Bavarian Nordic announced today a new agreement with the U.S. Department of Defense’s (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), for the advanced development of prophylactic vaccine candidate MVA-BN WEV.
MVA-BN WEV is a multi-valent vaccine candidate since it incorporates antigens from all three equine encephalitis viruses: western, eastern and Venezuelan. It is based on Bavarian Nordic’s proprietary MVA-BN platform technology, which is also used in the company’s marketed vaccines against smallpox, mpox and Ebola. The platform is also employed the RSV vaccine candidate, currently in Phase 3 development in older adults.
The new agreement has a total value up to $83 million USD, of which the secured base agreement of $55 million covers the costs for a clinical Phase 2 dose finding study of MVA-BN WEV, further non-clinical studies, process development and manufacturing of clinical trial material. Furthermore, the agreement includes options valued at $28 million to support Phase 3 preparations.
The base agreement will run from 2023 through 2026 with the majority of revenue from the agreement being recognized in that timeframe. Based on current projections, the Phase 2 clinical study could start in 2024. Based on the ability of the MVA-BN vaccine platform to protect against multiple threats, this effort has the capability to pivot and expand to other threat agents of interest.
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MVA-BN WEV was initially developed under an agreement with DoD in 2018, that included the demonstration of protective efficacy in animals and a Phase 1 first-in-human trial of MVA-BN WEV. Data of the trial were reported in June 2020, showing that the vaccine was well tolerated and immunogenic across all dose groups. Venezuelan equine encephalitis virus neutralizing antibody responses were observed in all dose groups, with peak levels reached after the second vaccination. Recent data confirm neutralizing antibody responses also against western and eastern equine encephalitis viruses that were durable throughout the 6-months follow up period.
“We are proud to continue our partnership with the U.S. government on the development of a much-needed vaccine to combat equine encephalitis, which is another emerging disease, often leading to serious complications and even death. Using the same platform technology, upon which our mpox vaccine was also built, we are truly leveraging our core experience in R&D innovation and vaccine manufacturing to help build a stronger preparedness for the U.S. and its citizens, and we look forward to continuing our work with DoD on this important program, “said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic.
About Equine Encephalitis Viruses
Eastern, Venezuelan and western equine encephalitis viruses belong to the family alphavirus, and are transmitted through mosquitos, as well as birds and some mammals. While the viruses vary in infection rates and severity of disease, all three pathogens are associated with risks of flu-like symptoms, potential central nervous disorders, and death. All three viruses are considered as potential biological threats, having been investigated as potential biological weapons at various times in the past century. The viruses belong to the U.S. list of prioritized pathogens amongst other agents, like smallpox, anthrax and other lethal diseases, which are covered by the current vaccination policy for U.S. military personnel being deployed around the globe. However, there are currently no approved vaccines for human use against any of the equine encephalitis viruses.
In recent years, the U.S. has seen a rise in human cases of eastern equine encephalitis, particularly in the southern and northeastern parts of the country, correlating with increased observations of mosquitos carrying the virus in these regions. According to the U.S Centers for Disease Control and Prevention (CDC), 38 cases were reported in 2019, compared to an annual average of 7 cases over the past decade. On average, more than 4 of 10 infected individuals die after contracting the virus.