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news.US-based biopharmaceutical firm MacroGenics has received clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) to proceed with the Phase I human clinical trial for this drug candidate 'MGD007'.
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MGD007 is a Dual-Affinity Re-Targeting (DART) protein in development to treat colorectal cancer.
The company will receive a $5m milestone payment from Servier, France’s largest privately-held pharmaceutical company, triggered by the IND clearance.
MacroGenics president and CEO Scott Koenig said MGD007 has showed potent activity in preclinical studies supporting the treatment of colorectal cancer, the second leading cause of cancer-related deaths in the US, and an indication for which patients remain underserved despite recent advances in therapies.
"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," Koenig said.
As part of an agreement signed in September 2012, 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 the company’s completion of the Phase I trial of MGD007, a humanized DART molecule that recognizes both gpA33 and CD3.