BioWorld International Correspondent
ZICHRON YA'AKOV, Israel - Israeli start-up BiondVax Pharmaceuticals Ltd. has opened its first financing round, raising $4 million for an intranasal flu vaccine that would be effective over several years against all flu strains tested thus far, and those not yet evolved, it said.
BiondVax Founder and CEO Ron Babecoff told BioWorld International that the company could reach Phase II trials early in 2006 with no further funding needed.
Babecoff, trained in veterinary medicine, explained that the vaccine showed high activity in flu-infected mice that had been irradiated to destroy the native immune system and transplanted with human white blood cells. None of the more than 100 humanized mice vaccinated and exposed to full activation of the virus died, while all the unimmunized humanized control mice died.
The vaccine was created by immunologist Ruth Arnon during two decades of research at the Weizmann Institute of Science in Rehovot. Arnon was co-developer of Copaxone, the multiple sclerosis drug produced by Teva Pharmaceutical Industries Ltd., of Jerusalem.
"The vaccine is unique," Babecoff said. "Arnon integrated the conserved regions thus far common to all flu viruses tested. We found that the antibodies raised are effective against the Asian flu, the H5N1 flu [and in] mice with a life space of 24 months - that could be several years in humans."
Since the tests were done in humanized mice, Babecoff predicted a high likelihood of success in clinical trials of the vaccine that has been patented around the world.
"Once we are past Phase I and II, we will look for a major strategic financing partner for final clinical trials, and to register the vaccine in the U.S. with the FDA and worldwide," Babecoff said.
The nasal vaccine might be an advance over injected flu vaccines that are good for only one season and have complications that can be deadly in the elderly and ill. Also, it would continue to work for several years against new strains that appear every season by mutation.
About 220 million people get flu shots each year, and the market for flu vaccines is estimated to reach $2 billion by 2007, according to research done by Merrill Lynch, as the strains become more virulent.
Babecoff emphasized that the BiondVax vaccine might be able to stop epidemics and even the pandemics that re-occur every decade with new mutated strains.
"This is a truly universal flu vaccine," he said.