Core Insights - Adagene Inc. announced an amendment to its collaboration and license agreement with Exelixis, allowing Exelixis to utilize Adagene's SAFEbody technology platform for developing an antibody-drug conjugate (ADC) targeting a solid tumor [1][2] Company Overview - Adagene is a clinical-stage biotechnology company focused on developing novel antibody-based cancer immunotherapies, leveraging computational biology and artificial intelligence [5] - The company has established strategic collaborations with global partners to utilize its SAFEbody precision masking technology [5] Technology and Innovation - The SAFEbody technology enables antibodies or ADCs to remain "invisible" until they reach the tumor microenvironment, which enhances therapeutic index and minimizes toxicity to healthy cells [3][6] - Adagene's lead SAFEbody candidate, ADG126, is currently in a Phase 1b/2 study for metastatic microsatellite-stable colorectal cancer, with a Phase 2 trial expected to start before the end of 2025 [4][7] Clinical Development - ADG126 targets a unique epitope of CTLA-4 in regulatory T cells within the tumor microenvironment and is being studied in combination with anti-PD-1 therapy [7] - The SAFEbody platform is validated for various antibody-based therapeutic modalities, including Fc empowered antibodies and bi/multispecific T-cell engagers [7]

Core Insights - Adagene Inc. announced that its lead product ADG126 will be featured in two oral presentations at the CSCO Meeting in Jinan, China, from September 10-14, 2025 [1] Group 1: Clinical Developments - ADG126, a masked anti-CTLA-4 SAFEbody, is currently in Phase 1b/2 clinical studies in combination with pembrolizumab for treating advanced microsatellite-stable colorectal cancer (MSS CRC) [6][7] - The combination therapy has shown an objective response rate (ORR) of approximately 30% and over 80% disease control in refractory/resistant MSS CRC patients without liver metastasis, with a median overall survival (OS) of 19.4 months in the 10 mg/kg cohort [3] Group 2: Presentations at CSCO Meeting - Dr. Xu Ruihua will present updated results of the ADG126-P001 study on September 11, 2025, focusing on the efficacy of ADG126 combined with pembrolizumab in advanced MSS CRC [2] - Dr. Heinz-Josef Lenz will discuss the role of anti-CTLA-4 therapy in metastatic CRC, emphasizing the potential of ADG126 in treating cold tumors like MSS CRC [3] Group 3: Company Overview - Adagene Inc. is a clinical-stage biotechnology company focused on developing novel antibody-based cancer immunotherapies using its proprietary SAFEbody technology [4][5] - The company employs computational biology and artificial intelligence to design antibodies that meet unmet patient needs, and it has established strategic collaborations to enhance its research capabilities [4]

Core Insights - Adagene Inc. has appointed Dr. Axel Hoos as Executive Advisor, enhancing its leadership in immuno-oncology [1][2] - The company is advancing innovative antibody therapies targeting CTLA-4, aiming to improve efficacy and reduce toxicity in cancer treatment [2][6] - Dr. Hoos brings extensive experience in immuno-oncology, having previously led the development of YERVOY, the first FDA-approved immune checkpoint inhibitor [2][3][4] Company Overview - Adagene Inc. is a clinical-stage biotechnology company focused on developing novel antibody-based cancer immunotherapies using computational biology and artificial intelligence [5] - The company utilizes its SAFEbody precision masking technology to address safety and tolerability challenges in antibody therapeutics [6] Pipeline and Technology - Adagene's lead clinical program, ADG126, is a masked anti-CTLA-4 SAFEbody currently in phase 1b/2 studies, particularly targeting Metastatic Microsatellite-stable Colorectal Cancer [7] - The SAFEbody platform allows for tumor-specific targeting while minimizing off-tumor toxicity, enhancing the therapeutic window for antibody treatments [6][7]

Company Overview - Adagene Inc. is a clinical-stage biotechnology company focused on developing novel antibody-based cancer immunotherapies, utilizing computational biology and artificial intelligence to address unmet patient needs [3][4] - The company has established strategic collaborations with global partners to leverage its SAFEbody precision masking technology [3] Technology and Pipeline - Adagene's proprietary Dynamic Precision Library (DPL) platform includes NEObody™, SAFEbody, and POWERbody™ technologies, which are designed to enhance the safety and efficacy of antibody therapeutics [4] - The SAFEbody technology specifically targets the tumor microenvironment, allowing for tumor-specific antibody targeting while minimizing toxicity to healthy tissues [4] Clinical Programs - The lead clinical program, ADG126 (muzastotug), is a masked anti-CTLA-4 SAFEbody currently in phase 1b/2 clinical studies, focusing on Metastatic Microsatellite-stable (MSS) Colorectal Cancer in combination with anti-PD-1 therapy [5] - The SAFEbody platform is validated for use across various antibody-based therapeutic modalities, including Fc empowered antibodies and antibody-drug conjugates [5] Investor Engagement - Adagene's Chief Strategy Officer will participate in one-on-one investor meetings and a fireside chat at two upcoming investor conferences in New York in September [1][2] - Webcasts of the presentations will be available on the company's website for at least 30 days [2]

Core Insights - Adagene's ADG126 shows promising results in Phase 1b/2 trials for microsatellite stable colorectal cancer (MSS CRC), with a median overall survival (mOS) of 19.4 months for the 10 mg/kg dose cohort, outperforming historical benchmarks [1][4] - The company has aligned with the FDA on the design elements for Phase 2 and Phase 3 trials, with patient enrollment expected to begin in the second half of 2025 [1][5] - Sanofi has made a strategic investment of up to US$25 million in Adagene, extending the company's cash runway into 2027 [1][6] Pipeline Highlights - ADG126 demonstrated a 29% confirmed overall response rate (ORR) in MSS CRC patients, with less than 20% of patients experiencing Grade 3 treatment-related adverse events [4][5] - The 20 mg/kg cohort's mOS has not yet been reached, indicating ongoing potential for further positive outcomes [1][4] - Adagene plans to evaluate ADG126 in combination with Merck's KEYTRUDA in a Phase 1b/2 trial involving over 100 patients [6][7] Corporate Updates - Adagene has strengthened its leadership team with key appointments, including John Maraganore as Executive Advisor and Mickael Chane-Du as Chief Strategy Officer [10] - The company has entered into a partnership with ConjugateBio to develop novel antibody-drug conjugates [9] Financial Highlights - As of June 30, 2025, Adagene reported cash and cash equivalents of US$62.8 million, down from US$85.2 million at the end of 2024 [11] - Research and development expenses decreased by approximately 18% to US$12.0 million for the first half of 2025 compared to US$14.7 million in the same period of 2024 [12] - The net loss attributable to shareholders was US$13.5 million for the first half of 2025, an improvement from US$17.0 million in the same period of 2024 [14]

Core Insights - Adagene has partnered with ConjugateBio to provide a proprietary antibody for the development of bispecific antibody-drug conjugates (ADCs) [1][2][3] - The ADC market is projected to exceed $30 billion by 2030, indicating significant growth potential in this sector [2] - Adagene will receive an undisclosed upfront payment along with milestone and royalty payments, while retaining all non-ADC rights to the partnered antibody [3] Company Overview: Adagene - Adagene Inc. is a clinical-stage biotechnology company focused on novel antibody-based cancer immunotherapies, utilizing computational biology and artificial intelligence [4] - The company employs its SAFEbody precision masking technology to enhance safety and tolerability in antibody therapeutics, allowing for targeted action in the tumor microenvironment [5] - Adagene's lead clinical program, ADG126, is currently in phase 1b/2 studies for metastatic microsatellite-stable colorectal cancer, showcasing the application of its SAFEbody platform [6] Company Overview: ConjugateBio - ConjugateBio is a privately held biotechnology company specializing in first-in-class bispecific ADCs targeting solid tumors, leveraging advanced linker-payload technologies [8] - The company aims to develop innovative therapeutics across a wide range of cancer indications, indicating a strong focus on addressing unmet medical needs in oncology [8]

Core Insights - Adagene Inc. is participating in the Jefferies Global Healthcare Conference 2025, highlighting its commitment to investor engagement and communication [1][2]. Company Overview - Adagene Inc. is a clinical-stage biotechnology company focused on developing novel antibody-based cancer immunotherapies, utilizing computational biology and artificial intelligence [3]. - The company has established strategic collaborations with global partners to enhance its SAFEbody precision masking technology, which is at the forefront of scientific innovation [3]. Technology and Pipeline - Adagene's proprietary Dynamic Precision Library (DPL) platform includes NEObody™, SAFEbody, and POWERbody™ technologies, which are designed to improve the safety and tolerability of antibody therapeutics [4]. - The SAFEbody technology specifically addresses safety challenges by masking the binding domain of biologic therapies, allowing for targeted action in the tumor microenvironment while reducing toxicity to healthy tissues [4]. Clinical Programs - The lead clinical program, ADG126 (muzastotug), is a masked anti-CTLA-4 SAFEbody targeting regulatory T cells in the tumor microenvironment, currently in phase 1b/2 studies in combination with anti-PD-1 therapy for Metastatic Microsatellite-stable Colorectal Cancer [5]. - The SAFEbody platform is versatile and can be applied to various antibody-based therapeutic modalities, including Fc empowered antibodies and antibody-drug conjugates [5].

Core Insights - Adagene Inc. announced updated data from its Phase 1b/2 study of ADG126 in advanced microsatellite stable colorectal cancer (MSS CRC) with promising efficacy and safety results [1][2][3] Efficacy - ADG126 in combination with pembrolizumab achieved a 29% confirmed overall response rate (ORR) in the 20 mg/kg cohorts, while the 10 mg/kg cohorts had an ORR of 17% [1][3] - The median overall survival (OS) for the 10 mg/kg cohorts was reported at 19.4 months, with the median OS for the 20 mg/kg cohorts not yet reached [3][4] - All six responders in the 20 mg/kg cohorts remain on treatment, with four patients on study for over forty weeks [1] Safety - The 20 mg/kg Q6W dosing regimen demonstrated fewer than 20% Grade 3 adverse events, with no treatment discontinuations [2][4] - The study indicated a significant reduction in treatment-related toxicities while maintaining a near 30% ORR [2] Study Design - A total of 67 MSS CRC patients with no liver metastases were treated with ADG126 at either 10 mg/kg or 20 mg/kg, in combination with pembrolizumab [2] - The dosing regimens included a loading dose of 20 mg/kg followed by either 10 mg/kg every three weeks or 20 mg/kg every six weeks [2] Future Plans - As data continue to mature, the company plans to discuss the dosing regimen with regulatory bodies for the next phase of clinical development [4]

Core Insights - Adagene Inc. has appointed Dr. John Maraganore as Executive Advisor to provide strategic guidance and mentorship to the company's leadership team [1][2] Company Overview - Adagene Inc. is a clinical-stage biotechnology company focused on developing novel antibody-based cancer immunotherapies, utilizing computational biology and artificial intelligence [4] - The company has established strategic collaborations with global partners to leverage its SAFEbody precision masking technology [4] Technology and Innovation - Adagene's proprietary Dynamic Precision Library (DPL) platform includes NEObody™, SAFEbody®, and POWERbody™ technologies, aimed at addressing safety and tolerability challenges in antibody therapeutics [5] - The SAFEbody technology allows for tumor-specific targeting of antibodies while minimizing on-target off-tumor toxicity in healthy tissues [5] Clinical Development - Adagene's lead clinical program, ADG126 (muzastotug), is a masked anti-CTLA-4 SAFEbody currently in phase 1b/2 clinical studies, particularly targeting Metastatic Microsatellite-stable Colorectal Cancer [6] - The SAFEbody platform is validated for application across various antibody-based therapeutic modalities, including Fc empowered antibodies and antibody-drug conjugates [6] Leadership and Expertise - Dr. John Maraganore previously served as CEO of Alnylam, where he led the company through the approval and commercialization of four RNA interference therapeutic medicines, creating over $25 billion in market capitalization [2][3] - He has extensive experience advising and mentoring life sciences CEOs and sits on the boards of public and private companies [3]

Core Insights - Adagene Inc. is set to present a poster at ASCO 2025, showcasing its advancements in antibody-based therapies [1][2] Company Overview - Adagene Inc. is a clinical-stage biotechnology company focused on developing novel antibody-based cancer immunotherapies, utilizing computational biology and artificial intelligence [3] - The company has established strategic collaborations with global partners to enhance its SAFEbody precision masking technology [3] Technology and Pipeline - Adagene's proprietary Dynamic Precision Library (DPL) platform includes NEObody™, SAFEbody, and POWERbody™ technologies, aimed at addressing safety and tolerability issues in antibody therapeutics [4] - The SAFEbody technology allows for tumor-specific targeting of antibodies while minimizing toxicity to healthy tissues [4] Clinical Programs - The lead clinical program, ADG126 (muzastotug), is an anti-CTLA-4 SAFEbody currently in phase 1b/2 studies, focusing on Metastatic Microsatellite-stable Colorectal Cancer [5] - ADG126 targets a unique epitope of CTLA-4 in regulatory T cells within the tumor microenvironment and is being studied in combination with anti-PD-1 therapy [5] Upcoming Presentation Details - The poster presentation titled "Safety and Efficacy of ADG126 (an Anti-CTLA-4 Masking Antibody) in Combination with Pembrolizumab" will take place on May 31, 2025, at ASCO 2025 [7]