NEW YORK – Immune-Onc Therapeutics on Thursday said that the US Food and Drug Administration has cleared its investigational new drug application for IO-108, allowing it to begin a Phase I trial evaluating the LILRB2-targeting antagonist antibody as a treatment for various solid tumors.
The Palo Alto, California-based company is poised to begin a Phase I multicenter trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and the recommended Phase II dose of IO-108, both as a single agent and in combination with the checkpoint inhibitor pembrolizumab (Merck's Keytruda). Investigators will look for early efficacy signals as well as biomarkers that may inform the design of future trials and shed light on the biological mechanisms underlying patients' responses.
Once Immune-Onc determines the recommended Phase II dose of IO-108, the firm will study the efficacy, safety, and tolerability of IO-108 and the IO-108-pembrolizumab combination in specific tumor indications.
LILRB2 is expressed on myeloid cells such as monocytes, dendritic cells, macrophages, and neutrophils. IO-108 is designed to block the interaction between LILRB2 and immune-suppressing ligands such as HLA-G, ANGPTL, SEMA4A, and CD1d. In preclinical studies, IO-108 treatment resulted in enhanced pro-inflammatory responses and anti-tumor immunity and demonstrated to Immune-Onc that the drug could benefit patients with solid tumors who are resistant to checkpoint inhibitors, as well as those who are sensitive to these agents.
"The clearance of the IO-108 IND represents another major milestone for Immune-Onc as we progress our pipeline of novel myeloid checkpoint inhibitors targeting the LILRB family of immune inhibitory receptors," Immune-Onc CEO Charlene Liao said in a statement.