Adagene (ADAG) H.C. Wainwright 4th Annual Immune Cell Engager Virtual Conference summary

Pipeline and muzastotug

• Muzastotug is a masked anti-CTLA-4 designed to deplete intratumoral Tregs; clinical studies span monotherapy and combinations, with more than 250 patients treated.

• In first-line HCC, a randomized Roche study of muzastotug plus atezolizumab showed ORR nearly double or triple the doublet control; OS remained unreached after more than two years, versus ~18 months for control.

• In MSS CRC, 10 and 20 mg/kg cohorts support repeat dosing at 10–20x the ipilimumab dose; updated 20 mg/kg ORR, DOR and OS data are expected before the Phase II readout.

• Muzastotug plus pembrolizumab in neoadjuvant settings was highlighted as an early opportunity for Treg-depleting CTLA-4 therapy.

SAFEbody platform and ADG138

• SAFEbody differentiation centers on precision masking tailored to antibody binding interfaces and controlled activation in the tumor microenvironment.

• ADG138 is a dual-masked HER2×CD3 T-cell engager; HER2 and CD3 masks provide 200-fold and 100-fold masking, respectively, with ~300-fold difference versus unmasked drug in monkey studies.

• China clinical clearance was received in September 2026, with first-in-human dosing expected in 2026; preclinical HER2-low tumor models showed complete responses at 0.1 mg/kg.

• Dose escalation will assess safety, activation, dose levels and frequency; emerging Phase I safety and early efficacy data are expected as the trial progresses.

Autoimmune T-cell engager programs

• A masked-CD3/CD20 engager showed robust peripheral and tissue B-cell depletion with significantly reduced CRS, potentially enabling doses otherwise difficult to reach.

• Novel multi-target T-cell engager designs are in development for deeper B-cell depletion; collaborations are being considered to advance these programs.