MAIA Biotechnology Awarded $2.3 Million Grant by National Institutes of Health for THIO-101 Phase 2 Trial of Cancer-Fighting Agent
MAIA Biotechnology (NYSE American: MAIA) has secured a $2.3 million NIH grant to expand its THIO-101 Phase 2 clinical trial of ateganosine for advanced non-small cell lung cancer (NSCLC) treatment. The grant will support U.S. patient enrollment over 2025-2027 for third-line treatment of patients resistant to chemo and immunotherapy.
The trial has shown promising results, with median overall survival of 17.8 months in 22 third-line treatment patients, significantly higher than the 5-6 months typical with standard chemotherapy. The trial's expansion phase began in July 2025 in Taiwan, following FDA IND clearance in 2023.
MAIA Biotechnology (NYSE American: MAIA) ha ottenuto una sovvenzione NIH di 2,3 milioni di dollari per espandere la sua sperimentazione clinica di fase 2 THIO-101 di ateganosina per il trattamento del cancro al polmone non a piccole cellule avanzato (NSCLC). La sovvenzione supporterà l'arruolamento di pazienti negli Stati Uniti nel 2025-2027 per il trattamento di terza linea in pazienti resistenti a chemioterapia e immunoterapia.
Lo studio ha mostrato risultati promettenti, con mediana della sopravvivenza globale di 17,8 mesi in 22 pazienti in terza linea, significativamente superiore ai 5-6 mesi tipici della chemioterapia standard. La fase di espansione dello studio è iniziata a luglio 2025 a Taiwan, dopo l'autorizzazione FDA IND nel 2023.
MAIA Biotechnology (NYSE American: MAIA) ha asegurado una subvención de la NIH de 2,3 millones de dólares para ampliar su ensayo clínico de fase 2 THIO-101 de ateganosina para el tratamiento del cáncer de pulmón de células no pequeñas avanzado (NSCLC). La subvención apoyará el enrolamiento de pacientes en EE. UU. durante 2025-2027 para el tratamiento de tercera línea en pacientes resistentes a quimioterapia e inmunoterapia.
El ensayo ha mostrado resultados prometedores, con mediana de supervivencia global de 17,8 meses en 22 pacientes en tercera línea, significativamente superior a los 5-6 meses típicos de la quimioterapia estándar. La fase de expansión del ensayo comenzó en julio de 2025 en Taiwán, tras la aprobación IND de la FDA en 2023.
MAIA Biotechnology (NYSE American: MAIA)가 Ateganosine의 THIO-101 2상 임상시험을 확장하기 위한 230만 달러 NIH 보조금을 확보했다. 이 보조금은 2025-2027년 미국 내 환자 등록을 지원하여 화학요법과 면역요법에 내성을 가진 3차 치료 환자를 대상으로 한다.
시험은 3차 치료 환자 22명에서 전체 생존 중앙값 17.8개월의 유망한 결과를 보였으며, 표준 화학요법의 일반적 5-6개월보다 현저히 높다. 시험의 확장 단계는 FDA IND 승인을 받은 2023년 이후 2025년 7월 대만에서 시작됐다.
MAIA Biotechnology (NYSE American: MAIA) a obtenu une subvention NIH de 2,3 millions de dollars pour développer son essai clinique de phase 2 THIO-101 d’ateganosine pour le traitement du cancer du poumon non à petites cellules avancé (NSCLC). La subvention soutiendra l’inscription des patients américains entre 2025 et 2027 pour le traitement de troisième ligne chez des patients résistants à la chimiothérapie et à l’immunothérapie.
Le essai a montré des résultats prometteurs, avec une médiane de survie globale de 17,8 mois chez 22 patients en troisième ligne, nettement supérieure aux 5-6 mois typiques de la chimiothérapie standard. La phase d’expansion de l’essai a commencé en juillet 2025 à Taïwan, après l’autorisation FDA IND en 2023.
MAIA Biotechnology (NYSE American: MAIA) hat eine NIH-Förderung in Höhe von 2,3 Millionen USD erhalten, um seine THIO-101-Phase-2-Studie von Ateganosin für die Behandlung des fortgeschrittenen nicht-kleinzelligen Lungenkrebs (NSCLC) auszuweiten. Die Förderung wird die Einschreibung von US-Patienten in den Jahren 2025-2027 für die Drittlinientherapie von Patienten unterstützen, die auf Chemotherapie und Immuntherapie resistent sind.
Die Studie hat vielversprechende Ergebnisse gezeigt, mit einem medianen Gesamtüberleben von 17,8 Monaten bei 22 Patienten in der Drittlinie, deutlich höher als die typischen 5-6 Monate bei Standard-Chemotherapie. Die Expansionsphase der Studie begann im Juli 2025 in Taiwan, nach der FDA-IND-Zulassung im Jahr 2023.
حصلت MAIA Biotechnology (NYSE American: MAIA) على منحة NIH بقيمة 2.3 مليون دولار لتوسيع تجربة المرحلة الثانية THIO-101 لعِ Ateganosine لعلاج سرطان الرئة غير صغير الخلايا المتقدم NSCLC. ستدعم المنحة تسجيل المرضى الأميركيين خلال 2025-2027 لعلاج الخط الثالث للمرضى المقاومين للعلاج الكيميائي والمناعة.
أظهرت التجربة نتائج واعدة، مع متوسط البقاء على قيد الحياة الإجمالي 17.8 شهراً لدى 22 مريضاً في الخط الثالث، وهو أعلى بكثير من 5-6 أشهر المعتادين في العلاج الكيميائي القياسي. بدأت مرحلة التوسع في يوليو 2025 في تايوان، عقب موافقة FDA IND في 2023.
MAIA Biotechnology（NYSE American: MAIA）已获得价值230万美元的NIH资助，用于扩大其THIO-101的ateganosine阶段2临床试验，用于治疗晚期非小细胞肺癌（NSCLC）。该资助将支持2025-2027年在美国的患者招募，用于对化疗和免疫治疗耐药的患者的第三线治疗。
该试验已显示出有希望的结果，在22名第三线治疗患者中，总体生存中位数为17.8个月，明显高于标准化疗通常的5-6个月。试验的扩展阶段于2025年7月在台湾启动，此前于2023年获得FDA IND批准。
- Secured significant $2.3 million NIH grant funding over three years
- Strong clinical results showing 17.8 months median overall survival vs. 5-6 months for standard treatment
- FDA IND clearance enables immediate U.S. patient enrollment expansion
- Multi-continental trial expansion provides access to larger patient pool
- No established standard of care exists for third-line NSCLC treatment
- Trial is still in Phase 2, with significant development work ahead
Insights
NIH's $2.3M grant for MAIA's lung cancer drug trial validates promising early results showing 3x longer survival than standard treatments.
MAIA Biotechnology has secured a
The preliminary survival data is particularly noteworthy. The trial's Parts A and B showed a median overall survival of 17.8 months among 22 third-line NSCLC patients (with 95% confidence interval lower bound of 12.5 months). This significantly outperforms historical standards for third-line NSCLC treatments, which typically achieve only 5-6 months of overall survival.
From a clinical perspective, this
The NIH funding significantly derisks MAIA's clinical development program by offsetting trial costs over three years (2025-2027). The international expansion into the U.S. will accelerate patient recruitment, potentially shortening the timeline to complete the Phase 2 study. The FDA's previous IND clearance in 2023 means U.S. enrollment can begin immediately, with the first expansion patient already dosed in Taiwan in July 2025.
THIO-101 Phase 2 trial to enroll patients in the U.S. as part of the expansion of the study in third-line treatment for advanced non-small cell lung cancer (NSCLC)
CHICAGO, Sept. 24, 2025 (GLOBE NEWSWIRE) -- MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, announced today that the National Institutes of Health (NIH) has awarded a
The grant is intended to support expenses related to the enrollment of U.S. patients who are resistant to chemo and immunotherapy. The NIH grant allocations will be distributed over three years from 2025-2027.
“We are thrilled to receive this prestigious NIH grant for the expansion of our Phase 2 trial. It’s a great honor to have the support of the National Institutes of Health as we seek to further validate the efficacy of our lead agent ateganosine and its potential to be a breakthrough treatment within the vastly underserved NSCLC market,” said CEO Vlad Vitoc, M.D. “With the clearance of FDA Investigational New Drug (IND) for THIO-101 in 2023, we can begin enrolling U.S. patients in the expansion phase of the trial immediately.”
“The NIH grant is a tremendous achievement and a testament to the dedication, collaboration, and hard work of everyone involved in the clinical development of ateganosine,” added Victor Zaporojan, M.D., MAIA’s senior medical director. “Ateganosine represents a potential solution for the significant unmet clinical need in third-line NSCLC, where no established standard of care exists and where the overall survival outcomes observed with ateganosine have not been achieved by other therapies. By enrolling patients in the United States, our trial will gain access to a substantially larger patient pool across multiple continents, further strengthening the impact and relevance of our study.”
In Parts A and B of THIO-101, median overall survival (OS) for the 22 patients in third-line treatment was 17.8 months as of June 30, 2025, with a
Research referenced in this press release is supported by the National Cancer Institute of the National Institutes of Health under Award Number R44CA309843. The content is solely the responsibility of MAIA and does not necessarily represent the official views of the National Institutes of Health.
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 THIO-101 Phase 2 Clinical Trial
THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine administered prior to cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of ateganosine administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of ateganosine using Overall Response Rate (ORR) as the primary clinical endpoint. The expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. Treatment with ateganosine followed by cemiplimab (Libtayo®) has shown an acceptable safety profile to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.
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
MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.
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