Clinical-stage biopharmaceutical company Obsidian Therapeutics Inc (Nasdaq:OBX) on Wednesday announced enrolment of the first patient in the registration-enabling cohort of its Phase 1/2 Agni-01 study evaluating amsokigene autoleucel (amsoki-cel, formerly OBX-115) in patients with immune checkpoint inhibitor (ICI)-resistant advanced or metastatic melanoma.

Following discussions with the FDA, Obsidian is pursuing a single-arm trial design intended to support a future BLA submission through an accelerated approval pathway.

The cohort follows positive Phase 1/2 results showing a 67% objective response rate at the recommended Phase 2 dose, including two complete responses among 15 patients.

Enrolment in the registration-enabling cohort is anticipated to be completed by the end of Q1 2027 and Obsidian expects topline data by year-end 2027.

The company is also evaluating amsoki-cel in patients with non-small cell lung cancer (NSCLC) in the Agni-01 trial. NSCLC Phase 1 data are expected in the first half of 2027.