As Bavarian Nordic prepares to deliver on a large smallpox vaccine stockpiling contract with the U.S. government, the vaccine specialist is working to build out a new fill-finish manufacturing line at its headquarters in Denmark. Now, the company has new financing in the form of a €30 million loan from the European Investment Bank to apply toward the project.
Expected to be complete in 2021, Bavarian Nordic’s new manufacturing line will allow the company to handle final production of its smallpox vaccine Imvamune plus other shots. For years, the company has relied on a contract manufacturer for final production of the vaccine. According to BN, the first task for the project will be to validate the plant for final production of freeze-dried Imvamune as part of a U.S. stockpiling deal awarded last year.
In September, the company secured a contract with the U.S. government for freeze-dried Imvamune worth up to $539 million. As a result, BN committed to investing $75 million in the new manufacturing line to support its transition to moving Imvamune manufacturing entirely in-house.
The development comes after Bavarian Nordic last year posted a major phase 3 trial failure for cancer vaccine Prostvac as a monotherapy, sending shares down by more than half at the time. But the company has worked to regroup by advancing its pipeline of other vaccines and delivering on its smallpox contracts; the company has also licensed the prostate cancer candidate to Bristol-Myers Squibb for testing with that drugmaker's immuno-oncology meds.
Elsewhere in BN’s pipeline, the company last week reported positive data from a phase 2 booster study of its RSV candidate. For the work, investigators re-enrolled 88 participants from a previous test of the vaccine to give them a follow-on dose to simulate an annual booster shot.
The company reports that a booster induced an immune response that was seen particularly in those participants whose responses had been fading after a year. The biotech said the results will inform phase 3 development.
Bavarian Nordic is advancing its RSV vaccine in a field that could yield blockbuster sales. In phase 2, the biotech tested its vaccine in elderly subjects, a group in which Novavax’s candidate previously flunked in phase 3. Now, Novavax’s vaccine is in a late-stage maternal immunization study. Pfizer and GlaxoSmithKline are also working on their respective RSV vaccine programs.