| June 19, 2017

Deal with European Investment Bank will help pharmaceutical firm bring M-001 — designed to protect against current, future, seasonal and pandemic flu strains — closer to market

The European Investment Bank (EIB) and BiondVax Pharmaceuticals Ltd., a developer of a universal flu vaccine candidate, said they have reached an €20 million ($22 million) loan agreement that will help the Israeli firm bring its vaccine closer to market.

The aim of the loan is to help BiondVax “develop a more universal vaccine, effective in preventing a range of different types of flu,” said Carlos Moedas, European commissioner for research, science and innovation, said in a joint emailed statement. As the flu virus changes, “we need to develop new ways to combat the disease.”

Flu viruses mutate frequently and unpredictably. Since it is impossible to predict future mutations, current flu vaccines may target strains that are not represented in the current wave of influenza. Mainly due to vaccine-virus mismatch, current flu vaccine effectiveness is on average only about 40% in the general population, and in elderly people as low as 9%.

In addition, current vaccines take about 4 to 6 months to produce, and a new one must be produced each year. So when a mismatch is identified at the beginning of the flu season, there is insufficient time to make a new vaccine for that specific season.

The World Health Organization (WHO) reports up to 500,000 annual seasonal flu-related deaths, mostly affecting people above 65 years old. Seasonal flu is the eighth leading cause of death in the United States, and it causes high social and economic burdens to patients, their families, and health care providers.

BiondVax’s M-001 vaccine candidate is designed to protect against current and future, seasonal and pandemic flu strains. The Israeli firm isolated nine linked sections from three proteins found in nearly all strains of flu discovered over the past 75 years.

Clinical and pre-clinical trials have shown that M-001 is safe and immunogenic and that it has the capacity to enhance and broaden coverage of current flu vaccines, the statement said. M-001 has also shown potential to improve upon current seasonal flu vaccines and to serve as an immediate effective response to new flu pandemic strains. The vaccine candidate has been tested in a Phase IIb clinical trial.

“We now have the resources to launch Phase 3 trials and set up a mid-sized commercial manufacturing plant,” said Dr. Ron Babecoff, CEO of BiondVax. “The EIB’s funding is a monumental step forward for BiondVax towards bringing M-001 to the market.”

An event organized to mark the collaboration and the granting of the loan took place Monday at the EIB Headquarters in Luxembourg, with Ambroise Fayolle, EIB Vice-President responsible for innovation, and Dr. Ron Babecoff, CEO of BiondVax, in attendance.

BiondVax, established in 2005, licensed the technology from the Weizmann Institute, where it was developed in the mid-90s. The company shares are traded on the Nasdaq and in Tel Aviv.

Source: http://www.timesofisrael.com/biondvax-gets-e20-million-loan-for-universal-flu-vaccine/