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]

Core Insights - MAIA Biotechnology, Inc. is advancing its THIO-101 Phase 2 clinical trial, with the first five patients enrolled in the expansion phase in Taiwan and Turkey, indicating progress in its development of targeted immunotherapies for cancer [1][2][3] Company Overview - MAIA is a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, with its lead program being ateganosine (THIO), a potential first-in-class telomere-targeting agent for non-small cell lung cancer (NSCLC) [1][8] - The company aims to improve and extend the lives of cancer patients through innovative therapies [8] Clinical Trial Details - The THIO-101 trial is a multicenter, open-label, dose-finding Phase 2 study designed to evaluate the anti-tumor activity of ateganosine followed by PD-(L)1 inhibitors in patients with advanced NSCLC who have shown resistance to prior treatments [7] - The trial has two primary objectives: to assess the safety and tolerability of ateganosine and to evaluate its clinical efficacy using Overall Response Rate (ORR) as the primary endpoint [7] Scientific Insights - Ateganosine works by inducing telomerase-dependent telomeric DNA modification, leading to selective cancer cell death and activation of immune responses [6] - The treatment has shown promise in preclinical models, suggesting potential for profound tumor regression in advanced cancer cases [6] Market Context - Lung cancer, particularly NSCLC, remains a significant public health challenge, especially in regions like Turkey where smoking and air pollution are major contributors to the disease [3][4] - The high prevalence of smoking accounted for 89.6% of lung cancer cases in Turkey, highlighting the urgent need for effective treatment options [4]

Core Insights - MAIA Biotechnology, Inc. presented significant findings regarding ateganosine at the ESMO Congress 2025, highlighting its potential in treating non-small cell lung cancer (NSCLC) with limited treatment options [1][2] Group 1: Clinical Trial Highlights - The e-posters showcased at ESMO indicated exceptional extended survival rates in third-line NSCLC patients, with one patient surviving 30 months after starting therapy in March 2023 [2] - The THIO-101 Phase 2 clinical trial is designed to evaluate the anti-tumor activity of ateganosine followed by PD-(L)1 inhibitors, focusing on patients who have shown resistance to previous treatments [5] - The trial aims to assess both the safety and tolerability of ateganosine and its clinical efficacy using Overall Response Rate (ORR) as the primary endpoint [5] Group 2: About Ateganosine - Ateganosine is a first-in-class investigational telomere-targeting agent currently in clinical development for NSCLC, aiming to induce selective cancer cell death and activate immune responses [4] - The drug works by modifying telomeric DNA and has shown promise in inducing tumor regression in advanced cancer models when combined with PD-(L)1 inhibitors [4] Group 3: Company Overview - MAIA Biotechnology focuses on developing targeted immunotherapies for cancer, with ateganosine being a key component of its pipeline aimed at improving treatment outcomes for patients with telomerase-positive cancer cells [7]