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Preclinical Study Published in Cancer Research Demonstrates Anti-Tumor Activity of Micromet's BiTE Antibody at Well Tolerated Doses

BETHESDA, Md., January 22, 2008 /PRNewswire-FirstCall/ -- Micromet, Inc. , a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases, today announced the publication of a new preclinical study in Cancer Research(1) demonstrating that efficacious doses of a BiTE(R) antibody targeting epithelial cell adhesion molecule (EpCAM or CD326) are well tolerated in two mouse cancer models. BiTE antibodies join cytotoxic T cells with cancer cells for a tightly controlled elimination of cancer cells.

EpCAM is one of the most frequently and highly expressed tumor-associated antigens and is found on the majority of colon, lung, breast, prostate, ovarian, gastric, pancreas and on cancer stem cells. Like other tumor- associated antigens used as targets for antibody-based therapeutics, EpCAM is expressed on certain normal tissues. In order to assess the safety profile of an EpCAM-specific BiTE antibody, Micromet's researcher constructed a murine- specific BiTE antibody, called muS110, that is similar to the human-specific BiTE antibody MT110 with respect to structure, binding strength, efficacy and epitope recognition on EpCAM. EpCAM was found to be similarly expressed by mice and humans.

Low doses of muS110 that prevented growth of orthotopic breast cancer and formation of lung metastases in mice were well tolerated. Treatment with MuS110 did not lead to any damage of EpCAM-expressing normal tissues at any dose studied. This indicates that the EpCAM-specific BiTE antibody did recognize EpCAM on tumor cells but not on cells of normal tissues.

"We were pleased to see that an EpCAM-specific BiTE antibody showed anti- tumor activities at well tolerated doses," commented Patrick Baeuerle, Micromet's Chief Scientific Officer. "It appears that normal tissues expressing EpCAM are not affected by our BiTE antibody. We are now looking forward to testing the safety and clinical activity of MT110, a human EpCAM- specific BiTE antibody, in a phase 1 clinical trial in the near future."

About BiTE(R) Antibodies

BiTE(R) 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 development platform. The most advanced BiTE antibody is MT103 (MEDI-538), targeting CD19, and has provided proof-of-concept for the platform in an ongoing phase 1 clinical study in advanced non-Hodgkin's lymphoma patients. Three other BiTE antibodies, targeting EpCAM (CD326), CEA and MCSP, are in pre-clinical development.

About Micromet, Inc. (

BiTE is a registered trademark of Micromet. Micromet, Inc. is a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases. Three of its antibodies are in clinical development. MT103 (MEDI-538), the first antibody developed utilizing the BiTE(R) antibody technology platform in Micromet's product pipeline, is being evaluated in a phase 2 clinical trial for the treatment of patients with acute lymphoblastic leukemia and a phase 1 clinical trial for the treatment of patients with non-Hodgkin's lymphoma. BiTE antibodies represent a new class of antibodies that activate a patient's own cytotoxic T cells to eliminate cancer cells. Micromet is developing MT103 in collaboration with MedImmune, a subsidiary of AstraZeneca plc. The second clinical stage antibody is adecatumumab (MT201), a human monoclonal antibody targeting EpCAM expressing tumors. Adecatumumab is being developed by Micromet in collaboration with Merck Serono in a phase 1b clinical trial evaluating MT201 in combination with docetaxel for the treatment of patients with metastatic breast cancer. The third clinical stage antibody is MT293 (formerly D93), also known as TRC093, a first-in-class humanized monoclonal antibody that inhibits angiogenesis and tumor cell growth by binding cleaved collagen. MT293, which is currently being tested in a phase 1 clinical trial, is licensed to TRACON Pharmaceuticals, Inc. and is being developed for the treatment of patients with cancer and age-related macular degeneration. In addition, Micromet has established a collaboration with Nycomed for the development and commercialization of MT203, Micromet's human antibody neutralizing the activity of granulocyte/ macrophage colony stimulating factor (GM-CSF), which has potential applications in the treatment of various inflammatory and autoimmune diseases, such as rheumatoid arthritis, psoriasis, or multiple sclerosis.

Forward-Looking Statements

This release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include the risk that product candidates that appeared promising in early research, preclinical studies or clinical trials do not demonstrate safety and/or efficacy in subsequent clinical trials, the risk that encouraging results from early research, preclinical studies or clinical trials may not be confirmed upon further analysis of the detailed results of such research, preclinical study or clinical trial, the risk that additional information relating to the safety, efficacy or tolerability of our product candidates may be discovered upon further analysis of preclinical or clinical trial data, the risk that we or our collaborators will not obtain approval to market our product candidates, the risks associated with reliance on outside financing to meet capital requirements, and the risks associated with reliance on collaborators, including MedImmune, Merck Serono, TRACON and Nycomed, for the funding or conduct of further development and commercialization activities relating to our product candidates. You are urged to consider statements that include the words "ongoing," "may," "will," "would," "could," "should," "believes," "estimates," "projects," "potential," "expects," "suggests," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," or the negative of those words or other comparable words to be uncertain and forward-looking. These factors and others are more fully discussed in our periodic reports and other filings with the SEC.

Any forward-looking statements are made pursuant to Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and, as such, speak only as of the date made. Micromet, Inc. undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.

(1) Cancer Res 2008;68(1):143-51

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Posted: January 2008