Adagene(US:ADAG)2024-11-07 15:10Safety and Efficacy of ADG126 - ADG126 (Muzastotug) demonstrated improved safety and efficacy profiles compared to ipilimumab, driven by precision masking and enhanced antibody-dependent cellular cytotoxicity (ADCC) [1] - The rate of Grade 3 and higher treatment-related adverse events (TRAEs) for ADG126 in combination with pembrolizumab was significantly lower than historically reported rates for other anti-CTLA-4 therapies [6] - Repeat dosing of ADG126 at 10 mg/kg in combination with pembrolizumab showed encouraging clinical efficacy and well-tolerated safety, supporting its potential as a best-in-class anti-CTLA-4 therapy [7] Clinical Trial Results - The clinical trial for ADG126 in combination with pembrolizumab showed durable disease control and early survival benefits in patients with advanced MSS CRC, with a dose-dependent efficacy observed [5] - One patient in the trial experienced an 80% decrease in target lesions after treatment with ADG126 and pembrolizumab, correlating with a 100% decrease in carcinoembryonic antigen (CEA) levels [6] Dosing Regimen and Future Studies - A single dose of ADG126 at 10 mg/kg resulted in a three-fold increase in active drug exposure in tumor tissue compared to ipilimumab at 1 mg/kg, while maintaining similar plasma active drug levels [6] - Adagene is evaluating a new dosing regimen of ADG126 at 20 mg/kg followed by a 10 mg/kg maintenance dose in combination with pembrolizumab, with data expected in 2025 [7] Technology and Platform - The unique epitope of ADG126 allows for cross-reactivity across species, enhancing pharmacokinetic modeling and tumor-specific engagement of CTLA-4 [3] - The ongoing clinical studies validate the SAFEbody platform's applicability to various antibody-based therapeutic modalities, including antibody-drug conjugates [11] - Adagene's SAFEbody technology aims to minimize on-target off-tumor toxicity while enabling tumor-specific targeting in the tumor microenvironment [10]