The Danish biopharmaceutical company Bavarian Nordic's US-based subsidiary, BN ImmunoTherapeutics Inc. has gained approval from the US Food & Drug Administration (FDA) to start clinical trials of its breast cancer vaccine, MVA-BN-HER2. Patient enrolment in a Phase I/II study in the US is expected to start in the very near future, writes Bavarian Nordic in a press release.
Another study is planned in Europe, the two studies enrolling approx. 60 patients. In addition to evaluating the safety and tolerability of MVA-BN-HER2, the studies will also explore the effect of the vaccine on tumour growth and patients' clinical progress. In Europe, the vaccine will furthermore be tested in first line therapy of metastatic breast cancer.
Peter Wulff, president and CEO of Bavarian Nordic comments: “Entering clinical trials with our breast cancer vaccine marks yet another important milestone for Bavarian Nordic. In a short time, BN ImmunoTherapeutics has succeeded in making the necessary progress for the company’s first cancer vaccine to enter clinical trials. This strengthens not only our pipeline, but also our strategy to make vaccines against cancer an important value driver in Bavarian Nordic.”
Bavarian Nordic has operations in Denmark, Germany, the US and Singapore. The company's patented MVA-BN technology is one of the world's safest, multivalent vaccine vectors for development of vaccines against infectious diseases (smallpox and HIV) and cancer. Bavarian Nordic has ongoing development contracts with the US government to develop Imvamune as a safe third-generation smallpox vaccine. Collaboration partners include GlaxoSmithKline, Pharmexa, Impfstoffwerk Dessau-Tornau and Vaccine Solutions.