Washington Editor

When it comes to biotech, Hawaii is more than a conference destination.

A Honolulu company, Hawaii Biotech Inc., continues to attract government funding, and last week received $15.5 million through three separate awards. The grants are earmarked to fund preclinical development of its West Nile virus and dengue vaccines, as well as a significant portion of an eventual Phase I trial of the latter vaccine.

"This funds one of the most expensive components for a company like us - preclinical development," President and CEO David Watumull told BioWorld Today. "All the proteins used in our vaccines have to be produced according to cGMP, which is very expensive. Because we received this funding, we can use it for commercial applications for preclinical development."

The grants come from the National Institutes of Health in Bethesda, Md.

For West Nile virus, a $5.9 million Phase II Small Business Innovation Research grant was awarded by the National Institute of Neurological Disorders and Stroke. Its aims include the production, purification and release-testing of the antigens used in the vaccine. It also will fund toxicology studies, process development, potency studies, safety and efficacy studies in monkeys, as well as for preparation of an investigational new drug application.

"The proteins we produce are very native-like," Watumull said. "That's the reason for the robust protection that we saw in [preclinical] West Nile studies."

For dengue fever, a grant worth $6.3 million and another for $3.3 million were awarded by the National Institute of Allergy and Infectious Disease as part of the BioShield program. The first includes funding for manufacturing, release-testing, fill/finish of dengue antigens, mouse immunogenicity studies, an investigational new drug application and for Phase I. The first human study will be conducted in collaboration with CSL Ltd., a pharmaceutical company in Australia. The other grant includes funding for monkey challenge studies, process development, toxicology studies and manufacturing of the monoclonal antibodies used for antigen purification.

Hawaii Biotech believes that vaccines based on its technology are protective but safer than traditional vaccines, and the proteins serve as new or improved targets for small-molecule therapeutics.

The company, which was founded in 1982 by nine professors at the University of Hawaii, still collaborates with the school and others on emerging diseases and bioterrorism threats such as West Nile, new flu strains, anthrax, dengue, Ebola and severe acute respiratory syndrome. Hawaii Biotech also boasts virtually unlimited production capability. It plans to create a warehouse of FDA-approved vaccines to rapidly vaccinate large numbers of people.

The grants bring total federal funding for Hawaii Biotech's emerging disease and bioterrorism program to more than $31 million, including $12 million in Department of Defense and NIH anthrax funding, as well as smaller federally funded projects in Ebola, malaria and tick-borne encephalitis. The company also has a self-funded flu program.

Outside of such areas, Hawaii Biotech also has a cardiovascular program directed toward inflammatory causes of the disease.

"We believe we have a new class of compounds," Watumull said, "that can impact inflammation without the side effects of other anti-inflammatory drugs."

That program was integrated into the company three years ago, when Watumull came on board to run the business. He merged his former company, based on that cardiovascular program, with the vaccine technology already in development at Hawaii Biotech. A year ago, the company raised $8.5 million in its first round of venture capital financing, and continues to move forward with its variety of programs.

"We're going to keep our heads down and, in the next 12 to 15 months, work on our two lead projects for West Nile virus and cardiovascular disease through to IND," Watumull said.

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