Adagene (ADAG) investor relations material

Platform and technology differentiation

• AI-driven protein engineering enables the creation of novel masked antibodies with enhanced conformational diversity and epitope targeting.

• Lead compound ADG126 binds a unique CTLA-4 epitope, showing up to 10x stronger ADCC than first-generation antibodies.

• Proprietary masking technology expands the therapeutic window, allowing higher, safer dosing and reducing toxicity in combination regimens.

• Masking is protease-sensitive, requiring both high protease and CTLA-4 expression for activation, enhancing tumor selectivity.

• Strong masking efficiency (3-4x higher than some competitors) prevents off-target effects until activation in the tumor microenvironment.

Clinical data and treatment landscape

• MSS-CRC represents 95% of colorectal cancer cases, with non-liver metastasis patients as a key target subgroup.

• ADG126 plus pembrolizumab shows a confirmed response rate of 29% at high dose, with low grade 3 toxicity (<20%) and no grade 4/5 events.

• Median overall survival in lower dose cohorts is 19 months, outperforming standard of care regimens (10–15 months).

• Higher dose cohorts demonstrate dose-dependent efficacy, with improved response rates and durability.

• Physicians are excited by the potential for a chemo-free immunotherapy regimen with high response and tolerability.

Regulatory and development strategy

• Accelerated approval via single-arm studies is no longer viable; randomized phase 2 (60 patients, two dose levels) will inform pivotal phase 3.

• Phase 2 initiation is planned before year-end, with global enrollment and key sites in the US, South Korea, and China.

• Phase 3 will use overall survival as the primary endpoint, aligning with recent FDA guidance.

• FDA has been supportive, allowing a streamlined phase 2 design without monotherapy arms.

• H2 2026 is a potential milestone for phase 2 completion.