- Trial to begin enrolling in April; expected primary completion in mid-2027 -
- Primary study endpoint of rate of major pathological response -
SAN DIEGO and SUZHOU, China, Feb. 27, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced an investigator initiated (IIT) Phase 2 neoadjuvant trial of ADG126 for patients with stage II or stage III colorectal cancer.
The new study (NCT06846268), led by primary investigator Dr. Yong Wei Peng, Senior Consultant at the Department of Haematology-Oncology, National University Cancer Institute, Singapore, is expected to begin patient enrollment in April 2025. Patients will receive high doses of ADG126 in combination with KEYTRUDA® prior to surgery. The trial’s primary endpoint is the rate of Major Pathologic Response (MPR), defined as ≤10% residual viable tumor in the surgical specimen, and will be evaluated in up to 20 patients. Secondary endpoints include complete pathological response, disease-free survival, and safety/tolerability. Additionally, the study will explore the pharmacodynamic effects of neoadjuvant ADG126 and pembrolizumab on the tumor microenvironment’s immune profile, as well as the pharmacokinetic profile of ADG126 in tumor tissues, to further elucidate the compound’s unique mechanism of action and enhanced therapeutic index.
“The foundation for this neoadjuvant study is supported by the compelling combination efficacy and safety profile of ADG126 with pembrolizumab in late-stage MSS CRC patients,” said Peter Luo, Chairman, CEO, and President of R&D at Adagene. “We believe that advancing immunotherapy into the curative neoadjuvant setting holds significant promise. By combining CTLA-4-mediated T regulatory cell depletion with anti-PD-1’s ability to reinvigorate exhausted T cells, this approach restores anti-tumor immunity, offering patients a head start and the potential for long-term clinical benefits.”
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.
