UI-102 / United Immunity - LARVOL DELTA

Phase 1/2 Study of UI-102 in Selected Advanced Cancers (clinicaltrials.gov) - P1/2 | N=140 | Recruiting | Sponsor: United Immunity, co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Oncology • Solid Tumor

Phase 1/2 Study of UI-102 in Selected Advanced Cancers (clinicaltrials.gov) - P1/2 | N=140 | Not yet recruiting | Sponsor: United Immunity, co., Ltd.

First-in-human • New P1/2 trial • Oncology • Solid Tumor

A M2-like tumor-associated macrophage-targeted nanoparticulate TLR7/8 agonist, UI-102, reprograms its phenotypes to induce potent anti-tumor immunity (AACR 2026) - "Biodistribution and TAM accumulation were examined in an orthotopic mouse model, comparing UI-102 with resiquimod sulfate and the naked TLR7/8 agonist used in the UI-102 formulation. UI-102 exhibited broad and potent anti-tumor activity across diverse cancer models, correlating with the degree of myeloid/macrophage infiltration in the TME. UI-102 effectively targets and reprograms immunosuppressive TAMs to an M1-like phenotype, thereby unleashing a strong anti-tumor immune response. This unique mechanism positions UI-102 as a promising novel immunotherapeutic agent for a wide range of solid tumors. A first-in-human clinical trial of UI-102 in solid tumors is planned for initiation in Q1 2026."

First-in-human • Oncology • Solid Tumor • CD8