Bavarian Nordic, which already holds a smallpox vaccine stockpiling contract, has expanded its partnership with the U.S. government to include an R&D pact on a prophylactic vaccine against the equine encephalitis virus.
The U.S. Department of Defense will provide funding valued at up to $36 million for the project. BN’s job is to use its proprietary MVA-BN platform to develop a vaccine against three strains of the potentially deadly mosquito-borne virus, for which no preventative vaccine currently exists.
BN already has a candidate that demonstrated efficacy against the Eastern, Venezuelan and Western equine encephalitis viruses in preclinical models. The current grant will cover additional preclinical studies, GMP production and demonstration of safety and immunogenicity in clinical studies.
If the vaccine delivers positive proof-of-concept data, the DOD could follow on with additional funding to support its FDA licensure and production so that the DOD can use it on individuals deployed to regions considered at high risk of the illness.
“This type of collaboration further validates our model for preparedness, which could prove useful in the years to come for this, and potentially other rare and tropical diseases,” said Bavarian Nordic President and CEO Paul Chaplin in a statement.
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The Danish company has created a diverse pipeline of vaccines using its MVA-BN vaccine platform, including smallpox vaccine Imvamune, which is the subject of a national stockpile contract worth up to $539 million with the HHS’ Biomedical Advanced Research and Development Authority.
Although not yet approved in the United States, Imvamune is currently stockpiled by the U.S. government for emergency use. It is approved in Europe.
Under two previous contracts, the U.S. government has procured $233 million worth of Imvamune, but Chaplin said last week during the company’s 2017 full-year earnings call, all those delivered Imvamune doses, which have a three-year shelf life, have already expired. The new BARDA contract aims to replace that bulk of liquid-frozen vaccines with the new freeze-dried version, which BN said has a longer shelf life of five years and would simplify the storage and shipping logistics. With positive phase 3 data, BN plans to file the liquid-frozen version for an FDA review in the second half of 2018.
BN doesn’t expect the new $36 million equine encephalitis deal will impact its 2018 guidance. It currently sees about DKK 385 million ($63.5 million) in losses for the year, as it is spending DKK 510 million in R&D.