BiondVax Plans Phase II Flu Vaccine

BiondVax Pharmaceuticals has announced plans to start a second Phase II trial for the development of a product that is intended to enhance the effectiveness of existing flu vaccines. That product aims to be the forerunner of the company`s ultimate goal – the development of a universal flu vaccine.

The limitation of current vaccines, explains BiondVax CEO Ron Babecoff, is that they are strain specific. “Regular flu vaccines cause the body to produce antibodies that target a specific protein known as hemagglutinin on the surface of the influenza virus. But the hemagglutinin protein changes as the virus mutates and flu vaccines have to be constantly reformulated,” says Babecoff.

BiondVax`s technology solves this problem by targeting conserved areas of the influenza virus which are common to all strains. “In laboratory tests, our technology has proven capable of providing protection against all known strains of flu, including swine flu and avian flu.”

BiondVax’s product has been shown to enhance the effectiveness of existing flu vaccines by increasing the number of people that achieve a “protective” level of antibodies both against the specific flu strains targeted by the regular flu vaccine, as well as against other potential strain mutations.

The flu vaccine market is huge, with more than $4 billion in sales generated each year. Although many other companies are trying to develop a universal vaccine, BiondVax is the only one that has reached an advanced clinical stage.

A third Phase II trial is planned for late 2012, with the Phase III trial expected in 2013.  Launch of the flu vaccine enhancer product could potentially be as early as 2014.

“Raising the finance needed to do trials for the universal product and ultimately obtaining regulatory approval will be easier once we have succeeded in bringing our enhancement product to market,” adds Babecoff.

Financially, the company, which is listed on the Tel-Aviv Stock Exchange, appears to be in good shape.  In addition to having sufficient cash on hand to finance the next two years’ of operations, the company also has a $14 million  funding facility in place from Yorkville Advisors, ensuring its ability to complete the trials for the lead product.

BiondVax was co- founded by Ron Babecoff in 2003 and is based on a patent invented by Prof. Ruth Arnon, a co-inventor of Teva`s blockbuster copaxone drug and the Chairperson of BiondVax’s Scientific Advisory Board.  Another prominent member of the Scientific Advisory Board is Prof. Michel Revel, the inventor of another Israeli blockbuster drug – beta-interferon.

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