Retifanlimab (PD-1)

Background

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).

Clinical Development

Retifanlimab is being studied as monotherapy or in combination with other agents across multiple studies.

The molecule has been granted orphan drug designation by the U.S. Food and Drug Administration for the treatment of anal cancer.

Our Rights

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)

Clinical Trials

• Retifanlimab Phase 3 Study in Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT2) (NCT04472429)
• Retifanlimab Phase 3 Study in Squamous and Nonsquamous Non-Small Cell Lung Cancer (POD1UM-304) (NCT04205812)
• Other retifanlimab studies (clinicaltrials.gov)

Presentations & Publications

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.