Summary of Adagene (ADAG) Conference Call Company Overview - Adagene is focused on developing bio-better molecules, with its lead program being ADG-126, a masked anti-CTLA-4 therapy targeting microsatellite stable (MSS) colorectal cancer without liver metastasis [3][4] Key Data and Efficacy - At the ASCO conference, Adagene presented updated data showing a confirmed overall response rate (ORR) of 29% for ADG-126 at a dose of 20 mg/kg, with all responses ongoing [9] - The safety profile is reported as manageable, with no patients discontinuing due to adverse events, and less than 20% experiencing grade 3 adverse events [9][10] - In comparison, standard therapies for MSS colorectal cancer show a mid-single-digit response rate and a median overall survival (OS) of around 12 months [5][11] - Competitors like Agenus reported an ORR of 19% and a median OS of approximately 20 months, but with a 34% discontinuation rate due to adverse events [6][9] Safety Profile - The grade 3 adverse events reported were transient and involved immune-related adverse events, with only two cases out of twelve patients in the cohort [20][21] - The cohort also included patients with peritoneal involvement, which was previously excluded [23] Regulatory and Future Plans - Adagene plans to provide an update on regulatory interactions by Q3 2025 and is optimistic about the potential for a safe regimen with a high response rate [18][29] - The company is currently enrolling patients for a combination therapy involving ADG-126, pembrolizumab, and standard care, including patients with liver metastasis [25][26] Market Opportunities - The estimated incidence of MSS colorectal cancer without liver metastasis in the US is around 10,000 patients, while the neoadjuvant setting for stage II and III patients exceeds 100,000 [27] - Adagene is exploring the potential of ADG-126 in other tumor types, leveraging the efficacy of CTLA-4 in various indications [31][32] Pipeline and Future Catalysts - Adagene has preclinical assets, including a HER2 CD3 engager, which is IND ready and could enter clinical trials soon [34] - Upcoming catalysts include updates from the 20 mg/kg cohort, regulatory feedback, and preliminary data from a phase two trial in neoadjuvant colorectal cancer [36][37] Conclusion - Adagene is positioned to make significant advancements in the treatment of MSS colorectal cancer with its innovative therapies and is actively pursuing regulatory approvals and market expansion opportunities [38]