Adagene (ADAG) investor relations material

Company overview and technology

• Focuses on developing novel antibodies, including masked monoclonal antibodies, T-cell engagers, and ADCs, with proprietary masking technology SAFEbody.

• Lead program ADG126 (muzastotug) is a masked anti-CTLA-4 antibody showing improved therapeutic index over first-generation CTLA-4 inhibitors.

• SAFEbody technology offers high masking efficiency, reducing off-target binding until the mask is cleaved in the tumor microenvironment.

• Pipeline includes masked T-cell engagers such as ADG138, a dual masked HER2 CD3 engager.

Clinical data and differentiation

• ADG126 demonstrates up to 10x potency over ipilimumab without Fc engineering and can be dosed up to 20 mg/kg.

• Achieves higher response rates (25%-36%) in combination with pembrolizumab in MSS-CRC patients without liver metastasis, compared to standard of care and first-generation checkpoint inhibitors.

• Lower rates of serious adverse events and dose discontinuation observed despite high dosing.

• Efficacy is dose-dependent, with higher doses correlating to better outcomes.

Clinical development strategy

• Randomized phase II trial underway, testing two dose levels of ADG126 with pembrolizumab in 60 patients; primary endpoint is response rate.

• Phase III trial design would likely use overall survival as the primary endpoint, with physician's choice of therapy as control; co-primary endpoints (OS and response rate) considered as an upside scenario.

• Triplet therapy with ADG126, pembrolizumab, and fruquintinib shows promising safety and efficacy trends, with potential expansion to liver metastasis patients.