Roche Aligns with United Immunity on Master Clinical Supply Deal for mAb Checkpoint Inhibitor

Editor’s Take: The clinical supply agreement supports future studies to evaluate a TLR7/8 agonist in patients with advanced solid tumors.

United Immunity entered a master clinical supply agreement with Roche for Tecentriq (atezolizumab), a humanized anti-PD-L1 monoclonal antibody checkpoint inhibitor.

Programmed cell death ligand 1, or PD-L1, plays a role in certain malignancies by diminishing immune response to tumor cells. Most solid tumors do not respond to immune checkpoint inhibitors because their immunosuppressive tumor microenvironments limit anti-tumor immune activity.

Terms of Roche and United Immunity Pact

United Immunity’s agreement with Roche supports future clinical studies that evaluate UI-102, a toll-like receptor (TLR) 7/8 agonist. According to United Immunity, UI-102 reprograms immunosuppressive M2-like tumor-associated macrophages (TAMs) into pro-inflammatory M1-like TAMs.

The goal of this is to convert immunologically “cold” tumors—resistant to checkpoint inhibition—into “hot,” immune-responsive ones.

Preclinical Findings Encouraging, Clinical Trial Ongoing

United Immunity CEO Masato Kishida says in preclinical studies, UI-102 demonstrated enhanced anti-tumor activity in combination with immune checkpoint inhibitors. This compares with checkpoint inhibitor monotherapy in tumor models otherwise resistant to “checkpoint blockade.”

“We are pleased to collaborate with Roche to advance the development of UI-102 for patients with hard-to-treat cancers,” Kishida said. “[Preclinical] findings support potential of UI-102 to improve responses in patients with tumors not adequately treated with current immunotherapies.”

United Immunity is testing UI-102’s safety, tolerability, and efficacy in a Phase I/II first-in-human trial in patients with advanced solid tumors. The trial has been looking at UI-102 as both a monotherapy, and in combination with atezolizumab.