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Triggers $5M milestone payment from Servier
MacroGenics, Inc. (Nasdaq:MGNX), a clinical stage biopharmaceutical company focused on discovering and identifying innovative monoclonal antibody-based therapeutics for the treatment of cancer and autoimmune diseases, today announced that its investigational new drug (IND) for MGD007 has been cleared by the U.S. Food and Drug Administration (FDA) to proceed with the Phase 1 human clinical trial for this drug candidate.
MGD007 is a Dual-Affinity Re-Targeting (DART) protein being developed for the treatment of colorectal cancer. MacroGenics will receive a $5 million milestone payment from Servier, France’s largest privately-held pharmaceutical company, triggered by the IND clearance.
“MGD007 has demonstrated potent activity in preclinical studies supporting the treatment of colorectal cancer, the second leading cause of cancer-related deaths in the U.S., and an indication for which patients remain underserved despite recent advances in therapies,” said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “We look forward to initiating the Phase 1 study of MGD007, our second DART candidate to enter the clinic, in the second half of 2014.”
Under a September 2012 agreement, MacroGenics granted Servier an option to secure an exclusive license to MGD007 in all territories outside North America, Japan, Korea and India. Servier may exercise its option for MGD007 upon MacroGenics’ completion of the Phase 1 trial.
About MGD007:
MGD007 is a humanized DART molecule that recognizes both gpA33 and CD3. The molecule has been designed to bind to the CD3 protein found on T cells and redirect them to kill gpA33-expressing cells. 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. In preclinical studies, MGD007 mediated potent lysis of gpA33-positive colorectal cancer cell lines both in vivo and in vitro, and tumor growth inhibition was observed at very low doses. MacroGenics expects to initiate a Phase 1 study of MGD007 in colorectal cancer in the second half of 2014
