Bavarian Nordic Reports Interim Data From Phase I/II Studies With Breast Cancer Vaccine

Main Category: Breast Cancer
Also Included In: Immune System / Vaccines;  Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 19 Jun 2008 - 8:00 PST

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

The first study, performed in the US, is evaluating MVA-BN(R)-HER2 treatment following chemotherapy and Herceptin(R) treatment. In the second study, performed in Serbia and Poland, MVA-BN(R)-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(R) 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(R)-HER2 revealed that 12 patients developed an immune response (humoral and/or cellular response).

These preliminary data show that MVA-BN(R)-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(R) and that we have been able to show immunogenicity in this patient group suffering from this severe disease."

About Bavarian Nordic

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) is 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 A/S is listed on the OMX Nordic Exchange Copenhagen under the symbol BAVA.

Bavarian Nordic