M-001 Universal Flu Vaccine Patient Application Accepted in Australia

The M-001 universal influenza vaccine candidate patent application by BiondVax Pharmaceuticals was accepted in Australia and remains under examination in Europe, China, Japan, and the USA. 

The M-001 vaccine candidate is designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. 

BiondVax is currently conducting a pivotal, clinical efficacy, Phase 3 clinical trial of M-001 in 4,094 participants aged 50 years and older, were recruited prior to the 2018/19 flu season. 

And, preparations are proceeding towards the placebo-controlled trial’s 2nd flu season of 2019/20, in which at least 6,000 participants are expected to be enrolled. Results are expected by the end of 2020. 

BiondVax's proprietary technology utilizes a unique combination of conserved and common influenza virus peptides intended to stimulate 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 clinical trials, covering 698 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. 

Previously, on March 21, 2019, BiondVax reported that all participants have completed their final visit in a Phase 2 clinical trial conducted by several Vaccine Treatment and Evaluation Units (VTEUs) part of the U.S. Department of Health & Human Services (HHS)’s National Institutes of Health (NIH). 

Dr. Tamar Ben-Yedidia, BiondVax's Chief Science Officer, commented in a press release, "Our 5 patent families cover multimeric-multiepitope polypeptides as well as composition, use, formulation and production aspects of M-001, our Phase 3 universal flu vaccine candidate.” 

For additional disclosures, please visit Biondvax.com/clinical-trials.