Ikena Oncology, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for IK-175, the Company's novel aryl hydrocarbon receptor (AHR) antagonist, in combination with immune checkpoint inhibitors in patients with advanced urothelial carcinoma who have progressed on or within three months of receiving the last dose of checkpoint inhibitors. Fast Track designation is reserved for therapies that represent potential best-in-class therapeutic options for diseases with high unmet need. Therapies that receive Fast Track designation often have the opportunity to communicate more frequently with the FDA on trial design and data and may also be eligible for priority review and accelerated approval. IK-175 is the second of Ikena's candidates to receive Fast Track designation; the FDA has also granted the designation to IK-930, the Company's novel TEAD inhibitor, in patients with unresectable NF2-deficient malignant pleural mesothelioma. IK-175 targets AHR, a compelling cancer-driving transcription factor that prevents immune recognition in a multitude of cancers by modulation of innate and adaptive immunity. Patients with urothelial carcinoma are generally treated through a combination of standard-of-care options, including surgery, chemotherapy, radiation and immunotherapies, including checkpoint inhibitors. IK-175 is currently being studied in a Phase 1a/b clinical trial as a monotherapy and in combination with nivolumab in patients with advanced or metastatic solid tumors including urothelial carcinoma for which standard therapy is no longer effective or is intolerable (NCT04200963, or IK-175-001). Initial clinical data presented at the Society for Immunotherapy of Cancer (SITC) 2022 Annual Meeting demonstrated that IK-175 is well tolerated and showed encouraging, durable, anti-tumor activity in stage 1 of the trial's monotherapy and combination arms in urothelial carcinoma patients. The IK-175 program is being developed in collaboration with Bristol Myers Squibb and they have an option to
exclusively license the program through early 2024.