BioWorld Today

By Randy Osborne, Staff Writer

With a progressive strategy that’s “building an ecosystem,” Biondvax Pharmaceuticals Ltd. offered upbeat preliminary results from the BVX-006 phase II trial gauging the worth of M-001 in the Ness Ziona, Israel-based firm’s quest for a universal influenza vaccine, and analyst Ashok Kumar at Aegis Capital Corp. tagged what could be alluring prospects for would-be partners or buyers of the firm.

Biondvax uses a combination of conserved epitopes – which are common to most human flu virus strains regardless of their antigenic drift and shifts – derived from the flu virus as immunogens to make the vaccine. The idea is to activate the immune system in a longer-lasting way that could mean protection against not only the known strains of flu but future ones as well. Autoimmune trouble is unlikely since the epitopes aren’t found outside the virus.

The firm’s thesis continues to hold up. In the study, M-001 was injected intramuscularly to volunteers between the ages of 50 and 65, followed by a dose of the 2014-15 season trivalent flu vaccine three weeks later. Safe and well tolerated, the treatment sparked humoral immune responses, meeting the primary safety and secondary immunogenicity endpoints. As expected, elevated immune responses turned up to strains not included in the current seasonal flu shot, including drifted H3N2, the culprit of this year’s epidemic in the U.S.

Officials at the company could not be reached, but Kumar wrote in a research report that the Biondvax’s business development methodology could bring even bigger wins down the road. A larger, 222-patient phase IIb trial is ongoing in Europe in subjects ages 18 to 49. Called BVX-007, the study is part of a partnership with the UNISEC (Universal Influenza Vaccines Secured) consortium, established to develop a universal vaccine. The BVX-007 experiment will give M-001 followed by H5N1 pandemic vaccine, and results are due in the second half of next year. Once that study is finished, the firm will probably have enough data to start phase III trials in the U.S. to test the efficacy of M-001 in a large patient population that would include three targeted indications: universal seasonal primer for the elderly; universal pandemic primer; and universal standalone vaccine.

The Gates Foundation has invested $200 million in the development of RTS,S malaria vaccine at Glaxosmithkline plc, of London, and at Rockville, Md.-based Sanaria Inc., oil and energy companies are helping to pay for the development of malaria vaccine PfSPZ, Kumar noted. “While the primary motive of the U.S. oil companies is philanthropic, there are also economic drivers,” he pointed out. “There is a possibility that Biondvax could get public and/or industry funding due to the end point of improved public health and security against pandemic influenza.” It’s “increasingly common” for small biotech firms to handle early developmental steps and then cut licensing or merger/acquisition deals with established vaccine manufacturers and such could be the fate of Biondvax, he added. (See BioWorld Today, Jan. 29, 2008.)

Shares of Biondvax (NASDAQ:BVXV) closed Tuesday at $4.95, down 15 cents.

Flu has been much in the news lately. This week, Meriden, Conn.-based Protein Sciences Corp. disclosed top-line data showing that Flublok Quadrivalent – the quadrivalent version of FDA-approved trivalent Flublok shot – outperformed a traditional flu vaccine last season. The company disclosed the results of a trial comparing Quadrivalent to a traditional egg-based quadrivalent inactivated vaccine, finding superior performance of Flublok based on a significantly lower number of people contracting the flu after getting Quadrivalent. Enrolling about 9,000 subjects, ages 50 and older, the study gave half of them Quadrivalent and the other half got quadrivalent inactivated flu vaccine, egg-derived. Thirty-one percent more people were protected by Flublok than by the egg vaccine. The FDA seemed sold already. In the first part of June, U.S. regulators granted exclusivity to Flublok for a period of 12 years, an uncommon event that heads off any product similar to Flublok winning approval by the FDA before Jan. 16, 2025. Also in June, Melbourne, Australia-based CSL Ltd. and Biocryst Pharmaceuticals Inc., of Research Triangle Park, N.C., entered a licensing deal for the FDA-approved influenza treatment Rapivab (peramivir) that brought $33.7 million aboard for Biocryst, with as much as $12 million more possible if regulatory milestones are hit, while letting the firm keep rights to U.S. pandemic stockpile orders. Indicated for acute uncomplicated flu in adults 18 years and older, the neuraminidase inhibitor Rapivab is also licensed for use in Japan and Korea. CSL’s subsidiary Biocsl gets rights to commercialize the products in territories excluding those two along with Taiwan and Israel, and will take on the stockpiling responsibility outside the U.S. Tiered royalties are part of the deal, too. (See BioWorld Today, June 18, 2015.)