Press Releases September 9, 2026 08:00 AM

Adagene Achieves Milestone in Collaboration with Exelixis for Advancement of SAFEbody® Antibody-Drug Conjugate Candidates

Adagene achieves preclinical milestone in collaboration with Exelixis, triggering $2M milestone payment for SAFEbody antibody-drug conjugate candidates

By Avery Klein
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Adagene Inc., a clinical-stage biotechnology company, announced the achievement of a preclinical milestone with Exelixis relating to its SAFEbody platform. This milestone pertains to the development of XB404, an antibody-drug conjugate targeting ROR1/2-expressing tumors, which triggered a $2 million payment from Exelixis. Additional payments were also triggered by the selection of candidates for another ADC program using Adagene’s SAFEbody technology. The collaboration includes potential future development and commercialization milestones and royalties, underscoring the value of Adagene’s technology in creating safer, tumor-specific antibody therapies.

Adagene Achieves Milestone in Collaboration with Exelixis for Advancement of SAFEbody® Antibody-Drug Conjugate Candidates
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Key Points

  • Adagene reached a preclinical milestone with Exelixis for XB404, a SAFEbody antibody-drug conjugate targeting ROR1/2 tumors, resulting in a $2 million payment.
  • Exelixis can utilize Adagene's SAFEbody technology for additional masked antibody-drug conjugate programs, triggering further payments.
  • Adagene’s proprietary SAFEbody platform aims to improve safety and efficacy by masking antibodies to minimize off-tumor toxicity, currently validated in clinical-stage oncology programs such as muzastotug (ADG126).
  • Sectors impacted include biotechnology, pharmaceuticals, cancer immunotherapy, and healthcare technology innovation.

SAN DIEGO and SUZHOU, China, Sept. 09, 2026 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel antibody-based therapies, today announced the achievement of a milestone in its ongoing collaboration and license agreement with Exelixis, Inc. (“Exelixis”).

The milestone achievement is related to a preclinical milestone event for XB404 and resulted in a $2.0 million milestone payment from Exelixis. XB404, built with Adagene’s SAFEbody masking technology, is designed to deliver a cytotoxic payload to ROR1/2-expressing tumors while minimizing on-target, off-tumor side effects. An additional payment to Adagene was triggered by the selection of candidates for another SAFEbody® antibody-drug conjugate (ADC) program. Exelixis has the right to utilize Adagene's SAFEbody technology platform to generate masked monoclonal antibodies for the development of masked ADC candidates.

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

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, muzastotug (ADG126), is a masked, anti-CTLA-4 SAFEbody with FDA Fast Track designation that targets a unique epitope of CTLA-4 in regulatory T cells (Tregs) in the tumor microenvironment. Muzastotug is currently in Phase 1b/2 and Phase 2 clinical studies in combination with anti-PD-1 therapy, particularly focused on microsatellite stable (MSS) metastatic 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/multi-specific T-cell engagers.

For more information, please visit: https://investor.adagene.com.
Follow Adagene on WeChat, LinkedIn and X.

NEObody® is a registered trademark in the United States, China, Australia, Japan, Singapore, Switzerland, Korea, United Kingdom and the European Union. SAFEbody® is a registered trademark in the United States, China, Australia, Japan, Singapore, and the European Union.

FORWARD LOOKING STATEMENTS
This press release contains forward-looking statements, including statements regarding expected clinical development plans. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to Adagene’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or regulatory approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of the underlying drug candidates; Adagene’s ability to achieve commercial success for its drug candidates, if approved; Adagene’s ability to obtain and maintain protection of intellectual property for its technology and drugs; Adagene’s reliance on third parties to conduct drug development, manufacturing and other services; Adagene’s limited operating history and Adagene’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; Adagene’s ability to enter into additional collaboration agreements beyond its existing strategic partnerships or collaborations and other operations, as well as those risks more fully discussed in the “Risk Factors” section in Adagene’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Adagene, and Adagene undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

Investor Contacts:
Raymond Tam
[email protected]

Corey Davis
LifeSci Advisors
[email protected]

Media Contact:
Ian Stone
LifeSci Communications
[email protected]


Risks

  • Clinical and regulatory risks remain as drug candidates, including XB404 and muzastotug, must demonstrate safety and efficacy to advance through clinical trials and gain approvals.
  • Reliance on collaborations such as with Exelixis is critical; any failure in partnership outcomes, delays, or disputes could negatively impact development and commercial progress.
  • Financial risks related to funding and commercialization exist, as Adagene is a clinical-stage company with limited operating history and depends on milestone payments and future royalties to support its pipeline advancement.

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