Adagene to Host Virtual KOL Event to Discuss Anti-CTLA-4 SAFEbody® ADG126 in Advanced/Metastatic Microsatellite-Stable (MSS) Colorectal Cancer (CRC) on January 25, 2025

SAN DIEGO and SUZHOU, China, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced it will host a virtual key opinion leader (KOL) event on Saturday, January 25, 2025 at 1:00 PM ET, featuring Aurélien Marabelle, MD, PhD (Université Paris-Saclay), Daneng Li, MD (City of Hope), and Marwan Fakih, MD (City of Hope), who will join company management to discuss the unmet need and current treatment landscape for patients with advanced/metastatic microsatellite-stable (MSS) colorectal cancer (CRC) and why CTLA-4 targeting is essential for achieving durable responses in this cold tumor type. To register,

The event will provide a data update on the Phase 1b/2 study of ADG126 (muzastotug) in combination with KEYTRUDA^® (pembrolizumab) in advanced/metastatic MSS CRC being featured in a poster presentation at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium taking place January 23-25 in San Francisco, California. ADG126 is an anti-CTLA-4 SAFEbody that targets a unique CTLA-4 epitope on regulatory T cells (Tregs) within the tumor microenvironment. It combines potent intratumoral Treg depletion via strong ADCC/ADCP with partial CTLA-4 blockade to softly prime effector T cells, delivering powerful anti-tumor activity with reduced toxicity.

A live question and answer session will follow the formal presentations.

About Aurélien Marabelle, MD, PhD

Aurélien Marabelle, MD, PhD is a physician-scientist with expertise in oncology (MD) and immunology (PhD). His clinical practice is dedicated to early phase clinical trials of cancer immunotherapies within the Drug Development Department (DITEP) of Gustave Roussy Cancer Center in France. He leads a translational research laboratory (LRTI) within the INSERM U1015 with a focus on mechanisms of action of immune targeted therapies. He is also the director of the Clinical Investigation Center BIOTHERIS dedicated to intratumoral immunotherapies (INSERM CIC1428). He is a full professor of Clinical Immunology at the University of Paris Saclay. Dr. Marabelle is an active member of ESMO, ASCO, AACR, SITC, EATI and is the current vice-president of the French Society for Cancer Immunotherapies (FITC). He has published more than 280 peer-reviewed publications, has a H-index of 72 and is among the Highly Cited Researcher in the field of Clinical Medicine according to Clarivate/Web of Science.

About Daneng Li, MD

Daneng Li, MD is an Associate Professor in the Department of Medical Oncology at City of Hope Comprehensive Cancer Center in Los Angeles, California. Dr. Li received his medical doctorate from Weill Cornell Medical College in New York, before pursuing an internship and residency in internal medicine at New York-Presbyterian Hospital/Weill Cornell Medical Center. He then completed a hematology/oncology fellowship at Memorial Sloan-Kettering Cancer Center in New York City. Dr. Li’s clinical and academic research is focused on the multidisciplinary approach to the treatment of patients with gastrointestinal malignancies including development of novel therapeutics and incorporation of patient assessment tools to improve patient care. He has presented his research both nationally and internationally.

About Marwan Fakih, MD

Marwan Fakih, MD is Professor in the Department of Medical Oncology and Therapeutics Research at City of Hope and is the Judy and Bernard Briskin Distinguished Director in Clinical Research. Dr. Fakih received his medical degree from the American University of Beirut, Lebanon, in 1992. He subsequently completed a residency in Internal Medicine at the Detroit Medical Center/ Wayne State University (1992-95) and a fellowship in Hematology and Oncology at University of Pittsburgh (1998-2001). After fellowship, he served as an Assistant Professor at University of Pittsburgh (2001-2) before joining Roswell Park Cancer Institute (2002-2011). At Roswell Park, he was promoted to Associate Professor and served as Section Head for Gastrointestinal Cancer Section. In 2011, he joined University of Michigan as Professor of Medicine and Co-Director of the Gastrointestinal Program. Dr. Fakih joined City of Hope in 2012 where he serves as head of the Gastrointestinal Cancers Division and Vice Chair of Clinical Research in the Department of Medical Oncology, co-Director of the GI Program, Medical Director of the Briskin Center for Clinical Research, and the Associate Director for Clinical Sciences. Dr. Fakih’s research focuses on developmental therapeutics, especially in what pertains to the management of colorectal cancer. Over the last 20+ years, he has developed and completed more than 20 investigator-initiated clinical trials and published more than 250 peer reviewed manuscripts. His research has focused on targeted therapies against EGFR, HER-2, KRAS and BRAF mutations. In addition, his research has identified predictive biomarkers of response to immunotherapy both in MSS and MSI-H colorectal cancers, providing clear evidence for the impact of the pattern of metastatic disease on immunotherapy response. He is currently exploring multiple combinations of checkpoint inhibitors in first-line and refractory MSS metastatic colorectal cancer settings in order to overcome existing anti-PD1 resistance. Dr. Fakih is a member of the NCI Colorectal Cancer Task Force and serves as the Co-Chair of the SWOG Colorectal Cancer Subcommittee.

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/multispecific T-cell engagers.

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SAFEbody^® is a registered trademark in the United States, China, Australia, Japan, Singapore, and the European Union.

*KEYTRUDA^® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Safe Harbor Statement

This press release contains forward-looking statements, including statements regarding certain clinical results of ADG126, the potential implications of clinical data for patients, and Adagene’s advancement of, and anticipated preclinical activities, clinical development, regulatory milestones, and commercialization of its product candidates. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to Adagene’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or regulatory approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of Adagene’s drug candidates; Adagene’s ability to achieve commercial success for its drug candidates, if approved; Adagene’s ability to obtain and maintain protection of intellectual property for its technology and drugs; Adagene’s reliance on third parties to conduct drug development, manufacturing and other services; Adagene’s limited operating history and Adagene’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; Adagene’s ability to enter into additional collaboration agreements beyond its existing strategic partnerships or collaborations, and the impact of the COVID-19 pandemic on Adagene’s clinical development, commercial and other operations, as well as those risks more fully discussed in the “Risk Factors” section in Adagene’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Adagene, and Adagene undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

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