Themis Bioscience and CEPI – the Coalition for Epidemic Preparedness Innovations – announced today  a partnership under which Themis will provide advanced vaccine development and manufacturing for Lassa fever and MERS.

MERS/CDC
MERS/CDC

This is the first company agreement that CEPI has signed since it was established in 2017 as a coalition to finance and coordinate the development of new vaccines to prevent and contain infectious disease epidemics.

The investment of up to $37,500,000 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 Themis’ development efforts over a five-year period. Additional financial details were not disclosed.

Lassa fever is a disease endemic in West Africa associated with annual outbreaks. An ongoing outbreak in Nigeria is believed to have infected nearly a thousand people and caused 90 deaths this year alone. MERS, first identified in 2012, causes a severe respiratory illness and has been associated with a number of outbreaks in Saudi Arabia and neighboring countries.

Individuals acquiring these diseases in the regions of origin occasionally travel to other locations, becoming ill in areas outside the endemic regions. In 2015, for example, an individual returning to South Korea from the Middle East caused a large outbreak there that resulted in 186 cases and 36 deaths. The outbreak affected 24 hospitals, led to the temporary closure of more than 2000 schools, and had a significant impact on the South Korean economy.

Dr Richard Hatchett CEO of CEPI said:

“Establishing our partnership with Themis represents not only an important step in our journey towards tackling these diseases, but also a breakthrough in how we can partner and work with vaccine developers when traditional market incentives for development have failed.”

Image/ C. S. Goldsmith, P. Rollin, M. Bowen This transmission electron micrograph (TEM) depicted numbers of Lassa virus virions adjacent to some cell debris. The virus, a member of the virus family Arenaviridae, is a single-stranded RNA virus, and is zoonotic, or animal-borne that can be transmitted to humans. The illness, which occurs in West Africa, was discovered in 1969 when two missionary nurses died in Nigeria, West Africa.In areas of Africa where the disease is endemic (that is, constantly present), Lassa fever is a significant cause of morbidity and mortality. While Lassa fever is mild or has no observable symptoms in about 80% of people infected with the virus, the remaining 20% have a severe multisystem disease. Lassa fever is also associated with occasional epidemics, during which the case-fatality rate can reach 50%. There are a number of ways in which the virus may be transmitted, or spread, to humans. The Mastomys rodents shed the virus in urine and droppings. Therefore, the virus can be transmitted through direct contact with these materials, through touching objects or eating food contaminated with these materials, or through cuts or sores. Because Mastomys rodents often live in and around homes and scavenge on human food remains or poorly stored food, transmission of this sort is common. Contact with the virus also may occur when a person inhales tiny particles in the air contaminated with rodent excretions. This is called aerosol or airborne transmission. Finally, because Mastomys rodents are sometimes consumed as a food source, infection may occur via direct contact when they are caught and prepared for food.
Image/
C. S. Goldsmith, P. Rollin, M. Bowen

“As we can see with the current outbreak of Lassa fever in Nigeria, these diseases devastate lives and have far reaching economic consequences. Vaccines are a vital part of our fight against them but their development is costly, complex and challenging.”

Themis has established a versatile technology platform for the discovery, development and production of vaccines as well as other immune system activation approaches. The company will apply its platform technology to discoveries made by Institut Pasteur and the Paul Ehrlich Institut on Lassa fever and MERS, respectively, and will advance those vaccine candidates up to human proof-of-concept and safety studies.

Dr. Erich Tauber, CEO and founder of Themis said:

“This agreement is a substantial validation of our technology and capabilities. It also allows us to move several programs forward as part of CEPI’s initiative and in collaboration with leading institutions worldwide, which is an honor.”

“CEPI’s support will enable us to drive the development of these vaccines while we continue our own clinical and preclinical development programs.”

The investment with Themis is the first in CEPI’s planned portfolio programme. CEPI’s investments will support development up to the end of Phase II, providing clinical safety and immunological data, and the establishment of investigational stockpiles that will be ready for clinical efficacy trial testing during outbreaks. CEPI’s investments will also provide additional benefits to the wider vaccine community through the development of assays, reference standards and associated knowledge that may accelerate the development of other vaccines and medical counter measures against Lassa fever and MERS.

Themis’ most advanced proprietary development program is a vaccine against chikungunya virus, a mosquito-transmitted disease that can have serious debilitating long-term effects. The disease causes fever, joint pain and muscle pain, among other symptoms, and has no current treatment or prevention options. Themis’ chikungunya vaccine is in Phase 2 clinical studies in 600 patients across the US, EU and South and Central America. With its broadly applicable technology platform, Themis is also developing vaccines against Zika virus, Respiratory Syncytial Virus (RSV), norovirus and Cytomegalovirus (CMV), as well as other applications of harnessing the immune system to treat disease.