Immune-Onc Therapeutics Announces First Patient Dosed in Phase I Trial Evaluating IO-202, a First-In-Class Antibody for the Treatment of Acute Myeloid Leukemia

Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a cancer immunotherapy company focused on developing first-in-class biotherapeutics that target novel immunosuppressive myeloid checkpoints, announced today that the first patient has been dosed in its Phase I study evaluating IO-202, a first-in-class antibody targeting leukocyte immunoglobulin-like receptor B4 (LILRB4, also known as ILT3). The Phase I dose escalation and expansion trial will evaluate IO-202 in patients with acute myeloid leukemia (AML) with monocytic differentiation and in chronic myelomonocytic leukemia (CMML).

IO-202 is the first T-cell activator for AML. In preclinical studies, IO-202 has shown evidence of activating T cell cytotoxicity against leukemia cells and blocking leukemia infiltration.

“I am thrilled that we’ve met this important goal and with the support of our investigators are one step closer to bringing a new approach to the treatment of blood cancers, AML and CMML,” said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. "As we learn more about myeloid cell biology and its role in cancer, we see opportunities to explore the potential of IO-202 and other novel antibodies in other types of cancer, including solid tumors, in the near future.”

The dose-escalation phase of the trial will 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. In August, the company announced it had been awarded a Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) to support development of IO-202.

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, also known as ILT3), an immune inhibitory receptor, with high binding affinity and specificity. In October 2018, Immune-Onc and The University of Texas published 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.

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 (also known as ILT3), is being developed to treat acute myeloid leukemia and other cancers. IO-202 is the first T-cell activator for AML. In September 2020, Immune-Onc initiated a Phase I trial evaluating IO-202 in blood cancers, AML and CMML. The company plans to evaluate IO-202 in other blood cancers and solid tumors in the future. Immune-Onc’s preclinical pipeline includes IO-108, an antibody targeting LILRB2 (also known as ILT4) in IND-enabling studies, an anti-LAIR1 antibody, and multiple undisclosed programs for solid tumors and hematologic malignancies. For more information, please visit www.immune-onc.com and follow us on Twitter and LinkedIn.

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