Immune-Onc Therapeutics IND Application for First-In-Human Trial of IO-202, a Novel Antibody for the Treatment of Acute Myeloid Leukemia, Receives FDA Clearance

- Immune-Onc Expects Enrollment in its Phase 1 Trial to Begin in Q3 2020 -

Immune-Onc Therapeutics, Inc. ("Immune-Onc"), a clinical-stage cancer immunotherapy company, announced today 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. 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.

"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.

ABOUT IMMUNE-ONC THERAPEUTICS

Immune-Onc Therapeutics, Inc. ("Immune-Onc") is a clinical-stage cancer immunotherapy company dedicated to the discovery and development of novel biologic treatments for cancer patients. Headquartered in Palo Alto, California, Immune-Onc has assembled a diverse team with deep expertise in drug development and proven track records of success at leading biotechnology companies.

The company aims to translate unique scientific insights in myeloid biology and immune inhibitory receptors to discover and develop first-in-class biotherapeutics that target novel immunosuppressive myeloid checkpoints. Immune-Onc has a promising pipeline built upon strategic collaborations and cutting-edge research from The University of Texas, Albert Einstein College of Medicine, and Memorial Sloan Kettering Cancer Center.

Immune-Onc’s lead program IO-202, a first-in-class antibody targeting LILRB4, is being developed to treat acute myeloid leukemia and other cancers. IO-202 is the first T-cell activator for AML. Immune-Onc’s preclinical pipeline includes an anti-LILRB2 antibody, an anti-LAIR1 antibody, and multiple undisclosed programs for solid tumors and hematologic malignancies. For more information, please visit www.immune-onc.com.

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Contacts

Tara Cooper
The Grace Communication Group, LLC
media@immuneonc.com
650-303-7306