May 24, 2018
HJF today announced a license agreement of the vaccine for Nipah virus and Hendra virus from the Joint Technology Transfer Office of the Uniformed Services University (USU) and HJF. The license, supported by the Coalition for Epidemic Preparedness Innovations (CEPI), has been awarded to Profectus BioSciences, Inc. and Emergent BioSolutions Inc. (NYSE: EBS) who will collaborate to develop the human vaccine for Nipah and Hendra viruses. This investment of up to $25 million represents an innovative approach to funding vaccine development, unlocking research and development potential so that vaccines are ready for efficacy studies during an outbreak. The agreement will enable funding for development efforts over a five-year period.
“The current Nipah virus outbreak in India makes the development of a human vaccine an immediate need,” said Dr. Joseph Caravalho, President and CEO of HJF. “Enabling the transfer of medical findings between military research initiatives and private sector researchers is a key part of HJF’s vision to advance military medicine for the mutual benefit of military and civilian populations.”
Nipah virus and Hendra virus emerged in the 1990s causing serious disease outbreaks in humans and livestock in Australia, Malaysia, Singapore, Bangladesh and India. Recent Nipah outbreaks have resulted in acute respiratory distress syndrome and encephalitis, person-to-person transmission, and greater than 75 percent case fatality rates among humans. The viruses are found naturally in several species of Pteropid fruit bats (flying foxes). There is currently an outbreak of Nipah in India in a new location, where the death toll has risen to 10 in India's southern state of Kerala. Nipah’s human-to-human transmission has been documented, and an initially small outbreak could take the same course as the recent Ebola virus outbreak witnessed in West Africa.
The vaccine is based on Nipah virus and Hendra virus technology developed over more than 15 years by Dr. Christopher Broder and Dr. Katharine Bossart in the Department of Microbiology and Immunology at USU. The vaccine has already been evaluated in multiple animal models and has been demonstrated to be completely protective against not only Nipah virus infection but also Hendra virus infection, Nipah’s close relative. A formulation of this vaccine has been shown to be effective in preventing Hendra virus infection of horses in Australia where HJF licensed it to Zoetis Inc., who has marketed it since 2012.
HJF, through the USU-HJF Joint Office of Technology Transfer, licensed the technology to Profectus Biosciences to develop a version of the vaccine suitable for use in people. Dr. Broder, of USU, and Dr. Antony Dimitrov, of Profectus Biosciences, started their Nipah virus and Hendra virus collaboration in 2011 with support from the National Institutes of Health, Bethesda, Maryland. That pre-clinical Nipah vaccine support was critical in bringing this project to the current stage of development. As a next step in the Nipah vaccine development for use in people, Dr. Thomas Geisbert, at The University of Texas Medical Branch at Galveston and the Galveston National Laboratory, will conduct the preclinical studies at its biosafety level 4 facility; and HJF, USU, and Profectus will collaborate on the development of a clinical assay for the evaluation of the anti-Nipah virus vaccine response.
“Based on the success of this vaccine technology against both Nipah virus and Nipah’s close relative, Hendra virus, it is highly likely that the Nipah vaccine to be developed here will also work against Hendra virus,” said Dr. Broder.
The vaccine component is just a single protein from the virus known as the G glycoprotein which is produced in a soluble form (sG) in cell culture by genetic means and purified to exceedingly high levels. No virus or any infectious agent is involved in the production of the sG glycoprotein vaccine. “It is a single dose, extremely safe, simple and highly effective vaccine that has proven time and time again to provide complete protection against two incredibly deadly viral pathogens that are a biological threat to not only people but important livestock as well,” said Dr. Broder.
Katharine Bossart, Ph.D., founder and CEO of Integrated Research Associates, LLC, in San Rafael, CA, developed the sG vaccine with Dr. Broder while a student in his laboratory at USU. “Since the vaccine is just a recombinant piece of the virus, it is a type of vaccine known as a subunit, thus making it extremely safe to use,” Dr. Bossart said.
The Nipah and Hendra virus use the G glycoprotein to attach to and infect cells. Nipah and Hendra can infect and cause serious and often highly fatal disease in people and also in pigs, horses, cats, dogs, and several other animal species. When used as a vaccine, the immunized subject develops antibodies that bind to the virus’ G glycoprotein and effectively neutralizes the virus preventing it from infecting cells within the host.
Dr. Broder, in collaboration with Dr. Dimiter Dimitrov, who is now a professor at the University of Pittsburgh, developed an antibody therapy as a treatment against Nipah and Hendra virus previously. This antibody was given to the government of Queensland, Australia for humanitarian purposes and has been successfully tested in a Phase 1 clinical trial in that country.
See related press release from CEPI, dated May 24, 2018, at http://cepi.net/node/285.