Good efficacy in early data on MVA-BN-HER2

Kvistgard, Denmark-based Bavarian Nordic says that novel preclinical study data show that its MVA-BN-HER2 vaccine has "exceptional and significant efficacy," both in terms of inducing broad immunity as well as antitumor activity. In addition, immunization with the agent induced an antigen-specific Th 1-type CD4 T-cell response, Her-2 specific cytotoxic T-lymphocyte response and anti-Her-2 antibodies.

BN Immunotherapeutics, the firm's California, USA-based subsidiary developing vaccines against cancer, will include this data in its current filing of an Investigational New Drug application with the US Food and Drug Administration. The vaccine has been released from the firm's facility in Berlin, Germany, and, with regulatory approval, Phase I studies are due to start before the end of the year. According to BN, the vaccine showed activity in both preventive as well as therapeutic settings in multiple animal models with Her-2 expressing tumors. In the most dramatic instance, a 14-day highly-aggressive lung metastasis model, the product nearly eradicated the tumor by the 14-day evaluation point, while a single injection administered as late as three days after the intravenous induction of the experimental lung metastasis, resulted in the same effect.