Micromet Shows Feasibility of Subcutaneous Delivery of BiTE Antibody in Preclinical Primate Study

Tuesday, April 15, 2008 General News
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BETHESDA, Md., April 14 Micromet, Inc.(Nasdaq: MITI), a biopharmaceutical company developing novel, proprietaryantibodies for the treatment of cancer, inflammation and autoimmune diseases,presented data at the annual meeting of the American Association for CancerResearch (AACR) in San Diego, CA, showing good bioavailability and predictableserum levels of subcutaneously administered BiTE(R) antibodies(1). BiTEantibodies are designed to direct the body's cytotoxic, or cell-destroying, Tcells against tumor cells, and represent a new therapeutic approach to cancertherapy.

Micromet conducted a pharmacokinetic study in non-human primates exploringdifferent routes of administration of its BiTE antibody MT110, which istargeting EpCAM (CD326) and is the most advanced BiTE antibody with potentialapplication for the treatment of solid tumors. Continuous intravenousadministration, as currently used in an ongoing phase 1 clinical trial withMT103 (MEDI-538), was compared to subcutaneous administration by dailyrepeated bolus injection and continuous administration using mini-pumps, whichare commercially available and routinely used by patients with diabetes forthe delivery of insulin. Both subcutaneous regimens resulted inbioavailability of MT110 of 30 to 40 percent, with constant serum troughlevels over the six-day treatment period.

"Our pre-clinical results are paving the way for the development ofalternative routes of administration for MT110 and other BiTE antibodies tofurther enhance the quality of life of patients under treatment," commentsPatrick A. Baeuerle, Micromet's chief scientific officer. "A very convenientmini-pump system, designed for life-long use by diabetes patients for insulindelivery, may become an attractive alternative to repeated subcutaneousinjection."

About BiTE Antibodies

BiTE(R) antibodies are designed to direct the body's cytotoxic, orcell-destroying, T cells against tumor cells, and represent a new therapeuticapproach to cancer therapy. BiTE antibodies have been shown to induce animmunological synapse between a T cell and a tumor cell in the same manner asobserved during physiological T cell attacks. These cytolytic synapses enablethe delivery of cytotoxic proteins from T cells into tumor cells, ultimatelyinducing a self-destruction process in the tumor cell referred to asapoptosis, or programmed cell death. In the presence of BiTE antibodies, Tcells have been demonstrated to serially eliminate tumor cells, which explainsthe activity of BiTE antibodies at very low concentrations and at very lowratios of T cells to target cells. Through the process of killing cancercells, T cells proliferate, which leads to an increased number of T cells atthe site of attack.

Several antibodies in Micromet's product pipeline are BiTE antibodies andhave been generated based on Micromet's proprietary BiTE antibody platform.The most advanced BiTE antibody is MT103 (MEDI-538), targeting CD19, and hasprovided proof-of-concept in an ongoing phase 1 clinical study in patientswith advanced non-Hodgkin's lymphoma. MT110, which is targeting EpCAM (CD326)and is the first BiTE antibody with potential applications in the treatment ofsolid tumors, has completed preclinical development. Two additional BiTEantibodies, targeting CEA and MCSP, are in preclinical development.

About Micromet, Inc. (www.micromet-inc.com)

Micromet, Inc. is a biopharmaceutical company developing novel,proprietary antibodies for the treatment of cancer, inflammation andautoimmune diseases. Three of its antibodies are currently in clinical trials,while the remainder of the product pipeline is in preclinical development. TheBiTE(R) antibody MT103 is in a phase 2 clinical trial for the treatment ofpatients with acute lymphoblastic leukemia and in a phase 1 clinical trial forthe treatment of patients with non-Hodgkin's lymphoma. BiTE antibodiesrepresent a

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