Adagene (ADAG) Morgan Stanley 22nd Annual Global Healthcare Conference summary

Scientific and clinical strategy

• Focus on novel epitope targeting and masking technology to enhance antibody-based cancer immunotherapies, specifically for CTLA-4, enabling higher ADCC effect and robust translational research.

• SAFEbody masking technology allows targeted delivery of antibodies to tumor tissues and T-regulatory cells, reducing off-target effects.

• CTLA-4 is chosen for its proven survival benefit in combination with PD-1, offering long-term benefit and low recurrence in cancer therapy.

Lead program and clinical data

• Lead program ADG126 targets metastatic microsatellite stable colorectal cancer (MSS CRC), a large population with high unmet need due to poor response to current immunotherapies.

• Combination of anti-CTLA-4 and PD-1 shows tumor response rates around 20% and promising progression-free survival (PFS), with data to be presented at ESMO.

• Dose escalation studies indicate a strong dose-dependent disease control rate, with 10 mg/kg Q3W showing confirmed ORR of about 20% and PFS of seven months.

• Safety profile at higher doses is favorable, with low grade 3 toxicity and manageable late-onset toxicity, supporting further dose exploration.

Trial design and patient selection

• Trials focus on liver metastasis-free and peritoneal metastasis-free populations to allow sufficient time for immunodoublet therapies to show benefit.

• Exclusion of aggressive metastasis types enables more cycles of therapy and better outcomes; combining with standard therapies could broaden eligible populations.

• Ongoing expansion cohorts and new studies include a 20 mg/kg loading dose and a 30 mg/kg monotherapy trial in China, pushing dosing boundaries.