MAIA Biotechnology Announces Late-Breaking Abstract of THIO-101 Updates Selected for Oral and Poster Presentation at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting
MAIA Biotechnology announced that its late-breaking abstract from the THIO-101 Phase 2 clinical trial has been selected for presentation at the 2024 SITC Annual Meeting. The presentation will showcase new efficacy and safety data for THIO combined with cemiplimab in advanced non-small cell lung cancer (NSCLC) patients who failed multiple standard treatments. As of August 1, 2024, 16 patients had survival follow-up exceeding 12 months, with 9 in third-line treatment showing interim median survival of 10.6 months, significantly surpassing the standard-of-care survival of 5.8 months.
MAIA Biotechnology ha annunciato che il suo abstract ad impatto recente proveniente dallo studio clinico di Fase 2 THIO-101 è stato selezionato per la presentazione al Meeting Annuale SITC 2024. La presentazione mostrerà nuovi dati di efficacia e sicurezza per THIO combinato con cemiplimab in pazienti con carcinoma polmonare non a piccole cellule (NSCLC) avanzato che hanno fallito diversi trattamenti standard. A partire dal 1 agosto 2024, 16 pazienti hanno avuto un follow-up sulla sopravvivenza superiore ai 12 mesi, con 9 in trattamento di terza linea che mostrano una sopravvivenza mediana interina di 10,6 mesi, superando notevolmente la sopravvivenza standard di cura di 5,8 mesi.
MAIA Biotechnology anunció que su resumen de última hora del ensayo clínico de Fase 2 THIO-101 ha sido seleccionado para su presentación en la Reunión Anual SITC 2024. La presentación mostrará nuevos datos de eficacia y seguridad de THIO combinado con cemiplimab en pacientes con cáncer de pulmón no microcítico (NSCLC) avanzado que no respondieron a múltiples tratamientos estándar. A partir del 1 de agosto de 2024, 16 pacientes tuvieron un seguimiento de la supervivencia que superó los 12 meses, con 9 en tratamiento de tercera línea mostrando una supervivencia mediana provisional de 10,6 meses, superando significativamente la supervivencia estándar de 5,8 meses.
MAIA Biotechnology는 THIO-101 2상 임상 시험의 최신 초록이 2024 SITC 연례 회의에서 발표될 예정이라고 발표했습니다. 이번 발표는 여러 표준 치료에 실패한 진행성 비소세포 폐암 (NSCLC) 환자에서 cemiplimab과 THIO의 조합에 대한 새로운 효능 및 안전성 데이터를 선보일 것입니다. 2024년 8월 1일 기준으로 16명의 환자가 12개월 이상의 생존 추적 조사를 받았으며, 3차 치료를 받은 9명의 환자는 10.6개월의 중간 생존 기간을 보여 주었고, 이는 표준 치료의 5.8개월 생존 기간을 상당히 초과합니다.
MAIA Biotechnology a annoncé que son résumé à fort impact du trial clinique de Phase 2 THIO-101 a été sélectionné pour être présenté lors de la réunion annuelle SITC 2024. La présentation mettra en avant de nouvelles données d'efficacité et de sécurité pour THIO combiné avec cemiplimab chez des patients atteints de cancer du poumon non à petites cellules (NSCLC) avancé ayant échoué à plusieurs traitements standards. Au 1er août 2024, 16 patients avaient un suivi de survie dépassant 12 mois, avec 9 en traitement de troisième ligne montrant une survie médiane provisoire de 10,6 mois, dépassant significativement la survie standard de soin de 5,8 mois.
MAIA Biotechnology gab bekannt, dass sein Late-Breaking-Abstract aus der THIO-101 Phase 2-Studie für die Präsentation auf dem 2024 SITC Jahresmeeting ausgewählt wurde. Die Präsentation wird neue Wirksamkeits- und Sicherheitsdaten für THIO in Kombination mit cemiplimab bei fortgeschrittenen nicht-kleinzelligem Lungenkrebs (NSCLC)-Patienten vorstellen, die mehrere Standardbehandlungen nicht erfolgreich abgeschlossen haben. Am 1. August 2024 hatten 16 Patienten eine Überlebensnachverfolgung von über 12 Monaten, wobei 9 im dritten Behandlungsbereich eine zwischenzeitliche mediane Überlebenszeit von 10,6 Monaten aufwiesen, was die Standardüberlebenszeit von 5,8 Monaten erheblich übersteigt.
- Interim median survival in third-line treatment reached 10.6 months, significantly higher than standard-of-care (5.8 months)
- 16 patients showed survival follow-up exceeding 12 months
- Selection as late-breaking abstract indicates potential practice-changing research
- None.
Insights
The selection of MAIA's late-breaking abstract for SITC presentation represents promising progress in their THIO-101 Phase 2 trial. The interim data shows 10.6 months median survival in third-line NSCLC patients, significantly outperforming the standard-of-care survival of 5.8 months - an
The sequential combination of THIO with cemiplimab appears to demonstrate durable responses, with 16 patients surviving beyond 12 months, including 9 patients in third-line treatment. This suggests potential for long-term therapeutic benefits and immune memory formation, which could differentiate THIO from existing treatment options in the challenging late-line NSCLC setting.
- Late breaking abstract to provide new updates from THIO-101 Phase 2 clinical trial in non-small cell lung cancer (NSCLC)
- Poster to highlight long-term therapeutic benefits of THIO sequenced with cemiplimab beyond treatment cessation
“We are honored to have our THIO-101 data recognized by SITC in a late-breaking abstract, a category reserved for research that has the potential to change medical practices. We believe that our latest data is compelling and further supports the ability of THIO to produce cancer cell specific immune memory and to remain active against cancer cells after extended periods of time,” said Vlad Vitoc, M.D., Chairman and CEO of MAIA. “Our findings to date are particularly significant for advanced-stage patients resistant to CPI and chemotherapy treatments who are in desperate need of new treatment options. In our opinion, the combination of THIO with a CPI is showing promise as a durable and effective NSCLC treatment.”
Presentation details:
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Telomere-Targeting Agent THIO in Sequential Combination with Cemiplimab Demonstrates Long Term Therapeutic Benefits Beyond Treatment Cessation — A Phase 2 Trial in Advanced Immune Checkpoint Inhibitor Resistant Non-Small Cell Lung Cancer Patients |
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Abstract number: |
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1492 |
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Session: |
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Late Breaking Abstract Session 1 |
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Friday, November 8, 2024 |
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11:45 a.m.-12:15 p.m. CST |
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MAIA Presenter: |
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Victor Zaporojan, M.D., Sr. Medical Director |
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Poster access: |
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MAIA’s poster will be available at maiabiotech.com/publications on November 8, 2024 |
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According to SITC, a late-breaking abstract (LBA) submission is solely for abstracts with late-breaking data from interventional clinical trials in humans. The reference does not refer to abstracts that are submitted “late,” as in after submission deadlines.
As of August 1, 2024, 16 patients in the THIO-101 trial had survival follow-up surpassing 12 months, including 9 in third line treatment (3L). Interim median survival follow-up in 3L was 10.6 months. THIO's substantial survival benefit in third line NSCLC surpasses current standard-of-care overall survival of 5.8 months.1
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 Regeneron’s PD-1 inhibitor 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 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
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