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Marketed antibodies targeting PD-1 have shown clinical efficacy in the treatment of various tumors. These antibodies act as checkpoint inhibitors, releasing the “brakes” on the immune system that are often imposed by tumors as a means to evade immune detection. MGA012 is a humanized, proprietary anti-PD-1 monoclonal antibody being developed for use as monotherapy as well as in combination with other potential cancer therapeutics. MGA012 was licensed to Incyte Corporation in 2017 under a global collaboration and license agreement. (Learn More: Collaborations).
Incyte is pursuing development of MGA012 monotherapy through three registration-directed studies in MSI-high endometrial cancer, Merkel cell carcinoma and anal cancer. Incyte is also pursuing development of MGA012 in combination with multiple product candidates from its pipeline, and MacroGenics is currently studying MGA012 in combination with two DART molecules, MGD009 and MGD007.
In October 2017, MacroGenics announced that it had entered into a global collaboration and license agreement with Incyte. MacroGenics retains the right to develop its own pipeline assets in combination with MGA012, with Incyte commercializing MGA012 and MacroGenics commercializing its asset(s), if any such potential combinations are approved.
In addition, MacroGenics retains the right to manufacture a portion of both companies’ global clinical and commercial supply needs of MGA012. MacroGenics intends to utilize its commercial-scale GMP facility, which became fully operational in 2018. (Learn More: Incyte MGA012 Collaboration).