Immune-Onc Therapeutics Receives China Investigational New Drug (IND) Approval for the Phase 1 Study of IO-108, a Novel Antagonist Antibody Targeting LILRB2 (ILT4), in Patients with Solid Tumors

– Multicenter Phase 1 study to evaluate IO-108 as both monotherapy and in combination with pembrolizumab in China –

– Represents the first LILRB2-targeting antibody with IND clearance in China and the company’s fourth IND globally –

– A Phase 1 trial evaluating IO-108 in patients with advanced solid tumors is currently enrolling in the U.S. –

PALO ALTO, CA, May 16, 2022 / Business Wire / -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints, today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application to initiate a Phase 1 study of IO-108, a novel antagonist antibody targeting Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2, also known as ILT4) for the treatment of solid tumors.

“NMPA’s timely acceptance and approval of the IND for IO-108 represents a remarkable milestone for the company,” said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. “It is our first IND submission and clearance outside the U.S., and our company’s fourth IND globally. Antagonist antibodies targeting the LILRB family of myeloid checkpoints represent a promising new approach in cancer immunotherapy that are expected to be complementary to and synergistic with T-cell checkpoint inhibitors such as anti-PD-1 or anti-PD-L1. We look forward to bringing these first-in-class therapeutics to cancer patients in China.” 

“IO-108 is a significant program in our pipeline of myeloid checkpoint inhibitors and the first LILRB2-targeting antibody with IND submission and clearance in China,” commented by Maggie Gu, China general manager of Immune-Onc. “We look forward to working closely with investigators to launch and execute the high-quality Phase 1 clinical trial to explore IO-108’s potential in treating solid tumors in China, concurrently with the U.S. Phase 1 clinical trial."

The multicenter Phase 1 study will consist of a monotherapy cohort, a combination therapy cohort, and a dose expansion cohort to evaluate the safety, tolerability, pharmacokinetics, and efficacy of IO-108 alone and in combination with pembrolizumab. The Chinese study will also confirm the recommended Phase 2 dose selected from the U.S. Phase 1 clinical trial of IO-108 in solid tumors. Immune-Onc plans to evaluate the efficacy, safety, and tolerability of IO-108 in combination with pembrolizumab in indication-specific expansion cohorts in China.

ABOUT LILRB2 (ILT4)

LILRB2, also known as ILT4, is expressed mostly by myeloid cells, including monocytes, macrophages, dendritic cells, and neutrophils. In solid tumors, activation of LILRB2 by its ligands, including HLA-G, ANGPTLs, SEMA4A, and CD1d, induces a tolerogenic phenotype in myeloid cells, thereby suppressing T cell activation and promoting tumor immune evasion.

ABOUT IO-108

IO-108 binds to LILRB2 with high affinity and specificity and blocks the interaction of LILRB2 with multiple ligands that are involved in cancer-associated immune suppression including HLA-G, ANGPTLs, SEMA4A, and CD1d. Ex vivo studies show that treatment with IO-108 produces pro-inflammatory activity and an enhanced antigen-presenting cell (APC) phenotype to multiple stimuli, including T cell activators, and STING and TLR agonists. As a single agent, IO-108 reverts the anti-inflammatory myeloid cell phenotype caused by “tumor conditioning” to pro-inflammatory phenotype and promotes the differentiation of monocytes and immature dendritic cells into pro-inflammatory dendritic cells, which are critical in generating productive anti-tumor immune responses. IO-108 potentiates the effect of PD-1 blocking antibodies on CD4+ T cell activation in co-cultures with allogeneic macrophages. Moreover, IO-108 monotherapy inhibits the growth of solid tumors in a preclinical model, which is associated with immune cell activation. IO-108 presents a favorable pharmacokinetic and safety profile in preclinical models.

 In the ongoing Phase 1 study of IO-108 in adult patients with advanced or refractory solid tumors in the US (NCT05054348), IO-108 has been well-tolerated to date, both as a monotherapy and in combination with pembrolizumab. The company has received the IND clearance in China and plans to evaluate IO-108 in solid tumors in China in 2H 2022.

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. The U.S. Food and Drug Administration granted IO-202 Orphan Drug Designation for treatment of AML in 2020 and Fast Track Designation for treatment of relapsed or refractory AML in 2022. Additional assets in Immune-Onc’s pipeline include IO-106, a first-in-class antagonist antibody targeting LAIR1 for collagen-rich solid tumors, 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.

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