GAITHERSBURG, Md. and CARLSBAD, Calif., Aug. 21, 2006 (PRIMEZONE) -- MedImmune, Inc. (Nasdaq:MEDI) and Micromet, Inc. (Nasdaq:MITI) today announced that MedImmune has filed an investigational new drug application (IND) with the U.S. Food & Drug Administration (FDA) for MT103 (also known as MEDI-538) for the treatment of patients with B-cell-derived non-Hodgkins lymphoma (NHL) not eligible for curative therapy. MT103 is a recombinant single-chain bispecific T-cell engager, or BiTE(R), molecule. It targets the CD19 antigen, which is uniquely expressed on B cells.
"The specific targeting of T-cells against tumor cells by MT103 represents a new approach to cancer therapy with potential benefits for patients suffering from certain lymphomas and leukemias, particularly those who have not responded to previous therapies," commented Dirk Reitsma, M.D., vice president, clinical development, oncology, MedImmune, Inc. "Pending FDA review, we plan to begin dosing patients soon in a Phase 1 study designed to extend the clinical progress made to date in European studies by our partner, Micromet."
MedImmune and Micromet AG, a wholly owned subsidiary of Micromet, Inc., entered an agreement in 2003 to jointly develop MT103. Under the terms of the companies' collaboration agreement, Micromet will receive a milestone payment from MedImmune triggered by the IND filing.
In MedImmune's planned Phase 1 open-label, single-arm, dose escalation trial in the U.S., investigators will assess the safety, tolerability and antitumor activity of continuous intravenous (IV) infusion of MT103 in patients with B-cell-derived NHL who have not responded to or have become refractory to previous therapies. Other endpoints include MT103's pharmacokinetics, pharmacodynamics, and immunogenicity as well as exploration of the molecule's mechanism of action. Doses will be given for a four-week period, with an option for an additional four weeks of therapy if disease improvement or stabilization is observed.
"We look forward to extending the clinical trial program for MT103 into the United States," said Carsten Reinhardt, senior vice president, clinical development, Micromet, Inc. "Given the encouraging interim results of the ongoing European Phase 1 trial with responses seen in an extensively pretreated patient population, we hope to substantiate the therapeutic potential of this molecule."
The ongoing Phase 1 trial being conducted by Micromet in Germany is investigating the safety and tolerability of a continuous infusion of MT103 over a four- to eight-week period at escalating dose levels in patients with relapsed, indolent B-cell NHL. In this study, approximately 20 patients have been treated to date over longer dosing periods than in previous studies. In the first three cohorts of patients in this trial (who received doses of 0.5 up to 5 micrograms per meter squared over 24 hours for four to eight weeks), no dose limiting toxicities have been observed. Evaluation of a fourth dose level, which is 15 micrograms per meter squared over 24 hours, is currently ongoing. Pharmacodynamic effects have been observed at 5 and 15 micrograms per meter squared over 24 hours with complete depletion of malignant B cells as well as significant T cell expansion in the majority of patients. Three out of five patients receiving 15 micrograms per meter squared over 24 hours of MT103 for at least two weeks showed clinical responses assessed by central radiology. One patient had a complete tumor response and two patients showed partial tumor responses according to standardized Cheson criteria. These preliminary data from the ongoing European Phase 1 trial of MT103 were presented at the 11th Congress of the European Hematology Association in June 2006 (1).
About MT103 (MEDI-538)
MT103 is a BiTE(R) molecule being developed as a potential treatment for certain types of B-cell lymphomas. BiTE(R) molecules are part of a novel class of antibody derivatives that may have the potential to selectively direct and activate the human immune system to act against cancer cells. This action is believed to occur as a result of the molecule's stimulation of T cells to target and destroy cancer cells that express a specific antigen. MT103 specifically targets the CD19 antigen, which is present on B cells, but not on other types of blood cells or healthy tissues.
In February 2006, the FDA approved an orphan drug designation for MT103 for the treatment of 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 (EMEA) for the treatment of mantle cell lymphoma and chronic lymphocytic leukemia.
References
(1) Bargou et al., MT103 (anti-CD19 x anti-CD3-BiTE) induces B cell depletion, clearance of bone marrow infiltration and clinical responses in heavily pre-treated NHL patients: first data from dose-escalation study MT103-104, 11th Congress of the European Hematology Association held on June 15 - 18, 2006 in Amsterdam
About MedImmune, Inc.
MedImmune strives to provide better medicines to patients, new medical options for physicians, rewarding careers to employees, and increased value to shareholders. Dedicated to advancing science and medicine to help people live better lives, the company is focused on the areas of infectious diseases, cancer and inflammatory diseases. With more than 2,300 employees worldwide, MedImmune is headquartered in Maryland. For more information, visit the company's website at http://www.medimmune.com.
This announcement contains, in addition to historical information, certain forward-looking statements that involve risks and uncertainties, in particular, related to the research and development of a BiTE molecule targeting CD19 for the potential treatment of certain lymphomas. Such statements reflect management's current views and are based on certain assumptions. Actual results could differ materially from those currently anticipated as a result of a number of factors, including risks and uncertainties discussed in MedImmune's filings with the U.S. Securities and Exchange Commission. There can be no assurance that such development efforts will succeed, that such products will receive required regulatory clearance or that, even if such regulatory clearance is received, such products will ultimately achieve commercial success.
About Micromet, Inc. (www.micromet-inc.com)
Micromet, Inc. is a biopharmaceutical company focusing on the development of novel, proprietary antibody-based products for cancer, inflammatory and autoimmune diseases. Two product candidates are currently in clinical trials. Adecatumumab (MT201), a recombinant human monoclonal antibody, is being evaluated in Phase 2 clinical trials for the treatment of patients with breast cancer and prostate cancer. MT103 is being studied in a Phase 1 clinical trial for the treatment of patients with NHL. Micromet has established a drug development platform based on its BiTE(R) technology, a unique, antibody-based format that leverages the cytotoxic potential of T cells, the most powerful 'killer cells' of the human immune system. Micromet has established collaborations with MedImmune, Inc. and Serono.
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. Such forward-looking statements include statements regarding the efficacy, safety, and intended utilization of Micromet's product candidates, the conduct and results of future clinical trials, plans regarding regulatory filings, future research, discovery of new product candidates, and clinical trials, and plans regarding partnering activities. Factors that may cause actual results to differ materially include difficulties encountered in integrating merged businesses, the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials, the risk that we will not obtain approval to market our products, the risks associated with reliance on outside financing to meet capital requirements, and the risks associated with reliance on collaborative partners for future revenues under the terms of our existing collaboration agreements, further clinical trials, development and commercialization of product candidates. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "potential," "expects," "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, including the "Risk Factors" sections of such reports.