Bavarian Nordic today 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 Bavarian Nordic 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.