On February 5, 2014 MacroGenics reported that Servier has exercised its exclusive option to develop and commercialize MGD006, a DART-based product candidate developed by MacroGenics (Press release MacroGenics, FEB 5, 2014, View Source [SID:1234500769]). Servier will gain exclusive development and commercial rights in all countries outside of the U.S., Canada, Mexico, Japan, South Korea and India. In those countries, MacroGenics will retain development and commercialization rights. As a result of the exercise, MacroGenics will receive a $15 million payment from Servier. In addition, the Investigational New Drug (IND) application for MGD006 has cleared the 30 day review period by the U.S. Food and Drug Administration (FDA), triggering an additional $5M payment to MacroGenics by Servier.
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MGD006 is a humanized Dual-Affinity Re-Targeting (DART) molecule in development for hematologic malignancies that recognizes both CD123 and CD3. In pre-clinical studies, the results of which were presented at the 55th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in November 2013, MGD006 was shown to redirect T cells via their CD3 component to kill CD123-expressing leukemia cells at very low concentrations of the DART. MacroGenics expects to initiate a Phase 1 study in the second quarter of 2014 for the treatment of relapsed and refractory acute myeloid leukemia (AML), representing the initial execution of an important strategic effort by the company to apply T-cell directed cancer immunotherapy in significant areas of unmet clinical need, including both hematologic malignancies and solid tumors.
"Servier is committed to bringing novel targeted therapies to patients with cancer, and the MacroGenics team has shown preliminary evidence of the successful application of its proprietary DART platform to multiple promising product candidates for the treatment of solid and hematologic cancers," said Dr. Emmanuel Canet, President of Research and Development at Servier. "In particular, MGD006 has shown the ability to kill AML blasts in vitro and in vivo at very low doses. We are committed to moving this candidate into clinical development in collaboration with MacroGenics and continuing to build our long-term partnership."
Under the September 2012 agreement, Servier was granted options to obtain three separate exclusive licenses to develop and commercialize novel anti-cancer DART-based molecules, consisting of MGD006 and MGD007, as well as a third DART-based molecule, in all countries other than the U.S., Canada, Mexico, Japan, South Korea and India. In addition to the $20 million upfront payment and $20 million related to the option exercise and IND clearance, MacroGenics may be eligible to receive up to approximately $1 billion in additional license grant fees, and clinical development, regulatory and sales-based milestones. Both parties will share the clinical development costs for each program following the exercise of such option. Finally, MacroGenics may receive tiered, double-digit royalties on future net sales.
"We are thrilled that Servier has exercised its option to develop MGD006 and we share their belief that next generation bi-specific antibodies are a critical new frontier in medicine," commented Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "We believe DART-based molecules have the potential to provide a significant impact on the treatment paradigm for patients with cancer and autoimmune disorders and look forward to continuing our relationship with Servier."