Muzastotug

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/2Results 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 MedicineDate 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 ~30% with durable duration of response (DoR) and over 80% disease control in refractory/resistant MSS CRC with no liver metastasis (NLM), while maintaining less than 20% of Grade 3 treatment-related adverse events (TRAEs). These ORR and DoR outcomes are likely to translate into overall survival benefit, as demonstrated by the 10 mg/kg cohorts exhibiting a median OS of 19.4 months. 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. Follow Adagene on WeChat, LinkedIn and X. SAFEbody® is a registered trademark in the United States, China, Australia, Japan, Singapore, and the European Union. Investor Contacts: Raymond Tamraymond_tam@adagene.com Corey DavisLifeSci Advisorscdavis@lifesciadvisors.com