Adagene (ADAG) Stifel 2025 Virtual Targeted Oncology Forum summary

Company and technology overview

• Focus on developing best-in-class anti-CTLA-4 therapies with unique SAFEbody masking technology, enabling targeted activation in disease tissues and improved safety profiles.

• Pipeline includes phase 2 masked anti-CTLA-4, masked 4-1BB, and T-cell engagers, with technology licensed to partners for ADC and TCE development.

• SAFEbody technology allows for systemic delivery and activation only in disease tissues, reducing toxicity and enabling novel drug combinations.

• Collaborations with Sanofi and Exelixis leverage the platform for additional therapeutic modalities.

• Cash balance and financial stability were highlighted.

Clinical and preclinical data highlights

• Anti-CTLA-4 SAFEbody shows promising safety and efficacy in combination with Keytruda for MSS CRC, a cold tumor with limited immunotherapy options.

• Preclinical models demonstrate high Treg depletion in tumors, improved T effector/Treg ratios, and manageable toxicity at higher doses compared to existing therapies.

• Human PK modeling indicates rapid achievement of steady-state drug levels in tumors with a 20 MPK loading dose, supporting higher response rates.

• Lower discontinuation and toxicity rates compared to traditional anti-CTLA-4 therapies, enabling higher dosing regimens.

• Tenfold higher ADCC effect over existing therapies without Fc engineering, supporting enhanced tumor targeting.

Strategic focus and future plans

• Emphasis on targeting non-liver metastasis MSS CRC patients for immunotherapy, with combination strategies for liver metastasis populations.

• Ongoing and planned trials to further evaluate safety and efficacy in broader patient populations, including combination with standard therapies.

• Upcoming data releases include OS data for various dosing regimens and regulatory updates on registration trial design and patient selection.

• Plans to update on duration of response and new dosing regimens, including 20 MPK Q6W.