May 14 – BioWorld reported that BiondVax puts pegs in place for final push in universal flu vaccine effort http://www.bioworld.com/content/biondvax-puts-pegs-place-final-push-universal-flu-vaccine-effort . Clinical trials on the BiondVax vaccine are being carried out simultaneously in Europe and the USA. The possibility that BiondVax is bringing a vaccine to the market that could eradicate the flu has caught the attention of the scientific and professional media with a Scientific American article on May 14th about the M-001 flu vaccine:
and an April 1oth Nature Medicine article stating that the BiondVax’s M-001 vaccine is in trials as a standalone vaccine and as a priming step before administration of the seasonal flu vaccine.
At the beginning of April, NIAID (US National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH)) reported on the beginning in the United States of their sponsored trial of a universal Influenza vaccine intended to protect against multiple strains of the virus. https://www.niaid.nih.gov/news-events/niaid-sponsored-trial-universal-influenza-vaccine-begins . The trial is conducted under an FDA Investigational New Drug (IND) marking M-001’s clinical debut in the United States. Almost immediately afterwards, the first participant was enrolled in the United States in a Phase 2 clinical trial of the BiondVax’s universal flu vaccine candidate, M-001.
The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) allowed BiondVax already last year to proceed with the pivotal Phase 3 clinical trial plan for M-001. The CHMP wrote that a successful pivotal efficacy trial could suffice for approval of the vaccine. BiondVax signed a Master Service Agreement with a contract research organization (CRO) in March, 2018, and the Phase 3 trial is planned to begin later this year, prior to the 2018/19 Northern Hemisphere flu season. 9,630 participants aged 50 years and over will be enrolled across four to six countries in eastern Europe. The pivotal trial is expected to follow participants for up to two flu seasons.
In June 2017, the European Investment Bank (EIB) signed a €20 million non-dilutive co-funding agreement to support M-001’s commercial scale production and Phase 3.
The Israeli Ministry of Economy granted BiondVax 20% of a NIS 20 million budget towards construction. The company secured a lease for an entire floor (approximately 20,000 square feet or 1850m2) in the Jerusalem Bio Park, a biotech hub on the Hadassah Ein Kerem campus, and construction began in January, 2018 and is expected to be opened August 2018. BiondVax intends to produce a batch in the new facility for the upcoming Phase 3 clinical trial’s second participant group.
BiondVax (Nasdaq: BVXV) is an advanced clinical stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is designed to provide multi-season protection against current and future, seasonal and pandemic influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common influenza virus peptides, activating both arms of the immune system for a cross-protecting and long-lasting effect. In a total of 6 completed Phase 1/2 and Phase 2 human clinical trials, covering 698 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. Please visit www.biondvax.com.