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 results of the clinical trial are expected by the end of October 2020.
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
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 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
To date, BiondVax has completed 7 clinical trials (two Phase 1/2 and five Phase 2) covering 818 patients and in each trial, BiondVax’s vaccine was shown to be safe, well-tolerated, and immunogenic. A recent phase II trial in the United States funded by the US National Institute of Health reported results in 2020, and a pivotal, clinical efficacy, Phase 3 trial in over 12,000 participants is ongoing across seven European countries:
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.