Micromet Presents Update On Blinatumomab's Response Rate And Duration In A Phase 1 Study In Non-Hodgkin's Lymphoma Patients

Main Category: Lymphoma / Leukemia / Myeloma
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 09 Jun 2009 - 0:00 PDT

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Micromet, Inc. (Nasdaq: MITI), a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases, last week presented an update from an ongoing clinical study of the BiTE(R) antibody blinatumomab (MT103) for non-Hodgkin's lymphoma (NHL) at the 14th Congress of the European Hematology Association (EHA), held June 4 to 7 in Berlin, Germany. Blinatumomab is a novel therapeutic antibody that activates a patient's T cells to seek out and destroy cancer cells.

The poster presentation gave an update of an ongoing phase 1 trial of blinatumomab in relapsed NHL patients including a follow-up on response duration as well as pharmacodynamic activity(1). A dose-dependent clinical activity has been observed in these patients including partial and complete responses following treatment with single agent blinatumomab(2). The data show that 11 out of 12 patients having received a dose of 0.06 mg/m(2) per day during the first treatment cycle have responded according to standard Cheson criteria. Remissions appear to be durable without further treatment with a median relapse free interval of 13 months for the seven patients in the 0.06 mg/m(2) per day dose cohort reported at ASH in 2008(2). The most common adverse events (AEs) included lymphopenia, pyrexia, and leukopenia. The vast majority of AEs occurred early during treatment and improved or resolved during treatment. Permanent treatment discontinuation due to AEs resulted from infections, liver enzyme increases and fully reversible central nervous system events.

"The observation of high response rate and durable objective responses indicates the potential that blinatumomab and BiTE antibodies, in general, may have in fighting cancer," said Micromet's Senior Vice President and Chief Medical Officer, Carsten Reinhardt, M.D.

(1) Klinger, M. et al. (2009). Pharmacodynamic analyses of peripheral blood from relapsed B-NHL patients treated with anti-CD19/-CD3 bispecific BiTE(R) antibody blinatumomab. 14th Congress of EHA, abstract number 430

(2) Bargou, R. et al. (2008). Sustained Response Duration Seen after Treatment with Single Agent Blinatumomab (MT103/MEDI-538) in the Ongoing Phase I Study MT103-104 in Patients with Relapsed NHL. ASH 2008, abstract number 267

About Micromet, Inc.

Micromet, Inc. is a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases. Its product development pipeline includes novel antibodies generated with its proprietary BiTE(R) antibody platform, as well as conventional monoclonal antibodies. BiTE antibodies represent a new class of antibodies that activate the T cells of a patient's immune system to eliminate cancer cells. Four of Micromet's antibodies are currently in clinical trials. Its BiTE antibody blinatumomab (MT103) is in a phase 2 clinical trial for the treatment of patients with acute lymphoblastic leukemia (ALL), and in a phase 1 clinical trial for the treatment of patients with non-Hodgkin's lymphoma (NHL). A second BiTE antibody, MT110, is in a phase 1 clinical trial for the treatment of patients with solid tumors. MT110 binds to the epithelial cell adhesion molecule, or EpCAM, which is overexpressed in many solid tumors. Micromet's human monoclonal antibody adecatumumab (MT201) also binds to EpCAM and is being developed under a collaboration with Merck Serono. Adecatumomab is in a phase 2 clinical trial in colorectal carcinoma patients after complete resection of liver metastases, and a phase 1b clinical trial evaluating adecatumumab in combination with docetaxel for the treatment of patients with metastatic breast cancer. Micromet's monoclonal antibody MT293, also known as TRC093, is licensed to TRACON Pharmaceuticals, Inc., and is in a phase 1 clinical trial for the treatment of patients with cancer.

In addition, Micromet has established a collaboration with Nycomed for the development and commercialization of MT203, a 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. Nycomed has filed a clinical trial application and is expected to commence a phase 1 clinical trial of MT203 in the first half of 2009. Micromet's licensee Morphotek, a wholly-owned subsidiary of Eisai, is also expected to initiate a first phase 1 clinical trial with Micromet's glycolipid-binding human antibody MT228 for the treatment of melanoma. Micromet also has entered into an option, collaboration and license agreement with Bayer Schering Pharma AG under which Bayer Schering Pharma was granted an exclusive option to license a specified BiTE antibody against an undisclosed solid tumor target.

Micromet's preclinical product pipeline includes several novel BiTE antibodies generated with its proprietary BiTE antibody platform technology. BiTE antibodies targeting CEA, MSCP, CD33, HER2, EGFR and other targets are in various stages of preclinical development.

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. These forward-looking statements include statements regarding the efficacy, safety and intended utilization of blinatumomab and other product candidates, the conduct, timing and results of future clinical trials, and expectations of the future expansion of our product pipeline and collaborations. You are urged to consider statements that include the words "ongoing," "may," "will," "believes," "potential," "expects," "plans," "anticipates," "intends," 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, 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. These factors and others are more fully discussed in Micromet's Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2009, filed with the SEC on May 11, 2009, as well as other filings by the company with the SEC.

Source: Micromet, Inc