Adagene's ADG126 to be Highlighted in Two Presentations at the 2025 Chinese Society of Clinical Oncology (CSCO) Meeting in Jinan, China
MWN-AI** Summary
Adagene Inc. (Nasdaq: ADAG) is set to showcase its promising clinical antibody therapy, ADG126, at the upcoming 2025 Chinese Society of Clinical Oncology (CSCO) Meeting in Jinan, China, from September 10-14. The drug will be featured in two pivotal oral presentations, highlighting its potential in treating microsatellite stable (MSS) colorectal cancer (CRC) through a masked anti-CTLA-4 blockade mechanism.
One presentation will focus on the updated results from the ADG126-P001 Phase 1b/2 study, which evaluates the combination of ADG126 and pembrolizumab. Dr. Xu Ruihua, a noted figure in oncology, will discuss the safety and efficacy of this treatment, particularly its ability to deplete regulatory T cells intratumorally, thus enhancing immune response against tumors. Another key presentation by Dr. Heinz-Josef Lenz will provide insights into immunotherapy options for advanced MSS CRC, emphasizing the necessity for anti-CTLA-4 therapies in addressing this historically challenging area for immunotherapy.
Notably, ADG126 has shown an objective response rate (ORR) of approximately 30% in patients with refractory MSS CRC, achieving over 80% disease control without significant adverse effects. The therapy’s safety profile allows for higher and more frequent dosing schedules, which may translate to improved long-term survival benefits, as indicated by a median overall survival (OS) of 19.4 months in certain cohorts.
Adagene's innovative SAFEbody technology is fundamental to ADG126’s design, providing a targeted approach to immunotherapy while mitigating on-target off-tumor toxicity. As Adagene continues to advance its clinical programs, the outcomes presented at CSCO could pave the way for new treatment paradigms in the management of CRC.
MWN-AI** Analysis
As Adagene Inc. (Nasdaq: ADAG) prepares to showcase its ADG126 at the 2025 Chinese Society of Clinical Oncology (CSCO) Meeting, investors should closely monitor developments. With dual presentations highlighting promising Phase 1b/2 results, the potential for ADG126 to enhance treatment options for microsatellite stable (MSS) colorectal cancer (CRC) could drive significant interest and investment.
Adagene's unique approach with its masked anti-CTLA-4 therapy demonstrates a commitment to addressing serious challenges in immunotherapy. The compelling 30% objective response rate and over 80% disease control in a refractory MSS CRC cohort offer a favorable profile compared to existing treatments. Furthermore, the ability to deliver higher and more frequent doses with a manageable safety profile of <20% Grade 3 treatment-related adverse events positions ADG126 as a competitive alternative that could boost longer-term survival rates.
With key opinion leaders like Dr. Xu Ruihua and Dr. Heinz-Josef Lenz presenting at CSCO, the coverage and analysis generated are likely to attract the attention of both clinicians and investors. This could lead to heightened visibility and potentially influence market sentiment positively.
Investors should also consider that Adagene's SMART technology enhances the safety and efficacy of immunotherapies. Such innovations could establish a solid market position and partnerships with larger pharmaceutical companies seeking cutting-edge solutions.
Given the momentum heading into CSCO, coupled with the anticipated clinical results and expert endorsement, there is potential for ADAG to see upward price movement. On the other hand, investors should remain cautious of biopharma's inherent volatility, particularly before and after major conference presentations. An informed approach that weighs both the opportunities and risks will be crucial for stakeholders as developments unfold.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
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 .
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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
FAQ**
How might Adagene Inc. (ADAG) expand its market presence in both San Diego and Suzhou given the promising results of ADG126 in MSS CRC highlighted at the CSCO Meeting in China?
In what ways can the collaboration between Adagene Inc. (ADAG) and local research institutions in San Diego and Suzhou enhance the development of its SAFEbody technology?
Considering the advancements presented by Adagene Inc. (ADAG), how do the clinical outcomes for ADG126 influence investment strategies in biotech firms based in San Diego and China?
What are the key similarities and differences between the regulatory environments in San Diego and Suzhou that could impact the clinical trials conducted by Adagene Inc. (ADAG) for its novel therapies?
**MWN-AI FAQ is based on asking OpenAI questions about Adagene Inc. (NASDAQ: ADAG).
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