LG Chem's immuno-oncology drug wins domestic phase 1 approval

LG Chem's independently developed next-generation immuno-oncology drug LB-LR1109 will enter into phase I clinical trials in Korea.

Last Thursday, the Ministry of Food and Drug Safety (MFDS) approved a phase 1 clinical trial, in which LG Chem's immune checkpoint inhibitor candidate LB-LR1109 will be administered to humans for the first time.

The trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and pharmacodynamics of LB-LR1109 in advanced or metastatic solid tumors at six medical institutions -- Seoul National University Hospital, Seoul National University Bundang Hospital, National Cancer Center, Severance Hospital, Asan Medical Center, and Samsung Medical Center.

Previously, LG Chem confirmed the dose-dependent anticancer effect of LB-LR1109 in animal models of solid tumors. Based on this, the company received an IND from the U.S. Food and Drug Administration last December and began recruiting patients for phase 1 trials in May this year.

LB-LR1109, developed by LG Chem, is a single antibody drug candidate that inhibits LILRB1, an immune system evasion (immune gateway) signaling molecule expressed on various immune cells, and HLA-G, a protein expressed on cancer cells that prevents immune cells from attacking them, by interfering with the binding of LILRB1 and HLA-G, which simultaneously activates the overall function of immune cells in the body.

"The target protein, LILRB1, is commonly expressed on the surface of many immune cells, including natural killer (NK) cells and macrophages (phagocytic cells), as well as T cells, which are representative immune cells," LG Chem said. "In this respect, LB-LR1109 is differentiated from existing immune checkpoint inhibitors that focus on the action of a single immune cell, such as T cells."

The trial will allow LG Chem to determine the maximum tolerated dose (MTD) of LB-LR1109 and the RP2D for entry into a phase 2 clinical trial.

The primary endpoints are the number of participants with dose-limiting toxicities (DLTs) and the incidence of treatment-emergent adverse events. The secondary endpoints are overall response rate (ORR), progression-free survival (PFS), and overall survival (OS). The target primary study completion date is November 2025 with the completion deadline of February 2027.