MONDAY, SEPTEMBER 26, 2016

BiondVax’s universal flu vaccine continues forward motion

M-001, the BiondVax Pharmaceuticals Ltd. candidate for a universal influenza vaccine, is showing positive results from its phase two clinical trial, says Dr. Ron Babecoff, president and chief executive.

M-001 – technically known as the Multimeric-001 vaccine – not only has been found to be safe, well-tolerated and able to induce humoral immune responses, but the vaccine also elicited responses against strains that weren’t included in the standard influenza seasonal vaccine, Babecoff told Vaccine News Daily in an interview on Thursday.


“This has shown we’re able to have more responses for more strains with this vaccine,” providing improved and broader coverage against multiple influenza-type A and B virus strains, specifically, said Babecoff, who co-founded the Israel-based BiondVax in 2003.

 
The company’s technology utilizes a “proprietary combination” of conserved and common epitopes from influenza virus proteins to activate both arms of the immune system to create a cross-protecting and longer-lasting effect. BiondVax holds an exclusive worldwide license to develop, manufacture and commercialize this vaccine, which Babecoff said will be available in 2017 or 2018.

 
In BiondVax’s recent BVX-006 Phase II clinical trial, M-001 was injected intramuscularly to volunteers aged 50 to 65 and then followed up three weeks later with the 2014-15 season trivalent influenza vaccine. Preliminary results, Babecoff said, show M-001 successfully meets both the primary safety and secondary immunogenicity endpoints. 


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


The company plans to obtain regulatory approval for M-001 as a primer to a pandemic or seasonal vaccine. Then, once enough safety and efficacy from real world data has been accumulated, the product will be tested and hopefully approved as a universal standalone vaccine for any existing or future pandemic or seasonal flu. 


Upcoming plans are to administer the 1 mg dose of M-001 in upcoming trails such as the BVX-007 in Europe. This increased dose, Babecoff said, is expected to further improve the immune responses against multiple flu strains when given as a primer or as a standalone product. This dose also may be particularly beneficial to people with weakened immune systems, such as the elderly, according to the company. 


In June, the U.S. Food and Drug Administration accepted BiondVax’s Investigational New Drug Application for its M-001 vaccine. The FDA’s acceptance of an IND authorizes the distribution and administration of medical products in the U.S. that haven’t yet been approved for commercial use so that they may be used to conduct clinical trials. 


The FDA’s okay, Babecoff said, allows the publicly-traded company (Nasdaq: BVXV and Tase: BVXV) to continue its clinical program. The company’s most-recent phase 2 trail for its M-001 was FDA-approved. 


“Our program toward making a universal flu vaccine continues,” said Babecoff, adding that he’s honored to ring Nasdaq’s closing bell on Friday’s trading. 


He and other BiondVax executives have been meeting this week with various U.S.-based institutional investors and financial analysts following the company’s recent initial public offering, which Babecoff said garnered almost $10 million on Nasdaq. 


The money raised, he said, will enable BiondVax to promote and speed up its clinical activities, while developing the business side of operations to benefit shareholders.