MAIA Biotechnology opens second U.S. site for THIO-101 trial
MAIA Biotechnology has activated its second U.S. clinical site for the Phase 2 THIO-101 expansion trial at Central Alabama Research. The trial evaluates ateganosine as a third-line treatment for non-small cell lung cancer. The expansion includes 44 active sites across 6 countries in Europe and Asia, plus 2 in the U.S.
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MAIA Biotechnology, Inc. has activated its second U.S. clinical site for the Phase 2 THIO-101 expansion trial at Central Alabama Research in Homewood, Alabama. The expansion part of THIO-101 evaluates ateganosine, a dual-action molecule, as a third-line treatment for non-small cell lung cancer (NSCLC) in patients who have previously failed treatment with checkpoint inhibitors and chemotherapy. The additional data from the trial's expansion may further support an accelerated approval filing with the FDA.
The THIO-101 expansion trial is ongoing in Europe and Asia with 44 active sites in 6 countries along with 2 in the U.S. Parts A and B of the Phase 2 trial provided key inputs for MAIA's market strategy by identifying optimal dosing for a well-defined patient population. The trial operates under FDA Fast Track designation.
Clinical Trial Details
The Phase 2 clinical trial is a multicenter, open-label, dose finding study designed to evaluate ateganosine's anti-tumor activity when followed by PD-(L)1 inhibition. The trial tests the hypothesis that low doses of ateganosine administered prior to cemiplimab will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance after first-line treatment.
| Trial Component | Description |
|---|---|
| Trial Name | THIO-101 |
| Phase | Phase 2 |
| Design | Multicenter, open-label, dose finding |
| Primary Endpoint | Overall Response Rate (ORR) |
| Treatment | Ateganosine followed by cemiplimab |
| ClinicalTrials.gov Identifier | NCT05208944 |
Phase 3 Trial Progress
In parallel with the Phase 2 clinical trial, MAIA is actively screening and enrolling patients in a pivotal Phase 3 clinical trial designed to assess overall survival for ateganosine sequenced with a CPI compared to investigator's choice of chemotherapy. The Phase 3 trial features a 1:1 randomization of up to 300 patients. MAIA has received regulatory approval to screen patients in Taiwan, Turkey, select European Medicines Agency (EMA) countries, and Georgia.
About Ateganosine
Ateganosine (THIO, 6-thio-dG or 6-thio-2'-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development for NSCLC. The modified nucleotide induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate and adaptive immune responses.
What are the key milestones MAIA must achieve to support an accelerated approval filing with the FDA?
How will the ongoing Phase 3 trial results influence the market strategy for ateganosine if Phase 2 data is positive?
What are the potential challenges in expanding clinical sites and patient enrollment across diverse regions?
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