Date: 2014-07-24
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: Macrogenics (USA - Md) Servier (France)
Product: MGD007
Action
mechanism: 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.
Disease: colorectal cancer
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On July 24, 2014, MacroGenics, a clinical stage biopharmaceutical company focused on discovering and identifying innovative monoclonal antibody-based therapeutics for the treatment of cancer and autoimmune diseases, announced that its investigational new drug (IND) for MGD007 has been cleared by the FDA to proceed with the Phase 1 human clinical trial for this drug candidate."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. MacroGenics will receive a $5 million milestone payment from Servier , triggered by the IND clearance
