Micromet Initiates Trial For Solid Tumor Treatment

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Micromet starts phase 1 clinical trial with its BiTE antibody MT110. The study will explore the safety, pharmacokinetics, pharmacodynamics and anti-tumor activity of MT110 in patients with lung and gastrointestinal cancers.

MT110 targets the epithelial cell adhesion molecule (EpCAM or CD326), which is highly expressed on colon, lung, breast, prostate, ovarian, gastric and pancreas cancers. Additionally, EpCAM has been found on cancer stem cells of colon, breast, prostate and pancreas cancers. Cancer stem cells are believed to cause metastases and recurrence of these cancers. MT110 is the second BiTE antibody in clinical trials, and the fourth clinical program in Micromet's product pipeline. The first BiTE antibody, MT103 (MEDI-538), is now in phase 1 and phase 2 clinical trials for the treatment of haematological cancers.

"BiTE antibodies enable the patients' own T cells to very efficiently eliminate tumor cells," comments Patrick Baeuerle, Chief Scientific Officer of Micromet, "In various experimental tumor models, we have demonstrated the high therapeutic potential of EpCAM-specific BiTE antibodies, and we are now looking forward to determining the safety and the therapeutic potential of MT110 in patients."

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"Having obtained clinical proof of concept for our BiTE antibody technology with MT103 in haematological cancers, we are excited about exploring the potential of MT110 in treating solid tumors," comments Carsten Reinhardt, Chief Medical Officer of Micromet. "Based on its unique mode of action, MT110 may be suited to treat established tumors as well as disseminated cancer cells, which frequently give rise to metastases."

About BiTE Antibodies

BiTE antibodies are designed to direct the body's cytotoxic, or cell-destroying, T cells against tumor cells, and represent a new therapeutic approach to cancer therapy. BiTE antibodies have been shown to induce an immunological synapse between a T cell and a tumor cell in the same manner as observed during physiological T cell attacks. These cytolytic synapses enable the delivery of cytotoxic proteins from T cells into tumor cells, ultimately inducing a self-destruction process in the tumor cell referred to as apoptosis, or programmed cell death. In the presence of BiTE antibodies, T cells have been demonstrated to serially eliminate tumor cells, which explains the activity of BiTE antibodies at very low concentrations and at very low ratios of T cells to target cells. Through the process of killing cancer cells, T cells proliferate, which leads to an increased number of T cells at the site of attack.

Several antibodies in Micromet's product pipeline are BiTE antibodies and have been generated based on Micromet's proprietary BiTE antibody platform. The most advanced BiTE antibody is MT103 (MEDI-538), targeting CD19, and has provided proof-of-concept in an ongoing phase 1 clinical study in patients with advanced non-Hodgkin's lymphoma. MT110, which is targeting EpCAM (CD326) and is the first BiTE antibody with potential applications in the treatment of solid tumors, is in a phase 1 clinical trial in patients with lung and gastrointestinal cancers. Two additional BiTE antibodies, targeting CD33 and MCSP, are in preclinical development.

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