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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).
A Phase 1 study of MGA012 is currently ongoing. After completing the dose escalation portion of the study and achieving a recommended Phase 2 dose, MacroGenics is now enrolling patients across multiple dose expansion cohorts (including endometrial, cervical and non-small cell lung cancers as well as sarcoma). MacroGenics intends to leverage the potential power of combination immunotherapy treatments by coupling MGA012 with other assets from its pipeline of product candidates.
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 is expected to be fully operational in 2018. (Learn More: Incyte MGA012 Collaboration).