Vaccines are big business: The global vaccine market topped $11 billion last year and is expected to nearly double by 2010. Yet ImmunoBiosciences Inc. sees room for improvement both in marketed and experimental vaccines, and believes its Immune Complex Vaccine (ICV) platform technology may hold the answer.

"So far, everything we've tried it on has improved," said Craig Whitfill, president and CEO of the Raleigh, N.C.-based start-up.

The ICV technology combines antigens with neutralizing antibodies specific to those antigens. The resulting immune complex "jump-starts" the immune reaction, Whitfill explained, recruiting more immune elements than a traditional vaccine, which must be recognized and processed by the immune system before antibodies can be created.

"It's a better method of presenting the vaccine to the host," he said, adding that the key is to combine the right amount of antibody and antigen.

Preclinical research indicates the ICV approach can stimulate a stronger immune response, the company said. The complex also is better recognized by the immune system, potentially reducing pathogenic side effects associated with some vaccines.

ImmunoBiosciences has established proof of principle in vaccines for cattle, pigs, dogs and mice, as well as in human models.

The company holds worldwide human and animal usage rights to the technology, which Whitfill developed while working at the University of Arkansas.

Additional ICV data have come from agricultural biotech company Embrex Inc., a wholly owned subsidiary of Pfizer Inc. Whitfill previously served as senior director of manufacturing and technology at Embrex, which licensed rights to the ICV technology for avian vaccines. The company markets two ICV-based poultry vaccines, one for infectious bursal disease virus and one for Newcastle disease virus.

Whitfill left Embrex to found ImmunoBiosciences in 2004. The start-up raised an undisclosed amount of Series A funding in late 2005 from Manti Resources Inc. and Winn Explorations Inc., and is in the process of closing a multi-tranche Series B round.

But Whitfill expects future revenues to come in the form of up-front payments, milestones and royalties from licensees of the ICV technology. ImmunoBiosciences has met with several animal health companies, several of which are preparing to initiate their own proof-of-principle studies to see if ICV can improve their vaccines, he said.

ImmunoBiosciences also is discussing its technology with major human vaccine companies and has received "strong interest," Whitfill said. In addition to potentially improving the safety and efficacy of vaccines, he noted the ICV technology requires less antigen to stimulate an immune response - a potential cost savings for big pharma.

One of the most exciting opportunities Whitfill sees is in flu. In poultry, the ICV technology broadened the immunogenicity of a vaccine so that it provided protection against multiple variants of a virus. If such a benefit could also be conferred to human flu vaccines, it could eliminate the annual burden of strain selection, he said.

Another potential application of the ICV technology is in vaccines for newborns. In current practice, babies receive multiple series of vaccines over the first few weeks of their lives as physicians attempt to hit the window after maternal antibodies weaken so they no longer destroy the vaccine, but before they have weakened to the point where the newborn is exposed to the virus. ICV allows the vaccine to penetrate the maternal antibodies, potentially allowing a single administration to be effective.

Whitfill said the ICV technology also may be applicable to biotech vaccines in development, including therapeutic vaccines.

ImmunoBiosciences is in discussions with relevant biotech companies, he said. In addition to proof-of-principle studies being negotiated with potential pharma and biotech partners, the company also is working with government entities and universities on preclinical studies.