MAIA Biotech Reports Phase 3 Trial Milestone in Lung Cancer Treatment

CHICAGO, Sept. 22, 2026 /CourierPR/ -- MAIA Biotechnology, Inc., a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, has announced significant progress in its ongoing pivotal Phase 3 clinical trial, THIO-104, evaluating its novel telomere-targeting therapy as a third-line (3L) treatment for advanced non-small cell lung cancer (NSCLC).

The company has reached 65 randomized patients in its ongoing pivotal Phase 3 trial, THIO-104, which is designed to evaluate the telomere-targeting activity of its lead product candidate, ateganosine, when followed by PD-(L)1 inhibition in patients with advanced third-line NSCLC who have not responded to or developed resistance to treatment regimens containing checkpoint inhibitors and/or chemotherapy.

This milestone in the trial underscores the strong pace of patient enrollment, supporting continued advancement toward regulatory milestones. The THIO-104 trial currently has 38 trial sites activated in 6 foreign countries: Taiwan, Romania, Turkey, Georgia, Poland, and Hungary.

The most recent assessment of the clinical trial, which has been ongoing in MAIA’s phase 2 THIO-101 clinical trial, showed that ateganosine, when sequenced with a checkpoint inhibitor, demonstrated a 90.5% disease control rate (DCR) in heavily pretreated third-line NSCLC patients. This measure contrasts with the reported 25%, 35% DCRs for standard third-line chemotherapy regimens.

In July 2025, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for ateganosine for the treatment of NSCLC. This designation allows for more frequent FDA communication, potential rolling review, and eligibility for Accelerated Approval and Priority Review. If approved, ateganosine will hold FDA New Chemical Entity (NCE) five-year marketing exclusivity. An NCE is a small molecule drug with a novel active ingredient that hasn’t been previously approved or marketed.

The THIO-104 trial is a multicenter, open-label, randomized Phase 3 clinical trial designed to evaluate ateganosine’s telomere-targeting anti-tumor activity when followed by PD-(L)1 inhibition in patients with advanced third-line NSCLC who previously did not respond or developed resistance to treatment regimens containing checkpoint inhibitor and/or chemotherapy and have progressed. The trial has two primary objectives: to assess the clinical efficacy of ateganosine compared to investigator’s choice of chemotherapy, using median Overall Survival (OS) as the primary clinical endpoint, and to evaluate the safety and tolerability of ateganosine in sequential combination with a checkpoint inhibitor.