BiondVax Pharmaceuticals announces successful Phase II trial of influenza vaccine

BiondVax Pharmaceuticals, Ltd., announced Thursday that they met their primary and secondary endpoints with the Multimeric-001 Universal Influenza Vaccine during its first Phase II clinical trial.

The vaccine was found to be well tolerated and safe. It induced robust immune responses, which met both its primary safety and immunogenicity endpoints and a secondary immunogenicity endpoint. Multimeric-001 was also found to increase the performance of trivalent inactivated vaccine by increasing the hemagglutination inhibition seroconversion to strains of influenza included and not included in the TIV.

"We are very excited with these positive Phase IIa results," Dr. Ron Babecoff, BiondVax’s CEO, said. 'We have confirmed, in what is to our knowledge the first Phase II study of a universal influenza vaccine ever conducted in the world, that the Multimeric-001 vaccine is not only safe and immunogenic on its own, but it also has the potential to enhance the performance of traditional strain-dependant flu vaccines. We are more convinced than ever that this product will provide real benefit to people all over the world, bringing the ultimate goal of a universal influenza vaccine closer than ever before."

The Phase IIa trial was a randomized, double-blind, placebo-controlled study in 200 health volunteers conducted at two clinical research centers in Israel. The results of the trial suggested that the vaccine has the potential, when given in advance of future seasonal or pandemic influenza outbreaks, to raise the general preparedness rate of the population and to improve the protection and broaden cross-strain coverage offered by strain-dependent influenza vaccines.

BiondVax is preparing to conduct the next Phase II trial in the elderly - the population group most at risk for influenza infections and for whom current influenza vaccines are the least effective.

"The results of this Phase IIa trial are most gratifying," Dr. Tamar Ben Yedidia, BionVax’s chief scientific officer, said. "We have now shown, in three clinical trials in over 320 participants, that the Multimeric-001 vaccine is safe and effectively activates the immune system, both on its own as well as in conjunction with the traditional flu vaccines. This gives us much confidence as we proceed with further Phase II and Phase III studies."