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news.Danish drug maker Bavarian Nordic has said its subsidiary BN ImmunoTherapeutics has received approval to start clinical trials in the US with the breast cancer vaccine, MVA-BN-HER-2.
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The company said patient enrollment in the phase I/II study in the US is expected to start as soon as possible.
In addition to the US study, BN ImmunoTherapeutics is also planning to start a phase I/II study with MVA-BN-HER2 in Europe. The two studies are expected to enroll up to 60 patients.
The studies are designed to evaluate the safety and tolerability of MVA-BN-HER2. The studies will also evaluate the biological activity of the vaccine by measuring HER-2 specific immune responses in treated patients. In addition, the effect of the vaccine on the clinical progress of the patients and on tumor growth will also be explored.
MVA-BN-HER2 will be tested in numerous clinical settings to determine how to best incorporate it into standard therapy for the treatment of breast cancer. This will include treatment with MVA-BN-HER2 in combination with Herceptin and chemotherapy.