MAIA Biotechnology Abstract Selected for Poster Presentation at 2025 IASLC World Conference on Lung Cancer
MAIA Biotechnology (NYSE American: MAIA) announced that its abstract on ateganosine (THIO) treatment for non-small cell lung cancer (NSCLC) has been selected for poster presentation at the 2025 IASLC World Conference on Lung Cancer in Barcelona.
The presentation will highlight promising data from the THIO-101 trial, showing a median overall survival of 17.8 months with a 95% confidence interval lower bound of 12.5 months. Notably, the FDA has recently granted Fast Track designation for ateganosine in NSCLC treatment, potentially expediting its regulatory process towards Accelerated Approval and Priority Review.
MAIA Biotechnology (NYSE American: MAIA) ha annunciato che il suo abstract sull’impiego di ateganosina (THIO) nel trattamento del carcinoma polmonare non a piccole cellule (NSCLC) è stato selezionato per una presentazione poster al World Conference on Lung Cancer 2025 della IASLC a Barcellona.
La presentazione illustrerà i dati promettenti dello studio THIO-101, che riportano una sopravvivenza globale mediana di 17,8 mesi con un limite inferiore dell’intervallo di confidenza al 95% pari a 12,5 mesi. È importante notare che la FDA ha recentemente concesso la designazione Fast Track per ateganosina nel trattamento dell’NSCLC, potenzialmente accelerando il percorso regolatorio verso l’Accelerated Approval e la Priority Review.
MAIA Biotechnology (NYSE American: MAIA) anunció que su resumen sobre el tratamiento con ateganosina (THIO) para el cáncer de pulmón no microcítico (NSCLC) ha sido seleccionado para una presentación en póster en la Conferencia Mundial sobre Cáncer de Pulmón 2025 de la IASLC en Barcelona.
La presentación destacará datos prometedores del ensayo THIO-101, que muestran una supervivencia global mediana de 17,8 meses con un límite inferior del intervalo de confianza del 95% de 12,5 meses. Cabe destacar que la FDA otorgó recientemente la designación Fast Track para ateganosina en el tratamiento del NSCLC, lo que podría acelerar su proceso regulatorio hacia la Aprobación Acelerada y la Revisión Prioritaria.
MAIA Biotechnology (NYSE American: MAIA)는 비소세포폐암(NSCLC) 치료제인 아테가노신(THIO)에 대한 초록이 2025 IASLC 세계 폐암 학술대회(바르셀로나) 포스터 발표로 선정되었다고 발표했습니다.
이번 발표에서는 THIO-101 임상시험의 유망한 데이터를 소개할 예정이며, 중앙 생존기간(median overall survival)이 17.8개월이고 95% 신뢰구간의 하한이 12.5개월로 보고되었습니다. 특히 FDA가 최근 NSCLC에 대한 아테가노신에 대해 Fast Track 지정을 부여해 Accelerated Approval 및 Priority Review로의 규제 절차 진척이 가속화될 가능성이 있습니다.
MAIA Biotechnology (NYSE American: MAIA) a annoncé que son résumé sur le traitement par atéganosine (THIO) du cancer du poumon non à petites cellules (NSCLC) a été sélectionné pour une présentation en poster lors de la Conférence mondiale sur le cancer du poumon 2025 de l'IASLC à Barcelone.
La présentation mettra en avant des données prometteuses de l'essai THIO-101, montrant une survie globale médiane de 17,8 mois avec une borne inférieure de l'intervalle de confiance à 95 % de 12,5 mois. Il est à noter que la FDA a récemment accordé la désignation Fast Track pour l'ateganosine dans le traitement du NSCLC, ce qui pourrait accélérer son parcours réglementaire vers l'Accelerated Approval et la Priority Review.
MAIA Biotechnology (NYSE American: MAIA) gab bekannt, dass sein Abstract zur Behandlung von nicht-kleinzelligem Lungenkrebs (NSCLC) mit Ateganosin (THIO) für eine Posterpräsentation auf der IASLC World Conference on Lung Cancer 2025 in Barcelona ausgewählt wurde.
Die Präsentation wird vielversprechende Daten aus der THIO-101-Studie hervorheben, die eine mediane Gesamtüberlebenszeit von 17,8 Monaten mit einer unteren Grenze des 95%-Konfidenzintervalls von 12,5 Monaten zeigen. Erwähnenswert ist, dass die FDA kürzlich die Fast-Track-Designation für Ateganosin beim NSCLC erteilt hat, was den Zulassungsweg in Richtung Accelerated Approval und Priority Review beschleunigen könnte.
- Median overall survival (OS) of 17.8 months demonstrated in THIO-101 trial
- FDA Fast Track designation received for ateganosine in NSCLC treatment
- Potential eligibility for FDA Accelerated Approval and Priority Review
- None.
Insights
MAIA's ateganosine shows strong 17.8-month survival in late-stage lung cancer with FDA Fast Track designation accelerating potential approval.
The abstract selection for MAIA Biotechnology's poster presentation at the prestigious IASLC World Conference represents significant scientific validation for their telomere-targeting drug ateganosine (THIO). The reported median overall survival of 17.8 months with a lower confidence interval bound of 12.5 months is particularly noteworthy for third-line immune checkpoint inhibitor-resistant advanced NSCLC patients. This population typically has extremely limited treatment options and poor prognosis after failing previous therapies.
The FDA's Fast Track designation is a critical regulatory milestone that acknowledges both the unmet medical need and ateganosine's potential to address it. This designation provides MAIA with several advantages: more frequent FDA communication, potential Rolling Review of their New Drug Application, and eligibility for Accelerated Approval and Priority Review if criteria are met. The latter would reduce FDA review time from the standard ten months to six months, potentially bringing this therapy to market faster.
The progression-free survival (PFS) data mentioned but not fully detailed will be a key focus of their WCLC presentation. For context, meaningful PFS improvement in this heavily pretreated population would further strengthen ateganosine's clinical profile. The telomere-targeting mechanism of action of ateganosine represents a novel approach in lung cancer treatment, potentially offering a new option for patients who have exhausted standard therapies. The study's focus on sequencing with cemiplimab (an established PD-1 inhibitor) suggests potential synergistic effects that could expand treatment options in the immuno-oncology landscape.
Poster details durability and efficacy of ateganosine (THIO) treatment in non-small cell lung cancer (NSCLC)
CHICAGO, Sept. 05, 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 that an abstract titled “Study of THIO Sequenced with Cemiplimab in 3rd Line Immune Checkpoint Inhibitor-resistant aNSCLC: Improvement in PFS” was selected for poster presentation at the 2025 IASLC World Conference on Lung Cancer (WCLC) taking place September 6–9, 2025, in Barcelona, Spain.
“We are proud to accept IASLC’s invitation to present our exceptional ateganosine (THIO) data at its prestigious World Conference on Lung Cancer. Our participation gives us the opportunity to meet with elite scientists, researchers, and global industry leaders about our shared purpose in driving innovation in lung cancer treatments,” said MAIA Chairman and CEO Vlad Vitoc, M.D.
“Ateganosine is demonstrating substantial efficacy in our ongoing THIO-101 trial, with a median overall survival (OS) of 17.8 months with a
Conference details:
- MAIA representatives: Victor Zaporojan, M.D., Sr. Medical Director; Tomasz Jankowski, M.D., THIO-101 lead investigator and abstract presenting author
- Poster session: P1.11 - Metastatic Non-small Cell Lung Cancer – Immunotherapy
- Session time: Sunday, September 7, 2025, from 10:30 a.m. to 12:00 p.m.
- Poster available at maiabiotech.com/publications on the day of the presentation
The U.S. Food and Drug Administration (FDA) recently granted Fast Track designation for ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) for the treatment of non-small cell lung cancer (NSCLC). MAIA intends to utilize the incentives of the Fast Track Program to expedite the regulatory process for ateganosine. If relevant criteria are met during the Fast Track process, a drug will be eligible for FDA Accelerated Approval and Priority Review (FDA decision within six months).
About IASLC
The IASLC is a global multidisciplinary organization dedicated to eradication of all forms of lung cancer. From provision of educational events around the world and virtually to research projects and publications that advance the science of lung cancer, the IASLC's members are raising the bar for care of patients with lung cancer.
IASLC’s annual World Conference on Lung Cancer has played an integral part in facilitating progress by providing a platform for sharing cutting-edge research, collaboration, and networking among industry leaders, experts, and visionaries from around the world.
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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FAQ
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