Adagene(US:ADAG) Globenewswireยท2025-07-15 11:00Core Insights - Adagene Inc. has received FDA feedback on its clinical development plan for ADG126 in combination with Merck's KEYTRUDA for treating microsatellite stable colorectal cancer [2][4] - The company plans to begin patient enrollment for Phase 2 trials in the second half of 2025 [1] Company Overview - Adagene is a clinical-stage biotechnology company focused on developing novel antibody-based cancer immunotherapies using its SAFEbody technology [7][10] - The company's lead program, ADG126, is designed to target regulatory T cells in the tumor microenvironment [10] Clinical Development - ADG126 is currently in Phase 1b/2 clinical studies, with over 150 patients enrolled to date [3][10] - The Phase 2 trial will randomize patients to receive either 10 mg/kg or 20 mg/kg of ADG126 in combination with pembrolizumab, without cycle limitations [7] - The primary endpoint for the Phase 2 trial is overall response rate (ORR), with secondary endpoints including duration of response (DOR), progression-free survival (PFS), and overall survival (OS) [7] FDA Interaction - The FDA has endorsed the exploration of ADG126 at doses significantly higher than other anti-CTLA-4 antibodies, showing a nearly two-fold increase in ORR from 17% at 10 mg/kg to 29% at 20 mg/kg [5][6] - The FDA has agreed with the proposed standard-of-care control arm for the Phase 3 trial, confirming that an ADG126 monotherapy arm is not required [7] Future Directions - The company aims to identify a single optimized dose for the Phase 3 trial, which is a critical step towards obtaining FDA approval [6][7] - Future trials will focus on late-line patients with MSS CRC without liver metastases [7]