Adagene’s ADG126 to be Highlighted in Two Presentations at the 2025 Chinese Society of Clinical Oncology (CSCO) Meeting in Jinan, China

Rhea-AI Summary

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.

Positive

• 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

Negative

• None.

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 ~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 Tam
raymond_tam@adagene.com

Corey Davis
LifeSci Advisors
cdavis@lifesciadvisors.com

FAQ

What are the key clinical results of Adagene's ADG126 in MSS colorectal cancer?

ADG126 combined with pembrolizumab achieved a ~30% objective response rate, over 80% disease control in MSS CRC patients with no liver metastasis, and showed 19.4 months median overall survival in 10 mg/kg cohorts.

When and where will Adagene (ADAG) present ADG126 data at CSCO 2025?

Adagene will present ADG126 data in two presentations on September 11, 2025 at the CSCO Meeting in Jinan, China, with sessions at 14:00 and 14:45 CST.

What is the safety profile of Adagene's ADG126 treatment?

ADG126 maintained a favorable safety profile with less than 20% Grade 3 treatment-related adverse events, allowing for higher, more frequent, and repeat doses in combination with anti-PD-1 therapy.

Who are the key presenters for ADG126 at CSCO 2025?

The presenters are Dr. Xu Ruihua, President of Sun Yat-sen University Cancer Center and CSCO Chairman, and Dr. Heinz-Josef Lenz from USC's Keck School of Medicine.