BiondVax, NIAID kick off phase 2 universal flu vaccine study in U.S.

Already gearing up for a late-stage universal flu vaccine test in European countries, BiondVax has attracted its first participant to a phase 2 study sponsored by the National Institute of Allergy and Infectious Diseases.

Investigators will test BiondVax's candidate, M-001, in 120 adults ages 18 to 49 at three NIAID trial sites. The participants will either receive two shots of the vaccine or two shots of placebo a few weeks apart. Several weeks later, they'll receive an unadjuvanted quadrivalent vaccine.

In a statement, BiondVax CEO Ron Babecoff said his team is "honored to be merging the world-renowned clinical and biomedical expertise of NIAID-supported researchers with BiondVax’s universal flu vaccine development efforts." 

BiondVax is already prepping for a two-year phase 3 test of its vaccine in Eastern European countries, Babecoff previously told FiercePharma. The study will test the vaccine in about 9,600 participants ages 50 or older across four to six countries.

RELATED: BiondVax preps for phase 3 universal flu vaccine trial in Europe 

That test wouldn't support a U.S. approval, but Babecoff said he could envision a "bridging study" in the future to support a potential FDA nod. He noted that if the vaccine performs well, the FDA wouldn't "ignore" positive data, given the serious need for better flu vaccine options. 

Traditional egg-based flu vaccines take months to manufacture, forcing health officials to predict strains far ahead of the actual flu season. Because of strain mismatch and other factors, overall vaccine efficacy has ranged from just 10% to 60% in recent years, according to the CDC. Cell-based vaccines are quicker to manufacture, while a universal shot would ideally protect against all strains over multiple years. 

If M-001 succeeds in the phase 3 test, Babecoff said he and the BiondVax team would seek European market approval as soon as possible. 

RELATED: BiondVax, EU's UNISEC team up for universal flu jab Phase 2b 

The previously announced NIH aid adds to BiondVax's list of high-profile supporters. The company last year secured a €20 million loan from the European Investment Bank to help pay for late-stage testing and for a midsize manufacturing plant.

The company also has won support from the Israeli government and from the European Union's UNISEC consortium, an organizations advancing work in universal influenza vaccines. Weizmann Institute of Science professor Ruth Arnon, the inventor of Teva's blockbuster multiple sclerosis med Copaxone, designed the universal flu vaccine candidate and is on BiondVax's scientific advisory board.  

Besides BiondVax, large pharma companies such as Sanofi and Johnson & Johnson are working to improve flu vaccines. Smaller biotechs FluGen, Vaccitech and others are also involved in their own efforts.