MAIA Biotechnology has opened enrolment at a second clinical site in the US for its THIO-101 Phase II expansion trial, evaluating ateganosine for the treatment of non-small cell lung cancer (NSCLC).
The trial at Central Alabama Research will assess ateganosine as a third-line therapy in patients whose cancer has not responded to earlier treatments with checkpoint inhibitors and chemotherapy.
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This dose-finding, multi-centre, open-label study is active in Europe and Asia across 44 sites in six countries and now includes two in the US.
Parts A and B of the Phase II trial identified optimal dosing for the patient group, shaping the company’s market strategy. Data from the expanded trial can potentially support an accelerated approval application with the US Food and Drug Administration (FDA).
MAIA Biotechnology founder and CEO Vlad Vitoc said: “Adding our second US site reflects strong execution of our clinical strategy and continued momentum in the expansion of the THIO-101 trial.
“Broadening our site footprint enables more efficient patient enrolment as we advance the programme under the FDA fast track designation and work toward upcoming interim data milestones.”
Simultaneously, MAIA Biotechnology is enrolling participants in a pivotal Phase III clinical trial that randomises up to 300 patients to compare overall survival with ateganosine plus a checkpoint inhibitor versus the investigator’s choice of chemotherapy.
Regulatory approval for patient screening in this study has been secured in Georgia, Taiwan and Türkiye, as well as selected European Medicines Agency (EMA) countries.
Ateganosine (THIO, 6-thio-dG, or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent under evaluation for activity against NSCLC.
THIO-101’s primary objectives include safety, tolerability and overall response rate in advanced NSCLC patients not responsive to previous therapies.
In September 2025, MAIA Biotechnology touted the efficacy of its lead candidate, ateganosine, after a positive mid-stage trial outcome in NSCLC.
