MAIA Biotechnology Highlights Positive Efficacy Data from THIO-101 Phase 2 Clinical Trial in Non-Small Cell Lung Cancer
MAIA Biotechnology (NYSE American: MAIA) reported positive Phase 2 clinical trial results for ateganosine (THIO) in combination with cemiplimab for advanced non-small cell lung cancer (NSCLC) patients. The trial showed remarkable efficacy with 5.6 months median progression-free survival in third-line treatment (180 mg dose), more than double the standard of care of 2.5 months.
The study demonstrated an estimated median overall survival of 17.8 months, with confidence intervals showing a lower bound of 12.5 months (95% CI) and 10.8 months (99% CI). Two patients completed 33 treatment cycles, indicating ateganosine's potential for extended dosing. The company has initiated a Phase 2 expansion trial in July 2025 to further validate these promising results.
MAIA Biotechnology (NYSE American: MAIA) ha riportato risultati positivi di uno studio clinico di Fase 2 per ateganosina (THIO) in combinazione con cemiplimab in pazienti con carcinoma polmonare non a piccole cellule (NSCLC) in fase avanzata. Lo studio ha mostrato un鈥檈fficacia notevole con una sopravvivenza libera da progressione mediana di 5,6 mesi come trattamento di terza linea (dose 180 mg), superiore pi霉 del doppio rispetto allo standard di cura di 2,5 mesi.
Lo studio ha evidenziato inoltre una sopravvivenza globale mediana stimata di 17,8 mesi, con intervalli di confidenza che indicano un limite inferiore di 12,5 mesi (IC 95%) e 10,8 mesi (IC 99%). Due pazienti hanno completato 33 cicli di trattamento, suggerendo la possibilit脿 di somministrazioni prolungate di ateganosina. La societ脿 ha avviato un'espansione di Fase 2 a luglio 2025 per convalidare ulteriormente questi risultati promettenti.
MAIA Biotechnology (NYSE American: MAIA) inform贸 resultados positivos del ensayo cl铆nico de fase 2 de ateganosina (THIO) en combinaci贸n con cemiplimab en pacientes con c谩ncer de pulm贸n no microc铆tico (NSCLC) avanzado. El ensayo mostr贸 una eficacia notable con una mediana de supervivencia libre de progresi贸n de 5,6 meses en tercera l铆nea (dosis de 180 mg), m谩s del doble frente a la atenci贸n est谩ndar de 2,5 meses.
El estudio tambi茅n demostr贸 una mediana estimada de supervivencia global de 17,8 meses, con intervalos de confianza que indican un l铆mite inferior de 12,5 meses (IC 95%) y 10,8 meses (IC 99%). Dos pacientes completaron 33 ciclos de tratamiento, lo que sugiere el potencial de dosificaci贸n prolongada de ateganosina. La compa帽铆a inici贸 una ampliaci贸n del ensayo de fase 2 en julio de 2025 para validar m谩s estos resultados prometedores.
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鞐瓣惮電� 霕愴暅 於旍爼 齑濎儩臁挫鞎欔皰鞚� 17.8臧滌洈鞚措澕瓿� 氤搓碃頄堨溂氅�, 鞁犽甑皠鞚� 頃橅暅鞚� 12.5臧滌洈(95% CI) 氚� 10.8臧滌洈(99% CI)鞙茧 雮橅儉雮姷雼堧嫟. 霊� 氇呾潣 頇橃瀽臧� 33須� 旃橂 欤缄赴毳� 鞕勲頃� 鞎勴厡臧�雲胳嫚鞚� 鞛リ赴 韴棳 臧�電レ劚鞚� 鞁滌偓頃╇媹雼�. 須岇偓電� 鞚措煬頃� 鞙犽頃� 瓴瓣臣毳� 於旉皜 瓴�歃濏晿旮� 鞙勴暣 2025雲� 7鞗旍棎 2靸� 頇曥灔鞁滍棙鞚� 鞁滌瀾頄堨姷雼堧嫟.
MAIA Biotechnology (NYSE American: MAIA) a annonc茅 des r茅sultats positifs de son essai clinique de phase 2 茅valuant l'ateganosine (THIO) en combinaison avec le cemiplimab chez des patients atteints de cancer du poumon non 脿 petites cellules (NSCLC) avanc茅. L'茅tude a montr茅 une efficacit茅 remarquable avec une survie sans progression m茅diane de 5,6 mois en troisi猫me ligne (dose 180 mg), soit plus du double de la prise en charge standard de 2,5 mois.
L'茅tude a 茅galement rapport茅 une survie globale m茅diane estim茅e 脿 17,8 mois, avec des intervalles de confiance indiquant une borne inf茅rieure 脿 12,5 mois (IC 95 %) et 10,8 mois (IC 99 %). Deux patients ont compl茅t茅 33 cycles de traitement, sugg茅rant la possibilit茅 d'un sch茅ma d'administration prolong茅 de l'ateganosine. La soci茅t茅 a lanc茅 une extension de l'essai de phase 2 en juillet 2025 pour valider davantage ces r茅sultats prometteurs.
MAIA Biotechnology (NYSE American: MAIA) meldete positive Ergebnisse der Phase鈥�2鈥慡tudie zu Ateganosin (THIO) in Kombination mit Cemiplimab bei Patienten mit fortgeschrittenem nicht鈥慿leinzelligem Lungenkrebs (NSCLC). Die Studie zeigte eine bemerkenswerte Wirksamkeit mit einem medianen progressionsfreien 脺berleben von 5,6 Monaten in der Drittlinientherapie (180鈥憁g鈥慏osis), mehr als doppelt so hoch wie der Standard von 2,5 Monaten.
Die Untersuchung ergab au脽erdem ein gesch盲tztes medianes Gesamt眉berleben von 17,8 Monaten, mit Konfidenzintervallen, die eine Untergrenze von 12,5 Monaten (95% CI) bzw. 10,8 Monaten (99% CI) ausweisen. Zwei Patienten durchliefen 33 Behandlungszyklen, was auf das Potenzial f眉r verl盲ngerte Ateganosin鈥慓aben hinweist. Das Unternehmen startete im Juli 2025 eine Phase鈥�2鈥慐rweiterungsstudie, um diese vielversprechenden Ergebnisse weiter zu best盲tigen.
- Median progression-free survival of 5.6 months is more than double the standard of care (2.5 months)
- Strong median overall survival of 17.8 months demonstrated
- Extended dosing potential shown with 2 patients completing 33 treatment cycles
- Consistent tolerability and low toxicity reported
- None.
Insights
MAIA's ateganosine shows doubled PFS (5.6 vs 2.5 months) in advanced NSCLC, with impressive 17.8 months OS in heavily pretreated patients.
The THIO-101 Phase 2 trial data for ateganosine represents a significant clinical advancement for patients with advanced non-small cell lung cancer who have exhausted multiple treatment options. The reported 5.6-month progression-free survival is particularly noteworthy as it more than doubles the 2.5-month PFS typically seen with standard treatments in the third-line setting. For context, patients reaching this stage of treatment have already failed two prior therapy regimens and generally face extremely limited options with modest benefits.
Even more compelling is the 17.8-month median overall survival with robust confidence intervals (95% CI lower bound: 12.5 months; 99% CI lower bound: 10.8 months). These survival metrics substantially exceed what would be expected in this heavily pretreated population. The observation that two patients have completed 33 treatment cycles further validates the durability hypothesis, suggesting that ateganosine's mechanism - likely involving telomere targeting combined with immune checkpoint inhibition - may enable sustained disease control.
The sequential approach of administering ateganosine before cemiplimab (Libtayo庐) appears to be enhancing the immune response against these resistant tumors. The tolerability profile mentioned supports the potential for extended treatment, which is critical for maximizing survival benefit. The company's expansion of the Phase 2 trial initiated in July 2025 will be essential to confirm these encouraging signals across a larger patient population, potentially positioning ateganosine as a valuable new option in the challenging third-line NSCLC treatment landscape.
CHICAGO, Sept. 11, 2025 (GLOBE NEWSWIRE) -- MAIA Biotechnology, Inc. (NYSE American: MAIA) (鈥淢AIA鈥�, the 鈥淐ompany鈥�), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today highlighted positive efficacy data from its Phase 2 clinical trial, THIO-101, evaluating ateganosine (THIO) sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo庐) in patients with advanced non-small cell lung cancer (NSCLC) who had failed two or more standard-of-care therapy regimens.
As of June 30, 2025,
- Estimated median progression free survival (PFS) in third-line treatment (180 mg dose) was 5.6 months. The comparable PFS threshold in standard of care treatments is 2.5 months1.
- Estimated median overall survival (OS) was 17.8 months, with a
95% confidence interval (CI) lower bound of 12.5 months and a99% CI lower bound of 10.8 months, consistent with the prior data readout (May 15, 2025). - Across patients of all treatment lines, 2 patients have completed 33 cycles of therapy, highlighting ateganosine鈥� potential for extended dosing, which usually translates into longer patient survival.
鈥淭HIO-101 continues to reveal impressive efficacy with observed progression free survival of 5.6 months, which is more than double the standard of care PFS of just 2.5 months. The data also demonstrates the durability of ateganosine treatment through extended treatment cycles, which is in line with consistent tolerability and low toxicity,鈥� said MAIA Chairman and CEO Vlad Vitoc, M.D. 鈥淲e are seeking further validation of ateganosine鈥檚 strong efficacy in our THIO-101 Phase 2 expansion trial, which began enrolling patients in July 2025.鈥�
Details of THIO-101, including efficacy data and safety findings, are included in MAIA鈥檚 poster for the 2025 IASLC World Conference on Lung Cancer (WCLC), available at .
About Ateganosine
Ateganosine (THIO, 6-thio-dG or 6-thio-2鈥�-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鈥�-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鈥搒pecific 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鈥檚 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庐) 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庐) 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 .
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1 Shepherd F, et al. N Engl J Med 2005;353:123-132, Fossella F, et al. J Clin Oncol 2000;18(12):2354-62.
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