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MGD007 is a humanized DART® molecule that recognizes both the glycoprotein A33 antigen, or gpA33, and CD3 and was our first clinical DART molecule designed to target solid tumors. MGD007 is an Fc domain-bearing DART molecule engineered to have prolonged circulating serum half-life. The gpA33 antigen is found on over 95% of primary and metastatic human colorectal cancers, including cancer stem cells, which are thought to be responsible for tumor recurrence and metastasis. MGD007 was designed to redirect T cells, via their CD3 component, to kill gpA33-expressing cells.
An ongoing Phase 1 dose-escalation study of MGD007 was designed to characterize the safety and tolerability of MGD007 and establish the maximum tolerated dose (MTD) of MGD007 administered using various schedules of administration among patients with metastatic colorectal carcinoma. Pharmacokinetics, pharmacodynamics, and the anti-tumor activity of MGD007 is also being assessed.
In April 2014, we presented data from a pre-clinical study of MGD007 at the American Association for Cancer Research (AACR) Annual Meeting. We showed that MGD007 had robust activity against human colorectal cancer in murine xenograft models and a favorable pharmacokinetic profile in non-human primates. Key findings included:
Under the terms of a collaboration, MacroGenics retains full development and commercialization rights to MGD007 in the U.S., Canada, Mexico, Japan, South Korea and India. MacroGenics’ partner, Servier, has an option to obtain rights to MGD007 in all other countries. (Learn More: Servier DART Collaboration)