Data Presented at ASH Annual Meeting Indicates the Potential of T-Cell Engaging BiTE Antibody Blinatumomab as a Consolidation Treatment for Aggressive Leukemias
BETHESDA, Md., Dec. 8 /PRNewswire-FirstCall/ -- Micromet, Inc. , a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases, yesterday presented first interim data from a phase 2 clinical trial of BiTE(R) antibody blinatumomab (MT103/MEDI-538) in patients with acute lymphoblastic leukemia (ALL). Blinatumomab is a novel therapeutic antibody that activates a patient's T cells to seek out and destroy cancer cells. The presentation took place at the 50th annual meeting of the American Society of Hematology, held December 6 to 9 in San Francisco, CA.
The patients in this phase 2 clinical trial are in complete hematological remission following intense chemotherapy regimens, but retain ALL cancer cells in their bone marrow - so called minimal residual disease (MRD). Various reports have confirmed that ALL patients with MRD following chemotherapy have a significantly worse prognosis than patients without MRD. Interim results for the ongoing phase 2 clinical trial of blinatumomab for ALL find the BiTE antibody was able to eliminate MRD. Six patients have been enrolled so far in the trial. Four patients have concluded at least two cycles of therapy with blinatumomab. Three out of these four patients turned MRD-negative after the first treatment cycle. One patient achieved stable disease after the first treatment cycle and does not show signs of hematological relapse to date. Except for one patient with a port infection, no severe toxicities were recorded so far.
"Today patients with MRD-positive ALL after first line therapy have very few options for treatment, and a very high likelihood of relapse," commented Professor D. Hoelzer, chairman of the German Multicenter Study Group for Adult Acute Lymphoblastic Leukemia (GMALL). "The ability to convert a patient's MRD status from positive to negative could lead to better clinical outcomes. These data suggest that blinatumomab may hold the potential to be an effective consolidation therapy after prior incomplete response to chemotherapy or even targeted therapy."
"The level of response to blinatumomab in ALL patients observed in this trial combined with the unmet need for new therapies to treat this patient population may open the path towards an accelerated development in this indication," commented Micromet Senior Vice President and Chief Medical Officer Carsten Reinhardt, M.D.
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. Typically antibodies cannot engage T cells because T cells lack the appropriate receptors for binding antibodies. Previous attempts have shown the potential of T cells to treat cancer, but the therapeutic approaches tested to date have been hampered by cancer cells' ability to escape recognition by T cells. The use of BiTE antibodies that are specifically designed to engage T cells for attacking cancer cells may provide a more effective anti-tumor approach than conventional monoclonal antibodies.
Micromet, Inc. is a biopharmaceutical company with offices in Bethesda, Maryland and Munich, Germany. The Company is developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases. The Company uses its proprietary BiTE(R) antibody platform to create a new class of antibodies that specifically activate T cells from the patient's own immune system to eliminate cancer cells or other disease-related cells. Four of the Company's antibodies are currently in clinical trials, with the remainder of its product pipeline in preclinical development. The Company's lead program is a BiTE antibody known as blinatumomab, or MT103. It is 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. Micromet is developing blinatumomab in collaboration with MedImmune, a subsidiary of AstraZeneca plc. Micromet's second BiTE antibody in clinical development is MT110, which targets the epithelial cell adhesion molecule (EpCAM). The Company owns all rights to MT110, which is currently in a phase 1 clinical trial for the treatment of patients with solid tumors. The Company's third clinical stage antibody is adecatumumab, also known as MT201, a conventional human monoclonal antibody that targets EpCAM-expressing solid tumors. Micromet is developing adecatumumab 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. Micromet has licensed a fourth clinical stage antibody, MT293, to TRACON Pharmaceuticals, Inc. MT293 is being developed in a phase 1 clinical trial for the treatment of patients with cancer. The Company's preclinical programs include MT203, which is being developed in collaboration with Nycomed. MT203 is a traditional human antibody neutralizing the activity of granulocyte/macrophage colony stimulating factor (GM-CSF), which has potential applications in the treatment of inflammatory and autoimmune diseases, such as rheumatoid arthritis, psoriasis, or multiple sclerosis. Additional BiTE antibodies, targeting CEA, CD33, Her2, EGFR and MCSP, respectively, are in different stages of preclinical development.
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. These forward-looking statements include statements regarding the efficacy and intended utilization of our product candidates and the development of our BiTE antibody technology. You are urged to consider statements that include the words "may," "potential," or the negative of those words or other similar words to be uncertain and forward-looking. 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, and 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. These factors and others are more fully discussed in Micromet's Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2008, filed with the SEC on November 6, 2008, as well as other filings by the company 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.
Posted: December 2008