THIO-104 advances toward key 2027 interim survival analysis
CHICAGO, Sept. 23, 2026 (GLOBE NEWSWIRE) -- MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing immunotherapies for cancer, today announced that it has received regulatory approval by the Spanish Agency for Medicines and Medical Devices (AEMPS) and Portugal’s National Authority of Medicines and Health Products (INFARMED) to begin screening patients for its ongoing pivotal Phase 3 THIO-104 clinical trial in non-small cell lung cancer (NSCLC).
Spain and Portugal represent important European markets for NSCLC, with an estimated 30,000 new cases annually across the two countries. Spain has a substantial lung cancer burden associated with historical tobacco exposure, with lung cancer incidence among women continuing to rise. In Portugal, NSCLC accounts for approximately 82% of lung cancer cases, the highest proportion reported among five European populations evaluated in a comparative study.
“Expanding THIO-104 into Spain and Portugal represents another important step in the execution of our pivotal Phase 3 program,” said Vlad Vitoc, M.D., Chairman and Chief Executive Officer of MAIA. “Clinical trial participation can provide patients with access to investigational therapies in markets where access to newly approved lung cancer treatments has historically lagged. By establishing THIO-104 sites in Spain and Portugal, we are broadening access to a potentially important new treatment option for patients with advanced NSCLC who have progressed following standard of care treatments.”
To date, THIO-104 has enrolled 65 NSCLC patients resistant to chemotherapy and checkpoint inhibitor treatments at 28 clinical sites in 6 European countries and 10 sites in Taiwan. Among the six European countries, sites in Hungary, Poland, and Turkey are actively enrolling and dosing patients from populations with the highest lung cancer incidence and mortality rates in Europe and globally.1
MAIA targets 100 patients dosed in THIO-104 by year-end 2026 and expects to have sufficient survival data to conduct an interim data analysis in 2027.
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 to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine 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 (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.
About MAIA Biotechnology, Inc.
MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is ateganosine (THIO), a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.
Forward Looking Statements
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1 Sources: Global Cancer Observatory (GLOBOCAN), European Cancer Information System (ECIS), World Cancer Research Fund