Ateganosine (THIO-101)

October 7, 2026: MAIA Biotechnology (NYSE: MAIA) announced an enrollment milestone across its ateganosine (THIO) NSCLC program, with 150 patients treated across the ongoing Phase 2 THIO-101 and pivotal Phase 3 THIO-104 studies.

For THIO-101 Phase 2, enrollment is complete in Part C evaluating ateganosine sequenced with cemiplimab in advanced NSCLC. MAIA said it previously reported 90.5% interim disease control rate in the efficacy-evaluable population with at least one post-treatment tumor scan. The study’s primary clinical endpoint is overall response rate, and the company said safety has been acceptable to date in a heavily pre-treated population.

For THIO-104 Phase 3, 65 patients have been enrolled in the randomized trial in third-line NSCLC after progression following checkpoint inhibitor and/or chemotherapy. The study compares ateganosine followed by PD-(L)1 inhibition versus investigator’s choice of chemotherapy, with median overall survival as the primary efficacy endpoint. MAIA said it remains on track to reach 100 enrolled and dosed patients by year-end 2026 and to conduct an interim analysis in 2027.

The company also noted the FDA granted Fast Track designation to ateganosine for NSCLC in July 2025.