Ateganosine (THIO-101)

Sept. 16, 2026: MAIA Biotechnology (NYSE: MAIA) announced the first U.S. patient has been dosed in the Phase 2 THIO-101 expansion trial of ateganosine (THIO) in third-line non-small cell lung cancer. The milestone follows FDA clearance of MAIA’s amended IND, which the company said reflects improved manufacturing capabilities and efficiencies. The U.S. expansion is funded by a $2.3 million NIH grant, and three U.S. sites have been activated.

THIO-101 is a multicenter, open-label, dose-finding Phase 2 study evaluating ateganosine followed by cemiplimab (Libtayo) in advanced NSCLC patients who did not respond to, or progressed after, prior checkpoint inhibitor-based first-line treatment; the expansion specifically assesses overall response rate in third-line patients resistant to prior checkpoint inhibitors and chemotherapy. Primary objectives are safety/tolerability and efficacy, with ORR as the primary clinical endpoint.

MAIA said prior THIO-101 Parts A and B data showed overall survival beyond 24 months in eight patients receiving ateganosine sequenced with a checkpoint inhibitor, and that the regimen has shown an acceptable safety profile to date in a heavily pretreated population. The company also noted ateganosine has FDA Fast Track designation.