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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. Retifanlimab (previously known as MGA012) is an investigational, humanized, proprietary anti-PD-1 monoclonal antibody being developed for use as monotherapy as well as in combination with other potential cancer therapeutics. Retifanlimab was licensed to Incyte Corporation in 2017 under a global collaboration and license agreement. (Learn More: Collaborations).
As of December 2020, Incyte is pursuing development of retifanlimab in registration-directed trials as a monotherapy for patients with microsatellite instability-high endometrial cancer, Merkel cell carcinoma and squamous cell carcinoma of the anal canal (SCAC); and in combination with platinum-based chemotherapy for patients with non-small cell lung cancer and SCAC.
Retifanlimab has been granted orphan drug designation by the U.S. Food and Drug Administration for the treatment of anal cancer.
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 retifanlimab, with Incyte commercializing retifanlimab 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 retifanlimab. (Learn More: Incyte retifanlimab collaboration)
Relevant publications and presentations can be found at https://www.macrogenics.com/publications/.
The safety and efficacy of investigational agents and/or investigational uses of approved products have not been established.