MAIA Biotechnology Highlights Ongoing Momentum of Ateganosine Clinical Program at SITC 2025
MAIA (NYSE American: MAIA) reported clinical updates for its telomere‑targeting agent ateganosine at SITC 2025. The company confirmed 12 patients enrolled in the Phase 2 THIO-101 expansion (Part C) with enrollment active in EMA countries including Hungary and Poland, plus screening in Turkey and Taiwan. MAIA has begun screening patients in the Phase 3 THIO-104 trial. The FDA has granted Fast Track designation for ateganosine in NSCLC. MAIA reported an observed overall survival (OS) of 17.8 months in THIO-101 to date and a single patient with 912 days (30 months) survival as of September 17, 2025. Posters for THIO-101 and THIO-104 were filed on Form 8-K and posted on the company website on November 7, 2025.
MAIA (NYSE American: MAIA) ha fornito aggiornamenti clinici sul suo agente mirato ai telomeri, ateganosine, al SITC 2025. L'azienda ha confermato 12 pazienti arruolati nell'espansione di fase 2 THIO-101 (Parte C) con arruolamento attivo nei paesi EMA, tra cui Ungheria e Polonia, oltre allo screening in Turchia e Taiwan. MAIA ha avviato lo screening dei pazienti nello studio di fase 3 THIO-104. La FDA ha concesso la designazione Fast Track per ateganosine nel NSCLC. MAIA ha riportato una sopravvivenza globale (OS) osservata di 17,8 mesi in THIO-101 fino ad ora e un paziente con 912 giorni (30 mesi) di sopravvivenza al 17 settembre 2025. Poster per THIO-101 e THIO-104 sono stati presentati su Form 8-K e pubblicati sul sito web dell'azienda il 7 novembre 2025.
MAIA (NYSE American: MAIA) informó actualizaciones clínicas de su agente orientado a telómeros, ateganosina, en SITC 2025. La compañía confirmó 12 pacientes inscritos en la expansión de la fase 2 THIO-101 (Parte C) con inscripción activa en países de la EMA, incluyendo Hungría y Polonia, además de cribado en Turquía y Taiwán. MAIA ha comenzado el cribado de pacientes en el ensayo de fase 3 THIO-104. La FDA ha concedido designación de Fast Track para ateganosina en NSCLC. MAIA reportó una supervivencia global (OS) observada de 17,8 meses en THIO-101 hasta la fecha y un paciente con 912 días (30 meses) de supervivencia al 17 de septiembre de 2025. Los pósters de THIO-101 y THIO-104 fueron presentados en el Formulario 8-K y publicados en el sitio web de la empresa el 7 de noviembre de 2025.
MAIA (NYSE American: MAIA)는 SITC 2025에서 텔로미어 표적 제제인 ateganosine에 대한 임상 업데이트를 발표했습니다. 회사는 12명의 환자가 2상 THIO-101 확장(파트 C)에 등록되었으며 EMA 국가들(헝가리, 폴란드 포함)에서 등록이 활발하고 터키와 대만에서 선별 중임을 확인했습니다. MAIA는 3상 THIO-104 시험의 환자 선별을 시작했습니다. FDA는 NSCLC에서 ateganosine에 대해 패스트 트랙(Fast Track) 지정을 부여했습니다. MAIA는 THIO-101에서 현재까지 관찰된 전체생존기간(OS) 17.8개월과 2025년 9월 17일 기준 912일(30개월)의 생존을 보인 한 명의 환자를 보고했습니다. THIO-101 및 THIO-104 포스터는 Form 8-K로 제출되어 2025년 11월 7일 회사 웹사이트에 게시되었습니다.
MAIA (NYSE American: MAIA) a publié des mises à jour cliniques concernant son agent ciblant les télomères, ateganosine, lors du SITC 2025. La société a confirmé 12 patients inscrits dans l'expansion de la phase 2 THIO-101 (Partie C) avec un recrutement actif dans les pays de l'EMA, notamment la Hongrie et la Pologne, ainsi que le dépistage en Turquie et à Taïwan. MAIA a commencé le dépistage des patients dans l'essai de phase 3 THIO-104. La FDA a accordé une désignation Fast Track pour l'ateganosine dans le NSCLC. MAIA a rapporté une survie globale (OS) observée de 17,8 mois dans THIO-101 à ce jour et un seul patient avec 912 jours (30 mois) de survie au 17 septembre 2025. Des posters pour THIO-101 et THIO-104 ont été déposés sur le Form 8-K et publiés sur le site de l'entreprise le 7 novembre 2025.
MAIA (NYSE American: MAIA) hat klinische Updates zu seinem telomer-basierten Wirkstoff Ateganosin beim SITC 2025 bekannt gegeben. Das Unternehmen bestätigte 12 eingeschriebene Patienten in der Phase-2-Erweiterung THIO-101 (Teil C) mit aktivem Rekrutierungsstatus in EMA-Ländern, einschließlich Ungarn und Polen, sowie Screenings in der Türkei und Taiwan. MAIA hat mit dem Screenen von Patienten in der Phase-3-Studie THIO-104 begonnen. Die FDA hat Ateganosin eine Fast Track-Zulassung für NSCLC erteilt. MAIA berichtete von einer beobachteten Gesamtüberlebenszeit (OS) von 17,8 Monaten in THIO-101 bis dato und von einem Patienten mit 912 Tagen (30 Monaten) Überleben zum 17. September 2025. Poster zu THIO-101 und THIO-104 wurden am 7. November 2025 im Form 8-K eingereicht und auf der Website des Unternehmens veröffentlicht.
MAIA (NYSE American: MAIA) أصدرت تحديثات سريرية بخصوص وكedيرها المستهدف للتيلوميرات، أيتاجانوسين, في SITC 2025. أكدت الشركة تسجيل 12 مريضاً في توسيع المرحلة 2 THIO-101 (الجزء C) مع تسجيل نشط في دول EMA بما فيها المجر وبولندا، بالإضافة إلى فحص في تركيا وتايوان. بدأت MAIA فحص المرضى في تجربة المرحلة 3 THIO-104. منحت إدارة الغذاء والدواء الأمريكية (FDA) تعيين مسار سريع لـ Ateganosine في NSCLC. ذكرت MAIA بقاءً إجمالياً مرصوداً (OS) بمقدار 17.8 شهراً في THIO-101 حتى تاريخه ووجود مريض واحد بمدة بقاء 912 يوماً (30 شهراً) حتى 17 سبتمبر 2025. تم تقديم ملصقات THIO-101 وTHIO-104 على النموذج 8-K ونُشرت على موقع الشركة في 7 نوفمبر 2025.
- FDA Fast Track designation for ateganosine in NSCLC
- Observed OS of 17.8 months in THIO-101 to date
- 912 days (30 months) survival reported for a THIO-101 patient as of Sep 17, 2025
- 12 patients enrolled in THIO-101 expansion (Part C) to date
- Phase 3 THIO-104 patient screening has begun
- THIO-101 expansion enrollment only 12 patients to date
- Clinical evidence reported is interim and limited in sample size
Insights
Progress shows early operational momentum for THIO-101/THIO-104 but clinical benefit remains to be confirmed in pivotal readouts.
MAIA reports active expansion of the Phase 2 THIO-101 Part C with 12 patients enrolled to date and initiation of screening for the Phase 3 THIO-104 program, indicating site activation and cross‑region regulatory alignment after obtaining FDA Fast Track designation.
Operational risks include enrollment pace outside initial countries and the need to maintain consistent data collection across sites in Hungary, Poland, Turkey and Taiwan; the single‑patient 912‑day survival and a reported 17.8 months OS to date are notable individual outcomes but do not substitute for controlled efficacy evidence.
Monitor enrollment trajectory and enrollment milestones through
Clinical signals are encouraging at the patient level but lack confirmatory trial-level evidence for regulatory approval.
The program pairs ateganosine dosing with cemiplimab sequencing in ICI‑resistant advanced NSCLC and has publicized protocol posters and site interest at SITC, implying investigators view the design as clinically relevant.
Key dependencies are the durability and reproducibility of the reported 17.8 months OS across a broader cohort and predefined endpoints in THIO-104; single long-term survivors are hypothesis‑generating but insufficient for approval decisions.
Watch for formal interim analysis plans, predefined primary endpoint timing in the Phase 3 protocol, and any data readouts or safety signals in the next 6–18 months beginning from
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 Immunotherapy of Cancer, held November 5-9, 2025, in National Harbor, MD. The Trials in Progress posters focus on MAIA’s ongoing Phase 2 THIO-101 expansion (Part C) and Phase 3 THIO-104 clinical trials of its first-in-class small molecule telomere targeting agent, ateganosine, as a treatment for non-small cell lung cancer (NSCLC). The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ateganosine for the treatment of NSCLC.
MAIA’s Sr. Medical Director, Victor Zaporojan, M.D., presenter at SITC 2025 commented, “It was a privilege to return to SITC for its 40th anniversary. This event was an ideal forum to highlight the continued success of our Phase 2 clinical trial. We are making steady progress in the expansion phase of this trial, with patient enrollment now underway in European Medicines Agency (EMA) countries. Sites in Hungary and Poland, which were instrumental in Parts A and B of the trial, are actively screening patients along Turkey and Taiwan, and we have 12 patients enrolled in the expansion to date. We expect further momentum in identifying and enrolling patients for THIO-101 Part C in the near term”.
“We also began screening patients in our Phase 3 trial, THIO-104, and noticed great excitement from physicians in the sites we’re bringing our trial to,” added MAIA CEO Vlad Vitoc, M.D. “In this population, third-line NSCLC patients resistant to chemo and immunotherapy, current treatments show overall survival (OS) of around 6 months, and based on the 17.8 months OS observed in THIO-101 to date, we believe that our Phase 3 trial could lead to an early commercial approval of ateganosine by the FDA. It’s only a matter of successful execution to bring our novel NSCLC treatment to this large patient population with significant unmet medical need.”
The posters presented at SITC 2025 feature trial designs for the Phase 2 and Phase 3 studies in advanced NSCLC patients receiving ateganosine followed by a checkpoint inhibitor, cemiplimab (Libtayo®). As of September 17, 2025, a patient that began therapy in March 2023 in the THIO-101 Phase 2 trial has shown survival of 30 months, or 912 days.
“A novel therapy with proven efficacy, such as ateganosine, could strengthen existing treatment strategies and further advance the principles of precision oncology in lung cancer care worldwide,” said Tomasz Jankowski, M.D., Ph.D., key investigator for THIO-101 in Poland and co-author of many of MAIA’s scientific posters. “In Poland, where improving outcomes in advanced NSCLC remains a central focus, ateganosine has the potential to become an important addition to the therapeutic landscape, offering new hope for patients and clinicians alike.”
The posters presented at SITC 2025 were attached as exhibits to a Current Report on Form 8-K filed by the Company with the Securities and Exchange Commission (the “Commission”) on November 7, 2025 and available on the Commission’s website at www.sec.gov. In addition, the posters were made available on MAIA’s website at maiabiotech.com/publications on November 7, 2025.
- Presentation 1: A Phase 3 Study of Ateganosine (THIO) Sequenced with Immune Checkpoint Inhibitor (ICI) versus Standard of Care Chemotherapy in ICI-Resistant Advanced NSCLC: THIO-104 Trial in Progress
- Presentation 2: A Phase 2 Study of Ateganosine (THIO; 6-thio-2'-deoxyguanosine) in Combination with Immune Checkpoint Inhibitor (ICI) in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) Resistant to Prior ICI and Chemotherapy: THIO-101 Trial in Progress
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.
Investor Relations Contact
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FAQ
How many patients are enrolled in MAIA's Phase 2 THIO-101 expansion as of Nov 21, 2025?
What clinical survival results has MAIA reported for ateganosine in THIO-101?
Has MAIA started its Phase 3 THIO-104 trial for ateganosine (MAIA)?
Does ateganosine have any regulatory designation from the FDA?
Where can investors find the THIO-101 and THIO-104 posters presented at SITC 2025?
Which countries are active for THIO-101 Part C enrollment as of Nov 21, 2025?
