Immune-Onc Therapeutics Announces FDA Clearance of IND Application to Initiate Trial of IO-202, a First-in-Class Myeloid Checkpoint Inhibitor Targeting LILRB4, in Patients with Advanced Solid Tumors

– Multicenter Phase 1 study to evaluate IO-202 as monotherapy and in combination with an anti-PD-1

Excerpt from the Press Release:

PALO ALTO, Calif.–(BUSINESS WIRE)–Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting immunosuppressive myeloid checkpoints, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for IO-202, a first-in-class antibody targeting leukocyte immunoglobulin-like receptor B4 (LILRB4, also known as ILT3), for the treatment of solid tumors.

Myeloid cells are abundant and often immune suppressive in the solid tumor microenvironment. The LILRB4 receptor is expressed on monocytic myeloid cells, including dendritic cells, and contributes to a tolerogenic myeloid cell phenotype, resulting in decreased tumor immune surveillance. In preclinical data presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting, IO-202 was found to enhance dendritic cell function and T cell activation in vitro and promote anti-tumor immunity in a solid tumor model in vivo. These data provided a strong rationale to evaluate the therapeutic potential of IO-202 as a myeloid checkpoint inhibitor in solid tumors.

“The FDA clearance to begin our Phase 1 study for IO-202 in solid tumors is a major milestone for Immune-Onc, which represents the third IND for our pipeline and the second for IO-202,” said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. “We know that high LILRB4 expression on myeloid cells infiltrating solid tumors contributes to tumor immune evasion. IO-202 is a first-in-class myeloid checkpoint inhibitor targeting LILRB4, which may provide therapeutic benefit to multiple solid tumor types where evasion of the immune system allows disease to progress and create resistance to therapy, including to T cell checkpoint inhibitors. We look forward to advancing IO-202 into the clinic to evaluate its potential as a monotherapy and in combination with an anti-PD-1 in patients with solid tumors.

The Phase 1, multicenter, dose-escalation and dose expansion study will consist of a monotherapy cohort and a combination therapy cohort to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IO-202 alone and in combination with pembrolizumab, an anti-PD-1 antibody, followed by indication-specific expansion cohorts to be treated with IO-202 in combination with pembrolizumab at the recommended Phase 2 dose. Various biomarkers will be assessed to enable a mechanistic understanding of clinical data and inform future trials. This study may also provide an opportunity to identify preliminary efficacy signals.

ABOUT LILRB4 (also known as ILT3)

LILRB4, also known as ILT3, is an immune inhibitory transmembrane protein found on monocytic myeloid cells, including dendritic cells. LILRB4 inhibits antigen-presenting cell activation, resulting in immune tolerance. LILRB4 is also expressed on certain hematologic cancer cells and monocytic myeloid cells in the solid tumor microenvironment.

Click the button below to read the entire Press Release:

Continue Reading The Press Release