Profectus BioSciences and Emergent BioSolutions Receive $25 Million CEPI Contract to to Develop Nipah Virus Vaccine

Profectus BioSciences and Emergent BioSolutions Receive $25 Million CEPI Contract to to Develop Nipah Virus Vaccine
<span>CEPI&mdash;the Coalition for Epidemic Preparedness Innovations&mdash;today announced a collaboration with Profectus BioSciences, Inc. and Emergent BioSolutions Inc. (NYSE:EBS) under which Profectus and Emergent will receive up to $25 million to advance the development and manufacture of a vaccine against the Nipah virus (NiV), a bat-borne virus that can spread...</span>

CEPI—the Coalition for Epidemic Preparedness Innovations—today announced a collaboration with  Profectus BioSciences, Inc. and  Emergent BioSolutions Inc.  (NYSE:EBS) under which Profectus and Emergent will receive up to  $25 million  to advance the development and manufacture of a vaccine against the Nipah virus (NiV), a bat-borne virus that can spread to both humans and livestock.


Under the terms of the Framework Partnering Agreement for the collaboration among the three parties, Profectus will receive development funding from CEPI for advancing its Nipah virus vaccine and Emergent will provide technical and manufacturing support for the CEPI-funded program. Emergent, through a separate agreement with Profectus, has an exclusive option to license and to assume control of development activities for the Nipah virus vaccine from Profectus. The international nonprofit organization PATH will also be working with the consortium under a separate agreement with CEPI to work on clinical development.

Nipah virus and Hendra virus (HeV) are closely related Paramyxoviruses that cause respiratory and encephalitis disease in a variety of animal hosts and in humans. A natural reservoir for these viruses are flying foxes (bats of the genus Pteropus) found in Southeast Asia and Malaysia. Human infection occurs after direct exposure to tissues and secretions from infected horses, pigs, and bats. There is currently no approved vaccine or therapeutic against either NiV or HeV. The primary treatment for human cases is intensive supportive care, and the mortality rate is high at approximately 75% of cases.

The Southern India state of Kerala is currently in the midst of a Nipah virus outbreak, where the virus has killed 10 people. These are the first documented cases in Kerala.

Previously unidentified, a 1999 NiV outbreak killed 105 people in Malaysia. In addition, more than one million pigs were slaughtered to stem the spread of the virus, which caused significant trade loss and market turmoil. Outbreaks occur annually in Bangladesh and have been reported numerous times in India (CDC). NiV has a 75 percent mortality rate1. NiV is shed by bats in Southeast Asia and Malaysia and is transferred to humans via bat urine and saliva on fruit or from infected horses and pigs. It can also spread human-to-human.

Dr. Richard Hatchett, CEO of CEPI, said:

“The current outbreak of Nipah in India, the government of which is one of CEPI’s founders, demonstrates that this is a deadly pathogen that has already travelled thousands of kilometers, has serious epidemic potential and the ability to surprise us. This is the first funding agreement we have signed to develop a vaccine against Nipah and our partnership with Profectus, Emergent, and PATH represents a vital move forward in the global battle against this devastating disease.”

The 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.

Thomas Lynch, Chair and CEO of Profectus BioSciences, said:

“Profectus gratefully acknowledges CEPI’s leadership and funding of this strategic collaboration to rapidly produce a vaccine against the emerging Nipah virus threat. Nipah’s human-to-human transmission has been documented, and any initially small outbreak could take the same course as the recent Ebola outbreak. With CEPI’s support and the talents of these highly regarded global health innovation partners, we look forward to applying our expertise and technologies and leveraging our partnership with Emergent to rapidly advance our pre-IND vaccine candidate for Nipah virus as an effective countermeasure that will be positioned to save patients around the world from this devastating disease.”

Daniel J. Abdun-Nabi, CEO of Emergent BioSolutions, said:

“Emergent has a 20-year track record of success working with government and industry partners to provide life-saving medical countermeasures against identified biological agents particularly when a rapid response to an emerging outbreak may be necessary. We look forward to leveraging our expertise in advanced development and manufacturing, including our U.S. government-designated Center for Innovation in Advanced Development and Manufacturing, which is designed to provide surge manufacturing capabilities during public health emergencies. We expect to work closely with Profectus enabling our companies to provide synergistic and complementary capabilities for a successful collaboration with CEPI.”

Steve Davis, President and CEO of PATH, on the PATH-CEPI partnership:

“PATH is delighted to partner with CEPI and leverage the end-to-end capabilities of our Center for Vaccine Innovation and Access (CVIA), particularly our success record in clinical development and scaling the introduction of new vaccines in low-resource settings. PATH looks forward to collaborating with CEPI to achieve our shared goals for epidemic preparedness by equipping the world with new tools to protect against these deadly threats.”