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Macrogenics (MGNX) Announces Achievement of $10 Million Milestone Related to Retifanlimab Collaboration with Incyte (INCY)

February 11, 2021 7:40 AM EST

MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that a $10 million milestone has been achieved related to development progress of retifanlimab outside the U.S., under its exclusive global collaboration and license agreement with Incyte. Retifanlimab is an investigational anti-PD-1 monoclonal antibody designed by MacroGenics and licensed to Incyte (as INCMGA0012).

As previously announced in January 2021, the U.S. Food and Drug Administration (FDA) has accepted for Priority Review Incyte’s Biologics License Application (BLA) for retifanlimab as a potential treatment for adult patients with locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy. The Prescription Drug User Fee Act (PDUFA) target action date for retifanlimab is July 25, 2021. In addition, Incyte has stated it is pursuing development of retifanlimab as monotherapy in potentially registration-enabling studies in patients with MSI-high endometrial cancer and Merkel cell carcinoma.

In 2020, Incyte initiated two Phase 3 studies of retifanlimab in combination with chemo-radiation or chemotherapy in patients with advanced or metastatic non-small cell lung cancer (NSCLC) and in patients with metastatic SCAC, known as POD1UM-304 and POD1UM-303, respectively. Incyte is also pursuing development of retifanlimab in combination with multiple product candidates from its pipeline.

MacroGenics is currently evaluating retifanlimab in combination with margetuximab, an investigational Fc-engineered, anti-HER2 monoclonal antibody (mAb), in a potentially registration-enabling study of patients with HER2-positive gastric cancer. The Company also plans to initiate a study of retifanlimab in combination with enoblituzumab, an investigational Fc-engineered, anti-B7-H3 mAb, in patients with squamous cell carcinoma of the head and neck (SCCHN).

Under the collaboration agreement with Incyte, MacroGenics has received $65 million in milestones to date and is eligible to receive up to a total of $355 million in potential remaining development and regulatory milestones and up to $330 million in potential commercial milestones. If retifanlimab is approved and commercialized, MacroGenics would be eligible to receive royalties, tiered from 15 to 24 percent, on future worldwide net sales of the molecule.




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