Bavarian Nordic A/S announced on 8 Oct. the initiation of the first-in-human trial of MVA-BN® WEV, a prophylactic vaccine candidate against against three separate strains of the equine encephalitis virus, Eastern (EEEV), Venezuelan (VEEV), and Western (WEEV), for which there are currently no preventative vaccines available.
The program, which is funded by the U.S. Department of Defense Joint Project Manager for Chemical, Biological, Radiation, and Nuclear Medical (JPM CBRN Medical), is a multi-year agreement valued up to USD 36 million.
The Phase 1 trial will evaluate the safety, tolerability and immunogenicity of MVA-BN WEV in 45 healthy adults in three treatment groups receiving different doses of the vaccine. Topline results from the study are expected to become available in 2020.
A successful Phase 1, based on demonstrating a favorable safety and immunogenicity could lead to follow-on funding, beyond the initial contract award of USD 36 million, to support further preclinical, clinical development and manufacturing to support licensure in the U.S.
“After the recent FDA approval of our smallpox vaccine, which was developed in collaboration with various U.S. government agencies and has become an integral part of the national stockpile, we are excited to advance this new program, helping to fulfil the U.S. government’s goal to develop a broad range of medical countermeasures to protect U.S. citizens,” said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic. “The prevalence of Eastern equine encephalitis, which is currently on the rise in the U.S., highlights the importance of a vaccine to help fight these diseases. Again, we are leveraging the unique properties of our MVA-BN platform technology to address unmet medical needs, and we look forward to continuing our work with DOD on this important program.”
About Equine Encephalitis Viruses
Eastern, Venezuelan and Western equine encephalitis virus 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 against any of the equine encephalitis viruses.
Currently, the U.S. is experiencing the worst outbreak of Eastern equine encephalitis since monitoring of the disease began. In 2019 to-date, more than 30 cases, including nine deaths have been reported, mostly in northeastern parts of the U.S., where mosquitoes have been found to carry the virus.
This project is funded in whole or in part with federal funds under an Other Transaction Authority agreement with U.S. Army Contracting Command-New Jersey through the Medical CBRN Defense Consortium, contract MCDC-17-04-001/2018-315