Universal Flu Vaccine Ready For Pharma Licensing And Development

Israeli biotech firm, BiondVax, has announced that its patent for the universal flu vaccine has been approved by the European Union and Japanese patent authorities. The patent covers the “Multimeric Multi-Epitope Polypeptide Influenza Vaccines” family, which provides long lasting vaccination against multiple influenza strains in humans and has already been approved in the United States, Hong Kong, Australia, China, Russia, and Mexico. The company is also expecting to receive approval in Israel shortly.

With these two new patent approvals, the company says it is now ready to enter into world-wide licensing and development programs with pharmaceutical companies and governments to bring this vaccine into the market soon.

BiondVax’s universal flu vaccine, called Multimeric-001 (M-001), is designed to offer long-lasting protection against all the major forms of flu: bird, swine, Spanish, Hong Kong, Wisconsin, Brisbane, California, and other common forms of influenza. According to BiondVax, its universal flu vaccine will be broadly effective against various current and future flu strains.

Influenza (flu) is one of the most common infectious diseases, and can prove to be dangerous for elderly persons, children, and others with weak or compromised immune systems. Influenza is caused by any of countless strains of the influenza virus, which constantly mutates into new strains to survive. All of the currently available seasonal and pandemic flu vaccines are strain-specific and have to be prepared each flu season depending on the particular virus strain(s) causing the flu outbreaks.

The BiondVax universal flu vaccine contains nine linked sections from three proteins, which are common in nearly all strains of flu that have been discovered to date. The vaccine works by activating the immune system against these regions conserved in most influenza virus strains. BiondVax licensed this vaccine technology from the Weizmann Institute in Israel, where it was developed.

BiondVax’s Chief Scientist Tamar Ben-Yedidia, says, “BiondVax’s vaccine was designed to contain small pieces of the flu virus that do not change as they are required for the virus’s life cycle,” she said. “These small pieces are enough to teach the human immune system to recognize all flu strains, so that the body quickly stops the virus from causing illness. Based on these findings, BiondVax anticipates that the universal vaccine, when the development stage is completed, will be broadly effective against present and future strains in contrast to current vaccines that are strain specific.”

BiondVax has already completed two Phase 2 studies on M-001 in 440 people and obtained excellent results. In the clinical trials, M-001 was found to be safe and immunogenic against various flu strains. Furthermore, it enhanced the performance of traditional strain-dependent flu vaccines when given as part of a prime-boost regimen. The company has already discussed the future Phase 3 studies with the U.S. FDA.

According to the company’s press release, M-001 has several other advantages over conventional flu vaccines, such as being manufactured in only 6-8 weeks as compared to the 6-8 months required for conventional flu vaccines. Similarly, its fixed composition allows for year-round production and stockpiling.

BiondVax is developing M-001 to be used as a stand-alone universal flu vaccine and also as a pandemic primer, as it enhances the effectiveness of current strain-specific flu vaccines. The company met with U.S. BARDA earlier this year to discuss the development of its vaccine to prepare for a global pandemic influenza outbreak.