Bavarian Nordic reports interim data from Phase I/II studies with breast cancer vaccine

Bavarian Nordic's cancer research unit, BN ImmunoTherapeutics, has completed an interim analysis of its first two clinical studies with MVA-BN®-HER2, a cancer vaccine immunotherapy for breast cancer patients.

The first study, performed in the US, is evaluating MVA-BN®-HER2 treatment following chemotherapy and Herceptin®treatment. In the second study, performed in Serbia and Poland, MVA-BN®-HER2 is being evaluated following only chemotherapy or in combination with single-agent taxane chemotherapy. Both studies evaluate treatment of metastatic breast cancer patients, whose tumors overexpress HER2. Patients are vaccinated 3 times, at 3 week intervals, with the MVA-BN® viral vector which has been engineered to express the extracellular fragment of human HER2.

With 27 out of 30 patients vaccinated, enrolment in the studies is nearly completed. No drug-related severe adverse events have been reported thus far. The vaccine has been shown to be well tolerated and immunogenic.

Immune evaluation of samples from 18 patients treated with MVA-BN®-HER2 revealed that 12 patients developed an immune response (humoral and/or cellular response).

These preliminary data show that MVA-BN®-based, HER2 directed vaccination is a biologically active treatment for patients with HER2 positive breast cancer. The final study data are expected around the turn of the year 2008/2009.

Anders Hedegaard, President & CEO of Bavarian Nordic, commented: "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."