Hawaii Biotech believes that its experience and ability in producing protein antigens allows the Company to develop vaccines targeting numerous infectious diseases. These prophylactic vaccines are well suited to meet demanding requirements for safety, production yield, rapid response, and efficacy. The Companys vaccine technology is based on the production of high quality recombinant proteins using stable insect cell lines. The high quality of the proteins produced results in immune responses equivalent to, or better than, traditional live or inactivated virus approaches. Furthermore, the purified recombinant proteins provide for an improved safety profile. This platform technology is applicable to a wide variety of diseases including West Nile, dengue, tick borne encephalitis, influenza, hepatitis C, malaria, Japanese encephalitis, Ebola, Eastern equine encephalitis, and others. We have focused our attention on the development of vaccines against West Nile, dengue, and tick borne encephalitis viruses. Analysis by X-ray crystallography of one of HBIs dengue proteins was featured on the cover of the journal Nature (January 22nd, 2004).
Virtually unknown in the U.S. prior to 1999, the West Nile virus is now prevalent throughout the U.S. and Canada. While the majority of human infections result in mild to no symptoms, more severe forms of the disease can result in long term neuropathological effects and even fatalities. In mild cases flu-like symptoms are common but in the more severe cases encephalitis, meningitis, or polio-like symptoms are reported. In 2006 a total of 4,269 cases were reported by CDC across the U.S. One hundred seventy seven of these cases were fatal.
Live, attenuated virus approaches used by potential competitors have a small, but nevertheless real risk of causing severe, encephalitic West Nile disease. Hawaii Biotechs approach utilizes purified recombinant proteins that cannot cause disease and provide a substantial safety advantage.
Unlike most human viral diseases, West Nile causes both disease and death in animals. A well-validated model of human West Nile disease, the golden hamster, has been developed by Robert B. Tesh, M.D., of the University of Texas Medical Branch--Galveston and one of the leading researchers in this field. Dr. Tesh and his colleague, Dr. Douglas Watts have conducted several studies using various formulations of Hawaii Biotechs West Nile vaccine in this model. The results have shown that the vaccine provided 100% protection (all animals survived and remained healthy), while 50-75% of the control animals (animals not given vaccine) died and those not dying were sick.
Duane Gubler, ScD, former director of the Department of Vector Borne Infectious Disease (DVBID) at the Centers for Disease Control (CDC) and director of the Asia-Pacific Institute of Tropical Medicine and Infectious Diseases at the John A. Burns School of Medicine at the University of Hawaii, and now the director of the Signature Research Program in Emerging Infectious Diseases at the Duke-NUS Graduate Medical School in Singapore, is a consultant to Hawaii Biotech on this project.
Hawaii Biotech initiated an ascending dose Phase 1 clinical study of a recombinant protein West Nile virus vaccine in May of 2008 in Honolulu. Preliminary results in healthy human subjects suggested that this vaccine was well tolerated and produced neutralizing antibody titers in these volunteers.
Dengue is expanding globally with an estimated 50 million to 100 million cases of dengue world-wide annually with more than 20,000 deaths. It is carried by mosquitoes and causes severe flu-like symptoms that can lead to a life threatening hemorrhagic fever.
The potential annual dengue vaccine market is expected to be up to $1 billion, with a travelers' market of $300-$400 million annually. More than 90% of these revenues are attributable to travelers from the U.S., Europe, and Japan - who make more than 50 million visits per year to dengue endemic areas.
Hawaii Biotechs dengue vaccine solves previously insurmountable technical hurdles that have stymied dengue vaccine research for more than forty years. Using genetically engineered proteins from all four serotypes of dengue viruses, we are able to induce immunity in animals to all four dengue viruses - or tetravalent immunity. Alternative approaches have induced immune responses in humans against only one or two of the four dengue viruses, increasing the risk of the life-threatening, hemorrhagic form of the disease.
Animal efficacy trials have been completed and pre-clinical development has been funded in part with grants from the NIH-NIAID and the Pediatric Dengue Vaccine Initiative.
In August of 2009, Hawaii Biotech initiated a double-blind, placebo controlled, dose escalation safety study in healthy subjects Phase 1 clinical study in healthy subjects with a monovalent recombinant protein dengue virus vaccine at the Saint Louis University Center for Vaccine Development. Preliminary analysis of the results obtained in 2010 suggested that this vaccine was well tolerated and produced neutralizing antibody titers in these volunteers.