MAIA Biotechnology Announces Positive Efficacy Updates for Phase 2 THIO-101 Trial in Advanced Non-Small Cell Lung Cancer
MAIA Biotechnology (NYSE: MAIA) reported positive updates from its THIO-101 Phase 2 clinical trial, evaluating THIO in combination with cemiplimab for advanced non-small cell lung cancer (NSCLC) patients who failed multiple standard treatments.
Key findings as of January 15, 2025, showed a median overall survival (OS) of 16.9 months for 22 NSCLC patients who received at least one THIO dose in parts A and B of the trial. The analysis demonstrated a 95% confidence interval lower bound of 12.5 months and a 99% confidence interval lower bound of 10.8 months. This significantly outperforms standard-of-care chemotherapy treatments, which typically show OS of 5-6 months in similar settings.
The treatment has been well-tolerated in this heavily pre-treated population. Based on these results, MAIA is pursuing potential accelerated FDA approval through the ongoing expansion of the THIO-101 trial.
MAIA Biotechnology (NYSE: MAIA) ha riportato aggiornamenti positivi dal suo trial clinico di Fase 2 THIO-101, che valuta l'uso di THIO in combinazione con cemiplimab per pazienti con carcinoma polmonare non a piccole cellule avanzato (NSCLC) che hanno fallito multiple terapie standard.
I risultati chiave al 15 gennaio 2025 mostrano una mediana di sopravvivenza globale (OS) di 16,9 mesi per 22 pazienti NSCLC che hanno ricevuto almeno una dose di THIO nelle parti A e B del trial. L'analisi ha dimostrato un limite inferiore dell'intervallo di confidenza del 95% di 12,5 mesi e un limite inferiore dell'intervallo di confidenza del 99% di 10,8 mesi. Questo supera significativamente i trattamenti chemioterapici standard, i quali normalmente mostrano un'OS di 5-6 mesi in contesti simili.
Il trattamento è stato ben tollerato in questa popolazione pesantemente pre-trattata. Sulla base di questi risultati, MAIA sta perseguendo un potenziale approvazione accelerata dalla FDA attraverso l'espansione in corso del trial THIO-101.
MAIA Biotechnology (NYSE: MAIA) informó sobre actualizaciones positivas de su ensayo clínico de Fase 2 THIO-101, que evalúa el uso de THIO en combinación con cemiplimab para pacientes con cáncer de pulmón no microcítico avanzado (NSCLC) que han fallado múltiples tratamientos estándar.
Los hallazgos clave al 15 de enero de 2025 mostraron una supervivencia global mediana (OS) de 16.9 meses para 22 pacientes con NSCLC que recibieron al menos una dosis de THIO en las partes A y B del ensayo. El análisis demostró un límite inferior del intervalo de confianza del 95% de 12.5 meses y un límite inferior del intervalo de confianza del 99% de 10.8 meses. Esto supera significativamente los tratamientos de quimioterapia estándar, que normalmente muestran una OS de 5-6 meses en contextos similares.
El tratamiento ha sido bien tolerado en esta población que ha recibido múltiples tratamientos previos. Con base en estos resultados, MAIA está buscando una posible aprobación acelerada por parte de la FDA mediante la expansión continua del ensayo THIO-101.
MAIA Biotechnology (NYSE: MAIA)는 다수의 표준 치료에서 실패한 고급 비소세포 폐암(NSCLC) 환자를 위해 cemiplimab와 결합된 THIO를 평가하는 THIO-101 2상 임상시험에서 긍정적인 업데이트를 보고했습니다.
2025년 1월 15일 현재 주요 발견은 시험의 A 및 B 부분에서 최소 한 번의 THIO 용량을 받은 22명의 NSCLC 환자에 대해 중앙 전체 생존 기간(OS) 16.9개월을 보여주었습니다. 분석 결과 95% 신뢰구간 하한은 12.5개월, 99% 신뢰구간 하한은 10.8개월이었습니다. 이는 유사한 환경에서 일반적으로 5-6개월의 OS를 보이는 표준 화학요법 치료를 크게 초과합니다.
이 치료는 여러 신전 치료를 받은 모집단에서 잘 견뎌졌습니다. 이러한 결과를 바탕으로 MAIA는 THIO-101 임상시험의 진행 중인 확대를 통해 FDA의 잠재적인 신속 승인을 추구하고 있습니다.
MAIA Biotechnology (NYSE: MAIA) a annoncé des mises à jour positives de son essai clinique de phase 2 THIO-101, évaluant THIO en association avec le cemiplimab chez des patients atteints de cancer du poumon non à petites cellules (NSCLC) avancé ayant échoué à plusieurs traitements standards.
Les résultats clés au 15 janvier 2025 ont montré une survie globale médiane (SG) de 16,9 mois pour 22 patients atteints de NSCLC ayant reçu au moins une dose de THIO dans les parties A et B de l'essai. L'analyse a dévoilé une limite inférieure de l'intervalle de confiance à 95 % de 12,5 mois et une limite inférieure de l'intervalle de confiance à 99 % de 10,8 mois. Cela dépasse considérablement les traitements de chimiothérapie standards, qui montrent généralement une SG de 5-6 mois dans des contextes similaires.
Le traitement a été bien toléré dans cette population ayant subi de nombreux traitements préalables. Sur la base de ces résultats, MAIA vise une approbation accélérée par la FDA grâce à l'expansion en cours de l'essai THIO-101.
MAIA Biotechnology (NYSE: MAIA) berichtete über positive Neuigkeiten aus der Phase-2-Studie THIO-101, die THIO in Kombination mit Cemiplimab bei fortgeschrittenen Patienten mit nicht-kleinzelligem Lungenkrebs (NSCLC) untersucht, die mehrere Standardbehandlungen gescheitert haben.
Wesentliche Ergebnisse vom 15. Januar 2025 zeigten eine medianen Gesamtüberlebensdauer (OS) von 16,9 Monaten für 22 NSCLC-Patienten, die mindestens eine THIO-Dosis in den Teilen A und B der Studie erhalten hatten. Die Analyse zeigte eine untere Grenze des 95%-Konfidenzintervalls von 12,5 Monaten und eine untere Grenze des 99%-Konfidenzintervalls von 10,8 Monaten. Dies übertrifft deutlich die Standard-Chemotherapiebehandlungen, die typischerweise eine OS von 5-6 Monaten in ähnlichen Umgebungen zeigen.
Die Behandlung wurde in dieser stark vorbehandelten Population gut toleriert. Basierend auf diesen Ergebnissen strebt MAIA eine mögliche beschleunigte Genehmigung von der FDA durch die laufende Erweiterung der THIO-101-Studie an.
- Median overall survival of 16.9 months, significantly higher than standard chemotherapy (5-6 months)
- Treatment well-tolerated in heavily pre-treated patients
- Potential opportunity for accelerated FDA approval
- None.
Insights
The latest THIO-101 trial data represents a potential paradigm shift in advanced NSCLC treatment. The observed 16.9-month median overall survival is particularly striking when compared to the historical 5-6 month survival with standard chemotherapy in third-line treatment. The robust statistical confidence intervals (95% CI lower bound: 12.5 months; 99% CI lower bound: 10.8 months) provide strong evidence of THIO's clinical benefit.
The sequential combination of THIO with cemiplimab demonstrates a novel approach in immunotherapy. This treatment strategy could potentially address resistance mechanisms that limit the efficacy of current checkpoint inhibitors alone. The favorable safety profile in heavily pre-treated patients is particularly noteworthy, as this population typically experiences cumulative toxicities.
From a regulatory perspective, these results strongly position THIO for potential accelerated FDA approval. The substantial survival benefit observed in a third-line setting, where options are and prognosis is poor, could qualify THIO as a breakthrough therapy. The expansion of the THIO-101 trial will be important in confirming these findings and supporting regulatory submissions.
For MAIA Biotechnology, this represents a significant value inflection point. The advanced NSCLC market represents a substantial commercial opportunity, with third-line treatment being an area of high unmet need. If approved, THIO could become a standard of care in this setting, potentially generating significant revenue for this small-cap biotech company.
- Median overall survival (OS) from THIO treatment extends to 16.9 months
- Newest data strengthens regulatory strategy
As of January 15, 2025, third line (3L) data showed median overall survival (OS) of 16.9 months for the 22 NSCLC patients who received at least one dose of THIO (the intent-to-treat population) in parts A and B of the trial. The analysis demonstrated a
“Treatment with THIO now shows a
“With our latest overall survival results, our outlook for potential FDA commercial approval of THIO is stronger than ever,” Dr. Vitoc concluded.
Based on its regulatory strategy, MAIA believes there could be an opportunity for accelerated FDA approval of THIO depending on final results from the ongoing expansion of the THIO-101 trial.
About THIO
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 (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO 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. THIO 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, a 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 THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO 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 THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. Treatment with THIO followed by cemiplimab (Libtayo®) has been generally well-tolerated 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 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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1 Details on safety can be found on the previously announced SITC 2024 presentation available on MAIA’s website. |
2 Girard N, et al. J Thorac Onc 2009;12:1544-1549. |
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Investor Relations Contact
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Source: MAIA Biotechnology, Inc.
FAQ
What is the median overall survival rate in MAIA's THIO-101 Phase 2 trial for NSCLC?
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