MAIA Biotechnology to Initiate Phase 3 Pivotal Trial of THIO Sequenced with Checkpoint Inhibitor Compared with Chemotherapy Treatment in Advanced Non-Small Cell Lung Cancer Patients
MAIA Biotechnology (NYSE: MAIA) has announced plans to initiate THIO-104, a Phase 3 pivotal trial in 2025, evaluating THIO in sequence with checkpoint inhibitor (CPI) for third-line non-small cell lung cancer (NSCLC) patients resistant to checkpoint inhibitors and chemotherapy.
The multicenter, open-label trial will compare THIO's efficacy directly against chemotherapy, involving up to 300 patients in a 1:1 randomization. The study's primary endpoint is overall survival, with secondary endpoints including disease control rate, overall response rate, duration of response, progression-free survival, and safety.
Patient enrollment is expected to begin in the second half of 2025 across select countries in Asia, Europe, and the U.S. The company reports that THIO has shown superior performance compared to standard treatments in their ongoing THIO-101 Phase 2 trial.
MAIA Biotechnology (NYSE: MAIA) ha annunciato piani per avviare THIO-104, uno studio clinico di Fase 3 cruciale nel 2025, valutando THIO in sequenza con un inibitore del checkpoint (CPI) per pazienti con cancro polmonare non a piccole cellule (NSCLC) in terza linea resistenti agli inibitori del checkpoint e alla chemioterapia.
Lo studio multicentrico, aperto, confronterà l'efficacia di THIO direttamente con la chemioterapia, coinvolgendo fino a 300 pazienti in una randomizzazione 1:1. L'endpoint primario dello studio è la sopravvivenza globale, con endpoint secondari che includono il tasso di controllo della malattia, il tasso di risposta globale, la durata della risposta, la sopravvivenza libera da progressione e la sicurezza.
Si prevede che l'arruolamento dei pazienti inizi nella seconda metà del 2025 in alcuni paesi selezionati in Asia, Europa e Stati Uniti. L'azienda riporta che THIO ha mostrato prestazioni superiori rispetto ai trattamenti standard nel loro studio in corso THIO-101 di Fase 2.
MAIA Biotechnology (NYSE: MAIA) ha anunciado planes para iniciar THIO-104, un ensayo pivotal de Fase 3 en 2025, evaluando THIO en secuencia con un inhibidor de checkpoint (CPI) para pacientes con cáncer de pulmón de células no pequeñas (NSCLC) en tercera línea que son resistentes a los inhibidores de checkpoint y a la quimioterapia.
El ensayo multicéntrico, abierto, comparará la eficacia de THIO directamente con la quimioterapia, involucrando hasta 300 pacientes en una randomización 1:1. El objetivo principal del estudio es la supervivencia global, con objetivos secundarios que incluyen la tasa de control de la enfermedad, la tasa de respuesta global, la duración de la respuesta, la supervivencia libre de progresión y la seguridad.
Se espera que la inscripción de pacientes comience en la segunda mitad de 2025 en países seleccionados de Asia, Europa y EE. UU. La empresa informa que THIO ha mostrado un rendimiento superior en comparación con los tratamientos estándar en su ensayo THIO-101 de Fase 2 en curso.
MAIA Biotechnology (NYSE: MAIA)는 2025년에 THIO-104라는 3상 주요 임상 시험을 시작할 계획을 발표했습니다. 이 시험은 체크포인트 억제제(CPI)에 저항성을 보이는 3차선 비소세포 폐암(NSCLC) 환자들에게 THIO를 평가합니다.
다기관 공개 시험은 THIO의 효능을 화학요법과 직접 비교하며, 최대 300명의 환자를 1:1 무작위 배정으로 포함합니다. 연구의 주요 목표는 전체 생존율이며, 부차적인 목표로는 질병 조절률, 전체 반응률, 반응 지속 기간, 무진행 생존 및 안전성이 포함됩니다.
환자 모집은 2025년 하반기에 아시아, 유럽 및 미국의 일부 국가에서 시작될 것으로 예상됩니다. 회사는 THIO가 진행 중인 THIO-101 2상 시험에서 표준 치료에 비해 우수한 성능을 보였다고 보고했습니다.
MAIA Biotechnology (NYSE: MAIA) a annoncé des plans pour initier THIO-104, un essai pivot de Phase 3 en 2025, évaluant THIO en séquence avec un inhibiteur de point de contrôle (CPI) pour des patients atteints de cancer du poumon non à petites cellules (NSCLC) en troisième ligne, résistants aux inhibiteurs de point de contrôle et à la chimiothérapie.
L'essai multicentrique, en ouvert, comparera l'efficacité de THIO directement à celle de la chimiothérapie, impliquant jusqu'à 300 patients dans une randomisation 1:1. Le critère principal de l'étude est la survie globale, avec des critères secondaires comprenant le taux de contrôle de la maladie, le taux de réponse global, la durée de la réponse, la survie sans progression et la sécurité.
L'inscription des patients devrait commencer dans la seconde moitié de 2025 dans certains pays sélectionnés en Asie, en Europe et aux États-Unis. L'entreprise rapporte que THIO a montré des performances supérieures par rapport aux traitements standards dans son essai THIO-101 de Phase 2 en cours.
MAIA Biotechnology (NYSE: MAIA) hat Pläne angekündigt, THIO-104, eine entscheidende Phase-3-Studie, im Jahr 2025 zu starten, um THIO in Kombination mit einem Checkpoint-Inhibitor (CPI) bei Patienten mit nicht-kleinzelligem Lungenkrebs (NSCLC) in der dritten Linie zu bewerten, die gegen Checkpoint-Inhibitoren und Chemotherapie resistent sind.
Die multizentrische, offene Studie wird die Wirksamkeit von THIO direkt mit Chemotherapie vergleichen und bis zu 300 Patienten in einer 1:1-Randomisierung einbeziehen. Der primäre Endpunkt der Studie ist das Gesamtüberleben, während sekundäre Endpunkte die Krankheitskontrollrate, die Gesamtansprechrate, die Dauer des Ansprechens, das progressionsfreie Überleben und die Sicherheit umfassen.
Die Patientenrekrutierung wird voraussichtlich in der zweiten Hälfte des Jahres 2025 in ausgewählten Ländern in Asien, Europa und den USA beginnen. Das Unternehmen berichtet, dass THIO im laufenden THIO-101 Phase-2-Studie eine überlegene Leistung im Vergleich zu Standardbehandlungen gezeigt hat.
- THIO showing superior performance in ongoing Phase 2 trial
- Advancing to Phase 3 trial indicates development progress
- Large-scale trial with up to 300 patients
- Phase 3 trial not starting until second half of 2025
- No current FDA approval or revenue generation
- Targeting only third-line treatment patients
Insights
MAIA Biotechnology's announcement of a Phase 3 pivotal trial for THIO represents a significant milestone for this small-cap oncology company with a market cap of just
The trial design offers several strategic advantages. By directly comparing THIO+CPI sequencing against chemotherapy in a randomized setting with overall survival as the primary endpoint, MAIA is pursuing the gold standard for regulatory approval. This approach, if successful, could provide compelling evidence for FDA approval and subsequent commercial adoption.
While the company states THIO has "consistently and substantially outperformed standard treatment options" in their Phase 2 trial, investors should note that specific efficacy data points weren't disclosed in this announcement. The strength of the Phase 2 data will be important in predicting Phase 3 success probability.
For a company of MAIA's size, executing a 300-patient multicenter global trial represents a significant operational and financial undertaking. The extended timeline (enrollment beginning H2 2025) suggests potential capital needs before reaching key value-inflection points. This trial positioning indicates MAIA is pursuing a differentiated approach by potentially resensitizing tumors to checkpoint inhibition rather than developing another chemotherapy alternative.
The third-line NSCLC market, while smaller than frontline settings, represents a strategic entry point that could enable label expansion to earlier treatment lines if successful. This positions THIO as potentially the first approved therapy specifically for CPI-resistant NSCLC patients, addressing a growing population as checkpoint inhibitor use continues to expand in oncology.
“THIO has consistently and substantially outperformed standard treatment options in our THIO-101 Phase 2 trial to date. THIO-104 will give us direct comparative data from a randomized study in patients in third line of treatment,” said Vlad Vitoc, M.D., CEO of MAIA. “We expect that the results from this study will further illuminate THIO’s unmatched benefits for advanced stage NSCLC patients.
“Our initiation of THIO-104 will mark an important milestone along our goal for THIO’s FDA commercial approval,” Dr. Vitoc added.
MAIA expects to begin enrolling patients in THIO-104 in the second half of 2025 in select countries in
The primary endpoint of the clinical trial is overall survival for THIO sequenced with a CPI compared to investigator’s choice of chemotherapy in a third line setting. The secondary endpoints include disease control rate, overall response rate, duration of response, progression-free survival and safety.
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 third line of treatment for NSCLC for patients that are resistant to checkpoint inhibitors and chemotherapy.
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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Source: MAIA Biotechnology, Inc.
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