Tokyo, Japan, March 4, 2026 - United Immunity, Co., Ltd., a biotech company developing a Myeloid Targeting Platform™ for the next generation immunotherapies, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for UI-102.
UI-102 is a TLR7/8 agonist encapsulated in a pullulan nanoparticle (PNP) that selectively and actively targets macrophages and dendritic cells, notably M2-like tumor-associated macrophages (TAMs). TLR7/8 small molecule agonists have been shown to induce repolarization of immunosuppressive M2-like TAMs into immunoresponsive M1-like TAMs thereby promoting anti-tumor immune response. However, their clinical applications have been limited since systemic administration is associated with serious safety issues such as cytokine release syndrome. UI-102 aims to maximize therapeutic efficacy and reduce the risk of systemic immune activation by delivering the agonist primarily to tumors and M2-like TAMs.
"Most cancer patients do not respond to treatment with immunotherapies such as checkpoint inhibitors due to the immunosuppressive tumor microenvironment" commented Naozumi Harada, Scientific Founder and Chief Technology Officer. "UI-102 aims to convert treatment-resistant "cold" tumors into sensitive "hot" tumors. Masato Kishida, Chief Executive Officer, further states "this is an important milestone for the company since it brings years of research on our Myeloid Targeting Platform™ to the clinic".
A Phase 1/2 clinical trial will assess the safety, tolerability, and preliminary anti-tumor efficacy of UI-102 when administered as a monotherapy or in combination with checkpoint inhibitors in patients with advanced solid tumors. UI-102 showed strong single agent anti-tumor activity in various preclinical tumor models and also a clear synergism with checkpoint inhibitors in treatment-resistant tumor models. The company expects to initiate the study in April of this year. PDF