BiondVax CEO Dr. Ron Babecoff (upper row, center) and employees at the company’s new Jerusalem production facility. (photo credit: Courtesy)
New vaccines are developed every year, based on three strains of the influenza virus that experts believe to be most likely in the upcoming season. Frequent and unpredictable mutations of the virus, however, mean that vaccine effectiveness significantly varies from year to year.
According to the US Centers for Disease Control and Prevention, vaccine effectiveness since 2005 has varied from 10% to 60%, with an average of 40%. Some 80% of seasonal flu-related deaths occur among the elderly, due to their declining immune systems.
Approximately 500 million doses of vaccine are prepared every year, with a shelf life of just three months, exacting a heavy price on national health systems. The worldwide seasonal flu vaccine market is estimated to cost $5.9 billion by 2021.
Jerusalem-based BiondVax Pharmaceuticals, however, is edging closer to an unprecedented universal, multi-season and multi-strain flu vaccine capable of protecting all of us from current and future, seasonal and pandemic influenza virus strains. It’s a development that has eluded researchers for decade.
Based on technology developed by Prof. Ruth Arnon of the Weizmann Institute of Science in Rehovot, the company’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 that can stop any type of flu, whether seasonal or pandemic.
The recombinant protein, M-001, is currently undergoing phase three human clinical trials, after completing six clinical trials among 698 participants, ranging from young adults to the elderly. In all studies to date, the vaccine has been shown to be safe, well-tolerated, and immunogenic to a broad range of influenza strains.
“We have a shelf life of at least 24 months, which means we can produce and prepare the population against any pandemics that can occur,” Biondvax co-founder and CEO Dr. Ron Babecoff told The Jerusalem Post.
“We can change the whole way we are dealing and thinking about the flu, and we can have our flu shot whenever we want,” Babecoff said. “Health authorities can prepare predefined campaigns, which is not possible today with current flu vaccines.”
IN OCTOBER 2018, Nasdaq-listed BiondVax announced the successful enrollment of the last participant in the first season of its phase three trial in Eastern Europe.
More than 4,000 participants will be monitored for two flu seasons, and a second cohort of approximately 6,000 participants will be enrolled prior to next winter’s flu season.
Participants, ages 50 years and older, with half of them 65-plus, are randomly divided into two equal groups, one receiving M-001 and the other receiving a placebo.
Results are expected in the second half of 2020.
“The M-001 has some advantages over existing vaccines. It has broad coverage and a single formulation enabling year-round stockpiling and vaccination,” said Babecoff.
“This is how we can have one facility operating as a sustainable business, producing the flu vaccine according to market demand,” he said.
“Instead of the usual production time of four to six months in eggs, we produce it in a fermentation process in E. coli bacteria that takes only six to eight weeks.
Our shelf life is 24 months, and it’s growing now that we’re switching to pre-filled syringes.”
In August 2018, BiondVax moved to a new manufacturing facility at the Biotechnology Park of the Hebrew University of Jerusalem’s Hadassah Ein Kerem campus. The 20,000 square-foot facility will enable BiondVax to produce up to 40 million vaccine doses in bulk, and up to 20 million single-dose syringes.
“We are not alone in the quest for the Holy Grail of a universal vaccine, but we are far the first-in-class, best-in-class and the most advanced,” said Babecoff.
Leading the crucial clinical development stage of the vaccination is BiondVax’s chief science officer Dr. Tamar Ben-Yedidia, one of the leading women in Israeli biotechnology research today.
After joining Weizmann in 1994, she worked on the design of a peptide-based vaccine under the auspices of Arnon before joining BiondVax in 2004.
“The experience of being a high-level woman in this field is unique to Israel and doesn’t exist in other countries,” said Ben-Yedidia.
“My message to other women is to dream big and make it happen. Especially for Israelis, where we were all in the army and had significant responsibilities that were previously given to men alone. We commanded them in the army, so we can manage them in civilian life.”
To advance its technology, BiondVax has received considerable financial and research support, including 20 million euros ($22.68m.) from the European Investment Bank, and support from the Economy Ministry and the US National Institutes of Health.
“Because we are living together in packed cities, we need to be responsible for one another,” said Babecoff.
“Taking a vaccine is part of this responsibility. Just like we obey the law, there must be a law obliging populations to take vaccines. Just like the tetanus shot is taken every 10 years, this can be the same. In a very short period, we hope to be able to build herd immunity.”