistically significant difference between the vaccinated and placebo groups in the reduction of flu illness and severity and therefore failed to meet both the primary and secondary efficacy endpoints. But, the study’s primary safety endpoint was met.
August 13, 2020 - BiondVax currently anticipates announcing results from the pivotal Phase 3 clinical trial in late September to the end of October this year based on the schedule of current operational activities. However, there are no assurances that this timetable will be met in the event that we encounter any delays.
June 12, 2020 - BiondVax a clinical-stage biopharmaceutical company focused on developing and commercializing M-001, a universal influenza vaccine candidate announced its fourth-quarter and full-year financial results for the year ended December 31, 2019, and provided a business update.
June 10, 2020 - BiondVax announced the completion of the clinical study report of the 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. NIAID. As indicated when the preliminary trial data was published earlier, both primary objectives of the trial, to assess the safety and T cell immune responses to M‑001, were achieved.
July 8, 2019 - First Participant Enrolled in Second Cohort of BiondVax’s Pivotal, Clinical Efficacy, Phase 3 Universal Flu Vaccine Trial.
M-001 Influenza Vaccine Clinical Trials
Clinical Trial NCT03058692: Two Doses of Multimeric-001 (M-001) Followed by Influenza Vaccine.
Clinical Trial NCT03450915: A Pivotal Phase 3 Trial to Assess the Safety and Clinical Efficacy of the M-001 as a Standalone Universal Flu Vaccine.