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The Company’s breast cancer vaccine candidate is based on a HER-2/Neu antigen. The product combines MVA-BN® technology with an improved form of the HER-2 sequence in-licensed from the Danish biotech company Pharmexa A/S.
Preclinical development
Preclinical studies with the vaccine candidate have shown exceptional and significant efficacy, both in terms of inducing abroad immune response as well as in anti-tumour activity. In addition, the vaccine induced an antigen-specific Th1-type CD4 T-cell response, HER-2 specific CD8 cytotoxic T-lymphocyte response, and anti-HER-2 antibodies. The vaccine showed activity in both preventive as well as therapeutic settings in multiple animal models with HER-2 tumours. In a study with highly aggressive lung metastasis, the vaccine nearly eradicated the tumour after 14 days. The model also showed that a single injection of the vaccine administered as late as three days after the intravenous induction of the lung metastasis resulted in the same effect – near eradication of the metastasis. Moreover, the vaccine induced an extremely rapid antigenspecific immune response.
Clinical development
As planned, Bavarian Nordic initiated Phase I/II clinical studies in first half of 2007. Currently, patients with HER-2 positive, metastatic breast cancer are being enrolled in two clinical Phase I/II studies to be performed in three countries. The first study is ongoing in California, USA. The second study is enrolling patients in multiple centres in Serbia and Poland. In the US study, metastatic cancer patients are vaccinated after they have received chemotherapy; in the European study, chemotherapy and vaccination are combined. Patients may or may not receive Herceptin® concurrently. The studies are enrolling patients as planned, and no drug-related severe adverse events have been reported thus far. Initial data regarding patient immune response are expected in the first half of 2008.
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