CHICAGO — September 22, 2026
MAIA Biotechnology announced that enrollment has reached 65 patients in the pivotal Phase 3 THIO-104 trial evaluating investigational ateganosine (THIO) as a third-line treatment for advanced non-small cell lung cancer (NSCLC). The trial currently has 38 active sites across six countries, including Taiwan, Romania, Turkey, Georgia, Poland and Hungary. MAIA expects additional sites to begin enrolling and is targeting more than 100 randomized patients by the end of 2026 as the company advances the program toward potential regulatory milestones.
THIO-104 Evaluates Ateganosine in Third-Line NSCLC
THIO-104 is evaluating ateganosine in patients with advanced NSCLC who have progressed following earlier treatment, including immunotherapy-based standard regimens. MAIA is developing the therapy for a population with substantial unmet treatment needs in later-line disease. The company said statistical assessments of the Phase 3 program indicate a high probability of technical success, although the ultimate efficacy and regulatory outcome will depend on results from the ongoing clinical trial and regulatory review.
Ateganosine Shows Disease Control Signal in Phase 2
The latest assessment from the ongoing Phase 2 THIO-101 study showed a 90.5% interim disease control rate (DCR) among heavily pretreated patients with third-line NSCLC receiving ateganosine sequenced with a checkpoint inhibitor. MAIA compared this finding with reported DCRs of approximately 25% to 35% for standard third-line chemotherapy regimens. The Phase 2 findings remain interim clinical data and are separate from the pivotal THIO-104 trial.
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Telomere Targeting Drives MAIA’s Immuno-Oncology Strategy
Ateganosine is an investigational telomere-targeting agent designed to induce telomerase-dependent telomeric DNA damage and selective cancer cell death. The resulting telomeric fragments can activate innate cGAS/STING signaling and adaptive T-cell responses, providing the mechanistic rationale for sequencing ateganosine with PD-(L)1 checkpoint inhibitors. The FDA granted Fast Track designation for ateganosine in NSCLC in July 2025, providing potential benefits including more frequent agency interaction, rolling review eligibility and potential eligibility for Accelerated Approval and Priority Review. Ateganosine remains investigational and has not been approved for NSCLC.
Source :MAIA Biotechnology,press release
