IK-007

A large body of literature demonstrates that activation of the prostaglandin E₂ (PGE₂) / Prostaglandin E₂ Receptor 4 (EP4) metabolic pathway in cancer augments tumor initiation, progression and therapeutic resistance. Increased expression of these pathway components is associated with decreased survival, therapeutic and preventive precedent in a number of cancer types, including colorectal cancer (CRC) and non-small cell lung cancer (NSCLC). When activated, EP4 affects the activity of a broad range of cells within the innate and adaptive immune system culminating in an immunosuppressive tumor microenvironment. Ikena’s IK-007 is a first-in-class, oral, highly selective, and potent small-molecule EP4 receptor antagonist that is designed to revert the immunosuppressive state in the tumor microenvironment and re-sensitize immune resistant tumors.

Ikena is currently investigating IK-007 in two Phase 1b/2 clinical trials in combination with Merck’s anti-PD-1 antibody KEYTRUDA^® (pembrolizumab) in patients with checkpoint-refractory and -resistant solid tumors, namely advanced or progressive microsatellite stable CRC (NCT03658772) and advanced or metastatic post PD-1/L-1 NSCLC (NCT03696212). For both trials, Ikena is employing a robust, retrospective biomarker strategy relevant to T cell checkpoint inhibitors and EP4 signaling. The objective of these correlative biomarker studies is to identify patients most likely to benefit from IK-007 combined with pembrolizumab going forward.