MAIA Biotechnology Announces New Updates from Phase 2 Trial of Novel Cancer Treatment Agent
MAIA Biotechnology (NYSE American: MAIA) has announced positive updates from its Phase 2 THIO-101 trial, evaluating THIO sequenced with cemiplimab in advanced non-small cell lung cancer (NSCLC) patients who failed multiple standard therapies. Key highlights include:
1. Six patients have continued treatment for over 12 months, completing up to 21 cycles.
2. The THIO-cemiplimab combination shows significantly lower toxicity compared to standard treatments.
3. Treatment longevity suggests safety, efficacy, and ongoing benefits of MAIA's novel telomere-targeting therapy.
4. Current second-line NSCLC treatments typically last 3-4 months, while THIO patients are showing much longer treatment durations.
These results indicate THIO's potential as a durable and effective treatment for advanced NSCLC patients with options.
MAIA Biotechnology (NYSE American: MAIA) ha annunciato aggiornamenti positivi dal suo studio di fase 2 THIO-101, che valuta THIO sequenziato con cemiplimab in pazienti con cancro al polmone non a piccole cellule (NSCLC) in stadio avanzato che hanno fallito più terapie standard. Punti salienti includono:
1. Sei pazienti hanno continuato il trattamento per oltre 12 mesi, completando fino a 21 cicli.
2. La combinazione THIO-cemiplimab mostra una tossicità significativamente inferiore rispetto ai trattamenti standard.
3. La longevità del trattamento suggerisce sicurezza, efficacia e benefici continuativi della nuova terapia di MAIA mirata ai telomeri.
4. I trattamenti attuali di seconda linea per il NSCLC durano tipicamente 3-4 mesi, mentre i pazienti trattati con THIO stanno mostrando durate di trattamento molto più lunghe.
Questi risultati indicano il potenziale di THIO come trattamento durevole ed efficace per i pazienti con NSCLC avanzato con opzioni.
MAIA Biotechnology (NYSE American: MAIA) ha anunciado actualizaciones positivas de su ensayo de fase 2 THIO-101, que evalúa THIO secuenciado con cemiplimab en pacientes con cáncer de pulmón no microcítico (NSCLC) avanzado que no han respondido a múltiples terapias estándar. Los puntos destacados incluyen:
1. Seis pacientes han continuado el tratamiento durante más de 12 meses, completando hasta 21 ciclos.
2. La combinación THIO-cemiplimab muestra una toxicidad significativamente menor en comparación con los tratamientos estándar.
3. La longevidad del tratamiento sugiere seguridad, eficacia y beneficios continuos de la nueva terapia de MAIA dirigida a los telómeros.
4. Los tratamientos actuales de segunda línea para el NSCLC suelen durar entre 3 y 4 meses, mientras que los pacientes tratados con THIO están mostrando duraciones de tratamiento mucho más largas.
Estos resultados indican el potencial de THIO como un tratamiento duradero y eficaz para pacientes con NSCLC avanzado que tienen opciones.
MAIA 바이오테크놀로지(NYSE American: MAIA)는 여러 표준 치료에 실패한 진행성 비소세포 폐암(NSCLC) 환자를 대상으로 THIO와 세미플리맙을 조합한 제2상 THIO-101 임상 시험에서 긍정적인 업데이트를 발표했습니다. 주요 사항은 다음과 같습니다:
1. 6명의 환자가 12개월 이상 치료를 계속하며 최대 21 주기를 완료했습니다.
2. THIO-세미플리맙 조합은 표준 치료에 비해 낮은 독성을 보입니다.
3. 치료의 지속성은 MAIA의 새로운 텔로미어 타겟 치료의 안전성, 효능 및 지속적인 이점을 시사합니다.
4. 현재 2차 NSCLC 치료는 일반적으로 3-4개월 지속되지만, THIO 치료를 받은 환자는 훨씬 더 긴 치료 지속 기간을 보여줍니다.
이 결과는 THIO가 선택지가 없는 진행성 NSCLC 환자에게 지속 가능하고 효과적인 치료법이 될 가능성을 나타냅니다.
MAIA Biotechnology (NYSE American: MAIA) a annoncé des mises à jour positives concernant son essai de phase 2 THIO-101, évaluant THIO séquencé avec cemiplimab chez des patients atteints de cancer du poumon non à petites cellules (NSCLC) avancé ayant échoué à plusieurs thérapies standards. Les points clés incluent:
1. Six patients ont poursuivi le traitement pendant plus de 12 mois, complétant jusqu'à 21 cycles.
2. La combinaison THIO-cemiplimab présente une toxicité significativement inférieure par rapport aux traitements standards.
3. La longévité du traitement suggère la sécurité, l'efficacité et les avantages continus de la nouvelle thérapie ciblant les télomères de MAIA.
4. Les traitements actuels de deuxième ligne pour le NSCLC durent généralement 3-4 mois, tandis que les patients traités avec THIO montrent des durées de traitement beaucoup plus longues.
Ces résultats indiquent le potentiel de THIO en tant que traitement durable et efficace pour les patients atteints de NSCLC avancé avec des options.
MAIA Biotechnology (NYSE American: MAIA) hat positive Neuigkeiten aus seiner Phase-2-Studie THIO-101 veröffentlicht, die THIO in Kombination mit Cemiplimab bei Patienten mit fortgeschrittenem nicht-kleinzelligem Lungenkrebs (NSCLC), die mehrere Standardtherapien nicht erfolgreich durchlaufen haben, bewertet. Die wichtigsten Punkte sind:
1. Sechs Patienten haben die Behandlung über 12 Monate fortgesetzt und bis zu 21 Zyklen abgeschlossen.
2. Die Kombination aus THIO und Cemiplimab zeigt eine signifikant niedrigere Toxizität im Vergleich zu Standardbehandlungen.
3. Die Dauer der Behandlung deutet auf Sicherheit, Wirksamkeit und anhaltende Vorteile der neuartigen telomerenzielgerichteten Therapie von MAIA hin.
4. Aktuelle Behandlungen der zweiten Linie für NSCLC dauern normalerweise 3-4 Monate, während THIO-Patienten viel längere Behandlungsdauern zeigen.
Diese Ergebnisse deuten darauf hin, dass THIO das Potenzial hat, eine nachhaltige und wirksame Behandlung für fortgeschrittene NSCLC-Patienten mit Alternativen zu sein.
- Six patients have continued treatment for over 12 months, completing up to 21 cycles
- THIO-cemiplimab combination shows significantly lower toxicity compared to standard treatments
- Treatment longevity suggests safety, efficacy, and ongoing benefits of the novel therapy
- Patients on THIO are showing much longer treatment durations compared to typical second-line NSCLC treatments
- None.
Insights
The latest updates from MAIA Biotechnology regarding their Phase 2 trial of THIO combined with cemiplimab (Libtayo®) in advanced non-small cell lung cancer (NSCLC) patients are promising. The fact that six patients have been on the regimen for over 12 months, with some completing up to 21 cycles, is notable. Typically, patients who are on the second or third line of treatment see a much shorter treatment duration, often only 3-4 months. This extended duration suggests that THIO, in combination with cemiplimab, may offer a more durable and effective treatment alternative for patients with advanced NSCLC, a group that traditionally has very limited options. Additionally, the reported lower toxicity compared to standard treatments is a significant advantage, as it may improve patient compliance and quality of life.
The positive updates from MAIA Biotechnology's Phase 2 trial could significantly impact the company's stock. The extended treatment duration and lower toxicity profile of THIO provide a strong competitive edge over existing therapies. This could lead to increased investor confidence and potential market interest. Investors will be closely monitoring upcoming milestones, including further clinical results and potential FDA interactions. The ongoing trial success enhances MAIA's credibility and may attract strategic partnerships or acquisition interest, further boosting the stock's appeal.
As an oncologist, the results of the Phase 2 trial are very encouraging. The extended treatment duration and significantly lower toxicity are critical factors in providing a better quality of life for patients. For advanced NSCLC patients, who have already failed multiple lines of therapy, having a new treatment option that not only extends survival but does so with fewer side effects is highly valuable. This could potentially change the standard of care for these patients, making THIO combined with cemiplimab a preferred option in clinical practice.
- THIO followed by cemiplimab shown to be well tolerated throughout trial, with far lower toxicity compared to standard of care treatments
- 6 patients on trial regimen for more than 12 months have completed up to 21 cycles, with treatment ongoing
The trial’s therapeutic regimen is cycled every 3 weeks, with THIO 180mg administered in 60mg incremental doses on days 1, 2 and 3, followed by immune activation on day 4 (no dosing), and cemiplimab 350mg administered on day 5. As of the latest clinical cutoff date, June 12, 2024:
- 6 patients remain on treatment following at least 12 months of therapy.
- Treatment with THIO followed by cemiplimab has been well tolerated throughout the trial, with much lower toxicity compared to standard-of care treatments.
- Continuing treatment past 12 months demonstrates safety, efficacy and ongoing benefit from MAIA’s novel telomere targeting NSCLC therapy.
“Our longest treated patient so far has completed 21 cycles of THIO sequenced with a CPI, and 6 patients who have crossed the 12-month survival follow-up are continuing the treatment,” said Vlad Vitoc, M.D., Chairman and Chief Executive Officer of MAIA. “With current therapies, second-line patients’ treatment duration is usually around 3-4 months1 and third-line is even lower than that. It is very encouraging to see that our patients can remain on treatment for much longer. The ongoing benefits of THIO in longer-term patients are particularly notable, signifying THIO’s potential as a durable and efficacious treatment for advanced NSCLC patients faced with limited options.”
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 cemiplimab (Libtayo®) followed by THIO 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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Investor Relations Contact
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Source: MAIA Biotechnology, Inc.
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