CEPI, Emergent and Profectus Enter Vaccine Mfg. pact

CEPI (the Coalition for Epidemic Preparedness Innovations) has unveiled a new collaboration with Profectus BioSciences and Emergent BioSolutionsunder which they will receive up to $36 million to advance the development and manufacture of a vaccine against the Lassa virus-an estimated 100,000 to 300,000 cases of Lassa virus infection occur each year, according to the U.S. CDC.

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 Lassa virus vaccine. CEPI will provide $4.3 million to support the first phase of the project, with options to invest up to a total of $36 million over five years, including procurement of the vaccine for stockpiling purposes. Emergent will provide technical and manufacturing support for the CEPI-funded program.

Through a separate agreement with Profectus, Emergent has an exclusive option to license and to assume control of development activities for the Lassa-virus vaccine from Profectus. The global non-profit organization PATH will also be working with the consortium under a separate agreement with CEPI to work on clinical development. This is CEPI's second award to the collaboration following an award in May, 2018, for the development of a Nipah virus vaccine.

The Lassa virus is endemic in Benin, Ghana, Guinea, Liberia, Mali, Sierra Leone, and Nigeria, but probably exists in other West African countries as well. There is currently no approved vaccine that protects against Lassa virus.

This year has seen outbreaks of Lassa virus in Liberia, Nigeria, Sierra Leone, and South Sudan, with Nigeria facing its largest ever outbreak of the disease.

"With 472 confirmed cases to date and 121 deaths, 2018 has seen Nigeria battle its largest documented outbreak of Lassa virus on record," said Richard Hatchett, chief executive officer, CEPI. "Lassa fever continues to be a threat to public health in many parts of West Africa and has clearly demonstrated its potential to cause severe epidemics. In view of its epidemic potential, the World Health Organization has identified Lassa virus as a priority pathogen that needs further research and development. But despite the urgent need, no approved vaccine against the virus is currently available. CEPI's investment of up to $36 million, over a five-year period, adds another Lassa vaccine candidate to CEPI's growing portfolio and demonstrates our commitment to addressing this terrible disease."

Thomas Lynch, chief executive officer, Profectus BioSciences, said, "Profectus is pleased to partner with CEPI, Emergent, and PATH in the development of our VesiculoVax-vectored vaccine to protect against Lassa fever. Jointly we can address the substantial unmet medical need of those living in, or travelling to, areas where Lassa virus is endemic."

"Through our collaboration with Profectus, CEPI, and PATH, Emergent is pleased to be part of the solution to provide medical countermeasures for emerging infectious diseases where there are none currently such as for Lassa fever," said Daniel Abdun-Nabi, chief executive officer, Emergent BioSolutions. "Our Center for Innovation in Advanced Development and Manufacturing is designed for surge manufacturing during public health emergencies, when they count the most."

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