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Grant to Develop Chikungunya Virus Vaccine Awarded to Hawaii Biotech

Hawaii Biotech, Inc., in collaboration with Baylor College of Medicine and the Sabin Vaccine Institute at Texas Children’s Hospital, has been awarded a grant by The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, to develop a vaccine to protect against infection caused by the mosquito-borne chikungunya virus.

Senator Hirono and Governor Ige get a firsthand look at Hawaii Biotech's work in developing a Zika virus vaccine

Senator Hirono and Governor Ige get a firsthand look at Hawaii Biotech’s work in developing a Zika virus vaccine

Chikungunya virus is transmitted by the bite of the Aedes aegypti mosquito, the mosquito that also transmits dengue and Zika virus. Common symptoms of chikungunya virus infection are fever and joint pain. Other symptoms may include headache, muscle pain, joint swelling or rash. At this time there is no vaccine to prevent or therapeutic medicine to treat chikungunya virus infection. Chikungunya has emerged as a major arbovirus infection that threatens global public health.

The Small Business Innovation Research Phase I grant will be used to develop a vaccine using Hawaii Biotech’s proprietary recombinant subunit protein vaccine platform, which is also currently being used to develop a vaccine for Zika. The same platform technology was previously used to develop vaccines against similar mosquito-borne viruses including dengue and West Nile, which have been evaluated in human clinical studies.

David Clements, director of Vaccine Research at Hawaii Biotech, will be coordinating development efforts with Dr. Coreen Beaumier, assistant professor at the National School of Tropical Medicine at Baylor and co-director of Product Development at Sabin Vaccine Institute and Texas Children’s Hospital Center for Vaccine Development, together with Dr. Maria Elena Bottazzi, deputy director, and Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor and president of Sabin Vaccine Institute.

“We’re thrilled to partner with Hawaii Biotech on this important vaccine,” said Hotez. “Chikungunya, like Zika, is infecting large populations throughout the Latin America and Caribbean region. In addition, chikungunya transmission has now begun in Texas. This is a disease that will be endemic to the Western Hemisphere for years to come.”

“This award enables Hawaii Biotech to apply our knowledge and experience in recombinant subunit vaccine development to this important emerging disease threat,” said Clements. “The recent outbreaks of both chikungunya and Zika viruses in tropical and sub-tropical areas pose major public health threats to individuals living in these areas, as well as global travelers.”

“Hawaii Biotech is pleased to be able to contribute to the protection of people against illness from these mosquito-borne threats,” added Dr. Elliot Parks, HBI’s CEO.

“This grant offers us an exciting opportunity to partner our expertise in preclinical testing with Hawaii Biotech on an effort to develop a vaccine to Chikungunya virus, an emerging mosquito-borne threat,” said Beaumier.

Hawaii Biotech is also collaborating with Drs. Beaumier and Hotez and others at Baylor and Sabin Vaccine Institute in Houston on the development of a therapeutic West Nile virus vaccine.

“This funding will allow Hawaii Biotech to expand our productive collaborations with our colleagues at Baylor College of Medicine and the Sabin Vaccine Institute,” Parks added.

Hirono, Ige, Public Health, and Emergency Response Experts Raise Awareness, Call for Funding To Fight Zika

Senator Mazie K. Hirono, Governor David Ige, Hawaii Director of Health Dr. Virginia Pressler, State Administrator of Emergency Management Vern Miyagi, Healthcare Association of Hawaii emergency responders, and Dr. Elliot Parks, CEO of Hawaii Biotech today called for increased public awareness and additional federal resources to prepare for and fight the Zika virus in Hawaii and across the country. Senator Hirono and Governor Ige also got a firsthand look at Hawaii Biotech’s work to develop a Zika vaccine.

Senator Hirono and Governor Ige get a firsthand look at Hawaii Biotech’s work in developing a Zika virus vaccine.

Senator Hirono and Governor Ige get a firsthand look at Hawaii Biotech’s work in developing a Zika virus vaccine.

“As Hawaii continues to recover from the recent dengue fever outbreak, we must act before the Zika virus poses a major threat to Hawaii families,” said Senator Hirono. “Bringing together Governor Ige and Zika experts today underscored that we must ensure first responders, state and county governments, and pioneering scientists like Dr. Parks have the necessary resources to face Zika head on. Stopping a widespread U.S. Zika outbreak requires a comprehensive approach and that’s why I’ll continue to push for action on the President’s emergency funding request to fund vector control, education programs, and vaccine development in Hawaii.”

“We all have a stake in preventing the Zika virus and other mosquito borne illnesses from taking hold in Hawaii. We must continue our collaboration and coordinated statewide fight against these illnesses, and with much needed support from the federal government, we will work to reduce the risks here in Hawaii and across the country,” said Governor David Ige.

“Although Zika is not currently circulating in Hawaii and there have been no locally-acquired cases, the mosquitoes that can transmit Zika – the same species that transmit dengue fever and chikungunya – are found in Hawaii, so the virus could be brought into our state by an infected traveler if precautions are not taken,” said Health Director Dr. Virginia Pressler, Hawaii State Department of Health. “All of the cases identified here have been travel-related and infected while outside of Hawaii, and the risk of imported cases increases as we head into warmer summer months and peak travel season. It is crucial for infected individuals to avoid mosquito exposure for three weeks upon their return home. The Department of Health aggressively investigates all reported cases of Zika to reduce the possibility of the disease spreading in our state.”

“We thank Senator Hirono for highlighting the dangerous potential for a Zika outbreak in Hawaii. The recent fight against Dengue has prepared us for Zika however we must continue our efforts to eliminate the mosquito vector. County, state, and Federal agencies can provide support and guidance, but success can only come as the result of a strong and sustained community effort to eliminate the mosquito vector and its breeding grounds,” said State Administrator of Emergency Management Vern Miyagi.

“It’s important for Hawaii to prepare now in order to prevent or minimize a Zika outbreak,” said Chris Crabtree, Interim Director of Emergency Services, Healthcare Association of Hawaii Emergency Services. “HAH Emergency Services has been supporting the efforts of the state and community partners during the dengue outbreak, and is prepared to do the same for future outbreaks of any infectious disease including Zika. Active preparation can prevent or reduce the health impact of disease outbreaks and increase the safety of our residents and visitors. We support any increase in aid to fight Zika.”

“We strongly support Senator Hirono’s call for the Federal government’s leadership in the battle against the Zika virus. Hawaii Biotech is working diligently to rapidly develop a safe and effective vaccine to protect all of us from this dangerous virus,” said Dr. Elliot Parks, CEO of Hawaii Biotech, Inc.

For nearly three months, Congressional Republicans have failed to respond to the President’s emergency funding request, even though the virus continues to spread from South America. In Hawaii, there are nine confirmed cases of Zika since 2015, which includes a case of an infected infant born with microcephaly, a serious birth defect directly linked to Zika. On Friday, the first U.S. death caused by Zika was reported in Puerto Rico.

Senator Hirono is an original cosponsor of federal legislation that would fund the President’s emergency request to provide resources for education and outreach programs, shore up Hawaii health care workers’ response to Zika, increase Hawaii vector control programs, and support the work of companies like Hawaii Biotech, which is racing to develop a Zika vaccine.

Hawaii Biotech Receives Contract To Develop Dengue Vaccine

Hawaii Biotech, Inc. (HBI), announced today that the US Army SBIR Program awarded the company a Small Business Innovation Research (SBIR) Phase I contract to develop an effective dengue vaccine to protect military personnel against this potentially mission-aborting disease.

biotech

Current leading dengue vaccine candidates in clinical trails offer only partial protection and long immunization periods. International travelers and military personnel being deployed to tropical or subtropical regions require more immediate and more complete immunity.

Specifically, HBI will develop and test novel adjuvants to enhance the immunogenicity of an inactivated dengue vaccine candidate. This effort takes the initial steps toward developing the world’s first vaccine capable of rapidly generating complete, lasting protection from dengue fever.

“The growing outbreak of dengue fever in Hawaii highlights the need for stronger containment efforts now, and a commitment to preventing additional outbreaks in the future. This vaccine has the potential to seriously improve the response to dengue fever both in Hawaii, and around the world, and I am pleased that the Army has awarded this important research and development contract to a local Hawaii business,” said Tulsi Gabbard.

“This contract will enable Hawaii Biotech to apply our many years of experience in viral vaccine development and our knowledge of the challenges in developing a dengue vaccine to this important mission,” said Elliot Parks, CEO.

In Phase I, HBI will select suitable adjuvant formulations and then demonstrate protective efficacy in a mouse model with a single dengue serotype. Upon successful completion of Phase I, HBI will be eligible to apply for Phase II funding that will continue development of the inactivated dengue vaccine candidate. This will include expanding the work to all four dengue serotypes to establish feasibility of the required tetravalent vaccine for dengue and additional preclinical efficacy studies. A successful Phase II outcome will provide the basis for advancement of the dengue vaccine into clinical trials needed for regulatory approval and commercialization.

This contract was funded by the Army SBIR Program. The work is managed by the US Army Medical Research and Materiel Command under Contract No. W81XWH-15-C-0120 and will be managed and done in collaboration with the Viral and Rickettsial Diseases Department at the Naval Medical Research Center.

The views, opinions and/or findings contained in this report are those of the author and should not be construed as an official Department of the Army position, policy or decision unless so designated by other documentation. In conducting research using animals, the investigator will adhere to the Animal Welfare Act Regulations and other Federal statutes relating to animals and experiments involving animals and the principles set forth in the current version of the Guide for Care and Use of Laboratory Animals, National Research Council.

Hawaii Biotech Participating in Dengue Clinical Study

biotec

Hawaii Biotech, Inc. President and CEO Elliot Parks,  Ph.D., announced today that the company has initiated a Phase 1 clinical study with their monovalent dengue vaccine candidate.

The double-blind, placebo controlled, dose  escalation safety study in healthy subjects is being conducted at the Saint Louis  University Center for Vaccine Development.

Vaccine recipients in this study will also be monitored for virus neutralizing antibodies.  “This dengue clinical study is an important milestone in Hawaii Biotech’s maturation as a clinical stage company. In addition it confirms the versatility of our subunit vaccine technology platform,” Parks notes. “This Phase 1 study will also prepare us for the initial clinical testing of Hawaii Biotech’s tetravalent dengue vaccine.”

Hawaii Biotech’s dengue monovalent vaccine candidate is the first recombinant subunit vaccine for dengue to enter clinical studies. Previous dengue vaccine candidates tested in the clinic have been either live-attenuated or DNA-based vaccines.

Hawaii Biotech intends to test a dengue tetravalent vaccine candidate, developed using the company’s  recombinant subunit vaccine technology, within a year.

The first phase of clinical development program is designed to assess safety, determine a dose range and identify potential side effects. Results from this clinical study are expected within a year.

Hawaii Biotech’s dengue subunit vaccine candidate has been developed with financial assistance from the National Institutes of Health, the Department of Defense, and the Pediatric Dengue Vaccine Initiative.

About Dengue: Dengue, also known as “break-bone fever,” is a prevalent infectious disease in tropical and subtropical countries throughout the world. Approximately 3.5 billion people live in endemic countries and about 100 million people are infected with dengue every year. Dengue infections result in an estimated 20,000 deaths.

Dengue is caused by one of four closely related, but distinct, virus serotypes (DEN1, DEN2, DEN3, and DEN4), of the family Flaviviridae, which also includes yellow fever, West Nile, Japanese encephalitis, and tick-borne encephalitis viruses. Dengue is transmitted by the bite of a mosquito infected with any one of the four dengue viruses.

Infection with dengue virus results in severe flu-like symptoms that can lead to a life-threatening hemorrhagic fever. During the last quarter century, many tropical regions of the world have seen an increase in dengue cases. The southern United States is potentially susceptible to dengue epidemics as the types of mosquitoes that transmit dengue virus are prevalent there.