Bavarian Nordic updates on Phase I/II studies with breast cancer vaccine

Bavarian Nordic today provided updated data from its clinical studies
with its breast cancer vaccine, MVA-BN®-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®-based,
HER2 directed vaccination is a biologically active treatment for
patients with HER2 positive breast cancer; however the overall immune
response was moderate.

Additionally Bavarian Nordic has completed preclinical studies with
an improved version of the MVA-BN®-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 Bavarian Nordic decided to advance the clinical developmentof MVA-BN®-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 Bavarian Nordic'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.

Anders Hedegaard, President & CEO of Bavarian Nordic, said: "I am
pleased that we once again can confirm the unique safety profile of
MVA-BN® 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."


Asger Aamund
Chairman


Contact
Anders Hedegaard, President & CEO
Phone +45 23 20 30 64