BETHESDA and GAITHERSBURG, Md., Nov. 29 /PRNewswire-FirstCall/ -- Micromet, Inc. and MedImmune, Inc. today announced that new data from an ongoing Phase 1 clinical trial of MT103 in patients with late- stage non-Hodgkin’s lymphoma (NHL) will be presented at the 2007 Annual Meeting of the American Society of Hematology (ASH) on December 9 in Atlanta, Georgia. MT103, also known as MEDI-538, is a recombinant T-cell engaging antibody, or BiTE(R) antibody, targeting the CD19 antigen, which is uniquely expressed on B-cells. As the first BiTE antibody studied in humans, MT103 is currently being evaluated in Phase 1 and 2 clinical trials for the treatment of patients with various B-cell malignancies.
New data from the ongoing Phase 1 dose-escalating trial show evidence of objective complete and partial responses in relapsed follicular lymphoma (FL), mantle cell lymphoma (MCL), and chronic lymphocytic leukemia (CLL) patients. At the time of the analysis, dose levels tested ranged from 0.0005 to 0.030 mg/m2 per day, respectively. Among the 15 evaluable patients at dose levels of 0.015 and 0.030 mg/m2 per day, two complete responses, two partial responses, and two minimal responses were observed. One of the complete responses was in a patient with MCL. In addition, six patients experienced stable disease and three patients progressed during treatment. The full data set, which will include additional patients at a higher dose level than reported in the abstract, will be presented at ASH.
Six patients at dose levels 0.015 and 0.030 mg/m2 per day had tumor infiltration in the bone marrow, a location from which relapses of these diseases potentially emanate. The bone marrow infiltration in five out of six patients decreased during treatment with MT103, with a complete clearance of tumor cells from the bone marrow in three patients and partial clearance in the other two patients.
Complete and partial clinical responses were assessed according to Cheson criteria, and all responses were confirmed by a central review. Clinical responses and tumor clearance from the bone marrow demonstrate clinical activity of the BiTE antibody in those patients who received higher doses.
“We are pleased to see the number of objective responses to MT103 in a relapsed patient population, and are looking forward to providing a more detailed update at ASH about our exciting new clinical data with the first BiTE antibody in clinical trials,” commented Christian Itin, Ph.D., President and Chief Executive Officer of Micromet.
MT103 is a novel, highly-specific and highly-potent drug, with which objective responses are being seen in patients with FL and MCL who have progressed after multiple prior treatments. The most common adverse events observed in this study were fever, chills, leukopenia, lymphopenia, pyrexia and elevated liver enzymes. The majority of the adverse events have been fully reversible and in many cases resolved without discontinuation of MT103 administration. Less common adverse events included central nervous system events, which were fully reversible after discontinuation of the infusion. Dose escalation continues.
“These clinical responses to MT103 in patients with various B-cell malignancies are an important achievement in our partnership with Micromet,’' commented Dirk Reitsma, M.D., vice president, clinical development, oncology, MedImmune. “The expansion of research into the potential of BiTE technology in a clinical setting represents another pioneering effort by MedImmune to develop novel targeted cancer treatments for patients in need.”
About BiTE(R) Antibodies
BiTE(R) antibodies are designed to direct the body’s cytotoxic, or cell-destroying, T- cells against tumor cells, and may represent a new therapeutic approach to cancer therapy. BiTE molecules are part of a novel class of antibody derivatives with the potential to selectively direct and activate an individual’s cytotoxic T-cells, the body’s most potent killer cells, to act against cancer cells. 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 low concentrations and at low ratios of T-cells to target tumor 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 product development platform. In addition to current studies of MT103, three other BiTE antibodies, targeting EpCAM (CD326), CEA and MCSP, are in pre-clinical development.
BiTE is a registered trademark of Micromet.
About MT103
MT103, which is being co-developed with MedImmune as MEDI-538, is a BiTE antibody being developed with the intent to treat certain types of B-cell lymphomas. In February 2006, the U.S. Food and Drug Administration approved an orphan drug designation for MT103 for certain indolent B-cell lymphoma, excluding chronic lymphocytic leukemia and NHL with central nervous system involvement. MT103 also received orphan drug designation from the European Agency for the Evaluation of Medicinal Products for MCL and chronic lymphocytic leukemia. MT103 specifically targets the CD19 antigen, which is present on B-cells and B-cell-derived tumors, but not on other types of blood cells or healthy tissues.
Micromet and MedImmune are developing MT103 under the terms of a 2003 agreement in which MedImmune has obtained exclusive rights for the BiTE antibody in North America. Micromet has retained the rights to MT103 outside of North America.
About Micromet, Inc. (www.micromet-inc.com)
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 in Micromet’s product pipeline developed utilizing the BiTE(R) antibody technology platform, is being evaluated in a phase 2 clinical trial for the treatment of patients with acute lymphoblastic leukemia, and in a phase 1 clinical trial for the treatment of patients with non-Hodgkin’s lymphoma. BiTE antibodies represent a new class of therapeutic 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 Astra Zeneca 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 adecatumumab 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.
About MedImmune
MedImmune strives to provide better medicines to patients, new medical options for physicians and rewarding careers to employees. With approximately 3,000 employees worldwide and headquarters in Maryland, MedImmune is dedicated to advancing science and medicine to help people live better lives and is wholly owned by AstraZeneca plc . For more information, visit MedImmune’s website at http://www.medimmune.com.
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.
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CONTACT: Christopher Schnittker, SVP & CFO, +1-240-752-1421,
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for MedImmune
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