Ikena Oncology, Inc. presented initial clinical data from its ongoing IK-175 clinical program in urothelial carcinoma at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting in Boston, MA. Initial results demonstrate durable antitumor activity in heavily pretreated patients in both monotherapy and combination arms in urothelial carcinoma patients who all progressed on prior checkpoint inhibitors. Key Data Highlights: IK-175 Dose Escalation, Stage 1 of Dose Expansion Monotherapy in Urothelial Carcinoma, and Stage 1 of Combination with Nivolumab Expansion in Urothelial Carcinoma.

The study is an ongoing Phase 1b, open-label dose escalation and expansion study of IK-175 in those diagnosed with local or advanced solid tumors or unresectable urothelial carcinoma who have exhausted prior therapies and have seen disease progression on or within 12 weeks of the last dose of checkpoint inhibitor. IK-175 treats cancer through a novel mechanism, inhibiting the cancer-driving transcription factor known as the aryl hydrocarbon receptor (AHR) and modulating the tumor microenvironment. Through a body of translational data, including data generated with Ikena's internally discovered biomarkers and novel assays, AHR has been demonstrated to be upregulated in urothelial carcinoma and other solid tumors leading to an increase in immunosuppressive effects and resistance to checkpoint inhibitor treatment.

Responses are evaluated through RECIST 1.1. The expansion cohorts enrolled only urothelial carcinoma patients and are designed as Simon-2-stage cohorts. Both the monotherapy and combination arms advanced to stage 2 and enrollment is ongoing. Ikena's IK-175 program is being developed in collaboration with Bristol Myers Squibb.

Bristol Myers Squibb has an option to exclusively license the program through early 2024. The therapy is also being studied in a Phase 1, open-label, single-arm dose expansion study in combination with nivolumab in advanced head and neck cancer (IK-175-002).