Adagene(US:ADAG)2025-09-08 16:02Summary of Adagene Inc. Conference Call Company Overview - Company: Adagene Inc. - Industry: Biopharmaceuticals, specifically focused on antibody therapies for cancer treatment - Key Technologies: NEObody™, SAFEbody®, POWERbody™ Current Pipeline - Lead Program: ADG126, a novel masked anti-CTLA-4 antibody - Mechanism: Enhanced antibody-dependent cellular cytotoxicity (ADCC) and improved therapeutic index due to proprietary masking technology - Dosing: Currently dosing patients at 20 mg/kg every six weeks, up from an initial 10 mg/kg every six weeks [3][8] SAFEbody® Technology - Mechanism: Protease-sensitive masking technology that activates in the tumor microenvironment, requiring high levels of specific proteases and target expression [4][8] Collaboration with Sanofi - Investment: Sanofi made an equity investment of up to $25 million, with $17 million received at signing [5][6] - Collaboration: Expanded partnership includes a trial collaboration for a phase 1B/2 study evaluating a bispecific antibody in combination with ADG126 in solid tumors, targeting over 100 patients [6] Clinical Data and Safety - Safety Profile: Low discontinuation rate due to toxicity, allowing patients to receive multiple treatment cycles [9][10] - Response Rates: - 20 mg/kg cohort shows a response rate in the high 20% range - Median overall survival of 19 months compared to standard care's 10-12 months [12][10] - Confirmed overall response rate (ORR) at 29% for the 20 mg/kg cohort [12] Future Data Expectations - Next Data Update: Expected in early 2026 for phase 1B data set in combination with Keytruda [11] FDA Alignment - Phase 2 Trial Design: Randomized trial with two dosing levels (10 mg/kg and 20 mg/kg) to identify optimal dose for future phase 3 trials [13][15] Treatment Landscape - Potential Impact: If ADG126 shows a response rate above 20%, it could be clinically differentiated from current standard care, which has a median overall survival of 10-12 months [17][18] Pipeline Beyond ADG126 - Other Programs: ADG138, a double masker HER2/CD3 engager, is IND-ready and shows strong preclinical activity [22][24] Major Catalysts - Upcoming Data: More mature data from phase 1B expected in early 2026, including potential triplet combination data [26] - Business Development: Ongoing discussions for additional trial collaborations following positive data presentations [26] Financial Position - Cash Position: $63 million at the end of June, increased by $17 million from Sanofi investment, funding operations into 2027 [27]