UH Med Now

The John A. Burns School of Medicine (JABSOM), University of Hawaiʻi at Mānoa, and Hawaii Biotech, Inc. (HBI) have agreed to partner in the clinical development of a Filovirus vaccine. In the UH Ebola vaccine work, no infective virus will be in Hawaiʻi. There is zero risk from this work of human or animal infection. (Why? Read more about this type of technology HERE.)

The first generation recombinant subunit vaccine is aimed at providing protection against infection by the Ebola virus. There are currently no vaccines licensed for use against Ebola Virus Disease and other diseases caused by closely related viruses. Ebola vaccine candidates currently in clinical development have yet to demonstrate safety and efficacy in humans to gain regulatory approval.

The Filovirus vaccine was originally developed by Dr. Axel Lehrer and others at HBI while Dr. Lehrer was an employee with the company. Last year, Dr. Lehrer assumed a position with UH Mānoa, which allowed Dr. Lehrer to continue his important work on the development of the vaccine candidate within the JABSOM Department of Tropical Medicine, Medical Microbiology and Pharmacology. Based upon promising results from testing the recombinant Ebola vaccine candidate in animal models (this testing occurred on the U.S. mainland via collaborations with several biosafety laboratories) and the renewed interest in a safe and effective Ebola vaccine triggered by the current Ebola outbreak in West Africa, JABSOM, UH Mānoa and HBI have agreed to join forces to bring this vaccine into clinical studies. While the initial vaccine to be tested in humans is designed to protect against the Ebola virus alone, research at JABSOM and HBI is underway to formulate a trivalent vaccine that will also protect against two other closely related filoviruses, the Sudan virus and the Marburg virus.

“This partnership will leverage the research capability and the expertise in tropical medicine here at JABSOM with HBI’s experience in developing commercially viable vaccines against viruses that infect humans,” said Dr. Vivek R. Nerurkar, professor and chair of the Department of Tropical Medicine, Medical Microbiology and Pharmacology and director of the JABSOM Biocontainment Facility at UH Mānoa.

“We are delighted to be working closely with the Department of Tropical Medicine at UH Mānoa and contributing our long-standing experience in developing subunit vaccines to protect against hemorrhagic and neuro-invasive viruses,” said Dr. Elliot Parks, CEO of HBI. “Ours is a productive partnership with UH Mānoa which mutually strengthens our respective contributions to this joint vaccine development program. This joint collaboration furthers our goal to continue development of vaccines for emerging infectious diseases.”

Under this partnership, HBI will contribute commercial expertise in the manufacture of this vaccine and its components, quality assurance and control, clinical conduct, and regulatory affairs. The ultimate goal is a safe and effective Ebola vaccine to protect humans from this dangerous, and too often lethal, virus causing hemorrhagic fevers.

Dr. Axel Lehrer, the principal investigator, added, “I am pleased to have the opportunity to continue research on this vaccine candidate within the Department of Tropical Medicine, Medical Microbiology and Pharmacology at UH Mānoa. Retaining a relationship with HBI and its talented team whom I know well will help to assure continuity with the advanced development activities. HBI’s commercial sensibilities will complement the academic research environment at UH Mānoa”.

About Hawaii Biotech, Inc. (HBI):
Hawaii Biotech is a privately held biotechnology company focused on the development of prophylactic vaccines for established and emerging infectious diseases and anti-toxin drugs for biological threats. HBI has developed proprietary expertise in the production of recombinant proteins that have application to the manufacture of safe and effective vaccines, diagnostic kits, and as research tools. HBI completed successful first-in-human Phase 1 clinical studies with both West Nile virus and dengue vaccines in healthy human subjects. HBI has developed a product pipeline of recombinant subunit vaccines, including vaccine candidates for West Nile virus, tick-borne flavivirus, malaria, Crimean-Congo hemorrhagic fever, and Ebola. The company is also continuing the development of small molecule anti-toxin drugs for anthrax and botulism. HBI, founded in Hawaii in 1982, is headquartered in suburban Honolulu. For more information, please visit: www.hibiotech.com