Immune-Onc Therapeutics Doses First Patient in Phase 1 Clinical Trial of IO-202, a First-in-Class Myeloid Checkpoint Inhibitor Targeting LILRB4, in Patients with Advanced Solid Tumors

– Phase 1 multicenter dose-escalation and dose-expansion trial evaluating IO-202 as a monotherapy and in combination with an anti-PD-1 is initiated and expected to enroll 200 patients with advanced solid tumors –

– This is the second clinical trial for the IO-202 program; its first Phase 1 trial is currently enrolling patients with acute myeloid leukemia (AML) or chronic myelomonocytic leukemia (CMML) as monotherapy and in combination with azacitidine –

– IO-202 is one of three first-in-class programs from Immune-Onc’s pipeline of myeloid checkpoint inhibitors targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB) of myeloid checkpoints –

PALO ALTO, Calif.--(BUSINESS WIRE)--#ILT3--Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints, today announced that the first patient has been dosed in the Company’s Phase 1 clinical trial of IO-202, a first-in-class myeloid checkpoint inhibitor targeting Leukocyte Immunoglobulin-Like Receptor B4 (LILRB4, also known as ILT3) for the treatment of patients with advanced solid tumors (NCT05309187).

"We are very pleased to announce the initiation of our Phase 1 study of IO-202 in solid tumors, a significant achievement in our development strategy targeting the LILRB family of myeloid checkpoints to overcome immune suppression in the tumor microenvironment,” said Paul Woodard, M.D., chief medical officer of Immune-Onc. “We believe by targeting the LILRB4 checkpoint, IO-202 may reverse the immunosuppressive effects of tumor associated monocytic myeloid cells, enhance dendritic cell function, and promote T cell activation – thereby, unleashing the antitumor activities of the immune system and increasing the therapeutic benefit of T cell checkpoint inhibitors. We look forward to conducting this study and assessing the potential of IO-202 as a monotherapy and in combination with pembrolizumab across multiple solid tumor types.”

This study consists of two parts: a dose escalation portion to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IO-202 alone and in combination with pembrolizumab, an anti-PD-1; and a dose expansion portion using the recommended Phase 2 dose of IO-202 in combination with pembrolizumab in multiple solid tumor types. Various biomarkers will be explored to enable a mechanistic understanding of clinical data and inform future trials. This study may also provide an opportunity to identify preliminary efficacy signals for IO-202 as a monotherapy and as a combination with a PD-1 inhibitor in patients with advanced solid tumors.

ABOUT LILRB4 (also known as ILT3)

LILRB4, also known as ILT3, is an immune inhibitory transmembrane receptor expressed by monocytic myeloid cells, including dendritic cells, monocytes, monocytic myeloid-derived suppressor cells and tumor-associated macrophages. LILRB4 inhibits antigen-presenting cell function, resulting in immune tolerance. LILRB4 is also expressed on certain hematologic cancer cells. Immune-Onc and The University of Texas published pioneering research in Nature illuminating the role of LILRB4 in immune suppression and tumor infiltration in acute myeloid leukemia (AML) and presented the rationale for targeting LILRB4 in solid tumors at the 2021 American Association for Cancer Research (AACR) Annual Meeting.

ABOUT IO-202

IO-202 is a first-in-class LILRB4 antagonist antibody with broad potential as an immunotherapy in both blood cancers and solid tumors. In hematologic malignancies, preclinical studies showed that IO-202 converts a “don’t kill me” to a “kill me” signal by activating T cell killing and converts a “don’t find me” to a “find me” signal by inhibiting infiltration of blood cancer cells. In the context of solid tumors, preclinical studies showed that IO-202 enhances dendritic cell function and T cell activation in vitro and inhibits tumor growth in an immune competent model in vivo.

IO-202 has two ongoing clinical studies: Its first Phase 1 trial is currently enrolling patients with acute myeloid leukemia (AML) or chronic myelomonocytic leukemia (CMML) as a monotherapy and in combination with azacitidine (NCT04372433). The U.S. Food and Drug Administration granted IO-202 Orphan Drug designation for treatment of AML in 2020 and Fast Track designation for relapsed or refractory AML in 2022. The second Phase 1 trial of IO-202 is currently enrolling patients with advanced solid tumors to evaluate IO-202 as a monotherapy and in combination with an anti-PD-1 (NCT05309187).

ABOUT IMMUNE-ONC THERAPEUTICS, INC.

Immune-Onc Therapeutics, Inc. (“Immune-Onc”) is a private, clinical-stage cancer immunotherapy company dedicated to the discovery and development of novel myeloid checkpoint inhibitors for cancer patients. The company aims to translate unique scientific insights in myeloid cell biology and immune inhibitory receptors to discover and develop first-in-class biotherapeutics that disarm immune suppression in the tumor microenvironment.

Immune-Onc has a differentiated pipeline with a current focus on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB) of myeloid checkpoints. Immune-Onc’s focused platform approach has led to the development of several promising therapeutics across various stages of development, including IO-108, an antagonist antibody targeting LILRB2 (also known as ILT4), in Phase 1 clinical development for solid tumors and IO-202, a first-in-class antagonist antibody targeting LILRB4 (also known as ILT3), in Phase 1 clinical development for the treatment of acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), and solid tumors. Additional assets in Immune-Onc’s pipeline include IO-106, a first-in-class antagonist antibody targeting LAIR1, and multiple undisclosed programs for solid tumors and hematologic malignancies.

The company has strategic research collaborations with The University of Texas, Albert Einstein College of Medicine, and Memorial Sloan Kettering Cancer Center, and has invested in proprietary models, assays, and tools to interrogate the biology and translate this cutting-edge research into the development of novel therapies. Immune-Onc has received research grants from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) and the California Institute for Regenerative Medicine (CIRM) and a strategic investment from The Leukemia & Lymphoma Society Therapy Acceleration Program® (LLS TAP®). 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. For more information, please visit www.immune-onc.com and follow us on Twitter and LinkedIn.

Tara Cooper
The Grace Communication Group
tara@gracegroup.us
media@immuneonc.com
650-303-7306