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

Key Takeaway: Adagene has amended its collaboration agreement with Exelixis to develop a new antibody-drug conjugate using its SAFEbody technology. This technology allows for targeted delivery of therapeutics to tumor cells while minimizing effects on healthy cells. Adagene is set to receive milestones and royalties from this partnership, which underscores the potential of its innovative approach in cancer treatment.
Price reaction · baseline $2.11 (2025-09-15 close) · hit pre-market · clean, no other ADAG news in the window
day 0 close
+0.9%
day 1
-3.3%
day 3
-2.8%

Market Sentiment Analysis

POSITIVE FACTORS

  • Adagene expands collaboration with Exelixis, enhancing development potential.
  • SAFEbody technology shows promise for targeted cancer therapy.
  • Potential for significant milestones and royalties from new ADCs.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+212%
120-day peak, hindsight
Typical move
8.5%
average across 7 past catalysts
Lead asset
ADG126 Mono
Phase 1 · Advanced/Metastatic Solid Tumors

Full Press Release Details

SAN DIEGO and SUZHOU, China, Sept. 16, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG) today announced an amendment to the 2021collaboration 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.Follow Adagene onWeChat,LinkedInand X.
SAFEbody is a registered trademark in the United States, China, Australia, Japan, Singapore, and the European Union.

Adagene Contacts:

Frequently Asked Questions

What is the purpose of the collaboration between Adagene and Exelixis?

The collaboration aims to develop a novel antibody-drug conjugate using Adagene's SAFEbody technology.

What benefits does SAFEbody technology provide?

SAFEbody technology allows for targeted delivery of therapeutics to tumor cells while minimizing effects on healthy cells.

What is Adagene's lead clinical program?

Adagene's lead clinical program is ADG126, a masked anti-CTLA-4 SAFEbody targeting regulatory T cells.

When is the Phase 2 trial for ADG126 expected to start?

The Phase 2 trial for ADG126 is expected to commence before the end of 2025.

Last updated: Sep 16, 2025