Business Wire·Aug 5, 2026, 7:05 AM ET

Obsidian Therapeutics Announces First Patient Enrolled in the Registration-enabling Cohort of Phase 1/2 Agni-01 Study Evaluating Amsoki-cel (OBX-115) in Advanced Melanoma

Obsidian Therapeutics has initiated the first patient in the registration-enabling cohort of the Phase 1/2 Agni-01 study for amsokigene autoleucel (amsoki-cel) in patients with ICI-resistant advanced melanoma.
The company selected a single-arm trial design following FDA alignment to support a future BLA submission via the accelerated approval pathway.
Previous Phase 1/2 results showed a 67% objective response rate (ORR) at the recommended phase 2 dose (RP2D) with 2 complete responses among 15 patients.
Topline data from the registration-enabling cohort is expected by year-end 2027, with enrollment completion anticipated by the end of Q1 2027.
The study utilizes an IL2-free regimen with low-dose lymphodepletion, allowing for outpatient administration & less-invasive core needle biopsy tumor tissue procurement.
Amsoki-cel demonstrated a favorable safety profile in prior studies with no dose-limiting toxicities, treatment-related mortality, neurotoxicity syndrome, or ICU transfers.
Obsidian is also evaluating amsoki-cel in non-small cell lung cancer (NSCLC) patients, with Phase 1 data expected in the first half of 2027.
The primary endpoint for the trial is objective response rate (ORR) assessed by blinded independent central radiologist review using RECIST v1.1.