Adagene (ADAG) Stifel 2026 Targeted Oncology Virtual Forum summary

Company and technology overview

• Focus on developing novel masked antibodies, including monoclonal T-cell engagers and ADCs, with proprietary SAFEbody masking technology for improved therapeutic index.

• Lead program ADG126 (muzastotug), a masked anti-CTLA-4, shows 10x potency over ipilimumab without Fc engineering and high masking efficiency.

• SAFEbody technology reduces off-target binding and enhances cleavage specificity, differentiating it from other masking approaches.

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

Clinical development and data highlights

• ADG126 is dosed up to 20 mg/kg, with response rates of 25–36% in combination with pembrolizumab in late-line MSS-CRC patients without liver metastasis.

• Lower dose (10 mg/kg) yields 0–17% response rate, highlighting dose dependency.

• Serious adverse events and discontinuations are lower than peers, supporting a favorable safety profile at high doses.

• Combination with fruquintinib and pembrolizumab in triplet therapy shows higher response rates at higher ADG126 doses, with potential for use in liver metastasis patients.

Strategic collaborations and future plans

• Ongoing randomized phase II trial (1:1, 60 patients) tests two ADG126 doses with pembrolizumab; primary endpoint is response rate, informing future registrational phase III design.

• Collaboration with Incyte to combine ADG126 with a PD-1/TGF-β bispecific, aiming to address resistance mechanisms in MSS-CRC, including liver metastasis.

• Strategic partnership with Sanofi includes discovery, equity investment, and a trial evaluating ADG126 with Sanofi's PD-1/IL-15 conjugate in over 100 solid tumor patients.

• Preliminary data in HCC (liver cancer) shows safe combination with atezolizumab-bevacizumab and trends toward improved outcomes; higher ADG126 doses are being considered.

• NSCLC identified as a potential future indication, though no immediate plans to advance.