MAIA Biotechnology Achieves Patient Enrollment Milestones in Ongoing Phase 2 and Pivotal Phase 3 Clinical Trials in Non-Small Cell Lung Cancer

What MAIA announced

MAIA reported that 150 patients have been treated with ateganosine sequenced with an immune checkpoint inhibitor (CPI) across its ongoing Phase 2 and pivotal Phase 3 trials for non-small cell lung cancer (NSCLC). The company stated enrollment is complete for Part C of its Phase 2 study THIO-101 and that THIO-104, the pivotal Phase 3 trial, has enrolled 65 patients to date toward a planned 100-patient target by year-end 2026. MAIA also highlighted an interim disease control rate reported for the ateganosine-plus-CPI combination in an efficacy-evaluable population.

Sources: S1

THIO-101 Phase 2 trial status

THIO-101 is described by MAIA as a multicenter, open-label, dose-finding Phase 2 clinical trial testing ateganosine administered prior to the PD-(L)1 inhibitor cemiplimab. The company framed the trial as having two primary objectives: evaluating safety and tolerability of ateganosine as an anticancer compound and priming immune activator, and assessing clinical efficacy using Overall Response Rate (ORR) as the primary clinical endpoint. MAIA reported that Part C enrollment of THIO-101 is complete and stated an interim 90.5% disease control rate in the efficacy-evaluable population with at least one post-treatment tumor scan.

Sources: S1

THIO-104 Phase 3 enrollment progress

MAIA characterized THIO-104 as a multicenter, open-label, randomized Phase 3 trial in advanced third-line NSCLC patients, with median Overall Survival (OS) as the primary efficacy endpoint versus investigator’s choice chemotherapy. MAIA reported that 65 patients have been enrolled in THIO-104 so far, and that the trial is targeting 100 patients enrolled and dosed by year-end 2026. The company said it remains on track to conduct an interim analysis in 2027.

Sources: S1

Regulatory designation noted

MAIA reminded readers that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for ateganosine for the treatment of NSCLC in July 2025, and described the potential procedural benefits associated with that designation as explained in the release.

Sources: S1

Why MAIA says this matters (inference)

MAIA frames these milestones as progress toward advancing ateganosine as a telomere-targeting immunotherapy option in third-line NSCLC, a population the company describes as lacking an established standard of care after progression on checkpoint inhibitors and chemotherapy. The company points to the reported interim disease control rate and the completion of a Phase 2 expansion cohort as supporting signals to continue development into the pivotal Phase 3 study.

Sources: S1

What remains uncertain

• All clinical efficacy and safety statements in the release are issuer-reported and based on interim or ongoing data; they are not independently verified in this draft.
• The reported 90.5% interim disease control rate is described as observed in an efficacy-evaluable population; the release does not provide full population denominators, statistical analysis, or peer-reviewed data in support of that figure.
• Enrollment targets and timelines (for example, 100 patients enrolled and dosed by year-end 2026 and an interim analysis in 2027) are company targets and forward-looking statements that may be affected by enrollment rate, regulatory interactions, or other operational factors.
• FDA Fast Track designation does not constitute approval; the release does not claim regulatory approval and describes the designation’s procedural implications only.