Adagene (ADAG) investor relations material

Lead asset and platform overview

• ADG126, a masking CTLA-4 antibody, leverages proprietary SAFEbody technology for improved safety and higher dosing potential compared to first-generation CTLA-4 inhibitors.

• The platform enables activation of the antibody in the tumor microenvironment, allowing dosing up to 20 mg/kg, significantly higher than historical CTLA-4 therapies.

• Discontinuation rates due to adverse events remain below 10%, supporting a favorable tolerability profile.

Clinical data and development progress

• In late-line microsatellite stable colorectal cancer, confirmed response rates between 15% and 36% were observed, outperforming historical controls.

• Median overall survival in high-dose cohorts approached 20 months, with a 48% 24-month survival rate.

• Grade 3 adverse events at the highest dose (20 mg/kg) reached 50% in a small cohort, but no discontinuations occurred due to adverse events.

• Ongoing randomized phase II (Project Optimus) tests two dosing regimens in combination with pembrolizumab, aiming to replicate phase I-B results.

• Key endpoints include response rate, duration of response, and progression-free survival, with pivotal dose selection based on totality of data.

Regulatory and future trial plans

• Advancement to phase III requires phase II data and an end-of-phase II meeting with the FDA to finalize trial design.

• Phase III is expected to be a randomized trial comparing ADG126 plus KEYTRUDA to standard-of-care regimens, with overall survival as the primary endpoint.

• A co-primary endpoint of response rate may be considered for interim analysis and potential accelerated approval.