Ateganosine (THIO-104)

Sept. 22, 2026: MAIA Biotechnology (NYSE: MAIA) said 65 patients have been enrolled in the ongoing pivotal Phase 3 THIO-104 trial of ateganosine (THIO, 6-thio-dG) in advanced third-line NSCLC, with 38 activated sites across six countries. The company said it remains on track to exceed 100 randomized patients by year-end.

THIO-104 is an open-label, randomized Phase 3 study in patients with advanced 3L NSCLC whose disease progressed after checkpoint inhibitor and/or chemotherapy. Ateganosine followed by PD-(L)1 inhibition is being compared with investigator’s choice chemotherapy. The primary efficacy endpoint is median overall survival, with safety/tolerability as a primary objective.

The release also cites the most recent interim assessment from the ongoing Phase 2 THIO-101 trial: ateganosine sequenced with a checkpoint inhibitor showed a 90.5% disease control rate in heavily pretreated 3L NSCLC, versus reported 25%–35% DCRs for standard third-line chemotherapy regimens.

Regulatory status: the FDA granted Fast Track designation to ateganosine for NSCLC in July 2025. The company highlights potential rolling review, Accelerated Approval and Priority Review eligibility if applicable.