Company confirms 12 patients enrolled in Phase 2 THIO-101 to date as expansion trial adds new countries Posters for Phase 2 and Phase 3 clinical trials available CHICAGO , Nov. 21, 2025 (GLOBE NEWSWIRE) -- MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced highlights from two poster presentations delivered at SITC 2025, an annual conference hosted by the Society for Immu ...

Core Insights - MAIA Biotechnology has initiated patient enrollment in Romania for the Phase 2 THIO-101 Part C study, focusing on ateganosine as a treatment for advanced non-small cell lung cancer (NSCLC) patients [1][2] - The company aims to provide a promising alternative for NSCLC patients who have limited treatment options, with ateganosine showing a 38% response rate compared to current treatments with response rates of up to 6% [2][3] - The expansion of the study in Romania is part of MAIA's strategy to accelerate patient access to innovative therapies and pursue accelerated approval in the U.S. [2] Company Overview - MAIA Biotechnology is a clinical-stage biopharmaceutical company dedicated to developing targeted immunotherapies for cancer, with a focus on ateganosine as a potential first-in-class telomere-targeting agent for NSCLC [1][7] - The company received FDA's Fast Track Designation for ateganosine in July, which supports its goal of expedited development and review [2] Clinical Trial Details - The THIO-101 Phase 2 clinical trial is a multicenter, open-label study designed to evaluate the anti-tumor activity of ateganosine followed by PD-(L)1 inhibitors in advanced NSCLC patients who have previously shown resistance to other treatments [5][6] - The trial has two primary objectives: assessing the safety and tolerability of ateganosine and evaluating its clinical efficacy using Overall Response Rate (ORR) as the primary endpoint [5][6] Treatment Mechanism - Ateganosine works by inducing telomerase-dependent telomeric DNA modification, leading to selective cancer cell death and activation of immune responses [4] - The treatment aims to enhance and prolong immune response in patients with advanced NSCLC who have not responded to prior therapies [5]

Outstanding measure of efficacy relative to high-risk cancers with limited treatment options CHICAGO, Oct. 23, 2025 (GLOBE NEWSWIRE) -- MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced highlights from a recent presentation at the European Society for Medical Oncology (ESMO) Congress 2025 held in Berlin, Germany. Starting October 19, 2025, MAIA showcased two e-posters a ...

Core Insights - MAIA Biotechnology, Inc. has received a $2.3 million grant from the National Institutes of Health (NIH) to expand its THIO-101 Phase 2 clinical trial for advanced non-small cell lung cancer (NSCLC) [1][2][3] - The trial aims to enroll U.S. patients who are resistant to chemotherapy and immunotherapy, with the grant funding distributed over three years from 2025 to 2027 [2][3] - The median overall survival for patients in the third-line treatment of the trial was reported at 17.8 months, significantly higher than the 5 to 6 months observed with standard chemotherapy treatments [3][6] Company Overview - MAIA Biotechnology is focused on developing targeted immunotherapies for cancer, with its lead program being ateganosine, a first-in-class telomere-targeting agent for NSCLC [5][8] - The company aims to address the significant unmet clinical need in third-line NSCLC treatment, where no established standard of care currently exists [3][5] - The THIO-101 trial is designed to evaluate the safety and efficacy of ateganosine when followed by PD-(L)1 inhibitors, targeting patients who have progressed after previous treatments [6][7] Clinical Trial Details - THIO-101 is a multicenter, open-label, dose-finding Phase 2 clinical trial that tests the hypothesis that ateganosine can enhance immune response when administered before cemiplimab [6][7] - The trial has two primary objectives: to evaluate the safety and tolerability of ateganosine and to assess its clinical efficacy using Overall Response Rate (ORR) as the primary endpoint [6][7] - The expansion phase of the trial will allow access to a larger patient pool across multiple continents, enhancing the study's impact and relevance [3][6]