BETHESDA and GAITHERSBURG, Md., Dec. 10 /PRNewswire-FirstCall/ -- Micromet, Inc. and MedImmune, Inc. yesterday presented new data from an ongoing Phase 1 clinical trial showing potent single-agent activity of MT103 in patients with late-stage non-Hodgkin’s lymphoma (NHL). 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. MT103 is currently being evaluated in Phase 1 and 2 clinical trials for the treatment of patients with various B-cell derived cancers.
Data was presented yesterday at the 2007 Annual Meeting of the American Society of Hematology in Atlanta, Georgia. In the higher dose cohorts, clinical responses were observed in patients with mantle cell lymphoma (MCL) and follicular lymphoma (FL). Among the 18 evaluable patients at dose levels of 0.015 to 0.06 mg/m2 per day, three complete responses (CR) and four partial responses (PR) were observed. At 0.06 mg/m2 per day, three clinical responses were observed in three evaluable patients (one CR and two PR). No responses were observed among 12 evaluable patients at dose levels 0.0005, 0.0015 and 0.005 mg/m2 per day. In the subgroup of patients with MCL treated at 0.03 and 0.06 mg/m2 per day, three of five evaluable patients experienced a clinical response (two CR and one PR). All responses reported were assessed according to standardized Cheson criteria and were confirmed by central review.
In addition, MT103 showed reduction or clearance of tumor cells from various affected organs, including infiltrated bone marrow and liver. Complete or partial clearance of tumor cells from bone marrow was shown in eight of nine patients with bone marrow infiltration.
“The clinical responses observed in relapsed MCL patients are promising, and support additional evaluation of MT103 as a potential treatment for patients with MCL, who are in need of new therapeutic options,” commented Carsten Reinhardt, M.D., Ph.D., Chief Medical Officer, Micromet. “The anti- tumor activity and safety profile of MT103 demonstrated in this trial support the potential that BiTE antibodies have as a new class of therapeutic antibodies.”
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.
All patients treated in this study had relapsed NHL and were refractory after multiple treatments, and most patients were diagnosed with stage III or IV MCL and FL. Patients were dosed with MT103 for four or eight weeks, depending on their response to treatment.
“As seen in this trial, MT103 is a novel, highly specific and highly potent drug, with which objective responses are being seen in patients with various forms of non-Hodgkin’s lymphoma who have progressed after multiple prior treatments,” commented Dirk Reitsma, M.D., Vice President of Clinical Development and Oncology, MedImmune. “These Phase 1 clinical responses have prompted our partnership to expand our evaluation of MT103. We recently began a Phase 2 trial in adult acute lymphocytic leukemia, and also anticipate beginning a clinical trial in patients with chronic lymphocytic leukemia during the first quarter of 2008.”
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(R) antibody being developed for the treatment of 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.
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.
CONTACT: Christopher Schnittker, SVP & CFO of Micromet, +1-240-752-1421,
christopher.schnittker@micromet-inc.com; Investors: Susan Noonan,
+1-212-966-3650, susan@sanoonan.com, for Micromet, Inc., or Peter Vozzo of
MedImmune, +1-301-398-4358; Media: Andrea tenBroek of Schwartz
Communications, +1-781-684-0770, micromet@schwartz-pr.com, for Micromet,
Inc., or Jamie Lacey, +1-301-398-4035, for MedImmune
Web site: http://www.micromet-inc.com/
http://www.medimmune.com/
