Micromet, MedImmune initiate MT111 Phase 1 trial in patients with advanced gastrointestinal cancer

MedImmune, the global biologics unit of AstraZeneca PLC and Micromet, Inc. 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.

“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.”

"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."