– Patient enrollment is slated to commence in April, with the primary completion of the study anticipated by mid-2027 –

– The primary objective of the study is to assess the rate of major pathological response –

SAN DIEGO and SUZHOU, China, Feb. 27, 2025 — Adagene Inc. (Nasdaq: ADAG), a company focused on innovative antibody-based therapies, has announced an investigator-initiated Phase 2 trial of ADG126 as a neoadjuvant treatment for patients with stage II or III colorectal cancer.

The study (NCT06846268), spearheaded by Dr. Yong Wei Peng, Senior Consultant at the National University Cancer Institute, Singapore, is expected to begin recruiting patients in April 2025. Participants will receive high doses of ADG126 combined with KEYTRUDA® before undergoing surgery. The trial’s main goal is to determine the Major Pathologic Response (MPR) rate, defined as ≤10% of the initial tumor remaining in the surgical sample, which will be evaluated in up to 20 patients. Secondary goals include complete pathological response, disease-free survival, and safety/tolerability. The study will also examine how neoadjuvant ADG126 and pembrolizumab affect the tumor microenvironment’s immune profile and the pharmacokinetic profile of ADG126 in tumor tissues to understand the compound’s mechanism of action and therapeutic index.

According to Peter Luo, Chairman, CEO, and President of R&D at Adagene, “This neoadjuvant study builds on the encouraging efficacy and safety seen with ADG126 and pembrolizumab in patients with late-stage MSS CRC. We believe that using immunotherapy in the neoadjuvant setting is promising. By combining CTLA-4-mediated T regulatory cell depletion with anti-PD-1 to reactivate T cells, this approach can restore anti-tumor immunity, giving patients a potential advantage for long-term clinical benefits.”

About Adagene
Adagene Inc. (Nasdaq: ADAG) is a clinical-stage biotech company dedicated to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene utilizes computational biology and AI to create novel antibodies for unmet patient needs. The company has collaborations with global partners, leveraging its SAFEbody® precision masking technology.

Adagene’s pipeline, driven by its Dynamic Precision Library (DPL) platform with NEObody™, SAFEbody, and POWERbody™ technologies, features novel immunotherapy programs. The SAFEbody technology is designed to improve the safety and tolerability of antibody therapeutics by masking the binding domain of the biologic therapy. Activation in the tumor microenvironment allows for tumor-specific targeting, minimizing off-target toxicity.

Adagene’s lead program, ADG126 (muzastotug), is a masked, anti-CTLA-4 SAFEbody targeting a unique CTLA-4 epitope in regulatory T cells (Tregs) within the tumor microenvironment. ADG126 is currently in phase 1b/2 clinical studies with anti-PD-1 therapy, primarily in Metastatic Microsatellite-stable (MSS) Colorectal Cancer (CRC). The SAFEbody platform can be applied to various 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 regarding clinical results of ADG126, the potential impact of clinical data, and Adagene’s progress, preclinical activities, clinical development, regulatory milestones, and commercialization of its product candidates. Actual results may differ due to factors such as Adagene’s ability to demonstrate drug candidate safety and efficacy, clinical results that may not support further development or approval, regulatory decisions, Adagene’s commercial success, intellectual property protection, reliance on third parties, limited operating history, funding availability, additional collaboration agreements, and the impact of the COVID-19 pandemic. These risks are discussed in Adagene’s filings with the U.S. Securities and Exchange Commission. Adagene does not update forward-looking statements, except as required by law.

Investor and Media Contacts

Raymond Tam

raymond_tam@adagene.com

Bruce Mackle

LifeSci Advisors

bmackle@lifesciadvisors.com

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