The dose expansion cohort included patients who expressed high levels of AHR by immunohistochemistry. In the phase 1a/b IK175-001 trial (NCT04200963), it was investigated as monotherapy or in combination with nivolumab in 43 patients with locally advanced or metastatic solid tumors in a dose escalation phase and in a dose expansion cohort of patients with urothelial cancer. IK-175 is a selective, small molecular AHR inhibitor that induces T cell activity, interleukin (IL)-22 gene expression, and leads to an increase in inflammatory cytokines, including IL-2 and IL-9. Urothelial cancers have been associated with high AHR signaling.
2 Its activity has been linked to immunosuppression and tumorigenesis. 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 ICIs and supports our strategy of combining IK-175 with nivolumab to expand the number of cancer patients can benefit from immunotherapy,” Sergio Santillana, MD, chief medical officer at Ikena, said in a press release.ĪHR is a ligand-activated transcription factor that regulates innate and adaptive immune cells and can bind to immunosuppressive ligands. “There is an urgent need for new treatment options for urothelial carcinoma, many of whom find themselves out of options after progressing on ICIs. The designation was granted for use in combination with immune checkpoint inhibitors (ICIs) in patients who have progressed while receiving ICIs or within 3 months of receiving ICIs for advanced urothelial carcinoma.
The novel aryl hydrocarbon receptor (AHR) antagonist IK-175 received a Fast Track Designation from the FDA for patients with advanced urothelial carcinoma, according to a press release.
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