Muzastotug

Sept. 16, 2025 -- 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. 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. The content above comes from the network. if any infringement, please contact us to modify.

SAN DIEGO and SUZHOU, China, Sept. 05, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene or the Company”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced that ADG126 will be highlighted in two oral presentations at this year’s CSCO Meeting, taking place September 10-14 in Jinan, China. Harnessing the Power of Masked CTLA-4 Blockade: Updated ADG126-P001 Phase 1b/2Results of ADG126 + Pembrolizumab in Advanced MSS CRC Presenter: Dr. Xu Ruihua, Professor and President of Sun Yat-sen University Cancer Center and Chairman of the Chinese Society of Clinical Oncology (CSCO)Date and Time: Thursday, September 11 at 14:45-15:00 CST (China Standard Time)Location: Jinan, China Immunotherapy for mCRC Presenter: Dr. Heinz-Josef Lenz, Chair of the GI Oncology Program and co-director of the Colorectal Center at University of Southern California’s Keck School of MedicineDate and Time: Thursday, September 11 at 14:00-14:25 CST (China Standard Time)Location: Jinan, China “Microsatellite stable (MSS) colorectal cancer (CRC) remains one of the cold tumors where effective immunotherapy still remains elusive and I believe anti-CTLA-4 therapy should be part of the solution,” said Dr. Lenz. “By enabling CTLA-4-mediated intratumoral Treg depletion, the masked anti-CTLA-4 ADG126 (muzastotug) in combination with pembrolizumab, has shown compelling results in Phase 1b/2 dose expansion in MSS CRC. The safety profile of ADG126 allows higher, more frequent and repeat doses of anti-CTLA-4 in combination with anti-PD-1 therapy, and has shown promise to significantly improve longer-term survival benefit for MSS CRC patients. At CSCO, I will review the essential role of anti-CTLA-4 therapy in metastatic CRC including the approved Nivolumab+Ipilimumab in MSI-H CRC as well as the next generation Treg depleting anti-CTLA-4 in treating cold tumors like MSS CRC.” ADG126 is the first masked anti-CTLA-4 in combination with an approved anti-PD-1 therapy to achieve an objective response rate (ORR) of ~30% with durable duration of response (DoR) and over 80% disease control in refractory/resistant MSS CRC with no liver metastasis (NLM), while maintaining less than 20% of Grade 3 treatment-related adverse events (TRAEs). These ORR and DoR outcomes are likely to translate into overall survival benefit, as demonstrated by the 10 mg/kg cohorts exhibiting a median OS of 19.4 months. 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 in tumor microenvironment, 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 Metastatic 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/multi-specific 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. Investor Contacts: Raymond Tamraymond_tam@adagene.com Corey DavisLifeSci Advisorscdavis@lifesciadvisors.com