Adagene’s ADG126 to be Highlighted in Two Presentations at the 2025 Chinese Society of Clinical Oncology (CSCO) Meeting in Jinan, China
Adagene (Nasdaq: ADAG) announced that its ADG126 (muzastotug) therapy will be featured in two oral presentations at the 2025 CSCO Meeting in Jinan, China from September 10-14. The presentations will highlight ADG126's combination with pembrolizumab in treating microsatellite stable (MSS) colorectal cancer.
The masked anti-CTLA-4 therapy has shown promising results in Phase 1b/2 trials, achieving an objective response rate of ~30% with durable response and over 80% disease control in refractory/resistant MSS CRC patients with no liver metastasis. The treatment demonstrated a median overall survival of 19.4 months in the 10 mg/kg cohorts, while maintaining less than 20% Grade 3 treatment-related adverse events.
Adagene (Nasdaq: ADAG) ha annunciato che la sua terapia ADG126 (muzastotug) sarà presentata in due interventi orali al 2025 CSCO Meeting, che si terrà a Jinan, Cina, dal 10 al 14 settembre. Le comunicazioni illustreranno la combinazione di ADG126 con pembrolizumab nel trattamento del carcinoma colorettale microsatellite stabile (MSS).
La terapia anti‑CTLA‑4 mascherata ha mostrato risultati incoraggianti negli studi di Fase 1b/2, raggiungendo un tasso di risposta obiettiva di circa il 30% con risposte durature e un controllo della malattia superiore all'80% nei pazienti MSS CRC refrattari/resistenti senza metastasi epatiche. Nel cohort da 10 mg/kg il trattamento ha evidenziato una sopravvivenza globale mediana di 19,4 mesi, mantenendo meno del 20% di eventi avversi correlati al trattamento di grado 3.
Adagene (Nasdaq: ADAG) anunció que su terapia ADG126 (muzastotug) será objeto de dos presentaciones orales en el 2025 CSCO Meeting, que se celebrará en Jinan, China, del 10 al 14 de septiembre. Las ponencias destacarán la combinación de ADG126 con pembrolizumab en el tratamiento del cáncer colorrectal con microsatélites estables (MSS).
La terapia anti‑CTLA‑4 enmascarada ha mostrado resultados prometedores en ensayos de fase 1b/2, logrando una tasa de respuesta objetiva de aproximadamente el 30% con respuestas duraderas y un control de la enfermedad superior al 80% en pacientes con MSS CRC refractarios/resistentes sin metástasis hepáticas. En las cohortes de 10 mg/kg, el tratamiento mostró una supervivencia global mediana de 19,4 meses, con menos del 20% de eventos adversos relacionados con el tratamiento de grado 3.
Adagene (Nasdaq: ADAG)는 자사 치료제 ADG126(뮤자스토투그)이 9월 10일부터 14일까지 중국 지난에서 열리는 2025 CSCO 학술대회에서 두 건의 구두 발표로 소개될 예정이라고 발표했습니다. 발표에서는 ADG126과 펨브롤리주맙의 병용이 마이크로새틀라이트 안정형(MSS) 대장암 치료에 미치는 내용을 다룹니다.
마스킹된 항‑CTLA‑4 치료제는 1b/2상 시험에서 유망한 결과를 보였으며, 전이성 간 병변이 없는 난치/저항성 MSS 대장암 환자에서 약 30%의 객관적 반응률을 달성했고 반응이 지속되며 80% 이상 질병 조절을 보였습니다. 10 mg/kg 코호트에서 치료의 중앙 전체 생존기간은 19.4개월로 나타났으며, 치료 관련 3등급 이상 이상반응 비율은 20% 미만을 유지했습니다.
Adagene (Nasdaq: ADAG) a annoncé que son traitement ADG126 (muzastotug) fera l'objet de deux présentations orales au 2025 CSCO Meeting à Jinan, Chine, du 10 au 14 septembre. Les communications mettront en évidence la combinaison d'ADG126 avec le pembrolizumab pour le traitement du cancer colorectal microsatellites stables (MSS).
Le traitement anti‑CTLA‑4 masqué a montré des résultats prometteurs dans les essais de phase 1b/2, atteignant un taux de réponse objective d'environ 30% avec des réponses durables et un contrôle de la maladie supérieur à 80% chez des patients MSS CRC réfractaires/résistants sans métastases hépatiques. Dans les cohortes à 10 mg/kg, le traitement a démontré une survie globale médiane de 19,4 mois, tout en maintenant moins de 20% d'événements indésirables liés au traitement de grade 3.
Adagene (Nasdaq: ADAG) gab bekannt, dass seine Therapie ADG126 (muzastotug) in zwei mündlichen Vorträgen auf dem 2025 CSCO Meeting in Jinan, China, vom 10. bis 14. September vorgestellt wird. Die Präsentationen beleuchten die Kombination von ADG126 mit Pembrolizumab zur Behandlung von kolorektalem Krebs mit mikrosatellitenstabiler (MSS) Tumorbiologie.
Die maskierte Anti‑CTLA‑4‑Therapie zeigte in Phase‑1b/2‑Studien vielversprechende Ergebnisse und erreichte eine objektive Ansprechrate von etwa 30% mit anhaltenden Ansprechen sowie einem über 80%igen Krankheitskontrolle bei refraktären/resistenten MSS‑CRC‑Patienten ohne Lebermetastasen. In den 10 mg/kg‑Kohorten betrug das mediane Gesamtüberleben 19,4 Monate, bei weniger als 20% behandlungsbedingten Nebenwirkungen Grad 3.
- Achieved ~30% objective response rate (ORR) in MSS CRC patients
- Demonstrated over 80% disease control rate in patients with no liver metastasis
- Showed promising median overall survival of 19.4 months in 10 mg/kg cohorts
- Maintained low adverse event rate with less than 20% Grade 3 TRAEs
- None.
Insights
Adagene's ADG126 shows promising ~30% response rate in difficult-to-treat MSS colorectal cancer with 19.4 month survival benefit.
The upcoming presentation of ADG126 (muzastotug) data at CSCO represents a significant milestone in immunotherapy for colorectal cancer. The masked anti-CTLA-4 antibody approach is particularly notable because microsatellite stable (MSS) colorectal cancer has historically been considered a "cold tumor" resistant to immunotherapeutic approaches.
The reported ~30% objective response rate with durable response duration and >80% disease control in MSS CRC patients without liver metastasis is remarkable compared to historical immunotherapy performance in this population. Traditional immunotherapies typically show minimal effectiveness in MSS CRC, which represents approximately 85% of colorectal cancer cases.
Most impressive is the 19.4-month median overall survival demonstrated in the 10 mg/kg cohort. For context, refractory MSS CRC patients typically have survival measured in single-digit months with standard therapies.
The safety profile enabling higher, more frequent dosing of anti-CTLA-4 therapy is critical, as traditional CTLA-4 inhibitors like ipilimumab are often limited by toxicity concerns. The reported <20% Grade 3 treatment-related adverse events suggests a meaningful improvement in the therapeutic window.
ADG126's mechanism targeting intratumoral Treg depletion addresses a key immunosuppressive barrier in cold tumors. If these results are confirmed in larger studies, this could represent a breakthrough for the substantial population of MSS CRC patients who currently lack effective immunotherapy options.
SAN DIEGO and SUZHOU, China, Sept. 05, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene or the Company”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced that ADG126 will be highlighted in two oral presentations at this year’s CSCO Meeting, taking place September 10-14 in Jinan, China.
Harnessing the Power of Masked CTLA-4 Blockade: Updated ADG126-P001 Phase 1b/2
Results of ADG126 + Pembrolizumab in Advanced MSS CRC
| Presenter: | Dr. Xu Ruihua, Professor and President of Sun Yat-sen University Cancer Center and Chairman of the Chinese Society of Clinical Oncology (CSCO) | |
| Date and Time: | Thursday, September 11 at 14:45-15:00 CST (China Standard Time) | |
| Location: | Jinan, China | |
Immunotherapy for mCRC
| Presenter: | Dr. Heinz-Josef Lenz, Chair of the GI Oncology Program and co-director of the Colorectal Center at University of Southern California’s Keck School of Medicine | |
| Date and Time: | Thursday, September 11 at 14:00-14:25 CST (China Standard Time) | |
| Location: | Jinan, China | |
“Microsatellite stable (MSS) colorectal cancer (CRC) remains one of the cold tumors where effective immunotherapy still remains elusive and I believe anti-CTLA-4 therapy should be part of the solution,” said Dr. Lenz. “By enabling CTLA-4-mediated intratumoral Treg depletion, the masked anti-CTLA-4 ADG126 (muzastotug) in combination with pembrolizumab, has shown compelling results in Phase 1b/2 dose expansion in MSS CRC. The safety profile of ADG126 allows higher, more frequent and repeat doses of anti-CTLA-4 in combination with anti-PD-1 therapy, and has shown promise to significantly improve longer-term survival benefit for MSS CRC patients. At CSCO, I will review the essential role of anti-CTLA-4 therapy in metastatic CRC including the approved Nivolumab+Ipilimumab in MSI-H CRC as well as the next generation Treg depleting anti-CTLA-4 in treating cold tumors like MSS CRC.”
ADG126 is the first masked anti-CTLA-4 in combination with an approved anti-PD-1 therapy to achieve an objective response rate (ORR) of ~
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/multi-specific 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.
Investor Contacts:
Raymond Tam
raymond_tam@adagene.com
Corey Davis
LifeSci Advisors
cdavis@lifesciadvisors.com
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