BN IMMUNOTHERAPEUTICS INITIATES TRIALS OF CANCER VACCINE

BN ImmunoTherapeutics announced that the FDA has accepted its investigational new drug application for the company's breast cancer vaccine, MVA-BN-HER2. A clinical study of the vaccine will begin enrollment at multiple clinical sites in the U.S. in early 2007, and a parallel trial is expected to commence in Europe shortly thereafter.

The company's core technology is a proprietary recombinant viral vector platform based on modified vaccinia ankara BN that is being developed as an immunotherapy for breast, prostate and other cancers.

MVA-BN-HER2 will be tested in numerous clinical settings to determine how to best incorporate it into standard therapy for the treatment of metastatic breast cancer. This will include treatment with MVA-BN-HER2 in combination with trastuzumab and chemotherapy.

The Phase I/II studies are designed to evaluate the safety and tolerability of MVA-BN-HER2 and the biological activity of the vaccine by measuring HER-2-specific immune responses in treated patients. In addition, the effect of the vaccine on the clinical progress of patients and on tumor growth will also be explored.

In preclinical studies MVA-BN-HER2 demonstrated efficacy by inducing multi-pronged immunity as well as antitumor activity. Its in vivo antitumor activity was shown in multiple animal models with HER-2-expressing tumors. The vaccine also showed activity in both preventive as well as therapeutic settings. In the most dramatic model, a highly aggressive lung metastasis model, MVA-BN-HER2 virtually eradicated the tumor by the 14-day evaluation point. Near eradication of an aggressive metastasis was also seen after a single injection of MVA-BN-HER2 was administered three days after the intravenous induction of the experimental lung metastasis. Moreover, the vaccine induced an extremely rapid immune response.