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Company Announcement no. 23-06
30 October 2006
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MVA-BN®-based vaccine shows promise in breast cancer models

BN ImmunoTherapeutics, Bavarian Nordic’s California-based subsidiary developing vaccines against cancer, recently presented preclinical study data with the MVA-BN®-HER2 vaccine showing exceptional and significant efficacy, both in terms of inducing broad immunity as well as anti-tumor activity. In addition, immunization with MVA-BN®-HER2 showed to induce an antigen-specific Th 1-type CD4 T-cell response, Her-2 specific CD8 cytotoxic T-lymphocyte response, and anti-Her-2 antibodies.

These promising results will be included in BN ImmunoTherapeutics’ current filing for an Investigational New Drug application (IND) with the US Food and Drug Administration (FDA). The vaccine has been released from the Berlin facility and with regulatory approval, Phase I studies with MVA-BN®-HER2 are due to start before the end of 2006.

Results from the MVA-BN®-HER2 breast cancer vaccine program were presented at the 21st Annual Meeting of the International Society for Biological Therapy of Cancer in Los Angeles, California (October 26-29, 2006).

MVA-BN®-HER2 showed activity in both preventive as well as therapeutic settings in multiple animal models with Her-2 expressing tumors. In the most dramatic model (14-day experimental, highly aggressive lung metastasis model), MVA-BN®-HER2 nearly eradicated the tumor by the 14-day evaluation point. Equally impressive in this model was that a single injection of MVA-BN®-HER2 administered as late as 3 days after the intravenous induction of the experimental lung metastasis, resulted in the same effect – near eradication of an aggressive metastasis. Moreover, MVA-BN®-HER2 induced an extremely rapid antigen-specific immune response.

Peter Wulff, President & CEO, Bavarian Nordic said: “With these promising results based on our patented MVA-BN® technology,we have taken our first important step towards clinical trials with our cancer vaccines which we expect to be one of the company’s cornerstones in the future.”



Kvistgård, 30 October 2006

Asger Aamund
Chairman
Contacts:
Anders Hedegaard, President & CEO, Tel.: +45 3326 8383
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