Immune-Onc Therapeutics to Present Trial in Progress Poster for Phase 1 Study of IO-202 in Patients with Advanced Solid Tumors at the Society for Immunotherapy of Cancer Annual Meeting

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In addition, we are able to study IO-202 at a higher starting dose in solid tumors by leveraging safety data from our Phase 1 trial of IO-202 in AML and CMML.

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In addition, we are able to study IO-202 at a higher starting dose in solid tumors by leveraging safety data from our Phase 1 trial of IO-202 in AML and CMML.
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.
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 ).
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.

Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints, today announced that it will present a Trial in Progress poster at the Society for Immunotherapy of Cancer (SITC) Annual Meeting, being held in Boston and virtually from November 8 –12, 2022.

The poster presentation will highlight the trial design, dosing regimen, and study protocol for the company's ongoing 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).

“Our Phase 1 study of IO-202 supports a differentiated myeloid checkpoint inhibitor with best-in-class potential to provide benefit for patients with solid tumors,” said Paul Woodard, M.D., chief medical officer of Immune-Onc. “IO-202 blocks the LILRB4 pathway - specifically, interaction with its multiple ligands including apolipoprotein E and fibronectin - enabling the potential to reactivate or enhance anti-tumor T cell immune responses in patients with solid tumors.”

“In addition, we are able to study IO-202 at a higher starting dose in solid tumors by leveraging safety data from our Phase 1 trial of IO-202 in AML and CMML. We plan to combine IO-202 with various anti-PD-1s such as pembrolizumab and tislelizumab, among others. We look forward to continuing to build a strong body of evidence to support IO-202 as a novel immunotherapy with broad potential across multiple oncology indications,” he added.

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 or other anti-PD-1s 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.

Details of the presentation are as follows:

Title: A Phase 1 Trial of IO-202, An Antagonist Antibody Targeting Myeloid Checkpoint LILRB4 (ILT3), as Monotherapy and in Combination with Pembrolizumab in Adult Patients with Advanced Relapsed or Refractory Solid Tumors

Abstract #: 747

Presentation Session: Clinical Trials in Progress

Session Date and Time: Thursday, November 10, 2022, 9:00 AM - 9:00 PM ET

Location: Boston Convention & Exhibition Center, Hall C

Poster presentations will be accessible in person and virtually. All accepted abstracts will be available in a Journal for ImmunoTherapy of Cancer (JITC) supplement. For more information about the 37th SITC annual meeting, please visit https://www.sitcancer.org/home.

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 humanized IgG1 monoclonal antibody with high affinity and specificity towards LILRB4 (also known as ILT3). It blocks the interaction of LILRB4 with multiple ligands, including ApoE and Fibronectin, and has 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 data presented at the 2021 American Association for Cancer Research annual meeting demonstrate 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 in the U.S.: 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 inhibit 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. Those include 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 (first-in-class antagonist antibody targeting LAIR1), IO-312 (bi-specific antibody targeting LILRB4), and multiple undisclosed programs for solid tumors and hematologic malignancies.

Immune-Onc has established agreements with leading biopharmaceutical companies, including BeiGene and Regeneron, to support its global product development plans for IO-108 and IO-202. It 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 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 biopharmaceutical companies. For more information, please visit www.immune-onc.com and follow us on Twitter and LinkedIn.

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