Clinical Trials of the breast cancer vaccine MVA-BN-HER-2

COPENHAGEN, Jan 3, 2007(Reuters) - Danish vaccine maker Bavarian Nordic (BAVA.CO: Quote, Profile , Research) said on Wednesday that its U.S. subsidiary BN ImmunoTherapeutics received approval from the U.S. Food and Drug Administration (FDA) to start clinical trials with the breast cancer vaccine MVA-BN-HER-2.

Patient enrolment in a Phase I/II study in the United States will start as soon as possible, Bavarian said.

BN ImmunoTherapeutics also plans to start a Phase I/II study with the vaccine in Europe.

The two studies are expected to enroll up to 60 patients and are designed to evaluate the safety and tolerability of the vaccine. Its effect on the clinical progress of the patients and on tumor growth will also be explored.

To determine how best to incorporate the vaccine into standard therapy, it will also be tested in combination with traztuzumab (Herceptin) and chemotherapy.

In Europe, the vaccine will also be tested in first-line therapy of metastatic breast cancer, Bavarian said.

From the BN ImmunoTherapeutics press release:

MVA-BN(R)-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(R)-HER2 in combination with trastuzumab (Herceptin(R)) and chemotherapy. The Phase I/II studies are designed to evaluate the safety and tolerability of MVA-BN(R)-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. Reiner Laus, MD, President & CEO of BN ImmunoTherapeutics said: "We are excited about the potential of this vaccine for treatment of women with breast cancer. We have been able to rapidly advance our program from research into the clinical development stage, due to the strong preclinical safety and efficacy profile we have seen with this vaccine candidate. It is an important achievement in this program as well as in the development of our portfolio of vaccine candidates for the treatment of major cancers." In preclinical studies MVA-BN(R)-HER2 demonstrated efficacy by inducing multi-pronged immunity as well as anti-tumor activity. Its in vivo anti-tumor activity was shown in multiple animal models with HER-2 expressing tumors. MVA-BN(R)-HER2 also showed activity in both preventive as well as therapeutic settings. In the most dramatic model, a 14-day experimental, highly aggressive lung metastasis model, MVA-BN(R)-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(R)-HER2 was administered three days after the intravenous induction of the experimental lung metastasis. Moreover, MVA-BN(R)-HER2 induced an extremely rapid immune response. BN ImmunoTherapeutics' core technology is a proprietary recombinant viral vector platform based on Modified Vaccinia Ankara BN (MVA-BN(R)) that is being developed as an immunotherapy for breast, prostate and other cancers. Located in Mountain View, California, BN ImmunoTherapeutics is a subsidiary of Bavarian Nordic (CSE: BAVA), headquartered in Denmark.