Tokyo, Japan, August 05, 2026 - United Immunity, Co., Ltd., a biotech company developing a Myeloid Targeting Platform™ for the next generation immunotherapies, today announced the initiation of a first-in-human Phase 1/2 clinical trial of UI-102, its innovative therapy designed to reprogram the tumor immune environment. UI-102, a TLR7/8 agonist encapsulated in a pullulan nanoparticle, selectively converts immunosuppressive M2-like tumor-associated macrophages (TAMs) into immune-activating M1-like TAMs, consequently turning “cold” tumors into “hot” tumors responsive to immunotherapy.
The multi-center US study (ClinicalTrials.gov Identifier: NCT07605962) plans to enroll patients with advanced and/or metastatic solid tumors. Preclinical studies showed strong anti-tumor activity as a single agent and enhanced efficacy with checkpoint inhibitors in resistant tumor models, with a favorable safety profile in non-human primates.
“UI-102 has the potential to become a best-in-class treatment for patients unresponsive to current immunotherapies,” said Kenji Hashimoto, MD, PhD, Chief Medical Officer. “By selectively targeting M2-like TAMs, UI-102 aims to activate the immune system in cold tumors while minimizing systemic immune risks such as cytokine release syndrome associated with TLR7/8 agonists.”
About United Immunity Co., Ltd.
Unite the power of immunity and nanoparticle, change the future of patients
United Immunity is an innovative biotech company developing a Myeloid Targeting Platform™ comprising of pullulan nanoparticle (PNP) and PEG-free, pullulan-coated lipid nanoparticle (P-LNP) to target therapeutic payloads (small molecules, nucleic acids, peptides, proteins, etc.) to disease-associated macrophages and dendritic cells for the treatment of cancer, fibrosis, infectious diseases, autoimmune diseases, and inflammatory diseases. The company's lead program, UI-102, applies PNP to deliver a TLR7/8 small molecule agonist to tumor-associated macrophages and transform refractory cold tumors into immunoresponsive hot tumors. The company is also applying its P-LNP to generate in vivo CAR-macrophages for the treatment of cancer and autoimmune diseases. PDF