SBIR and STTR Success Story for
Hawaii Biotech, Inc.

(Information Posted/Updated on 08/10/2007)

Hawaii Biotech, Inc.
99-193 Aiea Heights Drive
Suite 200
Aiea, HI  96701

Contact:    Carolyn L. Weeks-Levy, Ph.D.
Phone:      808.792.1392
Fax:          808.792.1343
Web Site:

Project Title:  Recombinant Vaccine Development and Commercialization
Related Award(s):  R43, R44, UO1, UC1
Technology Developed:
Through the generous support of the SBIR Program among other prestigious sources, Hawaii Biotech has developed a protein production platform for the development of vaccines targeting numerous infectious diseases with the aim of meeting requirements such as safety, production yield, rapid response, and efficacy. The Company’s vaccine technology is based on the production of high quality recombinant proteins. The high quality of the proteins produced in this system result in immune responses equivalent to or better than traditional live or inactivated virus approaches. Furthermore, the purified recombinant proteins provide for a significantly improved safety profile. This platform technology is applicable to a wide variety of diseases including West Nile, influenza, dengue fever, hepatitis C, malaria, Japanese encephalitis, Eastern equine encephalitis, and others.

Key Words:  vaccine, recombinant, West Nile, malaria, influenza, dengue.
Uses of Technology/Products/Service:
The Company’s lead development projects using the protein production platform are a West Nile vaccine, seasonal influenza vaccine and dengue vaccine.

Proof-of-concept animal studies show that a number of HBI prototype vaccine formulations against West Nile are efficacious in the well-validated golden hamster model; similarly, positive immune response data have been obtained in mouse models with a prototype vaccine against influenza virus. The Company intends to file an Investigational New Drug application (IND) with the US Food and Drug Administration (FDA) to begin human clinical trials with its West Nile vaccine in 2007. Hawaii’s ethnically-diverse population makes it an ideal location to conduct such Phase I studies, and the local clinical research infrastructure is well-developed. Hawaii Biotech enjoys exceptional community and regional support, as Hawaii’s legislators work to diversify the State’s economy that currently, is heavily reliant on service-oriented industries.

Also in 2007, the Company has embarked on the development of its recombinant Influenza vaccine, designed to be safer than the current generation of Influenza vaccines manufactured in eggs. Once established, this technology could be applied to the development of a pandemic influenza vaccine as well. Finally, HBI’s dengue vaccine formulations have been tested in both mouse and primate studies for ability to induce protective immune responses. These studies have demonstrated that high titer virus neutralizing antibodies (PRNT) are induced by several candidate formulations and that these formulations protect against viremia following challenge with live dengue virus.

Benefit to Company:
Since 2001, Hawaii Biotech has successfully competed for more than $30 million in Federal and State grants, including those available through the SBIR mechanism. In turn, this validation of our scientific programs by the nation’s top researchers, and the exceptional commercial potential of the Company’s SBIR-funded product candidates, has been leveraged to attract additional millions in private investment and Hawaii State matching funds. Together, this investment has enabled the Company to grow during the past two decades from 15 to 50 highly-trained biotechnology employees; outfit 20,000 square feet of state-of-the-art molecular biology, cell culture and protein biochemistry laboratories; complete the preclinical development program and design the clinical development program for two product candidates (West Nile and dengue fever vaccines); obtain robust proof-of-concept data supporting vaccine development for other diseases such as tick-borne encephalitis and malaria and funding positive preliminary data for influenza. In addition this support has provided scientific assistance to biodefense researchers in the U.S. Department of Defense as well as to pathogen detection researchers in the U.S. Department of Agriculture. Other collaborators that have benefited from scientific and commercial collaboration with Hawaii Biotech include the University of Texas Medical Branch, Harvard Medical School, University of Hawaii and Walter Reed Army Institute of Research.

Hawaii Biotech has also generated $2 million in licensing royalties and product sales; spun-off a Federally-funded Drug Discovery division which acquired research projects involving Anthrax, Ebola and Botulism; now known as PanThera Biopharma, LLC; in addition to forming a separate privately-held biotechnology company, Cardax Pharmaceuticals, Inc. that is completing the preclinical development of a cardiovascular product candidate.

How Product Was Commercialized:
The recombinant vaccine products will be commercialized following safety and efficacy clinical trials in appropriate populations. HBI will focus on licensing its pipeline of vaccine candidates in order to achieve a stream of revenues from licensing fees, milestone payments and royalties.

Other Comments Related to Company's Success Story:
In recent years, the Hawaiian legislature has appropriated funds for a new $150 million biomedical research facility at the University of Hawaii; and, very recently, $12.5 million in matching funds for a $25 million NIH-sponsored Regional Biosafety Laboratory (RBL). NIH funded this new RBL specifically to develop early warning disease detection systems for imported pathogens such as pandemic Influenza, to which Hawaii is highly vulnerable. It will be among a series of Level 3 Biosafety Labs built across the nation funded by NIH. The RBL is meant to enable local researchers to develop new diagnostic tests, drugs and vaccines for infectious Asia-Pacific diseases such as avian influenza, SARS, tuberculosis and West Nile encephalitis. Given that mission, it’s clear that Hawaii Biotech stands to benefit from these government-sponsored initiatives.

Past R&D and/or Sales from this Project:   $30 million
Estimated Future Annual R&D and/or Sales from this Project:   $20.2 million