MAIA Biotechnology Announces Positive Efficacy Update for Phase 2 THIO-101 Clinical Trial in Non-Small Cell Lung Cancer

Business Wire

05-06-2025

CHICAGO--(BUSINESS WIRE)--MAIA Biotechnology, Inc. (NYSE American: MAIA) ('MAIA', the 'Company'), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced updated data from its THIO-101 pivotal Phase 2 clinical trial evaluating its lead clinical candidate, ateganosine (THIO), sequenced with Regeneron's immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC) who are resistant to immune therapy and chemotherapy.
As of May 15, 2025, third line (3L) data showed median overall survival (OS) of 17.8 months for the 22 NSCLC patients who received at least one dose of ateganosine (the intent-to-treat population) in parts A and B of the trial. The updated analysis continues to demonstrate a 95% confidence interval (CI) lower bound of 12.5 months and a 99% CI lower bound of 10.8 months. The treatment has been generally well-tolerated to date in this heavily pre-treated population. 1 Studies of standard-of-care (SOC) chemotherapy treatments for NSCLC in a similar setting have shown OS of 5 to 6 months. 2-3
'It is gratifying to see that our treatment further extends lives for these hard-to-treat patient populations, especially in third-line NSCLC treatment where patients are most resistant to therapy,' said MAIA Chairman and CEO Vlad Vitoc, M.D. 'This new benchmark of 17.8 months median OS is nearly triple the recognized SOC data for third-line NSCLC found in medical literature. We believe this is a substantial indicator of the potential ateganosine has to shift the NSCLC treatment landscape.'
MAIA's multiple potential regulatory pathways for ateganosine could provide accelerated FDA approval and robust exclusivity in NSCLC, with a potential FDA decision as early as next year.
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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