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

MWN-AI** Summary

Adagene Inc. announced an expansion of its collaboration and license agreement with Exelixis on September 16, 2025, to develop a third novel masked antibody-drug conjugate (ADC) using its proprietary SAFEbody technology. This amendment enables Exelixis to leverage Adagene's innovative platform to create a masked monoclonal antibody targeting a specified solid tumor, thereby enhancing the therapeutic potential of biologic cancer therapies. Under the revised agreement, Adagene stands to benefit from development and commercialization milestones as well as royalties on net product sales connected to this collaboration.

Peter Luo, Ph.D., CEO of Adagene, emphasized the advantages of the SAFEbody technology, which allows ADCs to be inactive until they arrive at the tumor microenvironment, thus minimizing potential safety issues associated with binding to healthy cells. This approach addresses a critical challenge in cancer treatment, where many therapeutic targets are also present in healthy tissues, leading to unwanted side effects.

Adagene's flagship SAFEbody candidate, ADG126, is currently undergoing Phase 1b/2 clinical trials for metastatic microsatellite-stable colorectal cancer (CRC), with a Phase 2 trial expected to launch before the year's end. The company's SAFEbody technology is tailored to improve safety and tolerability in antibody therapeutics by masking the binding domains until exposure to the tumor environment, focusing the drug's action on cancer cells while safeguarding healthy tissue.

Adagene aims to revolutionize antibody-based cancer immunotherapies through its computational biology-driven platform. The collaboration with Exelixis exemplifies this mission, underscoring the relevance and potential of conditional masking technologies in advancing oncology treatments.

MWN-AI** Analysis

Adagene Inc.'s recent expansion of its collaboration with Exelixis marks a significant advance in the biopharmaceutical arena, specifically in the domain of antibody-drug conjugates (ADCs). This partnership harnesses Adagene's SAFEbody technology, which enhances therapeutic targeting while minimizing off-target effects—a critical challenge in oncology therapeutics.

The SAFEbody platform offers a compelling value proposition: a system that masks antibodies against healthy tissues, effectively allowing them to remain inert until they reach tumor cells. This could pave the way for safer and more effective cancer treatments, addressing a pervasive problem in oncology drug development—the balancing act between efficacy and tolerability.

For investors and market watchers, this collaboration signifies several potential opportunities. Firstly, the ability for Adagene to receive development and commercialization milestones, along with royalties on net sales, could substantially bolster its revenue stream, depending on the success of the therapies developed from this partnership. With the initiation of Phase 2 trials for ADG126 expected by the end of 2025, significant catalysts may lie ahead that could potentially increase the company’s valuation.

Market conditions for biotech firms, particularly those focusing on innovative cancer therapies, remain robust, especially as the demand for effective treatments continues to grow. Adagene's strategic collaborations exhibit its strong position to leverage its unique technologies, appealing not only to investors guided by fundamentals but also to those motivated by innovative advancements in medicine.

In summary, investors should consider monitoring Adagene closely as its innovations may lead to significant clinical breakthroughs. The evolving partnership with Exelixis and the promising data from ongoing trials could provide value creation opportunities in the competitive biotech landscape, making Adagene a stock worth considering in a well-diversified portfolio focused on healthcare and biopharma innovation.

**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.

Source: GlobeNewswire

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 .
Follow Adagene on WeChat , LinkedIn and X.

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**

How is Adagene Inc. ADAG's SAFEbody technology expected to enhance the efficacy of antibody-drug conjugates in cancer therapy compared to traditional methods?

Adagene Inc.'s SAFEbody technology is designed to improve the targeting and safety profile of antibody-drug conjugates in cancer therapy by allowing for controlled drug release and minimizing off-target effects, thereby enhancing treatment efficacy compared to traditional methods.

What specific roles do San Diego and Suzhou play in the development and commercialization of Adagene Inc. ADAG’s immune modulating antibodies?

San Diego serves as Adagene Inc.'s primary research and development hub for innovating immune modulating antibodies, while Suzhou complements these efforts by providing manufacturing capabilities and facilitating commercialization in the Asian market.

In what ways does the clinical trial for ADG126 in metastatic colorectal cancer impact Adagene Inc. ADAG's partnership with Exelixis and their collaboration strategy?

The success of the ADG126 clinical trial in metastatic colorectal cancer could enhance Adagene Inc.’s reputation, potentially solidifying its partnership with Exelixis and reinforcing their collaboration strategy by demonstrating the viability of their innovative approaches in oncology.

Can you explain how Adagene Inc. ADAG’s use of artificial intelligence in antibody design differentiates it from other biotech companies in San Diego and Suzhou?

Adagene Inc. (ADAG) leverages advanced artificial intelligence for its proprietary antibody design platform, enabling faster, more precise therapeutic development, thus setting it apart from other biotech companies in San Diego and Suzhou that may rely on traditional methods.

**MWN-AI FAQ is based on asking OpenAI questions about Adagene Inc. (NASDAQ: ADAG).

Adagene Inc.

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