GAITHERSBURG and BETHESDA, MD
MedImmune, the global biologics unit of AstraZeneca PLC (NYSE: AZN) and Micromet, Inc. (NASDAQ: MITI) today announced the initiation of a Phase 1 trial of MEDI-565 (MT111) in patients with advanced gastrointestinal cancers.
MEDI-565 (MT111) is a BiTE® antibody designed to direct a patient's T cells, the body's most potent killer cells, against cancer cells that express carcinoembryonic antigen (CEA). CEA is a protein found on the surface of a number of gastrointestinal cancers, including colorectal, pancreatic, esophageal and gastric.
"The initiation of this trial represents an important step forward in our commitment to advancing our oncologic biologics pipeline addressing different mechanisms to treat cancer," said Gerald McMahon, Ph.D., MedImmune's Senior Vice President, Research and Development and Head of the Oncology Innovative Medicines unit. "We are very eager to understand the potential of this investigational agent."
This Phase 1 dose-escalation study will evaluate the safety, tolerability, and antitumor activity of the product candidate in adult patients with advanced gastrointestinal cancers, with dose escalation in subsequent cohorts based on safety and tolerability. Once the maximum tolerated dose is determined, additional study subjects with refractory colorectal or pancreatic cancer will be enrolled in a dose-expansion phase to further assess the safety and antitumor activity.
Preclinical studies have demonstrated potent activity of the CEA BiTE antibody against human cancer cell lines and inhibition of tumor growth in animal models.
"We are very pleased to see the third BiTE antibody enter the clinic," said Christian Itin, Ph.D., Micromet's President and Chief Executive Officer. "Pre-clinical results reported to date suggest that MT111 may represent a new approach to treating gastrointestinal cancers, and may also have potential applications in other solid tumors."
MedImmune and Micromet are advancing the development of this product candidate under a collaboration agreement signed in June 2003. Under the terms of the agreement, development and commercialization will be led by MedImmune in the U.S. and outside of Europe, and by Micromet in Europe.
Additional information regarding this Phase 1 study, including enrollment criteria and site locations, will be available soon on the U.S. government's clinical trials database at http://www.clinicaltrials.gov.
About BiTE Antibodies
BiTE® 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. BiTE antibodies have been shown to bind T cells to tumor cells, ultimately inducing a self-destruction process in the tumor cells 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 very low concentrations. Through the killing process, T cells start to proliferate, which leads to an increased number of T cells at the site of attack.
MedImmune, the worldwide biologics unit for AstraZeneca PLC (NYSE: AZN), has approximately 3,500 employees worldwide and is headquartered in Gaithersburg, Maryland. For more information, visit MedImmune's website at www.medimmune.com.
About Micromet, Inc.
Micromet, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of innovative antibody-based therapies for the treatment of cancer. Its product development pipeline includes novel antibodies generated with its proprietary BiTE® technology, as well as conventional monoclonal antibodies. The Company's lead product candidate blinatumomab (MT103) is currently the subject of a pivotal trial in patients with minimal residual disease positive acute lymphoblastic leukemia. Micromet has collaborations with a number of leading pharmaceutical and biotechnology companies, including Bayer Schering Pharma, Boehringer Ingelheim, MedImmune, Merck Serono, Nycomed and sanofi-aventis. Additional information can be found at www.micromet.com.
This release contains certain forward-looking statements regarding Micromet and the BiTE antibody MEDI-565 (MT111) 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 future development and applications of MEDI-565 (MT111). You are urged to consider statements that include the words "will," "potential," "may," 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 MEDI-565 (MT111) does not demonstrate safety and/or efficacy in clinical trials, delays in development and testing, the risk that MEDI-565 (MT111) will not receive marketing approval, and the risks associated with reliance on outside financing to meet capital requirements. These factors and others are more fully discussed in Micromet's Annual Report on Form 10-K for the fiscal year ended December 31, 2009, filed with the SEC on March 5, 2010, and Micromet's Quarterly Report on Form 10-Q for the quarter ended September 30, 2010, filed with the SEC on November 9, 2010, as well as other filings by the Company with the SEC.