SAN DIEGO and SUZHOU, China, Sept. 16, 2025 — Adagene Inc. (Nasdaq: ADAG) has announced an amendment to its 2021 agreement with Exelixis. According to the updated agreement, Exelixis will utilize Adagene’s SAFEbody technology platform to create a masked monoclonal antibody from Adagene’s pipeline. This antibody will be used to develop an antibody-drug conjugate (ADC) targeting a solid tumor target selected by Exelixis.
Adagene is eligible for milestone payments related to development and commercialization, as well as royalties on net sales of products developed for this target.
Adagene’s CEO, Peter Luo, Ph.D., stated that their SAFEbody technology allows an antibody or ADC to remain inactive until it reaches the tumor microenvironment, leading to a broad therapeutic index, as demonstrated by ADG126. He added that their ongoing collaboration with Exelixis underscores the potential of conditional masking to safely deliver a payload or immune-modulating antibody directly to tumor cells. He expressed pleasure in continuing the collaboration and anticipation for Exelixis’s development of SAFE-ADC® utilizing their SAFEbody technology.
Biologic cancer therapies often target proteins highly expressed in cancer cells, but these targets can also be present at lower levels in healthy cells. This can lead to safety and tolerability issues due to binding to healthy cells. Adagene’s SAFEbody platform addresses this challenge by masking antibodies to healthy cells, ensuring preferential binding to the target in tumor cells.
Adagene’s lead SAFEbody candidate, ADG126, is currently undergoing a Phase 1b/2 study for metastatic microsatellite-stable (MSS) colorectal cancer (CRC), with Phase 2 trial commencement anticipated before the end of 2025.
About Adagene
Adagene Inc. (Nasdaq: ADAG) is a clinical-stage biotechnology company focused on transforming the discovery and development of innovative antibody-based cancer immunotherapies. Adagene employs computational biology and artificial intelligence to design novel antibodies that address unmet global patient needs. The company has established strategic collaborations with global partners to leverage its SAFEbody precision masking technology across various scientific approaches.
Fueled by its Dynamic Precision Library (DPL) platform, encompassing NEObody™, SAFEbody, and POWERbody™ technologies, Adagene’s pipeline features highly differentiated immunotherapy programs. The SAFEbody technology is designed to improve the safety and tolerability of antibody therapeutics by using precision masking to shield the binding domain of the biologic therapy. Activation within the tumor microenvironment enables tumor-specific targeting of antibodies, reducing off-target toxicity in healthy tissues.
Adagene’s primary clinical program, ADG126 (muzastotug), is a masked, anti-CTLA-4 SAFEbody that targets a specific epitope of CTLA-4 in regulatory T cells (Tregs) within the tumor microenvironment. ADG126 is currently in Phase 1b/2 clinical studies in combination with anti-PD-1 therapy, with a focus on MSS CRC. Validated by ongoing clinical research, the SAFEbody platform is applicable 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.
Adagene Contacts:
Raymond Tam
Corey Davis
LifeSci Advisors
