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

Rhea-AI Summary

Adagene (Nasdaq: ADAG) has expanded its collaboration with Exelixis by amending their 2021 agreement to develop a third novel masked antibody-drug conjugate (ADC). Under the expanded agreement, Exelixis will use Adagene's SAFEbody technology platform to create a masked monoclonal antibody targeting solid tumors.

The SAFEbody platform is designed to make antibodies invisible until reaching tumor cells, avoiding unwanted binding to healthy cells. Adagene will receive development and commercialization milestones plus royalties on net sales. The company's lead SAFEbody candidate, ADG126, is advancing in a Phase 1b/2 study for metastatic microsatellite-stable colorectal cancer, with Phase 2 expected to start by end of 2025.

Positive

• Expansion of existing partnership demonstrates validation of SAFEbody technology
• Company eligible for development milestones, commercialization milestones, and royalties
• Lead candidate ADG126 advancing to Phase 2 clinical trials by end of 2025

Negative

• None.

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.

For more information, please visit: https://investor.adagene.com.
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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

FAQ

What is the new collaboration between Adagene (ADAG) and Exelixis?

Adagene and Exelixis expanded their 2021 agreement to develop a third novel masked antibody-drug conjugate (ADC) using Adagene's SAFEbody technology platform for solid tumor targets.

How does Adagene's SAFEbody technology work?

The SAFEbody technology makes antibodies invisible until they reach the tumor microenvironment, preventing unwanted binding to healthy cells while preferentially targeting tumor cells.

What are the financial terms of Adagene's expanded agreement with Exelixis?

Adagene will receive development and commercialization milestones, plus royalties on net sales of products developed using their SAFEbody technology.

What is the current status of Adagene's ADG126 clinical trials?

ADG126 is in a Phase 1b/2 study for metastatic microsatellite-stable (MSS) colorectal cancer, with Phase 2 trial expected to begin before the end of 2025.

What problem does Adagene's SAFEbody technology solve?

SAFEbody technology addresses the challenge of cancer therapy targets being expressed in both cancer and healthy cells, reducing unwanted safety and tolerability issues by masking antibodies from healthy cells.