Date: 2011-01-12
Type of information:
phase: 1
Announcement: initiation
Company: Medimmune (USA) Micromet (USA-Germany)
Product: MEDI-565 (MT111)
Action
mechanism: MEDI-565 (MT111) is a BiTE® antibody designed to direct a patient's T 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.
This is the third BiTE antibody to enter the clinic.
BiTE® antibodies are designed to direct the body's cytotoxic, or cell-destroying, T cells against tumor cells. 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.
Disease: advanced gastrointestinal cancer
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: MedImmune, the global biologics unit of AstraZeneca and Micromet have announced the initiation of a Phase 1 trial of MEDI-565 (MT111) in patients with advanced gastrointestinal cancers.
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.
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 commercialisation will be led by MedImmune in the U.S. and outside of Europe, and by Micromet in Europe.
