MAIA Biotechnology Announces Design for Expansion of THIO-101 Phase 2 Trial in Advanced Non-Small Cell Lung Cancer
MAIA Biotechnology (NYSE: MAIA) has announced the expansion design of its THIO-101 Phase 2 trial for advanced non-small cell lung cancer (NSCLC). The expanded study will evaluate overall response rates in third-line (3L) patients resistant to previous checkpoint inhibitor treatments and chemotherapy.
The trial will include two arms with up to 48 patients: Arm 1 evaluating THIO sequenced with Libtayo® (cemiplimab), and Arm 2 assessing THIO as monotherapy. An additional 100 patients will be enrolled for the registration phase across the U.S., Europe, and Asia.
Current data as of January 15, 2025, shows a Median Overall Survival (OS) of 16.9 months in third-line treatment, with a 95% confidence interval lower bound of 12.5 months. The treatment has been well-tolerated in heavily pre-treated patients. MAIA has amended its clinical supply agreement with Regeneron for Libtayo provision and plans to seek accelerated FDA approval.
MAIA Biotechnology (NYSE: MAIA) ha annunciato il design dell'espansione del suo studio THIO-101 di Fase 2 per il cancro polmonare non a piccole cellule avanzato (NSCLC). Lo studio ampliato valuterà i tassi di risposta complessivi nei pazienti di terza linea (3L) resistenti ai precedenti trattamenti con inibitori del checkpoint e alla chemioterapia.
Il trial includerà due bracci con un massimo di 48 pazienti: Braccio 1 che valuta THIO sequenziato con Libtayo® (cemiplimab), e Braccio 2 che valuta THIO come monoterapia. Ulteriori 100 pazienti saranno arruolati per la fase di registrazione negli Stati Uniti, in Europa e in Asia.
I dati attuali, aggiornati al 15 gennaio 2025, mostrano una Survival Overall Mediana (OS) di 16,9 mesi nel trattamento di terza linea, con un limite inferiore dell'intervallo di confidenza del 95% di 12,5 mesi. Il trattamento è stato ben tollerato in pazienti con pesante pre-trattamento. MAIA ha modificato il suo accordo di fornitura clinica con Regeneron per la fornitura di Libtayo e prevede di richiedere un'approvazione accelerata dalla FDA.
MAIA Biotechnology (NYSE: MAIA) ha anunciado el diseño de expansión de su ensayo THIO-101 de Fase 2 para el cáncer de pulmón no microcítico avanzado (NSCLC). El estudio ampliado evaluará las tasas de respuesta general en pacientes de tercera línea (3L) resistentes a tratamientos previos con inhibidores de puntos de control y quimioterapia.
El ensayo incluirá dos brazos con hasta 48 pacientes: Brazo 1 evaluando THIO secuenciado con Libtayo® (cemiplimab), y Brazo 2 evaluando THIO como monoterapia. Se inscribirán 100 pacientes adicionales para la fase de registro en EE. UU., Europa y Asia.
Los datos actuales, a partir del 15 de enero de 2025, muestran una Supervivencia Global Mediana (OS) de 16.9 meses en tratamiento de tercera línea, con un límite inferior del intervalo de confianza del 95% de 12.5 meses. El tratamiento ha sido bien tolerado en pacientes con un alto grado de pretratamiento. MAIA ha modificado su acuerdo de suministro clínico con Regeneron para la provisión de Libtayo y planea solicitar una aprobación acelerada de la FDA.
MAIA Biotechnology (NYSE: MAIA)는 진행성 비소세포 폐암(NSCLC)을 위한 THIO-101 2상 시험의 확장 설계를 발표했습니다. 확장된 연구는 이전의 체크포인트 억제제 치료와 화학요법에 저항성이 있는 3차 치료(3L) 환자에서 전체 반응률을 평가할 것입니다.
이 시험은 최대 48명의 환자를 포함하는 두 개의 팔로 구성됩니다: 팔 1은 Libtayo®(cemiplimab)와 함께 순서대로 THIO를 평가하고, 팔 2는 THIO를 단독 요법으로 평가합니다. 미국, 유럽, 아시아 전역에서 등록 단계에 추가로 100명의 환자가 등록될 예정입니다.
2025년 1월 15일 현재 데이터에 따르면, 3차 치료에서의 중위 전체 생존 기간(OS)은 16.9개월이며, 95% 신뢰 구간의 하한은 12.5개월입니다. 이 치료는 중증으로 사전 치료된 환자에게 잘 견디고 있습니다. MAIA는 Libtayo 제공을 위한 Regeneron과의 임상 공급 계약을 수정했으며 FDA의 신속 승인을 요청할 계획입니다.
MAIA Biotechnology (NYSE: MAIA) a annoncé le design d'expansion de son essai THIO-101 de Phase 2 pour le cancer du poumon non à petites cellules avancé (NSCLC). L'étude élargie évaluera les taux de réponse globaux chez les patients de troisième ligne (3L) résistants aux traitements antérieurs par inhibiteurs de points de contrôle et à la chimiothérapie.
L'essai comprendra deux bras avec jusqu'à 48 patients : Bras 1 évaluant THIO séquencé avec Libtayo® (cemiplimab), et Bras 2 évaluant THIO en monothérapie. 100 patients supplémentaires seront recrutés pour la phase d'enregistrement aux États-Unis, en Europe et en Asie.
Les données actuelles, à partir du 15 janvier 2025, montrent une survie globale médiane (OS) de 16,9 mois dans le traitement de troisième ligne, avec une limite inférieure de l'intervalle de confiance à 95 % de 12,5 mois. Le traitement a été bien toléré chez les patients ayant subi de nombreux traitements préalables. MAIA a modifié son accord de fourniture clinique avec Regeneron pour la fourniture de Libtayo et prévoit de demander une approbation accélérée de la FDA.
MAIA Biotechnology (NYSE: MAIA) hat das Erweiterungsdesign seiner THIO-101-Studie der Phase 2 für fortgeschrittenen nicht-kleinzelligen Lungenkrebs (NSCLC) angekündigt. Die erweiterte Studie wird die Gesamtansprechrate bei Patienten der dritten Linie (3L), die gegen frühere Behandlungen mit Checkpoint-Inhibitoren und Chemotherapie resistent sind, bewerten.
Die Studie wird zwei Arme mit bis zu 48 Patienten umfassen: Arm 1 bewertet THIO in Kombination mit Libtayo® (cemiplimab), und Arm 2 bewertet THIO als Monotherapie. Weitere 100 Patienten werden für die Registrierungsphase in den USA, Europa und Asien eingeschlossen.
Aktuelle Daten vom 15. Januar 2025 zeigen eine medianen Gesamtüberlebenszeit (OS) von 16,9 Monaten in der dritten Linie, mit einer unteren Grenze des 95%-Konfidenzintervalls von 12,5 Monaten. Die Behandlung wurde bei stark vorbehandelten Patienten gut vertragen. MAIA hat seine klinische Liefervereinbarung mit Regeneron für die Bereitstellung von Libtayo geändert und plant, eine beschleunigte FDA-Zulassung zu beantragen.
- Strong median overall survival of 16.9 months in third-line treatment
- Treatment well-tolerated in heavily pre-treated population
- Potential accelerated FDA approval pathway
- Expanded clinical supply agreement with Regeneron for Libtayo
- None.
Insights
MAIA Biotechnology's expansion of its THIO-101 Phase 2 trial represents a significant development for this small-cap biotech (
The 16.9-month median overall survival reported in the third-line setting is particularly noteworthy, as current third-line therapies rarely achieve such durability of response. For context, historical survival for similar patients is typically 4-6 months, making these preliminary results potentially transformative if confirmed in larger cohorts.
The two-arm expansion design (THIO+Libtayo vs. THIO monotherapy) serves dual purposes: it will help isolate THIO's independent contribution to efficacy while potentially strengthening the regulatory package. The amended Regeneron agreement provides critical support by supplying Libtayo throughout the expanded trial, reducing MAIA's cash burn—crucial for a company with resources.
The explicit mention of pursuing accelerated FDA approval suggests management believes the unmet medical need and preliminary efficacy data could support a faster regulatory pathway, potentially bringing THIO to market years earlier than a traditional approval process. For investors, this represents a significantly shortened timeline to potential commercialization.
While promising, caution is warranted as early-phase data from small patient populations often doesn't translate to larger trials. The expanded enrollment of up to 148 total patients (48 in expansion phase plus 100 in registration phase) will provide more definitive evidence of THIO's efficacy profile and commercial potential in this treatment-resistant population.
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Expansion study to enroll patients in the
U.S. and select countries inEurope andAsia - Multiple milestones attainable for 2025
The THIO-101 study in 3L will enroll up to 48 patients with two arms: Arm 1, continuing the evaluation of THIO sequenced with Libtayo® (cemiplimab); and Arm 2, evaluating THIO as a monotherapy, to further gain experience of THIO in the contribution of components. Treatment cycles for patients in both arms will administer THIO on 3 consecutive days, followed by immune activation on day 4. Arm 1 will administer Libtayo on day 5. The Company plans to enroll an additional 100 patients for the registration phase of the trial. MAIA expects to conduct the trials in the
MAIA recently announced an amended clinical supply agreement with Regeneron to include the expansion portion of THIO-101. Under terms of the amended agreement, MAIA continues to sponsor THIO-101 and Regeneron will provide Libtayo for the treatment of all patients including the additional patients in the expansion and potentially, the registration studies.
“We are excited to start the expansion arm of our THIO-101 trial which is designed to determine overall response rates in third line NSCLC. We expect to have new patients enrolled in the coming weeks,” said Vlad Vitoc, M.D., CEO of MAIA. “Through THIO-101 to date, THIO has delivered unprecedented disease control, response, and survival results. Continued efficacy and safety data generated by our study could support an FDA NDA submission directly, particularly as we plan to seek an accelerated approval of THIO in the
“We have multiple milestones that we believe are attainable for 2025 and we look forward to keeping our shareholders and investors well informed of our progress on value creation,” Dr. Vitoc added.
As of January 15, 2025, data indicated that Median Overall Survival (OS) in third-line treatment was reached at 16.9 months, with a
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Details on safety can be found on the previously announced SITC 2024 presentation available on MAIA’s website. |
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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Source: MAIA Biotechnology, Inc.
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