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.
A Phase 2 clinical trial in 120 adult volunteers, supported by the U.S. National Institute of Allergy and Infectious Diseases (NIAID), reported both primary objectives of the trial, to assess the safety and T cell immune responses to M‑001, were achieved. The clinical study report (CSR) concludes that “M-001 was safe in this study” and that “M-001 induced significant polyfunctional T cell responses.”
The NIAID-supported Phase 2 trial was conducted under an FDA Investigational New Drug application and NIAID’s Division of Microbiology and Infectious Diseases has submitted the final CSR to the US FDA.
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.
BiondVax (NASDAQ: BVXV) 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.
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
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
In a total of 6 completed Phase 1/2 and Phase 2 clinical trials, covering 698 participants, have been shown to be safe, well-tolerated, and immunogenic.
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
- This Phase 3 trial plans to enroll a total of 12,000 participants aged 50+ over two years.
- Participants will be immunized twice with the M-001 universal influenza vaccine candidate or placebo and then followed for up to 2 seasons.
- The trial will evaluate the number of influenza cases in each group and the severity of illness during the follow-up period.
- This trial is expected to take place in eastern European countries and begin prior to the 2018/19 Northern Hemisphere flu season.