BiondVax’s universal influenza vaccine meets safety and immunogenicity endpoints

Preliminary results of BVX-006 show that M-001 is well tolerated and provides improved flu immunity by enhancing antibody responses to multiple strains when administered as a primer in a 1 mg dose

BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV, TASE: BVXV) today announced positive preliminary results from its BVX-006 Phase II clinical trial of M-001, BiondVax's candidate for a universal influenza vaccine. In this trial, M-001 was injected intramuscularly to volunteers between the ages of 50 to 65, followed by an administration of the 2014/15 season trivalent influenza vaccine (TIV) 3 weeks later. M-001 was found to be safe and well tolerated and induced humoral immune responses, successfully meeting the primary safety and secondary immunogenicity endpoints.

Dr. Ron Babecoff, BiondVax’s President and CEO (Photo credit: PR)

M-001 in a 1mg dose, primed for immune responses in a manner consistent with previous data in this age group confirming BiondVax’s approach to the development of a universal influenza vaccine. Furthermore, as demonstrated in previous tests, a broadening of the immune response to elicit responses against strains not included in the standard influenza vaccine was detected.

M-001 also elevated the immune response to other strains which were not included in the current influenza seasonal vaccine including against the drifted H3N2 strain of influenza that has caused this year’s epidemic in the United States. These results support BiondVax’s claim that M-001 provides a broaden and improved coverage against multiple influenza type A and B virus strains.

In addition, the excellent safety profile demonstrated for the 1 mg dose of M-001 will enable BiondVax to safely administer this dose in upcoming trials (such as BVX-007 in Europe). The increased dose is expected to further improve the immune responses against multiple influenza strains when given as a primer or as a standalone product without an adjuvant. Furthermore, the 1mg dose can be particularly beneficial to a population with weakened immunity, such as the elderly.

Dr. Tamar Ben-Yedidia, BiondVax’s Chief Scientific Officer, noted that:

We are very pleased with the results of this trial, which provide us with additional supporting data that our M-001 increases the immune response against multiple flu strains. The results indicating that the 1mg dosage level was well tolerated is very important and these positive results support our continued research and ongoing trials.

Added Dr. Ron Babecoff, BiondVax’s President and CEO:

We are very happy with these results, as they demonstrate the importance and value to society of developing M-001. This successful trial brings us one step further towards the phase 3 clinical trial.