BN ImmunoTherapeutics Updates On Phase I/II Studies With Breast Cancer Vaccine

Main Category: Breast Cancer
Also Included In: Immune System / Vaccines;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 24 Feb 2009 - 2:00 PDT

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BN ImmunoTherapeutics, Inc. provided updated data from its clinical studies with its breast cancer vaccine, MVA-BN(R)-HER2, in development as therapy of metastatic breast cancer patients whose tumours over-express HER2. The study met its primary endpoint with regards to safety and by showing an immune response. Evidence of vaccine-induced anti-HER2 immune response was detected in approximately 70% of evaluated patients.

Clinically, the vaccine was well tolerated with no treatment-related severe adverse events. Currently, the disease has not progressed in 15 out of the 30 patients after a 6 month period. Also, in the group where vaccine was combined with chemotherapy, one complete response and one partial response were observed. These results confirm the positive interim data reported in 2008 and show that MVA-BN(R)-based, HER2 directed vaccination is a biologically active treatment for patients with HER2 positive breast cancer; however the overall immune response was moderate.

Additionally BN ImmunoTherapeutics has completed preclinical studies with an improved version of the MVA-BN(R)-HER2 vaccine. In those studies, the new vaccine induced up to 20-fold higher T-cell immune response as compared to the original version. Furthermore, it proved to be efficacious in additional tumour immunotherapy models in HER2 transgenic mice. The immunological situation regarding HER2 in those mice strongly resembles the situation in humans.

Based on those encouraging data from both clinical and preclinical studies BN ImmunoTherapeutics decided to advance the clinical development of MVA-BN(R)-HER2 in further clinical studies with the new and improved vaccine. Specifically, a new, single-site Phase I/II study in the US will be initiated by 2009 and evaluate 24 patients in both metastatic breast cancer as well as in an adjuvant therapy of breast cancer setting.

In order to strengthen the company's patent portfolio in the cancer therapy field, the company has, for a minor payment, acquired from Pharmexa the families of patents that it had previously licensed.

Reiner Laus, MD, President & CEO of BN ImmunoTherapeutics, said: "I am pleased that we once again can confirm the unique safety profile of MVA-BN(R) and that we have been able to show immunogenicity in this patient group suffering from this severe disease. We are committed to bring this new and improved version of the HER2 vaccine further through clinical development."

Located in Mountain View, California, BN ImmunoTherapeutics is a subsidiary of Bavarian Nordic, headquartered in Denmark.

Bavarian Nordic A/S is a leading industrial biotechnology company developing and producing novel vaccines for the treatment and prevention of life-threatening diseases with a large unmet medical need. The company's business strategy is focused in three areas: biodefence, cancer and infectious diseases. Bavarian Nordic's proprietary and patented technology, MVA-BN(R), has been demonstrated in clinical trials to be one of the world's safest, multivalent vaccine vectors. Bavarian Nordic has ongoing contracts with the US government for the late-stage development and procurement of the company's third-generation smallpox vaccine, IMVAMUNE(R).

Bavarian Nordic is listed on the OMX NASDAQ under the symbol BAVA.

For more information, please visit: http://www.bavarian-nordic.com

"Safe Harbour" Statement under the Private Securities Litigation Reform Act of 1995:

Except for the historical information contained herein, this release contains "forward-looking statements" within the meaning of the Private Securities Reform Act of 1995. No "forward-looking statement" can be guaranteed, and actual results may differ materially from those projected. Bavarian Nordic undertakes no obligation to publicly update any "forward-looking statement", whether as a result of new information, future events, or otherwise. Additional information regarding risks and uncertainties is set forth in the current Annual Report and in Bavarian Nordic's periodic reports, if any, which we incorporate by reference.

BN ImmunoTherapeutics
http://www.bavarian-nordic.com