Adagene Expands SAFEbody® Collaboration and License Agreement with Exelixis to Develop Third Novel Masked Antibody-Drug Conjugate

SAN DIEGO and SUZHOU, China, Sept. 16, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG) today announced an amendment to the 2021 collaboration and license agreement with Exelixis. Under the terms of the amended agreement, Exelixis will utilize Adagene’s SAFEbody technology platform to generate a masked monoclonal antibody from the company’s pipeline for the development of an antibody-drug conjugate (ADC) against an Exelixis-nominated solid tumor target.

Adagene is eligible to receive development and commercialization milestones and royalties on net sales of products developed around this target.

Peter Luo, Ph.D., Chief Executive Officer of Adagene said, “Our SAFEbody technology enables an antibody or ADC to be invisible until it reaches the tumor microenvironment, resulting in a wide therapeutic index, as seen with ADG126. Our evolving partnership with Exelixis highlights the potential of conditional masking to safely deliver a payload or immune modulating antibody directly to tumor cells. We are very pleased to continue to collaborate with Exelixis and look forward to the company’s development of SAFE-ADC^® that leverage our SAFEbody technology.”

Biologic cancer therapy targets are expressed at high levels in cancer cells, but many are also expressed at lower levels on healthy cells. Binding to healthy cells may lead to unwanted safety or tolerability issues. Adagene’s SAFEbody platform is designed to overcome this challenge by masking antibodies to healthy cells while preferentially binding to the target in tumor cells.

Adagene’s most advanced SAFEbody candidate, ADG126, is currently in a Phase 1b/2 study in metastatic microsatellite-stable (MSS) colorectal cancer (CRC), with the Phase 2 trial commencement expected before the end of 2025.

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, 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 MSS 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.

Adagene Contacts:

Raymond Tam
raymond_tam@adagene.com

Corey Davis
LifeSci Advisors
cdavis@lifesciadvisors.com

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