The fast track designation for IK-175 reflects the FDA’s interest in the potential role of our AHR antagonist to overcome the development of resistance to checkpoint inhibitors and supports our strategy of combining IK-175 with nivolumab to expand the number of cancer that can benefit from immunotherapy,” Sergio Santillana, MD, chief medical officer of Ikena Oncology, stated in a news release. “There is an urgent need for new treatment options for urothelial carcinoma, many of whom find themselves out of options after progressing on checkpoint inhibitors. IK-175 is designed to targeted AHR, which is a cancer-driving transcription factor that prevents immune recognition in a multitude of cancers by modulation of innate and adaptive immunity. The FDA has granted a fast track designation to the novel aryl hydrocarbon receptor (AHR) antagonist IK-175 in combination with nivolumab (Opdivo) for the treatment of patients with advanced urothelial carcinoma who have progressed on or within 3 months of receiving the last dose of checkpoint inhibitors.
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