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MGD007 is a humanized, Dual-Affinity Re-Targeting, or 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. The primary mechanism of action of MGD007 is its ability to redirect T cells, via their CD3 component, to kill gpA33-expressing cells.
In 2014, we initiated a Phase 1 dose-escalation study with MGD007. This study is designed to characterize the safety and tolerability of MGD007 and establish the maximum tolerated dose (MTD) of MGD007 administered on either weekly or every three week schedules of administration among patients with metastatic colorectal carcinoma. Pharmacokinetics, pharmacodynamics, and the anti-tumor activity of MGD007 will also be assessed.
We continue to enroll patients in the Phase 1 study.
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 has 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)