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). 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 anoral, selective, small-molecule EP4 receptor antagonist that has the potential to change the immunosuppressive state in the tumor microenvironment and re-sensitize to the activity of checkpoint inhibitors.

Ikena is currently investigating IK-007 in a Phase 1b clinical trial in combination with Merck’s anti-PD-1 antibody KEYTRUDA® (pembrolizumab) in patients with advanced or progressive microsatellite stable (MSS) CRC (NCT03658772), which represents approximately 80% of all patients with CRC. These patients generally do not respond to approved checkpoint inhibitors.

We have identified an association between higher levels of PGEM, a metabolite in the EP4 pathway, in urine samples collected at study entry with those patients that demonstrated increased clinical benefit. We are enrolling patients in a dose expansion cohort using baseline levels of urinary PGEM to enrich for MSS CRC patients, who we believe will be more likely to respond to treatment. We expect to complete enrollment for the Phase 1b clinical trial in the second half of 2021.