Announcement • Aug 06

Obsidian Therapeutics, Inc. Enrolls First Patient In Registration-Enabling Cohort Of Phase 1/2 Agni-01 Study Evaluating Amsoki-Cel In Advanced Melanoma

Obsidian Therapeutics, Inc. announced the first patient has been enrolled in the registration-enabling cohort of the Phase 1/2 Agni-01 multicenter study of amsokigene autoleucel (amsoki-cel, formerly OBX-115), an engineered TIL cell therapy armored with pharmacologically regulatable membrane-bound IL15 (mbIL15), in patients with immune checkpoint inhibitor (ICI)-resistant advanced or metastatic melanoma. The single-arm registration-enabling cohort is part of the ongoing Agni-01 study (NCT06060613), which is a multicenter Phase 1/2 study, and designed to further evaluate the safety and efficacy of amsoki-cel at the recommended phase 2 dose (RP2D) in patients with ICI-resistant advanced melanoma. The primary endpoint is objective response rate (ORR) as measured per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) by blinded independent central radiologist review (BICR). Enrollment is anticipated to be completed by end of First Quarter 2027. Initiation of the registration-enabling cohort follows positive Phase 1/2 results from the Agni-01 study, where amsoki-cel demonstrated strong efficacy with a 67% ORR at the RP2D (n=10/15), including two complete responses in a patient population with high unmet need, difficult-to-treat advanced melanoma. Amsoki-cel has also delivered a consistent, favorable safety profile with low-dose lymphodepletion and no IL2 in the treatment regimen. There were no reported dose-limiting toxicities, treatment-related mortality, immune effector cell-associated neurotoxicity syndrome or ICU transfers. Obsidian is also investigating 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. Obsidian leverages its cytoDRiVE platform to develop engineered TIL cell therapies. Obsidian’s lead investigational TIL program, amsoki-cel, is a novel engineered tumor-derived autologous T cell immunotherapy (tumor-infiltrating lymphocyte [TIL] cell therapy) armored with pharmacologically regulatable membrane-bound IL15 (mbIL15). Amsoki-cel has the potential, if approved, to become a meaningful therapeutic option for patients with advanced (unresectable or metastatic) melanoma and other solid tumors by leveraging the expected benefits of mbIL15 and Obsidian’s proprietary, differentiated manufacturing process designed to enhance persistence, antitumor activity, and clinical safety of TIL cell therapy. Obsidian is investigating amsoki-cel in the phase 1/2 Agni-01 multicenter trial in patients with advanced solid tumors (NCT06060613).

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Obsidian Therapeutics, Inc. Enrolls First Patient In Registration-Enabling Cohort Of Phase 1/2 Agni-01 Study Evaluating Amsoki-Cel In Advanced Melanoma

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