SAN DIEGO and SUZHOU, China, Aug. 26, 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 Adagene’s Chief Strategy Officer, Mickael Chane-Du, will participate in one-on-one investor meetings and a fireside chat at two investor conferences in September, both taking place in New York, New York. H.C. Wainwright 27th Annual Global Investment Conference Fireside Chat Date: Mon ...

SAFEbody option exercised and up to US$25 million strategic investment by Sanofi, with cash runway extended into 2027 Sanofi will conduct a Phase 1b/2 trial in combination with ADG126 in over 100 patients Strengthened leadership team with key additions Partnered with ConjugateBio for development of bispecific ADCs Muzastotug (ADG126) Phase 1b/2 in MSS CRC shows 19.4-month median OS (mOS) in 10 mg/kg dose cohorts; mOS for 20 mg/kg cohorts has not yet been reached Alignment with FDA on Phase 2 and Phase 3 tri ...

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]