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 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]