Adagene to Announce Updated Data from Phase 1b/2 Study of Muzastotug in Combination with KEYTRUDA® (pembrolizumab) in Colorectal Cancer at ASCO Gastrointestinal Cancers Symposium
Adagene (NASDAQ: ADAG) will present updated clinical data from its Phase 1b/2 study of ADG126 (muzastotug) in combination with KEYTRUDA® for microsatellite stable colorectal cancer (MSS CRC) at the ASCO Gastrointestinal Cancers Symposium. The presentation will take place on January 25, 2025, in San Francisco.
The study previously showed efficacy at 10 mg/kg Q3W dose, and new data will include results from a 20 mg/kg loading dose followed by 10 mg/kg Q3W in combination with pembrolizumab. The company will also host a virtual KOL event featuring experts from Université Paris-Saclay and City of Hope to discuss the unmet need in MSS CRC treatment and the importance of CTLA-4 targeting for achieving durable responses in this cold tumor type.
Adagene (NASDAQ: ADAG) presenterà dati clinici aggiornati dal suo studio di Fase 1b/2 su ADG126 (muzastotug) in combinazione con KEYTRUDA® per il cancro colorettale microsatellite stabile (MSS CRC) al Simposio ASCO sui Tumori Gastrointestinali. La presentazione si svolgerà il 25 gennaio 2025, a San Francisco.
Lo studio ha già mostrato efficacia con una dose di 10 mg/kg ogni tre settimane, e i nuovi dati includeranno risultati da una dose di carico di 20 mg/kg seguita da 10 mg/kg ogni tre settimane in combinazione con pembrolizumab. L'azienda ospiterà anche un evento virtuale con esperti dell'Université Paris-Saclay e della City of Hope per discutere della necessità insoddisfatta nel trattamento del MSS CRC e dell'importanza del targeting di CTLA-4 per ottenere risposte durature in questo tipo di tumore freddo.
Adagene (NASDAQ: ADAG) presentará datos clínicos actualizados de su estudio de fase 1b/2 de ADG126 (muzastotug) en combinación con KEYTRUDA® para el cáncer colorrectal estable en microsatélites (MSS CRC) en el Simposio ASCO sobre Cánceres Gastrointestinales. La presentación tendrá lugar el 25 de enero de 2025, en San Francisco.
El estudio mostró previamente eficacia con una dosis de 10 mg/kg cada tres semanas, y los nuevos datos incluirán resultados de una dosis de carga de 20 mg/kg seguida de 10 mg/kg cada tres semanas en combinación con pembrolizumab. La empresa también organizará un evento virtual con expertos de la Université Paris-Saclay y City of Hope para discutir la necesidad no atendida en el tratamiento de MSS CRC y la importancia de la medición de CTLA-4 para lograr respuestas duraderas en este tipo de tumor frío.
Adagene (NASDAQ: ADAG)는 ASCO 위장관 암 심포지엄에서 KEYTRUDA®와 함께한 ADG126(무자스토투그)의 1b/2상 연구에서 업데이트된 임상 데이터를 발표할 예정입니다. 발표는 2025년 1월 25일 샌프란시스코에서 진행됩니다.
이 연구는 10 mg/kg의 3주마다 투여하는 용량에서 효능을 보여주었으며, 새로운 데이터는 20 mg/kg의 로딩 용량과 그 뒤에 10 mg/kg의 3주마다 투여하는 결과를 포함할 것입니다. 회사는 또한 Université Paris-Saclay와 City of Hope의 전문가들이 참여하는 가상 KOL 이벤트를 개최하여 MSS CRC 치료의 충족되지 않은 필요성과 이 차가운 종양 유형에서 지속적인 반응을 달성하기 위한 CTLA-4 표적의 중요성에 대해 논의할 것입니다.
Adagene (NASDAQ: ADAG) présentera des données cliniques mises à jour de son étude de phase 1b/2 sur ADG126 (muzastotug) en combinaison avec KEYTRUDA® pour le cancer colorectal stable en microsatellites (MSS CRC) lors du symposium ASCO sur les cancers gastro-intestinaux. La présentation aura lieu le 25 janvier 2025 à San Francisco.
L'étude a montré précédemment une efficacité à une dose de 10 mg/kg toutes les trois semaines, et les nouvelles données incluront les résultats d'une dose de chargement de 20 mg/kg suivie par 10 mg/kg toutes les trois semaines en combinaison avec le pembrolizumab. L'entreprise organisera également un événement virtuel KOL avec des experts de l'Université Paris-Saclay et de la City of Hope pour discuter des besoins non satisfaits dans le traitement du MSS CRC et de l'importance du ciblage de la CTLA-4 pour obtenir des réponses durables dans ce type de tumeur froide.
Adagene (NASDAQ: ADAG) wird aktualisierte klinische Daten aus seiner Phase 1b/2-Studie zu ADG126 (Muzastotug) in Kombination mit KEYTRUDA® für stabilen Mikrosatelliten-Krebs (MSS CRC) auf dem ASCO-Gastrointestinal-Krebs-Symposium präsentieren. Die Präsentation findet am 25. Januar 2025 in San Francisco statt.
Die Studie zeigte zuvor eine Wirksamkeit mit einer Dosis von 10 mg/kg alle drei Wochen, und die neuen Daten werden Ergebnisse einer Lade-Dosis von 20 mg/kg enthalten, gefolgt von 10 mg/kg alle drei Wochen in Kombination mit Pembrolizumab. Das Unternehmen wird auch eine virtuelle KOL-Veranstaltung mit Experten der Université Paris-Saclay und der City of Hope ausrichten, um über den ungedeckten Bedarf in der Behandlung von MSS CRC und die Bedeutung der CTLA-4-Targetierung zu sprechen, um dauerhafte Reaktionen bei dieser kalten Tumorart zu erzielen.
- Previous demonstration of efficacy at 10 mg/kg Q3W dose in Phase 1b/2 trial
- Collaboration with Merck for combination therapy with KEYTRUDA®
- Expansion of dosing regimen to include 20 mg/kg loading dose
- None.
SAN DIEGO and SUZHOU, China, Jan. 21, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced it will share updated clinical data from ADG126 in microsatellite stable colorectal cancer (MSS CRC) at the ASCO Gastrointestinal (GI) Cancers Symposium in San Francisco, CA on Saturday, January 25, 2025.
This Phase 1b/2, open-label, multicenter dose escalation and expansion combination study of ADG126 in combination with Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab; 200 mg, Q3W) in MSS CRC previously demonstrated efficacy at the 10 mg/kg Q3W dose.
New data will include initial results from the 20 mg/kg loading dose followed by 10 mg/kg Q3W in combination with pembrolizumab.
ASCO-GI Poster Presentation Details
Title: Update of phase 1b/2 study of muzastotug (ADG126, an anti-CTLA-4 SAFEbody) in combination with pembrolizumab in advanced/metastatic MSS CRC
Date: Saturday, January 25
Time: 7:00 a.m. – 7:55 a.m. Pacific Time
Onsite Location: Moscone West, San Francisco
Abstract Number: 193
Poster Board: H5
Following the presentation, the poster will also be available on the Publications page of the Company’s website.
Virtual KOL Event to Discuss Anti-CTLA-4 SAFEbody® ADG126 in Advanced/Metastatic Microsatellite-Stable (MSS) Colorectal Cancer (CRC) on January 25, 2025
Company will host a virtual key opinion leader (KOL) event on Saturday, January 25, 2025 at 1:00 PM ET, featuring Aurélien Marabelle, MD, PhD (Université Paris-Saclay), Daneng Li, MD (City of Hope), and Marwan Fakih, MD (City of Hope), who will join company management to discuss the unmet need and current treatment landscape for patients with advanced/metastatic microsatellite-stable (MSS) colorectal cancer (CRC) and why CTLA-4 targeting is essential for achieving durable responses in this cold tumor type. To register, click here.
About Adagene
Adagene Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage biotechnology company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational biology and artificial intelligence to design novel antibodies that address globally unmet patient needs. The company has forged strategic collaborations with reputable global partners that leverage its SAFEbody® precision masking technology in multiple approaches at the vanguard of science.
Powered by its proprietary Dynamic Precision Library (DPL) platform, composed of NEObody™, SAFEbody, and POWERbody™ technologies, Adagene’s highly differentiated pipeline features novel immunotherapy programs. The company’s SAFEbody technology is designed to address safety and tolerability challenges associated with many antibody therapeutics by using precision masking technology to shield the binding domain of the biologic therapy. Through activation in the tumor microenvironment, this allows for tumor-specific targeting of antibodies in tumor microenvironment, while minimizing on-target off-tumor toxicity in healthy tissues.
Adagene’s lead clinical program, ADG126 (muzastotug), is a masked, anti-CTLA-4 SAFEbody that targets a unique epitope of CTLA-4 in regulatory T cells (Tregs) in the tumor microenvironment. ADG126 is currently in phase 1b/2 clinical studies in combination with anti-PD-1 therapy, particularly focused on Metastatic Microsatellite-stable (MSS) Colorectal Cancer (CRC). Validated by ongoing clinical research, the SAFEbody platform can be applied to a wide variety of antibody-based therapeutic modalities, including Fc empowered antibodies, antibody-drug conjugates, and bi/multispecific T-cell engagers.
For more information, please visit: https://investor.adagene.com.
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SAFEbody® is a registered trademark in the United States, China, Australia, Japan, Singapore, and the European Union.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Safe Harbor Statement
This press release contains forward-looking statements, including statements regarding certain clinical results of ADG126, the potential implications of clinical data for patients, and Adagene’s advancement of, and anticipated preclinical activities, clinical development, regulatory milestones, and commercialization of its product candidates. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to Adagene’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or regulatory approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of Adagene’s drug candidates; Adagene’s ability to achieve commercial success for its drug candidates, if approved; Adagene’s ability to obtain and maintain protection of intellectual property for its technology and drugs; Adagene’s reliance on third parties to conduct drug development, manufacturing and other services; Adagene’s limited operating history and Adagene’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; Adagene’s ability to enter into additional collaboration agreements beyond its existing strategic partnerships or collaborations, and the impact of the COVID-19 pandemic on Adagene’s clinical development, commercial and other operations, as well as those risks more fully discussed in the “Risk Factors” section in Adagene’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Adagene, and Adagene undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.
Investor Contact:
Bruce Mackle
LifeSci Advisors
bmackle@lifesciadvisors.com
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