On May 29, 2020 Immune-Onc Therapeutics, Inc. ("Immune-Onc"), a clinical-stage cancer immunotherapy company, reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for IO-202, an antibody targeting an immune inhibitory receptor LILRB4 (Press release, Immune-Onc Therapeutics, MAY 29, 2020, View Source [SID1234558724]). IO-202 is the first T-cell activator for acute myeloid leukemia (AML). In preclinical studies, IO-202 has shown evidence of activating T cell cytotoxicity against leukemia cells and blocking tumor infiltration. Immune-Onc’s first Phase 1 trial with IO-202 will evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity in AML patients with monocytic differentiation and in chronic myelomonocytic leukemia (CMML) patients.
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"The FDA clearance to proceed with the first-in-human trial of IO-202 in AML and CMML is an important milestone for our company," said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. "Acute myeloid leukemia is a devastating disease that needs new approaches and better treatment options. We look forward to working with investigators as we advance the first anti-LILRB4 antibody into the clinic."
The Phase 1 trial will begin with a dose-escalation phase to identify the optimal dose of IO-202. Once the recommended dose of IO-202 is selected, the trial will enroll patients in an expansion cohort to evaluate IO-202 as monotherapy. There is potential to evaluate IO-202 in combination with other agents with a protocol amendment. Biomarkers will be assessed to enable a mechanistic understanding of clinical data and inform future trials.
ABOUT AML and CMML
AML, the most common acute leukemia (blood and bone marrow cancer) in adults, is characterized by the proliferation of abnormal myeloblasts (a type of white blood cell) in the bone marrow. Nearly 20,000 new cases are expected in the U.S. in 2020. Despite advances in treatment, less than 30 percent of acute myeloid leukemia patients are alive five years after initial diagnosis.
CMML is a cancer that starts in blood-forming cells in the bone marrow and invades the blood. The condition is rare, with about 1,100 cases in the U.S. each year.
ABOUT IO-202
IO-202 is a first-in-class monoclonal antibody that blocks signaling of leukocyte immunoglobulin-like receptor B4 (LILRB4), an immune inhibitory receptor, with high binding affinity and specificity. In October 2018, Immune-Onc and The University of Texas announced the publication of pioneering research in Nature (DOI: 10.1038/s41586-018-0615-z) illuminating the roles of LILRB4 in immune suppression and tumor infiltration in AML. IO-202 is the first T-cell activator for AML. Preclinical studies showed that IO-202 can convert a "don’t kill me" to "kill me" signal by activating T cell killing of AML cells and a "don’t find me" to "find me" signal by inhibiting leukemia infiltration. IO-202 will be evaluated in AML and CMML in a Phase 1 trial, and Immune-Onc plans to explore its potential in other hematologic malignancies and solid tumors in future trials.