5 August 2020 - - US-based clinical-stage cancer immunotherapy company Immune-Onc Therapeutics, Inc has been awarded a Small Business Innovation Research Direct to Phase II grant from the National Cancer Institute of the National Institutes of Health, the company said.

The grant, in the amount of USD 2.14m over two years, will support development of IO-202, a first-in-class antibody targeting leukocyte immunoglobulin-like receptor B4 (LILRB4), for acute myeloid leukemia, the most common acute leukemia in adults, and for chronic myelomonocytic leukemia, a rare form of leukemia.

The highly competitive SBIR programmes enable small businesses to explore technological potential and pursue commercialization of innovations.

In May, Immune-Onc's IO-202 Investigational New Drug application received clearance from the US Food and Drug Administration.

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 I trial with IO-202 will evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity in AML patients with monocytic differentiation and in CMML patients.

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 US in 2020.

Despite advances in treatment, less than 30% 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 US each year.

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 I trial, and Immune-Onc plans to explore its potential in other hematologic malignancies and solid tumors in future trials.

Immune-Onc Therapeutics 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 programme 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.