On June 13, 2024 LG Chem and AVEO Oncology, an LG Chem company, reported that it has enrolled the first patient in the United States for a Phase 1 clinical study of LB-LR1109 (NCT06332755; LG project code LR19155), LG Chem’s first proprietary anti-cancer investigational drug candidate (Press release, LG Chem, JUN 13, 2024, View Source [SID1234644316]). LG Chem will be collaborating closely with AVEO Oncology, its wholly owned subsidiary, that specializes in oncology development and commercialization, to advance strategies for late-stage clinical development and regulatory approval.
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This is a Phase 1, multi-center, open-label, non-randomized, dose escalation study designed to determine the recommended Phase 2 dose of LB-LR1109 and to evaluate safety, tolerability, preliminary efficacy, pharmacokinetics, immunogenicity, and pharmacodynamics of LB-LR1109, and its potential impact on quality of life. The study is evaluating participants with unresectable and metastatic non-small cell lung cancer, head and neck squamous cell carcinoma, renal cell carcinoma, urothelial carcinoma, or malignant melanoma who have progressed on standard of care treatment options.
In preclinical studies of LB-LR1109, LG Chem observed dose-dependent anti-cancer effects. Subsequently, the company received approval for an Investigational New Drug application from the U.S. Food and Drug Administration (FDA) in December last year.
Leukocyte Immunoglobulin Like Receptor B-1 (LILRB1), a protein released by cancer cells to prevent immune cell attacks, is commonly expressed on the surfaces of several immune cells, including T cells, natural killer cells (NK cells), and macrophages (phagocytic cells). This mechanism is believed to work by activating the tumor-eradicating cells such as T cells, NK cells, and macrophages simultaneously.i This simultaneous activation of overall immune cell functions may differentiate it from existing therapies that focus on single immune cells like T cells.
"We are excited to partner with LG Chem on their first proprietary anti-cancer compound," said Dr. Alex Spira, Director of Next Oncology of Virginia Cancer Specialists Research Institute and the Phase 1 Trial Program. "There is a high unmet need for patients that have progressed on standard of care treatment which necessitates the need to explore novel immune checkpoint inhibitors such as LB-LR1109."
Jeewoong Son, MD, President of LG Chem Life Sciences Company, stated, "We are focusing all our capabilities to provide innovative treatments that will be recognized by medical professionals and patients, as we aim to improve the lives of patients with cancer. While this is the first oncology compound from LG Chem, we are developing a robust pipeline that target novel oncology targets. We will continue to offer differentiated treatment options in the oncology field, where there is the greatest unmet medical need."
The advancement of this program into the clinic brings LG Chem and AVEO Oncology one step closer to realizing our vision of becoming one of the world’s leading oncology companies with a robust clinical pipeline of innovative therapies.