SAN DIEGO and SUZHOU, China, Sept. 05, 2025 – Adagene Inc. (Nasdaq: ADAG), referred to as “Adagene” or “the Company,” a biotechnology firm dedicated to transforming the discovery and development of novel antibody-based therapies, announced today that its compound, ADG126, will be featured in two oral presentations at the upcoming CSCO Meeting, scheduled from September 10-14 in Jinan, China.
Exploring the Efficacy of Masked CTLA-4 Blockade: Updated ADG126-P001 Phase 1b/2 Findings for ADG126 + Pembrolizumab in Advanced MSS CRC
| Presented by: | Dr. Xu Ruihua, Professor and President of Sun Yat-sen University Cancer Center and Chairman of the Chinese Society of Clinical Oncology (CSCO) | |
| Scheduled for: | Thursday, September 11, from 14:45-15:00 CST (China Standard Time) | |
| Venue: | Jinan, China | |
Immunotherapeutic Strategies for mCRC
| Presented by: | Dr. Heinz-Josef Lenz, Chair of the GI Oncology Program and Co-director of the Colorectal Center at the University of Southern California’s Keck School of Medicine | |
| Scheduled for: | Thursday, September 11, from 14:00-14:25 CST (China Standard Time) | |
| Venue: | Jinan, China | |
“Microsatellite stable (MSS) colorectal cancer (CRC) continues to be a challenging ‘cold tumor’ where successful immunotherapy is yet to be established, and I am convinced that anti-CTLA-4 therapy will play a crucial role in addressing this,” stated Dr. Lenz. “By facilitating CTLA-4-mediated intratumoral Treg depletion, the masked anti-CTLA-4 ADG126 (muzastotug), when combined with pembrolizumab, has demonstrated promising results in the Phase 1b/2 dose expansion study for MSS CRC. The favorable safety profile of ADG126 permits higher, more frequent, and repeated doses of anti-CTLA-4 alongside anti-PD-1 therapy, showing potential to significantly enhance long-term survival for MSS CRC patients. At CSCO, I will discuss the vital role of anti-CTLA-4 therapy in metastatic CRC, including the approved Nivolumab+Ipilimumab regimen for MSI-H CRC, as well as the next-generation Treg-depleting anti-CTLA-4 in treating cold tumors like MSS CRC.”
ADG126 is notable as the first masked anti-CTLA-4 in combination with an approved anti-PD-1 therapy to achieve an objective response rate (ORR) of approximately 30% with a durable duration of response (DoR) and over 80% disease control in patients with refractory/resistant MSS CRC without liver metastasis (NLM), while maintaining Grade 3 treatment-related adverse events (TRAEs) at less than 20%. These positive ORR and DoR outcomes are anticipated to translate into overall survival benefits, evidenced by the 10 mg/kg cohorts showing a median OS of 19.4 months.
About Adagene
Adagene Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage biotechnology company committed to revolutionizing the discovery and development of novel antibody-based cancer immunotherapies. Adagene employs a combination of computational biology and artificial intelligence to engineer innovative antibodies designed to address significant unmet patient needs globally. The company has established strategic collaborations with leading global partners, leveraging its SAFEbody® precision masking technology through multiple cutting-edge scientific approaches.
Empowered by its proprietary Dynamic Precision Library (DPL) platform, which integrates NEObody™, SAFEbody, and POWERbody™ technologies, Adagene boasts a highly differentiated pipeline of novel immunotherapy programs. The company’s SAFEbody technology is engineered to mitigate safety and tolerability concerns associated with many antibody therapeutics by utilizing precision masking technology to shield the biologic therapy’s binding domain. This mechanism enables tumor-specific targeting of antibodies within the tumor microenvironment upon activation, thereby minimizing undesirable on-target off-tumor toxicity in healthy tissues.
Adagene’s lead clinical candidate, ADG126 (muzastotug), is a masked anti-CTLA-4 SAFEbody that targets a distinct epitope of CTLA-4 within regulatory T cells (Tregs) in the tumor microenvironment. ADG126 is currently undergoing Phase 1b/2 clinical studies in combination with anti-PD-1 therapy, with a particular focus on Metastatic Microsatellite-stable (MSS) Colorectal Cancer (CRC). Validated by ongoing clinical research, the SAFEbody platform is adaptable to a broad spectrum of antibody-based therapeutic modalities, including Fc-empowered antibodies, antibody-drug conjugates, and bi/multi-specific T-cell engagers.
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