MAIA Biotechnology Announces Expansion of Clinical Supply Agreement with Regeneron for Phase 2 Trial in Non-Small Cell Lung Cancer
MAIA Biotechnology has expanded its 2021 clinical supply agreement with Regeneron for the Phase 2 THIO-101 trial. The expansion will evaluate THIO's efficacy when administered sequentially with Libtayo® (cemiplimab) in third-line non-small cell lung cancer (NSCLC) patients who were resistant to previous checkpoint inhibitor treatments and chemotherapy. Under the amended agreement, MAIA remains the trial sponsor while Regeneron will supply Libtayo® for all patients. The trial has shown promising results in disease control, progression-free survival, and overall response rates. MAIA plans to begin new patient enrollment soon and is exploring potential accelerated approval opportunities in the United States.
MAIA Biotechnology ha ampliato l'accordo di fornitura clinica del 2021 con Regeneron per la fase 2 della sperimentazione THIO-101. L'ampliamento valuterà l'efficacia di THIO quando somministrato in sequenza con Libtayo® (cemiplimab) in pazienti con carcinoma polmonare non a piccole cellule (NSCLC) di terza linea che sono risultati resistenti ai precedenti trattamenti con inibitori dei checkpoint e alla chemioterapia. Ai sensi dell'accordo modificato, MAIA rimane lo sponsor dello studio mentre Regeneron fornirà Libtayo® per tutti i pazienti. Lo studio ha mostrato risultati promettenti nel controllo della malattia, nella sopravvivenza libera da progressione e nei tassi di risposta globale. MAIA prevede di iniziare presto l'arruolamento di nuovi pazienti e sta esplorando potenziali opportunità di approvazione accelerata negli Stati Uniti.
MAIA Biotechnology ha ampliado su acuerdo de suministro clínico de 2021 con Regeneron para el ensayo de fase 2 THIO-101. La expansión evaluará la eficacia de THIO cuando se administre secuencialmente con Libtayo® (cemiplimab) en pacientes con cáncer de pulmón de células no pequeñas (NSCLC) en tercera línea que fueron resistentes a tratamientos anteriores con inhibidores de puntos de control y quimioterapia. Según el acuerdo modificado, MAIA sigue siendo el patrocinador del ensayo mientras que Regeneron suministrará Libtayo® para todos los pacientes. El ensayo ha mostrado resultados prometedores en el control de la enfermedad, la supervivencia libre de progresión y las tasas de respuesta general. MAIA planea comenzar pronto la inscripción de nuevos pacientes y está explorando posibles oportunidades de aprobación acelerada en los Estados Unidos.
MAIA Biotechnology는 2021년 Regeneron과의 임상 공급 계약을 확대하여 THIO-101 2상 시험을 진행하고 있습니다. 이 확대는 이전의 체크포인트 억제제 치료와 화학요법에 저항성이 있는 3차 비소세포 폐암 (NSCLC) 환자에게 Libtayo®(cemiplimab)와 순차적으로 THIO의 효능을 평가할 것입니다. 수정된 계약에 따라 MAIA는 시험의 스폰서로 남아 있으며, Regeneron은 모든 환자를 위해 Libtayo®를 공급할 것입니다. 이 시험은 질병 조절, 무진행 생존 및 전반적 반응률에서 유망한 결과를 보여주었습니다. MAIA는 곧 새로운 환자 등록을 시작할 계획이며 미국에서의 가속 승인 기회를 탐색하고 있습니다.
MAIA Biotechnology a élargi son accord de fourniture clinique de 2021 avec Regeneron pour l'essai THIO-101 de phase 2. L'extension évaluera l'efficacité de THIO lorsqu'il est administré séquentiellement avec Libtayo® (cemiplimab) chez des patients atteints de cancer du poumon non à petites cellules (NSCLC) résistants aux traitements antérieurs par inhibiteurs de points de contrôle et à la chimiothérapie. Selon l'accord modifié, MAIA reste le sponsor de l'essai tandis que Regeneron fournira Libtayo® pour tous les patients. L'essai a montré des résultats prometteurs en matière de contrôle de la maladie, de survie sans progression et de taux de réponse globaux. MAIA prévoit de commencer bientôt le recrutement de nouveaux patients et explore les opportunités potentielles d'approbation accélérée aux États-Unis.
MAIA Biotechnology hat seine klinische Liefervereinbarung von 2021 mit Regeneron für die Phase-2-Studie THIO-101 erweitert. Die Erweiterung wird die Wirksamkeit von THIO prüfen, wenn es sequenziell mit Libtayo® (cemiplimab) bei Patienten mit nicht-kleinzelligem Lungenkrebs (NSCLC) in dritter Linie, die auf vorherige Behandlungen mit Checkpoint-Hemmern und Chemotherapie resistent waren, verabreicht wird. Nach der geänderten Vereinbarung bleibt MAIA der Sponsor der Studie, während Regeneron Libtayo® für alle Patienten bereitstellen wird. Die Studie hat vielversprechende Ergebnisse in Bezug auf die Krankheitskontrolle, das progressionsfreie Überleben und die Gesamtraten der Ansprechreaktionen gezeigt. MAIA plant, bald mit der Rekrutierung neuer Patienten zu beginnen und prüft mögliche Optionen für eine beschleunigte Zulassung in den Vereinigten Staaten.
- Trial shows favorable disease control, progression-free survival, and overall response rates
- Potential opportunity for accelerated FDA approval based on trial outcomes
- Secured continued supply of Libtayo® from Regeneron for expanded trial
- None.
Insights
The expansion of the clinical supply agreement with Regeneron marks a significant milestone for MAIA's THIO-101 trial. Early signs from the study show promising disease control, progression-free survival and overall response rates in third-line NSCLC patients who previously failed both checkpoint inhibitor and chemotherapy treatments - a notoriously difficult-to-treat population.
The continuation of Regeneron's Libtayo® supply support suggests confidence in the trial's preliminary results. The mention of potential accelerated approval pathway is particularly noteworthy, as it could significantly shorten the time to market if the expanded trial data remains positive. However, investors should note that success in early phases doesn't guarantee final approval and the company's small market cap of
- Expansion of 2021 clinical supply agreement for Phase 2 clinical trial
- Next stage of trial to further assess efficacy of THIO in third line non-small cell lung cancer patients
- MAIA expects new patient enrollment to begin soon in the expansion of THIO-101
The original 2021 agreement between MAIA and Regeneron was designed to supply the original THIO-101 trial through the dose selection and safety evaluation process. The THIO-101 trial has been amended and expanded to further evaluate efficacy at the target dose and target third line patient population.
"In keeping with our clinical strategy for THIO, we look forward to continuing our collaboration with Regeneron to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. So far, THIO-101 has demonstrated favorable disease control, progression free survival, overall response rates, and we remain on track to achieve our overall survival goals,” said MAIA Chairman and Chief Executive Officer Vlad Vitoc, M.D.
Under terms of the amended clinical supply agreement, MAIA continues to sponsor THIO-101 and Regeneron will provide Libtayo® for the treatment of all patients in the trial including the additional patients in the THIO 101 expansion. MAIA holds an exclusive worldwide patent license to develop and commercialize THIO.
MAIA expects to start enrolling new patients in the expansion of THIO-101 in the near future.
The company continues to evaluate its regulatory strategy and believes that there could be an opportunity for an accelerated approval in
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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