Adagene Announces FDA Fast Track Designation for Muzastotug (ADG126)

Core Insights - The FDA has granted Fast Track Designation to Adagene's muzastotug in combination with Merck's KEYTRUDA® for treating adult patients with microsatellite stable metastatic colorectal cancer (MSS mCRC) without active liver metastases, highlighting the potential of this therapy to meet an unmet medical need [1][2][3] 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 create innovative therapies [4][7] - The company employs its proprietary SAFEbody technology to enhance the safety and efficacy of antibody therapies by targeting the tumor microenvironment while minimizing systemic toxicity [6][7] Clinical Development - Muzastotug is a next-generation masked anti-CTLA-4 SAFEbody designed to overcome Treg resistance in tumors, showing promising efficacy and safety in heavily pretreated patient populations [2][3] - The ongoing Phase 2 trial will evaluate muzastotug in combination with pembrolizumab, with a focus on late-line patients with MSS CRC without liver metastases [5][7] - The primary endpoint for the Phase 2 trial is overall response rate (ORR), while the Phase 3 trial will focus on overall survival (OS) as the primary endpoint [5] Future Plans - Adagene plans to share updated topline Phase 1b/2 clinical data in the coming months and is preparing for a registration trial set to begin in 2027 [3][5]