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Adagene Announces Licensing Agreement with Third Arc Bio for Development of Two Masked CD3 T Cell Engagers Utilizing SAFEbody® Technology

MWN-AI** Summary

Adagene Inc. and Third Arc Bio, Inc. recently announced a significant licensing agreement that will enable Third Arc Bio to leverage Adagene’s innovative SAFEbody technology platform for the development of two masked CD3 T cell engagers targeting unique tumor-associated antigens. Under this agreement, Third Arc Bio will gain the rights to research, develop, and commercialize these candidate molecules globally. Adagene stands to receive an upfront payment of $5 million, with potential total milestones and royalties amounting up to $840 million, contingent on achieving predefined conditions.

Peter Luo, CEO of Adagene, praised the SAFEbody technology, emphasizing its capability to enhance therapeutic indices by activating antibodies specifically within tumor microenvironments. This mechanism improves safety, allowing for higher dosing and potentially increased efficacy—a quality that has been validated in ongoing studies with their lead candidate, muzastotug.

Third Arc Bio’s CEO, Peter Lebowitz, expressed enthusiasm about this partnership, highlighting how the SAFEbody technology will contribute to their expanding portfolio of innovative CD3- and CD28-targeting T cell engagers. This collaboration represents a pivotal step for both companies in advancing cutting-edge cancer immunotherapies.

Adagene, a clinical-stage biotechnology firm, focuses on creating novel antibody-based therapies by integrating computational biology and artificial intelligence. Its SAFEbody technology particularly addresses safety and tolerability issues in antibody therapeutics, enabling tumor-specific targeting while minimizing off-target toxicity. With active clinical programs and promising early results, Adagene continues to position itself at the forefront of immunotherapy development.

As both companies move forward with this collaboration, they aim to pave the way for advanced treatments in the oncology space, leveraging innovative technologies to meet unmet patient needs.

MWN-AI** Analysis

Adagene Inc.'s recent licensing agreement with Third Arc Bio presents a promising opportunity in the biotechnology sector, particularly for investors focused on immunotherapy and cancer treatment advancements. The partnership leverages Adagene's innovative SAFEbody technology platform to create masked CD3 T cell engagers, which are poised to enhance therapeutic efficacy by targeting unique tumor-associated antigens while minimizing off-target toxicity.

From a market perspective, Adagene's upfront payment of $5 million, alongside potential milestone payments up to $840 million, underscores the significant value of its intellectual property. The ability to receive royalties on end-user sales further solidifies a revenue-generating pathway that could positively impact the company’s future cash flows. Furthermore, Adagene's option to develop and commercialize these candidates in key Asian markets - Greater China, Singapore, and South Korea - offers a strategic advantage in capturing rapidly growing markets for immunotherapy treatments.

Investors should keep an eye on the progress of Adagene's existing clinical programs, particularly the ADG126 (muzastotug), which is in Phase 1b/2 and Phase 2 studies for MSS colorectal cancer. Positive clinical outcomes could enhance the company's valuation and investor sentiment, particularly if early data supports the efficacy of its SAFEbody technology.

In reviewing the potential impacts, risk factors associated with clinical trials and regulatory approvals must also be considered. However, the strategic positioning of both companies, combined with the promising pipeline for advanced cancer therapies, suggests a favorable outlook for Adagene.

Investors are advised to monitor key milestones and trial updates closely, as successful advancements could yield substantial returns. Adding ADAG to a diversified biotech portfolio may benefit those looking to capitalize on the growing trends in precision medicine and innovative cancer therapies.

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

Source: GlobeNewswire

SAN DIEGO and SUZHOU, China and SPRING HOUSE, Pa., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG) and Third Arc Bio, Inc. (“Third Arc Bio”), today announced a licensing agreement under which Third Arc Bio will utilize Adagene’s SAFEbody technology platform to generate masked CD3 T cell engagers against unique tumor associated antigens. Under the terms of the agreement, Third Arc Bio will receive rights to research, develop and commercialize two candidate molecules worldwide. Adagene will receive an upfront payment of $5 million and is eligible to receive development and commercial-based milestones of up to $840 million (if all milestones and conditions are achieved) as well as royalties on end-user sales. In addition, Adagene has a no-cost option to develop and commercialize these candidate molecules in Greater China, Singapore and South Korea.

Peter Luo, Ph.D., Chief Executive Officer of Adagene said, “Our SAFEbody technology allows activation of an antibody when it reaches the tumor microenvironment. The resulting wider therapeutic index from improved safety allows for higher dosing and potentially better efficacy, as seen from the data we continue to generate with muzastotug. We’re thrilled that Third Arc Bio will be utilizing our SAFEbody technology for a portion of their exciting pipeline programs.”

“Our agreement with Adagene will allow Third Arc Bio to advance highly innovative molecules with a superior therapeutic index and help build on our growing portfolio of novel CD3- and CD28-targeting T cell engagers,” said Peter Lebowitz, M.D., Ph.D., Chief Executive Officer of Third Arc Bio. “Adagene’s SAFEbody® technology expands the reach of our ArcStim Platform to additional novel targets.”

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. 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) 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/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.

About Third Arc Bio
Third Arc Bio is a clinical stage biotech company developing multifunctional antibodies that generate immune synapses to precisely activate or inhibit T cells. The lead program ARC101, is a bispecific T cell engager currently being evaluated in a Phase 1 trial for cancer patients with solid tumors expressing CLDN6. The company’s drug development engine delivers superior biologics optimized to create best-in-class T cell engagement by leveraging novel technologies that power a pipeline of high value therapeutics. The Third Arc Bio platforms include a solid tumor ARCStim Platform and an immunology & inflammation (I&I) ARCTag Platform that offers precision immune regulation to achieve superior efficacy and safety. To learn more, visit www.thirdarcbio.com .

About ARC101
ARC101 is a potential best-in-class T cell engager that targets solid tumors expressing CLDN6. ARC101 exhibits high specificity with no off-target binding, avoids other Claudin family proteins, and has potent cytotoxicity, a long half-life and optimal biophysical properties. ARC101 is currently in Phase 1 studies NCT06672185 , to assess its safety, tolerability, pharmacokinetics and antitumor activity in patients with advanced cancer.

Adagene Investor Contacts:
Raymond Tam
raymond_tam@adagene.com

Corey Davis, Ph.D.
LifeSci Advisors LLC
212-915-2577
cdavis@lifesciadvisors.com

Adagene Media Contact:
Lindsay Rocco
Elixir Health PR
862-596-1304
lrocco@elixirhealthpr.com

Third Arc Bio Contacts:
Peg Rusconi, Deerfield Group
peg.rusconi@deerfieldgroup.com

Amanda Jonhson, Deerfield Group
amanda.johnson@deerfieldgroup.com


FAQ**

How does the licensing agreement between Adagene Inc. (ADAG) and Third Arc Bio strengthen San Diego's position in the biotech industry, particularly in relation to immunotherapy advancements?

The licensing agreement between Adagene Inc. and Third Arc Bio bolsters San Diego's biotech industry by fostering collaboration and innovation in immunotherapy, attracting talent and investment, and positioning the region as a leader in advanced therapeutic solutions.

What implications does Adagene Inc.'s (ADAG) SAFEbody technology have for the biopharmaceutical landscape in Suzhou, China, especially as it relates to cancer treatment innovation?

Adagene Inc.'s SAFEbody technology positions Suzhou as a potential hub for innovative cancer treatments, offering precise targeting and reduced side effects, thereby enhancing the biopharmaceutical landscape and attracting investments and talent in the region.

In what ways might Third Arc Bio's collaboration with Adagene Inc. (ADAG) affect the growing biotech ecosystem in Spring House, PA, especially with regard to novel drug development?

Third Arc Bio's collaboration with Adagene Inc. could invigorate the biotech ecosystem in Spring House, PA, by accelerating novel drug development through shared resources, innovative technologies, and enhanced expertise, potentially attracting further investments and partnerships.

How could the successful commercialization of candidates resulting from the Adagene Inc. (ADAG) and Third Arc Bio partnership impact cancer treatment options available to patients in San Diego, Suzhou, and Spring House?

The successful commercialization of candidates from the Adagene Inc. and Third Arc Bio partnership could significantly expand and diversify cancer treatment options for patients in San Diego, Suzhou, and Spring House, ultimately improving patient outcomes and access to innovative therapies.

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

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