Adagene Stock Price, News & Analysis

Adagene Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage biotechnology company focused on the discovery and development of novel antibody-based cancer immunotherapies. According to the company, Adagene combines computational biology and artificial intelligence to design antibodies that aim to address globally unmet patient needs in oncology. Its work is grounded in proprietary antibody engineering technologies and a stated goal of transforming how antibody-based therapies are discovered and developed for cancer treatment.

Adagene is classified in pharmaceutical preparation manufacturing within the broader manufacturing sector. The company describes itself as operating a Dynamic Precision Library (DPL) platform, which is composed of three core technology families: NEObody™, SAFEbody®, and POWERbody™. This platform is presented as the engine behind a pipeline of immunotherapy programs. Across its public communications, Adagene emphasizes that its technologies are designed to generate therapeutic antibody candidates with functional epitopes and species cross-reactivity, and to address safety and tolerability challenges associated with many antibody therapeutics.

SAFEbody® precision masking technology

A central element of Adagene’s approach is its SAFEbody precision masking technology. The company states that SAFEbody is designed to use precision masking to shield the binding domain of a biologic therapy. This masking is intended to keep the antibody relatively inactive in healthy tissues and to preferentially activate binding within the tumor microenvironment. By doing so, the technology is described as aiming to achieve tumor-specific targeting of antibodies while minimizing on-target off-tumor toxicity in healthy tissues.

Adagene reports that this conditional activation concept can be applied to a variety of antibody-based therapeutic modalities, including Fc-empowered antibodies, antibody-drug conjugates (ADCs), and bi- or multi-specific T-cell engagers. The company also highlights that SAFEbody is a registered trademark in the United States, China, Australia, Japan, Singapore, and the European Union.

Lead clinical program: ADG126 (muzastotug)

Adagene’s lead clinical program is ADG126 (muzastotug), described as a masked, anti-CTLA-4 SAFEbody that targets a unique epitope of CTLA-4 in regulatory T cells (Tregs) in the tumor microenvironment. The company states that ADG126 is designed to overcome CTLA-4–mediated Treg resistance in tumors with an enhanced safety and efficacy profile. Muzastotug is characterized as a next-generation masked anti-CTLA-4 therapy engineered to deliver a therapeutic index that Adagene believes is beyond the reach of existing CTLA-4 therapies.

According to Adagene, ADG126 is in Phase 1b/2 and Phase 2 clinical studies in combination with anti-PD-1 therapy, particularly focused on metastatic microsatellite-stable (MSS) colorectal cancer (CRC) without liver metastases. The company has reported emerging clinical evidence of encouraging efficacy, deep and durable responses, and a favorable safety profile in heavily pretreated MSS CRC patients without active liver metastases when muzastotug is combined with pembrolizumab (KEYTRUDA®). Adagene also notes that the U.S. Food and Drug Administration (FDA) has designated muzastotug, in combination with pembrolizumab, as a Fast Track product for adult patients with microsatellite stable metastatic colorectal cancer without current or active liver metastases.

In regulatory updates, Adagene has described alignment with the FDA on key elements of its clinical development plan for muzastotug in MSS CRC, including inclusion and exclusion criteria, randomized Phase 2 dose optimization between 10 mg/kg and 20 mg/kg in combination with pembrolizumab, and Phase 3 trial design elements and endpoints. The company has indicated that overall response rate (ORR) is the primary endpoint for Phase 2, with duration of response (DOR), progression-free survival (PFS), and overall survival (OS) as secondary endpoints, while OS is planned as the primary endpoint for Phase 3.

Broader pipeline and technology applications

Beyond ADG126, Adagene describes a highly differentiated pipeline of novel immunotherapy programs built on its DPL platform. The company states that its technologies, including NEObody, SAFEbody, and POWERbody, are used to design antibodies that can be adapted to multiple formats. Adagene has indicated that its SAFEbody platform can be applied to Fc-empowered antibodies, ADCs, and bi/multi-specific T-cell engagers, and that it has forged strategic collaborations with global partners that leverage SAFEbody in different therapeutic approaches.

Public disclosures highlight collaborations and agreements with partners such as Exelixis, Sanofi, Third Arc Bio, and ConjugateBio. For example, Exelixis has licensed Adagene’s SAFEbody technology to generate masked monoclonal antibodies for ADC development against nominated solid tumor targets, and Adagene is eligible for development and commercialization milestones and royalties on net sales of products developed around those targets. Sanofi has agreed to make a strategic investment in Adagene and to evaluate ADG126 in combination with other anticancer therapies in a Phase 1b/2 trial in advanced solid tumors, while also exercising an option for an additional SAFEbody discovery program. Third Arc Bio has licensed SAFEbody technology to generate masked CD3 T cell engagers, and ConjugateBio is using a proprietary Adagene antibody in bispecific ADC development programs.

Use of computational biology and artificial intelligence

Across its investor and news communications, Adagene consistently states that it combines computational biology and artificial intelligence to design novel antibodies. This approach is presented as a way to systematically explore antibody structures and epitopes within its Dynamic Precision Library, with the goal of identifying candidates that can meet specific functional and safety criteria. The company positions this capability as central to generating antibodies that can address complex targets such as CTLA-4 and to tailoring masking strategies for different tumor microenvironments.

Clinical-stage focus and regulatory interactions

Adagene characterizes itself as a clinical-stage company. It reports that over 150 patients have received ADG126, either as monotherapy or in combination with anti-PD-1 therapy, and that it has completed enrollment for certain MSS CRC dose expansion cohorts in its Phase 1b/2 trial. The company has described multiple regulatory interactions, including a Type B (End of Phase 1) meeting with the FDA, alignment on Phase 2 and Phase 3 trial designs, and the Fast Track Designation for muzastotug in combination with pembrolizumab for MSS metastatic colorectal cancer without active liver metastases.

In addition to its clinical development activities, Adagene files periodic reports with the U.S. Securities and Exchange Commission (SEC) as a foreign private issuer, including Form 6-K current reports that incorporate press releases, financial results, and transaction disclosures by reference into its registration statements.

Strategic collaborations and capital support

Adagene has highlighted several strategic collaborations and financing arrangements that support its research and development activities. These include:

• A collaboration and license agreement with Exelixis to develop masked ADC candidates using SAFEbody technology, under which Adagene has received upfront and milestone payments and is eligible for additional milestones and royalties.
• A strategic investment and option exercise by Sanofi, involving the purchase of Series A non-voting convertible preferred shares and a plan to evaluate ADG126 in combination with other anticancer therapies in a Phase 1b/2 trial in advanced solid tumors. Adagene continues to own worldwide commercial rights to ADG126.
• A licensing agreement with Third Arc Bio for the use of SAFEbody technology to generate masked CD3 T cell engagers against unique tumor-associated antigens, with Adagene eligible for upfront, milestone, and royalty payments, and holding a no-cost option to develop and commercialize the candidate molecules in specified Asian territories.
• A partnering agreement with ConjugateBio under which Adagene provides a proprietary antibody for use in bispecific ADC development programs, in exchange for upfront, milestone, and royalty consideration, while retaining non-ADC rights to the antibody.

Through these collaborations, Adagene positions its technology platform as applicable both to its internal pipeline and to partnered programs, with the potential for milestone and royalty income tied to partner development and commercialization progress.

Geographic footprint and corporate structure

Adagene’s filings describe it as a foreign private issuer with operations that include entities such as Adagene Suzhou Limited, Adagene Pte. Ltd., Adagene Incorporated, Adagene Hong Kong Limited, Adagene Australia Pty Ltd., and Adagene AG. The company’s SEC filings list a principal address in Suzhou, Jiangsu Province, People’s Republic of China, though Stock Titan descriptions avoid specific street addresses. Adagene’s American depositary shares (ADSs) trade on the Nasdaq Global Market under the symbol ADAG, and each ADS represents a stated number of ordinary shares as disclosed in its filings.

Position within cancer immunotherapy

Within the cancer immunotherapy field, Adagene’s public materials emphasize its focus on CTLA-4–centered antibody programs and on cold tumors such as MSS colorectal cancer, where effective immunotherapy options have historically been limited. The company highlights that its design of masked and differentially engaging CTLA-4 antibodies aims to enable higher, more frequent, and repeat dosing in combination with anti-PD-1 therapy, while maintaining a safety profile that it characterizes as favorable based on reported rates of higher-grade treatment-related adverse events in clinical studies.

Adagene also notes that external experts in immuno-oncology have recognized the potential of its CTLA-4–targeting approach, and that its programs are aligned with scientific insights into regulatory T cell function and CTLA-4 biology. The company presents its SAFEbody and DPL platforms as tools to expand the therapeutic window of CTLA-4 and other antibody targets by enabling conditional activation in the tumor microenvironment.

Summary

In summary, Adagene Inc. is a clinical-stage biotechnology company whose publicly described strategy centers on a proprietary Dynamic Precision Library platform and SAFEbody precision masking technology to create antibody-based cancer immunotherapies. Its lead program, ADG126 (muzastotug), is a masked anti-CTLA-4 SAFEbody in clinical development for metastatic microsatellite-stable colorectal cancer in combination with anti-PD-1 therapy and has received FDA Fast Track Designation in a defined MSS metastatic colorectal cancer population. Through collaborations with global pharmaceutical and biotechnology partners and the application of computational biology and artificial intelligence, Adagene positions its platform and pipeline as contributing to the evolution of precision immunotherapy for cancer.