Extra funds will support 4,000-participant registrational Phase III study.
The U.S. Department of Health and Human Services has increased its procurement contract for Bavarian Nordic’s prophylactic smallpox vaccine candidate Imvamune® by $32 million, to a total of $544 million, in order to support a Phase III study. Under terms of the contract the government is stockpiling 20 million doses of Imvamune under a Project BioShield contract, and has already received the first eight million doses.
The pivotal 4,000-participant Phase III study is expected to start enrolling in 2013, and should support a subsequent BLA submission to FDA. Bavarian Nordic says the trial is larger than initially proposed, hence the need to request modification of its existing contract with the U.S. government to cover additional costs prior to starting the trial. Approval applications for Imvamune have already been submitted in Canada and Europe.
Imvamune is based on a live nonreplicating MVA-BN® virus, and is being sold to governments as a vaccine in development. To date the vaccine has been tested on over 3,400 individuals, including HIV and atopic dermatitis patients, without demonstrating any of the serious adverse events (including myopericarditis) that can be associated with traditional smallpox vaccines, the firm claims.
Bavarian Nordic is developing vaccines against cancer and infectious diseases. Imvamune is the lead candidate in its biodefense pipeline, which also includes a preclinical-stage prophylactic anthrax vaccine based on the MVA-BN platform. The firm’s cancer vaccine pipeline is headed by Prostvac, a Phase III-stage therapeutic vaccine candidate for the treatment of advanced prostate cancer.