Immune-Onc Therapeutics Receives FDA Fast Track Designation for IO-202, the First Anti-LILRB4 Myeloid Checkpoint Inhibitor, for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia (AML)
PALO ALTO, CA, February 17, 2022 / Business Wire / -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting immunosuppressive myeloid checkpoints, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for 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 relapsed or refractory acute myeloid leukemia (AML). The Company received Orphan Drug Designation for IO-202 for the treatment of AML in 2020.
“We are pleased that the FDA has granted IO-202 Fast Track designation in recognition of its potential to improve outcomes for people with relapsed or refractory AML,” said Paul Woodard, Ph.D., chief medical officer of Immune-Onc. “We look forward to working closely with the FDA to accelerate the clinical development of IO-202, which is currently being evaluated as a monotherapy and in combination with other agents in a Phase 1 dose escalation and expansion trial in patients with AML with monocytic differentiation and in chronic myelomonocytic leukemia (CMML).”
The FDA’s Fast Track designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need to get important new medicines to patients earlier. Drugs that receive Fast Track designation may be eligible for more frequent interactions and written communications with the FDA to discuss the development plan and data collection to support an approval pathway. The designation also supports the eligibility for Accelerated Approval and Priority Review if relevant criteria are met.
ABOUT LILRB4 (also known as ILT3)
LILRB4, also known as ILT3, is an immune inhibitory transmembrane protein found on monocytic myeloid cells, including dendritic cells. LILRB4 inhibits antigen-presenting cell activation, resulting in immune tolerance. LILRB4 is also expressed on certain hematologic cancer cells and monocytic myeloid cells in the solid tumor microenvironment. Immune-Onc and The University of Texas published pioneering research in Nature illuminating the role of LILRB4 in immune suppression and tumor infiltration in AML and presented the rationale for targeting LILRB4 in solid tumors at the AACR Annual Meeting 2021.
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 solid tumors, preclinical data showed that IO-202 enhances dendritic cell function and T cell activation in vitro and inhibits tumor growth in a solid tumor model in vivo.
IO-202 is currently in Phase 1 clinical development for the treatment of AML and CMML. The U.S. Food and Drug Administration granted IO-202 Orphan Drug Designations for treatment of AML in 2020. The company has received IND clearance to evaluate IO-202 in solid tumors in January 2022.
ABOUT IMMUNE-ONC THERAPEUTICS, INC.
Immune-Onc Therapeutics, Inc. (“Immune-Onc”) is a 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. In addition to advancing IO-202, a first-in-class antagonist antibody targeting LILRB4 (ILT3), into the clinic in 2020, Immune-Onc has advanced IO-108, an antagonist antibody targeting LILRB2 (ILT4), into the clinic for solid tumors in 2021. 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.
MEDIA CONTACT
Tara Cooper
The Grace Communication Group
tara@gracegroup.us
media@immuneonc.com
650-303-7306
Immune-Onc Therapeutics Announces FDA Clearance of IND Application to Initiate Trial of IO-202, a First-in-Class Myeloid Checkpoint Inhibitor Targeting LILRB4, in Patients with Advanced Solid Tumors
– Multicenter Phase 1 study to evaluate IO-202 as monotherapy and in combination with an anti-PD-1 –
PALO ALTO, CA, January 31, 2022 / Business Wire / -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting immunosuppressive myeloid checkpoints, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for IO-202, a first-in-class antibody targeting leukocyte immunoglobulin-like receptor B4 (LILRB4, also known as ILT3), for the treatment of solid tumors.
Myeloid cells are abundant and often immune suppressive in the solid tumor microenvironment. The LILRB4 receptor is expressed on monocytic myeloid cells, including dendritic cells, and contributes to a tolerogenic myeloid cell phenotype, resulting in decreased tumor immune surveillance. In preclinical data presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting, IO-202 was found to enhance dendritic cell function and T cell activation in vitro and promote anti-tumor immunity in a solid tumor model in vivo. These data provided a strong rationale to evaluate the therapeutic potential of IO-202 as a myeloid checkpoint inhibitor in solid tumors.
“The FDA clearance to begin our Phase 1 study for IO-202 in solid tumors is a major milestone for Immune-Onc, which represents the third IND for our pipeline and the second for IO-202,” said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. “We know that high LILRB4 expression on myeloid cells infiltrating solid tumors contributes to tumor immune evasion. IO-202 is a first-in-class myeloid checkpoint inhibitor targeting LILRB4, which may provide therapeutic benefit to multiple solid tumor types where evasion of the immune system allows disease to progress and create resistance to therapy, including to T cell checkpoint inhibitors. We look forward to advancing IO-202 into the clinic to evaluate its potential as a monotherapy and in combination with an anti-PD-1 in patients with solid tumors.”
The Phase 1, multicenter, dose-escalation and dose expansion study will consist of a monotherapy cohort and a combination therapy cohort to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IO-202 alone and in combination with pembrolizumab, an anti-PD-1 antibody, followed by indication-specific expansion cohorts to be treated with IO-202 in combination with pembrolizumab at the recommended Phase 2 dose. Various biomarkers will be assessed to enable a mechanistic understanding of clinical data and inform future trials. This study may also provide an opportunity to identify preliminary efficacy signals.
ABOUT LILRB4 (also known as ILT3)
LILRB4, also known as ILT3, is an immune inhibitory transmembrane protein found on monocytic myeloid cells, including dendritic cells. LILRB4 inhibits antigen-presenting cell activation, resulting in immune tolerance. LILRB4 is also expressed on certain hematologic cancer cells and monocytic myeloid cells in the solid tumor microenvironment. 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 AACR Annual Meeting 2021.
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 solid tumors, preclinical data showed that IO-202 enhances dendritic cell function and T cell activation in vitro and inhibits tumor growth in a solid tumor model in vivo.
IO-202 is currently in Phase 1 clinical development for the treatment of AML and chronic myelomonocytic leukemia (CMML). The U.S. Food and Drug Administration granted IO-202 Orphan Drug Designations for treatment of AML in 2020. The company has received IND clearance to evaluate IO-202 in solid tumors in January 2022.
ABOUT IMMUNE-ONC THERAPEUTICS, INC.
Immune-Onc Therapeutics, Inc. (“Immune-Onc”) is a 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. In addition to advancing IO-202, a first-in-class antibody targeting LILRB4 (ILT3), into the clinic in 2020, Immune-Onc has advanced IO-108, an antagonist antibody targeting LILRB2 (ILT4), into the clinic for solid tumors in 2021. Additional assets in Immune-Onc’s pipeline include IO-106, a first-in-class anti-LAIR1 antibody, 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.
MEDIA CONTACT
Tara Cooper
The Grace Communication Group
tara@gracegroup.us
media@immuneonc.com
650-303-7306
Immune-Onc Therapeutics to Present at the 40th Annual J.P. Morgan Healthcare Conference
PALO ALTO, CA, January 10, 2022 / Business Wire / -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting immunosuppressive myeloid checkpoints, today announced the Company will present at the virtual 40th Annual J.P. Morgan Healthcare Conference on Tuesday, January 11, 2022, at 12:30 PM PST/3:30 PM EST, during the Private Companies Track 2. Charlene Liao, Ph.D., chief executive officer of Immune-Onc, will provide a corporate overview, including recent clinical development progress and anticipated milestones for 2022 and beyond.
ABOUT IMMUNE-ONC THERAPEUTICS, INC.
Immune-Onc Therapeutics, Inc. (“Immune-Onc”) is a 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 antibody targeting LILRB4 (also known as ILT3), in Phase 1 clinical development for the treatment of acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML). The company also plans to evaluate IO-202 in solid tumors in 1H2022. The U.S. Food and Drug Administration granted IO-202 Orphan Drug Designation for treatment of AML in 2020. Additional assets in Immune-Onc’s pipeline include IO-106, a first-in-class anti-LAIR1 antibody, 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.
MEDIA CONTACT
Tara Cooper
The Grace Communication Group
tara@gracegroup.us
media@immuneonc.com
650-303-7306
Immune-Onc Therapeutics to Present at Evercore ISI 4th Annual HealthCONx Conference
PALO ALTO, CA, November 22, 2021 / Business Wire / -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting immunosuppressive myeloid checkpoints, today announced that management will participate in a fireside chat at the upcoming Evercore ISI 4th Annual HealthCONx Conference on Tuesday, November 30, 2021, at 4:45pm Eastern Time.
Presentation Details
Evercore ISI 4th Annual HealthCONx Conference
Presentation Date: Tuesday, November 30, 2021
Presentation Time: 4:45 – 5:05 PM ET (Webinar)
ABOUT IMMUNE-ONC THERAPEUTICS, INC.
Immune-Onc Therapeutics, Inc. (“Immune-Onc”) is a 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. IO-202, a first-in-class antibody targeting LILRB4 (also known as ILT3), is in Phase 1 clinical development for the treatment of acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML). The U.S. Food and Drug Administration granted IO-202 Orphan Drug Designation for treatment of AML in October 2020. The company also plans to evaluate IO-202 in solid tumors in 1H2022. IO-108, an antagonist antibody targeting LILRB2 (ILT4), entered clinic for solid tumors in October 2021. Additional assets in Immune-Onc’s pipeline include IO-106, a first-in-class anti-LAIR1 antibody, 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.
MEDIA CONTACT
Tara Cooper
The Grace Communication Group
tara@gracegroup.us
media@immuneonc.com
650-303-7306
Immune-Onc Therapeutics to Present Data Supporting Therapeutic Potential of LAIR1 Antagonist Antibodies at the Society for Immunotherapy of Cancer (SITC) 36th Annual Meeting
– Preclinical data to highlight potential of LAIR1 blockade in reversing T-cell and myeloid immunosuppression mediated by collagen –
PALO ALTO, CA, November 9, 2021 / Business Wire / -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting immunosuppressive myeloid checkpoints, today announced that the Company will present a scientific poster at the Society for Immunotherapy of Cancer 36th Annual Meeting (SITC 2021) being held November 10-14, 2021, in Washington, D.C., USA.
The poster will feature key preclinical data demonstrating the therapeutic potential of anti-LAIR1 antagonistic antibodies as immune checkpoint inhibitor therapy for solid tumors. LAIR1 (Leukocyte Associated Immunoglobulin-like Receptor 1) is an immune inhibitory transmembrane glycoprotein expressed on lymphocytes and myeloid cells and is activated by collagen and other ligands. Collagen is highly abundant in the stroma of many solid tumor types and thought to contribute to immune suppression. The data being presented suggest that LAIR1 blockade could potentially reverse collagen-mediated myeloid cell tolerogenic phenotype and T-cell suppression, thereby promoting a pro-inflammatory solid tumor microenvironment.
Presentation Details
Poster Title:
Antagonistic Antibodies Targeting LAIR1 Enhance T Lymphocyte Activation and Promote Inflammatory Phenotypes in Myeloid Cells
Abstract ID: 304
Presenter: Tao Huang, PhD, Director of Preclinical Development at Immune-Onc Therapeutics
Category: Checkpoint Blockade Therapy
Date: Saturday, Nov. 13, 2021
Time: 7:00 am – 8:30 pm EST
Location: Poster Hall at the Walter E. Washington Convention Center, D.C.
Poster presentations will be accessible in person and virtually. The poster will also be made available on the "Publications & Abstracts" section of the Company's website.
ABOUT IMMUNE-ONC THERAPEUTICS, INC.
Immune-Onc Therapeutics, Inc. (“Immune-Onc”) is a 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 in Phase 1 clinical development for solid tumors and IO-202, a first-in-class antibody targeting LILRB4 (also known as ILT3), in Phase 1 clinical development for the treatment of acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML). The company also plans to evaluate IO-202 in solid tumors in 1H2022. The U.S. Food and Drug Administration granted IO-202 Orphan Drug Designation for treatment of AML in October 2020. Additional assets in Immune-Onc’s pipeline include IO-106, a first-in-class anti-LAIR1 antibody, 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.
MEDIA CONTACT
Tara Cooper
The Grace Communication Group
tara@gracegroup.us
media@immuneonc.com
650-303-7306
Immune-Onc Therapeutics Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating IO-108, a Novel Antagonist Antibody Targeting LILRB2 (ILT4), in Patients With Advanced Solid Tumors
– Multicenter Phase 1 study to evaluate IO-108 as monotherapy and in combination with an anti-PD-1 –
– IO-108 is Company’s second program to advance to clinic –
PALO ALTO, CA, October 13, 2021 / Business Wire / -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting immunosuppressive myeloid checkpoints, today announced that the first patient has been dosed in the Company’s first-in-human clinical trial of IO-108, a novel antagonist antibody targeting the myeloid checkpoint Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2, also known as ILT4) for the treatment of solid tumors.
“The first patient dosed in our Phase 1 clinical trial for IO-108 represents a critical milestone in advancing the development and understanding of Immune-Onc’s novel myeloid checkpoint inhibitors targeting the LILRB family of immune inhibitory receptors. We believe our scientific platform holds vast promise and today’s news reflects our commitment to rapidly advancing programs in our portfolio that have the potential to improve outcomes for cancer patients,” said Paul Woodard, MD, chief medical officer of Immune-Onc. “With enrollment now underway, we look forward to reporting top line data next year.”
The Phase 1, multicenter, dose-escalation study will consist of a monotherapy cohort and a combination therapy cohort to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IO-108 alone and in combination with pembrolizumab, an anti-PD-1 antibody. Biomarkers will be assessed to enable a mechanistic understanding of clinical data and inform future trials. This study may also provide an opportunity to identify preliminary efficacy signals. After determination of the recommended Phase 2 dose, Immune-Onc plans to evaluate the efficacy, safety, and tolerability of IO-108 in combination with pembrolizumab and as monotherapy in indication-specific expansion cohorts.
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. In preclinical studies, treatment of various primary human immune cell systems containing myeloid cells with IO-108 results in enhanced pro-inflammatory responses to multiple stimuli that are relevant to anti-tumor immunity. As a single agent, IO-108 reverses the anti-inflammatory myeloid cell phenotype that results from “tumor conditioning” and promotes the differentiation of monocytes into pro-inflammatory dendritic cells. Moreover, IO-108 potentiates the effect of PD-1 blocking antibodies on CD4+ T cell activation in co-cultures with allogeneic macrophages. In mouse models IO-108 inhibits the growth of solid tumors, which is associated with enhanced T cell responses. Together these data demonstrate that IO-108 has the potential to provide additive or synergistic benefit in combination with standard-of-care immunotherapies and/or immunogenic therapies for solid tumors that are both resistant and sensitive to T-cell checkpoint inhibitors.
ABOUT LILRB2 (ILT4)
LILRB2, also known as ILT4, is expressed mostly on myeloid cells, including monocytes, dendritic cells, macrophages, and neutrophils. In solid tumors, interaction of LILRB2 with tumor microenvironment (TME) relevant ligands, including HLA-G, ANGPTLs, SEMA4A, and CD1d, makes myeloid cells pro-tumorigenic (tolerating or promoting tumor growth) and promotes tumor immune evasion.
ABOUT IMMUNE-ONC THERAPEUTICS, INC.
Immune-Onc Therapeutics, Inc. (“Immune-Onc”) is a 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 promising 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 in Phase 1 clinical development for solid tumors and IO-202, a first-in-class antibody targeting LILRB4 (also known as ILT3), in Phase 1 clinical development for the treatment of acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML). The company also plans to evaluate IO-202 in solid tumors. The U.S. Food and Drug Administration granted IO-202 Orphan Drug Designation for treatment of AML in October 2020. Additional assets in Immune-Onc’s pipeline include IO-106, a first-in-class anti-LAIR1 antibody, 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. 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.
MEDIA CONTACT
Tara Cooper
The Grace Communication Group
tara@gracegroup.us
media@immuneonc.com
650-303-7306
Immune-Onc Therapeutics Announces FDA Clearance of IND Application to Initiate First-In-Human Trial of IO-108, a Novel Antagonist Antibody Targeting LILRB2, in Patients with Advanced Solid Tumors
– Multicenter Phase 1 study to evaluate IO-108 as monotherapy and in combination with anti-PD-1 –
PALO ALTO, CA, August 12, 2021 / Business Wire / -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting immunosuppressive myeloid checkpoints, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for IO-108, a novel antagonist antibody targeting Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2, also known as ILT4) for the treatment of solid tumors. Preclinical data presented at the 2020 Society for Immunotherapy of Cancer’s annual meeting demonstrate that IO-108 functions as a myeloid checkpoint inhibitor. IO-108 reprograms immune-suppressive myeloid cells toward a pro-inflammatory phenotype, leading to enhanced innate and adaptive anti-tumor immunity.
“The clearance of the IO-108 IND represents another major milestone for Immune-Onc as we progress our pipeline of novel myeloid checkpoint inhibitors targeting the LILRB family of immune inhibitory receptors,” said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. “We are highly encouraged by the strength of the preclinical data of IO-108 and are pleased that our expertise in LILRB biology and translational sciences enables us to advance this asset into the clinic. We look forward to initiating the trial to further understand the role of LILRBs in cancer, and to test the potential of IO-108 in treating patients with advanced solid tumors.”
The Phase 1, multicenter, dose-escalation study will consist of a monotherapy cohort and a combination therapy cohort to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IO-108 alone and in combination with pembrolizumab, an anti-PD-1 antibody. Biomarkers will be assessed to enable a mechanistic understanding of clinical data and inform future trials. This study may also provide an opportunity to identify preliminary efficacy signals. After determination of the recommended Phase 2 dose, Immune-Onc plans to evaluate the efficacy, safety, and tolerability of IO-108 in combination with pembrolizumab and as monotherapy in indication-specific expansion cohorts.
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. In preclinical studies, treatment of various primary human immune cell systems containing myeloid cells with IO-108 results in enhanced pro-inflammatory responses to multiple stimuli that are relevant to anti-tumor immunity. As a single agent, IO-108 reverses the anti-inflammatory myeloid cell phenotype that results from “tumor conditioning” and promotes the differentiation of monocytes into pro-inflammatory dendritic cells. Moreover, IO-108 potentiates the effect of PD-1 blocking antibodies on CD4+ T cell activation in co-cultures with allogeneic macrophages. In mouse models IO-108 inhibits the growth of solid tumors, which is associated with enhanced T cell responses. Together these data demonstrate that IO-108 has the potential to provide additive or synergistic benefit in combination with standard-of-care immunotherapies and/or immunogenic therapies for solid tumors that are both resistant and sensitive to T-cell checkpoint inhibitors.
ABOUT LILRB2 (ILT4)
LILRB2, also known as ILT4, is expressed mostly on myeloid cells, including monocytes, dendritic cells, macrophages, and neutrophils. In solid tumors, interaction of LILRB2 with tumor microenvironment (TME) relevant ligands, including HLA-G, ANGPTLs, SEMA4A, and CD1d, makes myeloid cells pro-tumorigenic (tolerating or promoting tumor growth) and promotes tumor immune evasion.
ABOUT IMMUNE-ONC THERAPEUTICS, INC.
Immune-Onc Therapeutics, Inc. (“Immune-Onc”) is a 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 promising 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 in Phase 1 clinical development for solid tumors and IO-202, a first-in-class antibody targeting LILRB4 (also known as ILT3), in Phase 1 clinical development for the treatment of acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML). The company also plans to evaluate IO-202 in solid tumors. The U.S. Food and Drug Administration granted IO-202 Orphan Drug Designation for treatment of AML in October 2020. Additional assets in Immune-Onc’s pipeline include IO-106, a first-in-class anti-LAIR1 antibody, 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. 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.
MEDIA CONTACT
Tara Cooper
The Grace Communication Group
tara@gracegroup.us
media@immuneonc.com
650-303-7306
Immune-Onc Therapeutics Expands Global Footprint and Appoints Maggie Gu as China General Manager
– Gu brings significant clinical development and organization management experience as well as a leading voice in shaping the China drug innovation and clinical trial environment –
– Appointment establishes Immune-Onc presence in China, the second-largest pharmaceutical market in the world, where high unmet needs exist for novel cancer therapies –
PALO ALTO, CA, June 24, 2021 -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting immunosuppressive myeloid checkpoints, today announced that it has appointed Maggie Gu to the position of General Manager of China, responsible for establishing and operating Immune-Onc’s China entity as well as supporting global drug development and corporate strategic leadership. Ms . Gu will be based in the company’s new China headquarters located in Hangzhou, Zhejiang Province.
“The appointment of Maggie fills a critical role in our organization and our ability to expand Immune-Onc’s global footprint into China,” said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. “She brings a deep understanding of oncology to the management team, as well as a wealth of clinical development and organization management experience in the pharmaceutical industry in China. Her experience leading the development and registration activities of a series of innovative products in oncology, dermatology, respiratory and other areas in China will be instrumental as we seek to address the high need for innovative cancer treatments in this region and accelerate our pipeline of clinical and pre-clinical stage candidates targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB) family of myeloid checkpoints.”
Ms. Gu is an industry veteran with decades of clinical research and drug development experience. She joins Immune-Onc from Ipsen where, as vice president and head of R&D Shanghai Innovation Hub, she helped to establish a R&D footprint in China and advance the specialty care portfolio strategy. Prior, she served as vice president of clinical development in Shanghai Junshi Biosciences where she successfully led the team to achieve marketing authorization of Tuoyi® (toripalimab) as the first China-developed and approved anti-PD-1 drug. Prior to Junshi, Ms. Gu’s previous roles included senior director-clinical development in clinical operations at AstraZeneca, head of clinical operations and therapeutic area medical science director at GlaxoSmithKline, and medical affairs manager at Fujisawa.
“Immune-Onc has a promising pipeline of novel myeloid checkpoint inhibitors for cancer patients that is supported by truly exciting science. I look forward to helping to direct the Company’s global drug development strategy and to the opportunity to bring these innovative therapeutic candidates to patients in China, where high unmet treatment needs persist despite recent advancements,” said Ms. Gu.
Ms. Gu has been actively leading or involved in various committees shaping the China drug innovation and clinical trial environment including the R&D-based Pharmaceutical Association Committee (RDPAC) Clinical Research Working Group, Medical Intelligence Committee of Chinese Society of Clinical Oncology (CSCO), Clinical Research Promotion Committee, among others. Prior to joining the pharmaceutical industry, she worked in the Pediatric Research Institute, Children’s Hospital affiliated to Shanghai Medical University. Ms. Gu earned her master's degree in pediatric medicine at Shanghai Medical University.
ABOUT IMMUNE-ONC THERAPEUTICS, INC.
Immune-Onc Therapeutics, Inc. (“Immune-Onc”) is a 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 promising pipeline with a current focus on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB) of myeloid checkpoints.
Immune-Onc’s lead program IO-202, a first-in-class antibody targeting LILRB4 (also known as ILT3), is in Phase 1 clinical development for the treatment of acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML). The company also plans to evaluate IO-202 in solid tumors. The U.S. Food and Drug Administration granted IO-202 Orphan Drug Designation for treatment of AML in October 2020. Immune-Onc’s pipeline also includes IO-108, a novel antagonist antibody targeting LILRB2 (also known as ILT4) which is currently in the IND-enabling stage. Other preclinical assets include IO-106, a first-in-class anti-LAIR1 antibody, 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. 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.
MEDIA CONTACT
Tara Cooper
The Grace Communication Group
tara@gracegroup.us
media@immuneonc.com
650-303-7306
Immune-Onc Therapeutics Appoints Stuart Lutzker, M.D., Ph.D. to Scientific Advisory Board
– Biotech Veteran Brings Deep Scientific and Clinical Leadership to Immune-Onc as the Company Expands Clinical Development of its Novel Myeloid Checkpoint Inhibitors –
– Recent $6M Award from the California Institute for Regenerative Medicine (CIRM) Will Further Accelerate Clinical Development of IO-202, a First-in-Class LILRB4 Antagonist Antibody –
PALO ALTO, CA, May 4, 2021 / Business Wire / -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting immunosuppressive myeloid checkpoints, today announced the appointment of Stuart Lutzker, M.D., Ph.D. to Immune-Onc’s Scientific Advisory Board (SAB). A pioneer of the biotech industry, Dr. Lutzker brings decades of oncology drug discovery and development experience to the Immune-Onc team.
“We are delighted to welcome Dr. Lutzker to Immune-Onc’s Scientific Advisory Board. As we continue to advance our pipeline of novel immunotherapeutics, Dr. Lutzker’s vast drug development expertise and leadership will be a valuable addition to our team,” said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. “In addition to Dr. Lutzker’s appointment, we are honored to be recognized with a research award from the California Institute for Regenerative Medicine which together with our recently announced Series B1 and B2 funding and The Leukemia & Lymphoma Society’s Therapy Acceleration Program investment will further accelerate our clinical and pre-clinical development programs targeting myeloid checkpoints in blood cancers and solid tumors.”
“I am excited to join Immune-Onc’s Scientific Advisory Board and look forward to working with the company's experienced management team,” said Stuart Lutzker, M.D., Ph.D. "The data supporting Immune-Onc’s pipeline of clinical and pre-clinical stage candidates targeting the LILRB family of myeloid checkpoints are impressive, and I'm eager to work with the team to help move these programs through clinical development to ultimately make a meaningful impact for patients with cancer.”
Dr. Stuart Lutzker is an industry veteran with decades of oncology drug development and leadership experience. Most recently, Dr. Lutzker was Vice President of Oncology Early Clinical Development at Genentech from 2009-2021 where he led the early development of multiple now approved oncology drugs including Kadcyla®, Polivy®, Venclexta®, Cotellic® and Tecentriq®. Prior to Genentech, Dr. Lutzker was a medical oncologist and cancer researcher at the NCI-Designated Cancer Institute of New Jersey, where he divided his time between patient care and laboratory-based cancer research. Dr. Lutzker received his M.D./Ph.D. in Biochemistry from Columbia University College of Physicians and Surgeons. Following his residency and fellowship in Internal Medicine and Medical Oncology at Yale-New Haven Hospital, Dr. Lutzker completed post-doctoral research training in the Department of Molecular Biology at Princeton University. Dr. Lutzker has also served as faculty for the ASCO/AACR Methods in Clinical Cancer Research Workshop in Vail, CO.
On April 20, 2021, Immune-Onc was awarded a $6 million grant from the California Institute for Regenerative Medicine (CIRM). Proceeds from the grant will help fund clinical development of IO-202, a first-in-class LILRB4 antagonist antibody, in acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML).
CIRM, California’s Stem Cell Agency, was founded in 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Act, which allocated $3 billion in state funding for stem cell research conducted in California. In 2020, CIRM was funded again with the approval of Proposition 14, which provided $5.5 billion in general obligation bond funding to support stem cell and regenerative medicine research in California.
ABOUT IMMUNE-ONC THERAPEUTICS, INC.
Immune-Onc Therapeutics, Inc. (“Immune-Onc”) is a 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 promising pipeline with a current focus on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB) of myeloid checkpoints.
Immune-Onc’s lead program IO-202, a first-in-class antibody targeting LILRB4 (also known as ILT3), is in Phase 1 clinical development for the treatment of acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML). The company also plans to evaluate IO-202 in solid tumors. The U.S. Food and Drug Administration granted IO-202 Orphan Drug Designation for treatment of AML in October 2020. Immune-Onc’s pipeline also includes IO-108, a novel antagonist antibody targeting LILRB2 (also known as ILT4) which is currently in the IND-enabling stage. Other preclinical assets include IO-106, a first-in-class anti-LAIR1 antibody, 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. 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.
MEDIA CONTACT
Tara Cooper
The Grace Communication Group
tara@gracegroup.us
media@immuneonc.com
650-303-7306
Immune-Onc Therapeutics Announces First Public Presentation of Data for its Myeloid Checkpoint Inhibitor, IO-202, in Solid Tumors at AACR21
– IO-202, a first-in-class LILRB4 antagonist antibody, activates dendritic cells and inhibits solid tumor growth in preclinical studies –
PALO ALTO, CA, April 10, 2021 / Business Wire / -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints, announced today the first public presentation of preclinical data for its first-in-class myeloid checkpoint inhibitor, IO-202, an LILRB4 antagonist antibody, in solid tumors. The electronic poster will be presented as part of the Immune Checkpoints Session of the American Association for Cancer Research (AACR) Annual Meeting 2021 (#AACR21), taking place virtually April 10-15, 2021.
Myeloid cells are abundant and often immune suppressive in the solid tumor microenvironment (TME). LILRB4 (also known as ILT3) is expressed on monocytic myeloid cells, offering rationale for investigating the potential of IO-202 in solid tumors. IO-202 may be combined with anti-PD-(L)1, other immunotherapies, and/or immunogenic chemotherapy in future investigations of novel treatment approaches for solid tumors.
“It is widely recognized that only a minority of patients achieve a complete or durable response to T cell checkpoint inhibitor therapies. IO-202 is a first-in-class myeloid checkpoint inhibitor targeting LILRB4, a protein that contributes to cancer immune evasion, not only in blood cancers but also in many solid tumor types,” said An Song, Ph.D., chief scientific officer of Immune-Onc. “Today, for the first time, we report preclinical data showing that IO-202 enhances dendritic cell function and T cell activation in vitro and inhibits tumor growth in a solid tumor model in vivo. As we move toward the clinic, these data improve our understanding of the role of LILRB4 in the tumor microenvironment and reinforce the therapeutic potential of IO-202 in solid tumors.”
AACR E-Poster Presentation Details:
Title: IO-202, a first-in-class LILRB4 antagonist antibody, activates dendritic cells and inhibits solid tumor growth in preclinical studies (https://www.abstractsonline.com/pp8/#!/9325/presentation/2730)
Session PO.IM02.03 - Immune Checkpoints
Abstract Number: 1629
ABOUT LILRB4 (also known as ILT3)
LILRB4, also known as ILT3, is an immune inhibitory transmembrane protein found on monocytic myeloid cells, including antigen presenting cells (APCs). LILRB4 inhibits APC activation, resulting in immune tolerance. LILRB4 is also expressed on certain hematologic cancer cells and monocytic myeloid cells in the solid tumor microenvironment. 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).
About IO-202
Immune-Onc’s lead asset, 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 September 2020, Immune-Onc initiated a Phase I trial evaluating IO-202 in AML with monocytic differentiation and in chronic myelomonocytic leukemia (CMML). The U.S. Food and Drug Administration granted IO-202 Orphan Drug Designation for treatment of AML in October 2020.
ABOUT IMMUNE-ONC THERAPEUTICS, INC.
Immune-Onc Therapeutics, Inc. (“Immune-Onc”) is a clinical-stage cancer immunotherapy company dedicated to the discovery and development of novel myeloid checkpoint inhibitors 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 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 promising pipeline with a current focus on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB) of myeloid checkpoints. 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. For more information, please visit www.immune-onc.com and follow us on Twitter and LinkedIn.
MEDIA CONTACT
Tara Cooper
The Grace Communication Group
tara@gracegroup.us
media@immuneonc.com
650-303-7306
Immune-Onc Therapeutics Announces $73 Million in Series B1 and B2 Financing to Advance its Portfolio of Novel Immunotherapies in Blood Cancers and Solid Tumors
– Proceeds will support development of novel myeloid checkpoint inhibitors including its clinical program IO-202, a first-in-class LILRB4 antagonist antibody in blood cancers and solid tumors, and its preclinical programs IO-108 and IO-106, targeting LILRB2 and LAIR1 respectively –
– Oceanpine Capital led the round joined by several other new investors including The Leukemia & Lymphoma Society as a strategic investor –
PALO ALTO, CA, March 30, 2021 / Business Wire / -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting immunosuppressive myeloid checkpoints today announced the closing of a $73 million Series B1 and B2 financing. The round was led by Oceanpine Capital with participation from additional new investors including Octagon Capital and Sphera Healthcare, and existing investors, including Northern Light Venture Capital and Vivo Capital. In conjunction with this round of financing, Oceanpine CEO and managing partner Dave Chenn joins the Immune-Onc Board of Directors. In addition, the company received a strategic capital investment from The Leukemia & Lymphoma Society’s Therapy Acceleration Program® (LLS TAP), directed toward advancing the company’s work to treat blood cancers.
“We are delighted that this high-caliber group of new and existing investors share our excitement about the transformative potential of myeloid checkpoint inhibition and believe in Immune-Onc’s ability to deliver on this promise with our pipeline of first-in-class cancer immunotherapies,” said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. “This round of investment was substantially over-subscribed, enabling the company to accelerate the clinical development of multiple novel assets, and deliver what we believe is the next breakthrough in immunotherapy treatment for many of the world’s most devastating cancers.”
Proceeds from the financing will allow Immune-Onc to advance its portfolio of blood cancer and solid tumor immunotherapies targeting myeloid checkpoints with a focus on the LILRB family. Immune-Onc has raised more than $110 million from investors since the company began operations in 2016. In August 2020, 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 clinical development of IO-202.
“We are enthusiastic about Immune-Onc’s novel approach to cancer immunotherapy targeting myeloid checkpoints and their leading portfolio of first-in-class assets,” said Dave Chenn, CEO and managing partner of Oceanpine Capital. “We have full confidence in the company’s highly experienced management team and are excited to be at the forefront of this new area of research and development through our investment in Immune-Onc supporting their next phase of growth.”
Immune-Onc’s Pipeline
Immune-Onc’s research and development programs focus on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB) of myeloid checkpoints to overcome immune resistance of cancer. The company 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’s lead program IO-202, a first-in-class antibody targeting LILRB4 (also known as ILT3), is being developed to treat blood cancers, including acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML), 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 hematologic cancer cells.
In September 2020, Immune-Onc initiated a Phase I trial evaluating IO-202 in AML with monocytic differentiation and in CMML. The U.S. Food and Drug Administration granted IO-202 Orphan Drug Designation status for treatment of AML in October 2020. The company is also evaluating IO-202 in solid tumors and will present preclinical data for the first time on April 10, 2021 at the American Association for Cancer Research Annual Meeting (#AACR21).
Immune-Onc has active preclinical programs targeting other members of the LILRB family including IO-108, a novel antagonist antibody targeting LILRB2 (also known as ILT4) which is currently in the IND-enabling stage. The company presented preclinical data supporting IO-108 for the treatment of solid tumors at The Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting and plans to submit an investigational new drug application in mid-2021. Other preclinical assets include IO-106, a first-in-class anti-LAIR1 antibody, and multiple undisclosed programs for solid tumors and hematologic malignancies.
About The Leukemia & Lymphoma Society and Therapy Acceleration Program® (TAP)
The Leukemia & Lymphoma Society® (LLS) is a global leader in the fight against cancer. The LLS mission is to cure leukemia, lymphoma, Hodgkin’s disease and myeloma, and improve the quality of life of patients and their families. LLS TAP is a strategic initiative that builds business alliances and collaborations with biotechnology companies and academic researchers to identify potential breakthrough therapies with the ability to change the standard of care. LLS TAP funds late-stage pre-clinical studies, and proof of concept or registrational clinical trials to help advance therapeutics along the drug development and approval pathway. To learn more, visit www.LLS.org/therapy-acceleration-program. Follow LLS on Facebook, Twitter, and Instagram.
ABOUT IMMUNE-ONC THERAPEUTICS, INC.
Immune-Onc Therapeutics, Inc. (“Immune-Onc”) is a clinical-stage cancer immunotherapy company dedicated to the discovery and development of novel myeloid checkpoint inhibitors 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 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 promising pipeline with a current focus on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB) of myeloid checkpoints. 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. For more information, please visit www.immune-onc.com and follow us on Twitter and LinkedIn.
MEDIA CONTACT
Tara Cooper
The Grace Communication Group
tara@gracegroup.us
media@immuneonc.com
650-303-7306
Immune-Onc Therapeutics Announces Orphan Drug Designation of IO-202 (Anti-LILRB4) for Treatment of AML and Poster Presentation at ASH 2020
– “Trials in Progress” poster presentation at the American Society of Hematology (ASH) Annual Meeting to detail mechanisms of action, preclinical data and trial design –
– IO-202, targeting the immune inhibitory receptor LILRB4 (also known as ILT3), is being evaluated in a Phase I trial for acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML) –
PALO ALTO, CA, November 10, 2020 / Business Wire / -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a clinical-stage cancer immunotherapy company today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation status for its first-in-class antagonist antibody IO-202 for treatment of acute myeloid leukemia (AML). In addition, the company announced acceptance of its “Trials in Progress” poster presentation for IO-202 at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition. The meeting is taking place virtually December 5-8, 2020.
Orphan Drug Designation qualifies the sponsor for various development incentives of the Orphan Drug Act, including exemption of FDA application fees and tax credits for qualified clinical testing, to advance the evaluation and development of products that demonstrate promise for the diagnosis and treatment of rare diseases or conditions that affect fewer than 200,000 people in the United States. Orphan Drug Designation can also convey seven years of marketing exclusivity for a drug approved to treat an orphan disease in the United States.
“Receiving orphan drug designation for IO-202 in AML is another important milestone for Immune-Onc and underscores the need for effective new treatments for this aggressive and hard-to-treat cancer,” said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. “We are pleased with the progress we are making in advancing IO-202. As outlined in our ASH poster presentation, IO-202 holds promise for AML patients because it demonstrates novel mechanisms of action in overcoming immune suppression. IO-202 is one of several programs in our pipeline that target the LILRB family of immune inhibitory receptors. We are excited to continue our momentum in evaluating IO-202 and Immune-Onc's preclinical candidates in other cancers, including solid tumors, in the near future.”
ASH “Trials in Progress” Poster
Based on highly selective criteria, “Trials in Progress" abstracts are reviewed for the most innovative science. The abstract (#2867), “A First-in-Human (FIH) Phase 1 Study of the Anti-LILRB4 Antibody IO-202 in Relapsed/Refractory (R/R) Myelomonocytic and Monocytic Acute Myeloid Leukemia (AML) and R/R Chronic Myelomonocytic Leukemia (CMML)”, was selected for poster presentation in the 2020 ASH Annual Meeting Program. Lead investigator Courtney D. DiNardo, M.D., MSc, associate professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, will share the poster via a brief PowerPoint presentation with accompanying audio.
The poster (Abstract #2867) will be presented at Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster III, on Monday, December 7, 2020, 7:00 a.m. - 3:30 p.m. Pacific Time.
In addition to the presentation, the abstract was published online in the November supplemental issue of Blood and in the online meeting program on November 5, 2020.
ABOUT LILRB4 (also known as ILT3)
LILRB4, also known as ILT3, is an immune-modulatory transmembrane protein found on antigen presenting cells (APCs). It inhibits APC activation and induces immune tolerance via T-suppressor cells. It is expressed on certain hematologic cancer cells and immune suppressive myeloid cells in the solid tumor microenvironment. Immune-Onc and The University of Texas published pioneering research in Nature illuminating the role of LILRB4 in immune suppression and tumor infiltration in AML.
ABOUT IO-202
IO-202 is a first-in-class monoclonal antibody that antagonizes LILRB4 with high binding affinity and specificity. It has broad potential 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 hematologic cancer cells.
IO-202 is being evaluated in a Phase I trial in two forms of blood cancer, AML and CMML. The U.S. Food and Drug Administration granted IO-202 Orphan Drug Designation status for treatment of AML in October 2020.
In solid tumors, IO-202 has potential to be combined with anti-PD-(L)1, other immunotherapies, and/or immunogenic chemotherapy. The company plans to evaluate IO-202 in solid tumors and in other forms of blood cancer in the near future.
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 IMMUNE-ONC THERAPEUTICS
Immune-Onc Therapeutics, Inc. (“Immune-Onc”) is a clinical-stage cancer immunotherapy company dedicated to the discovery and development of novel myeloid checkpoint inhibitors 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 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 promising pipeline with a current focus on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB) of myeloid checkpoints. 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.
In addition to IO-202, Immune-Onc’s pipeline includes IO-108, an antibody targeting LILRB2 (also known as ILT4) in the IND-enabling stage of development. Additional preclinical candidates focused on myeloid checkpoints include 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.
MEDIA CONTACT
Tara Cooper
The Grace Communication Group
tara@gracegroup.us
media@immuneonc.com
650-303-7306
Immune-Onc Therapeutics to Present Preclinical Data for IO-108, a Novel Antagonist Antibody Targeting LILRB2 (ILT4) in Solid Tumors, at SITC 2020
PALO ALTO, CA, November 9, 2020 / Business Wire / -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a clinical-stage cancer immunotherapy company, will present preclinical data evaluating IO-108, a novel antagonist antibody targeting the myeloid checkpoint Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2, also known as ILT4) for the treatment of solid tumors, at The Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting & Pre-Conference Programs (SITC 2020). The full meeting takes place virtually November 9-14, 2020.
The poster (Abstract #686) titled, “Preclinical Characterization of a Novel Therapeutic Antibody Targeting LILRB2”, will be presented on Thursday, Nov. 12, from 4:50-5:20 p.m. EST and on Saturday, Nov. 14, from 1-1:30 p.m. EST.
“Immune-Onc’s unique scientific insights in myeloid cell checkpoints, with a particular focus on the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB), have led to a promising and differentiated immunotherapy pipeline,” said Charlene Liao, Ph.D., co-founder and CEO of Immune-Onc. “The preclinical data to be presented at SITC demonstrate the exciting potential of IO-108, a novel therapeutic agent targeting LILRB2. We look forward to advancing IO-108 into the clinic in 2021 to evaluate its safety and efficacy in patients with solid tumors.”
IO-108 binds to LILRB2 with high affinity and specificity and blocks the interaction of LILRB2 with ligands that are involved in cancer-associated immune suppression including HLA-G, ANGPTLs and SEMA4A. In assays with primary cells, IO-108 enhances pro-inflammatory activation of immune cells and induces differentiation of monocytes into activated dendritic cells. In ex vivo functional studies with samples from solid tumor patients, IO-108 reprograms immune suppressive myeloid cells to a pro-inflammatory phenotype, thereby enhancing T-cell activation. Together these data suggest that IO-108 has potential therapeutic benefit in solid tumors not responsive to T-cell checkpoint inhibitors. The company plans to file an Investigational New Drug (IND) application for IO-108 with the U.S. Food and Drug Administration in Q2 2021.
ABOUT LILRB2 (ILT4)
LILRB2, also known as ILT4, is expressed mostly on myeloid cells, including monocytes, dendritic cells, macrophages, and neutrophils. In solid tumors, interaction of LILRB2 with tumor microenvironment (TME) relevant ligands, including HLA-G, ANGPTLs, and SEMA4A, makes myeloid cells pro-tumorigenic (tolerating or promoting tumor growth) and promotes tumor immune evasion.
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 myeloid checkpoint inhibitors 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 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 promising pipeline with a current focus on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB) of myeloid checkpoints. 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’s lead program IO-202, a first-in-class antibody targeting LILRB4 (also known as ILT3), is being developed to treat acute myeloid leukemia (AML) 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 chronic myelomonocytic leukemia (CMML). The company plans to evaluate IO-202 in solid tumors and in other forms of blood cancer in the near future. In addition to IO-202, Immune-Onc’s pipeline includes IO-108, an antibody targeting LILRB2 (also known as ILT4) in the IND-enabling stage of development. Additional preclinical candidates focused on myeloid checkpoints include 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.
MEDIA CONTACT
Tara Cooper
The Grace Communication Group
media@immuneonc.com
650-303-7306
Immune-Onc Therapeutics Announces SITC Poster Presentation on IO-108, a Novel Cancer Immunotherapy Targeting LILRB2 (ILT4) for Solid Tumors
PALO ALTO, CA, October 15, 2020 -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a clinical-stage cancer immunotherapy company, today announced a poster presentation at the upcoming Society for Immunotherapy of Cancer (SITC) 35th annual meeting, November 10-15, 2020, which will be held virtually.
The presentation of Abstract 686, titled “Preclinical Characterization of a Novel Therapeutic Antibody Targeting LILRB2”, will highlight preclinical data evaluating the company’s IND candidate IO-108, an antagonistic antibody of LILRB2 (also known as ILT4), for the treatment of solid tumors.
“There is a growing recognition of the importance of LILRB2 as a myeloid checkpoint target in cancer immunotherapy,” said Charlene Liao, Ph.D., co-founder and CEO of Immune-Onc. “Immune-Onc is developing immunotherapies targeting LILRB2 and other leukocyte immunoglobulin-like receptors that hinder the immune response to cancer. The preclinical data being shared at the upcoming SITC meeting demonstrate the potential to enhance anti-tumor immunity by antagonizing LILRB2.”
Even numbered posters will be presented on Thursday, Nov. 12, from 4:50-5:20 p.m. EST and Saturday, Nov. 14, from 1-1:30 p.m. EST.
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.
MEDIA CONTACT
Tara Cooper
The Grace Communication Group
media@immuneonc.com
650-303-7306
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
– First-In-Human Trial Targeting the Immune Inhibitory Receptor, LILRB4 –
– Preclinical Data Show LILRB4 Plays a Role in Immune Suppression and Tumor Infiltration –
PALO ALTO, CA, September 16, 2020 / Business Wire / -- 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.
MEDIA CONTACT
Tara Cooper
The Grace Communication Group
tara@gracegroup.us
media@immuneonc.com
650-303-7306
Immune-Onc Therapeutics Awarded $2.14 Million National Cancer Institute SBIR Grant to Support Development of IO-202, a First-in-Class Antibody Targeting LILRB4
– Immune-Onc’s Phase I Trial to Evaluate IO-202 in Two Forms of Leukemia –
PALO ALTO, CA, August 4, 2020 / Business Wire / -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a clinical-stage cancer immunotherapy company, today announced it has been awarded a Small Business Innovation Research (SBIR) Direct to Phase II grant from the National Cancer Institute (NCI) of the National Institutes of Health (NIH). The grant, in the amount of $2.14 million 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 (AML), the most common acute leukemia in adults, and for chronic myelomonocytic leukemia (CMML), a rare form of leukemia. The highly competitive SBIR programs enable small businesses to explore technological potential and pursue commercialization of innovations.
“We are honored to receive financial support and scientific endorsement from the National Cancer Institute,” said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. “This Direct to Phase II SBIR award will help us advance our lead clinical program. We look forward to working with our investigators to initiate the first-in-human trial of IO-202 in two forms of leukemia: AML and CMML. We also plan to evaluate IO-202 in other blood cancers and solid tumors in the future.”
In May, Immune-Onc's IO-202 Investigational New Drug (IND) application received clearance from the U.S. Food and Drug Administration (FDA). 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.
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), 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.
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, 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. For more information, please visit www.immune-onc.com.
MEDIA CONTACT
Tara Cooper
The Grace Communication Group
media@immuneonc.com
650-303-7306
Immune-Onc Therapeutics IND Application for First-In-Human Trial of IO-202, a Novel Antibody for the Treatment of Acute Myeloid Leukemia, Receives FDA Clearance
– Immune-Onc Expects Enrollment in its Phase 1 Trial to Begin in Q3 2020 –
PALO ALTO, CA, May 29, 2020 / Business Wire / -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a clinical-stage cancer immunotherapy company, announced today that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for IO-202, an antibody targeting an immune inhibitory receptor LILRB4. IO-202 is the first T-cell activator for acute myeloid leukemia (AML). 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 1 trial with IO-202 will evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity in AML patients with monocytic differentiation and in chronic myelomonocytic leukemia (CMML) patients.
“The FDA clearance to proceed with the first-in-human trial of IO-202 in AML and CMML is an important milestone for our company,” said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. "Acute myeloid leukemia is a devastating disease that needs new approaches and better treatment options. We look forward to working with investigators as we advance the first anti-LILRB4 antibody into the clinic.”
The Phase 1 trial will begin with a dose-escalation phase to 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.
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), 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 1 trial, and Immune-Onc plans to explore its potential in other hematologic malignancies and solid tumors in future trials.
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, 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. For more information, please visit www.immune-onc.com.
MEDIA CONTACTS
Tara Cooper
The Grace Communication Group, LLC
media@immuneonc.com
650-303-7306
Immune-Onc Therapeutics Prepares for its Next Phase of Growth with New Leadership Appointments and Key Board Member Additions
– Paul Woodard, M.D. appointed Chief Medical Officer –
– An Song, Ph.D. promoted to Chief Scientific Officer –
– Zhengbin (Bing) Yao, Ph.D. joins Board of Directors and Gregory Cosma, Ph.D. appointed to Scientific Advisory Board –
PALO ALTO, CA, November 19, 2019 / Business Wire / -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a privately held cancer immunotherapy company, announced today the addition of several industry veterans to its executive team and advisory boards and the promotion of An Song, Ph.D. to Chief Scientific Officer from Senior Vice President of Development Sciences. Dr. Paul Woodard joins Immune-Onc from Bellicum Pharmaceuticals, Inc. where he most recently served as Senior Vice President, Clinical and Medical Affairs.
“We are thrilled to add such seasoned and strategic individuals to the executive and advisory teams guiding Immune-Onc through its next phase of growth as a clinical stage company,” said Charlene Liao, Ph.D., Co-founder and Chief Executive Officer of Immune-Onc. “As our Chief Medical Officer, Paul brings the right combination of deep expertise in oncology paired with proven strategic leadership and experience building teams and functions in a startup environment. The appointment of An to Chief Scientific Officer is a reflection of the contributions she has already made to the company in her current role and a recognition of the value that her experience will bring in guiding the translation of our science into development.”
“I can’t imagine a more exciting time to join Immune-Onc,” said Dr. Woodard. “I was first drawn to the novel science underlying the portfolio. As I learned more about Immune-Onc and their authentic passion for improving patient lives, it became clear to me that this was a company that I wanted to contribute to in a meaningful way with the goal of bringing much needed new treatment options to people with hard-to-treat cancers like acute myeloid leukemia.”
About Paul Woodard, M.D.
As Chief Medical Officer, Dr. Woodard will be responsible for clinical leadership and medical oversight of the Immune-Onc portfolio. These activities will include review and input of IND submissions, clinical protocol development and medical oversight of Immune-Onc trials, and oversight of internal and external clinical development, biometrics, safety, and regulatory functions and compliance.
Dr. Woodard has an extensive hematology and oncology background gained in academia and industry. His academic experience focused on pediatric hematopoietic stem cell transplantation and hematologic disorders at world-renowned institutions, including St. Jude Children’s Research Hospital, University of California, San Francisco, and Children’s Hospital, Los Angeles. In addition to patient care, at St. Jude, Dr. Woodard was responsible for Phase 1/2 trials in pediatric hematopoietic stem cell transplantation for malignant and non-malignant disorders.
Prior to joining Immune-Onc, Dr. Woodard worked on a wide range of drug development projects in solid tumors, hematologic malignancies, and non-malignant hematologic disorders. At Exelixis, Dr. Woodard worked on small molecule tyrosine kinase inhibitors for solid tumors. At Amgen, Dr. Woodard was the global development leader for Nplate® (romiplostim) in immune thrombocytopenia and myelodysplastic syndromes. At Genentech, Dr. Woodard was the global development team leader for Tecentriq® (atezolizumab) in hematologic malignancies and was an integral team member for the development of Tecentriq® combinations in solid tumors (including triple negative breast cancer) and hematologic malignancies. At Bellicum, Dr. Woodard was the Senior Vice President of Clinical and Medical Affairs, with oversight of the company’s cellular therapy portfolio and clinical trials in hematologic malignancies and solid tumors.
Dr. Woodard earned his medical degree at the University of North Carolina and completed his residency at the University of Virginia and fellowships in pediatric hematology-oncology at the University of North Carolina and in pediatric blood and marrow transplantation at the University of Minnesota.
About An Song, Ph.D.
Dr. Song joined Immune-Onc in July 2018 as Senior Vice President of Development Sciences. In the newly created role of Chief Scientific Officer, Dr. Song will have overall accountability for translational development of Immune-Onc’s portfolio and strategic oversight of research and antibody engineering.
Dr. Song is a translational scientist with 22 years of experience across basic research and drug development in oncology, autoimmunity, metabolic, infectious, and neurodegenerative diseases. Dr. Song joins Immune-Onc from Genentech where, as a Senior Director in BioAnalytical Sciences, she led the Assay Development and Technology group for the company’s large molecule portfolio globally and was a member of numerous scientific review bodies within the Genentech Research and Early Development (gRED) organization. During her 16-year tenure at Genentech, Dr. Song contributed to, and oversaw 40+ IND/CTA and BLA/MAA regulatory filings for products including Rituxan®, Avastin®, Herceptin®, Lucentis®, Kadcyla® and Tecentriq®. In addition, Dr. Song played a significant role in the development and approval of Ocrevus®.
Dr. Song received her Ph.D. in Biochemistry & Molecular Biology from Indiana University and completed a postdoctoral fellowship in immunology, followed by a faculty position as Assistant Professor (Research) at Stanford University. As an active member of the American Association of Pharmaceutical Scientists (AAPS), Dr. Song has served as an executive member of the Biotech Section and chair of the Therapeutic Product Immunogenicity (TPI) Focus Group/Community.
BOARD APPOINTMENTS
In addition, Immune-Onc bolstered its cadre of advisors with the appointment of Zhengbin (Bing) Yao, Ph.D. to its Board of Directors and Gregory Cosma, Ph.D. to its Scientific Advisory Board. “Both Bing and Greg bring significant experience in helping early-stage companies navigate the complexity of drug development,” commented Dr. Liao. “Bing and Greg’s perspectives are invaluable in supporting Immune-Onc in our mission to deliver transformative therapies to cancer patients.”
About Zhengbin (Bing) Yao, Ph.D.
Dr. Yao has more than 20 years of experience in the biopharmaceutical industry, with a proven track record of successfully leading the discovery and development of multiple biotherapeutics. Dr. Yao is currently Chairman of the Board and CEO of Viela Bio. Prior to this role, he was Senior Vice President, Head of Respiratory, Inflammation and Autoimmune iMED at MedImmune/AstraZeneca. During his tenure at MedImmune, he played key leadership roles in the development and approval of three novel biologics for autoimmune, respiratory, and immune-oncology indications. Previously, Dr. Yao also served as Senior Vice President, Head of Immuno-Oncology Franchise, AstraZeneca, as well as CEO for WuXi-MedImmune Joint Venture. Dr. Yao joined MedImmune in 2010 from Genentech, where he was the Head of Project Team Leaders for Immunology, Infectious Diseases, Neuroscience, and Metabolic Disease. He was Vice President and Head of Research for Tanox, before the company was acquired by Genentech in 2007. Dr. Yao also held several positions of increasing responsibility at Aventis and Amgen and currently serves on the Board of Directors for NexImmune. Dr. Yao received his Ph.D. in Microbiology and Immunology from the University of Iowa, followed by postdoctoral work at Immunex.
About Gregory Cosma, Ph.D.
As a former executive at Genentech and Bristol-Myers Squibb, Dr. Cosma has a long track record of success leading companies in translating science into approved therapies. As Vice President of Research and Early Development at Genentech from 2010-2019, Dr. Cosma led the Safety Assessment organization comprising Toxicology, Pathology, Product Quality and Occupational Toxicology and Nonclinical Operations. He also chaired the Genentech Development Review Committee (DRC), overseeing nonclinical development of the Genentech pipeline from Research to First-in-Human studies. While at Bristol-Myers Squibb from 2003-2010, Dr. Cosma held roles as the Executive Director for Drug Safety Evaluation and as the Therapeutic Area Head for Metabolic Diseases. Prior to these roles, Dr. Cosma was a Research Fellow at Pharmacia-Pfizer and an assistant professor in the College of Veterinary Medicine and Biomedical Sciences at Colorado State University. Dr. Cosma earned his doctorate in Pharmacology/Toxicology at the University of Kansas.
ABOUT IMMUNE-ONC THERAPEUTICS, INC.
Immune-Onc Therapeutics, Inc. (“Immune-Onc”) is a privately held cancer immunotherapy company dedicated to the discovery and development of novel biologic treatments 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 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. Its lead program, an antibody targeting LILRB4, is being developed to treat acute myeloid leukemia and other cancers. 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.
MEDIA CONTACTS
Tara Cooper
Cooper Communication Group
media@immuneonc.com
650-303-7306
Immune-Onc Therapeutics and University of Texas Report a Novel Target for Acute Myeloid Leukemia in Nature
PALO ALTO, Calif. & DALLAS & HOUSTON, October 17, 2018 / Business Wire / -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a privately held cancer immunotherapy company dedicated to the discovery and development of novel biologic treatments for cancer patients, announced today the publication of a study in Nature (DOI: 10.1038/s41586-018-0615-z) that provides new insights into immune regulation and the progression of acute myeloid leukemia (AML).
The study, led by The University of Texas Southwestern Medical Center (“UT Southwestern”) and The University of Texas Health Science Center at Houston (“UTHealth”), demonstrated that leukocyte immunoglobulin-like receptor B4 (LILRB4), an immune inhibitory receptor, orchestrates leukemia invasion pathways by creating an immune suppressive microenvironment. Researchers discovered that blocking LILRB4 signaling with antagonistic antibodies can impede AML development in preclinical models, making it a compelling therapeutic target.
“The immune suppressive microenvironment represents the next frontier in the development of novel approaches to treat cancers like acute myeloid leukemia that have a very poor prognosis,” said senior author Dr. Cheng Cheng “Alec” Zhang, Professor of Physiology at UT Southwestern. “Our findings provide new insights into the underlying biological mechanisms that drive immune suppression and tumor infiltration in acute myeloid leukemia.” Dr. Zhang is a Scientific Advisory Board member with Immune-Onc Therapeutics, who also owns stock and has a sponsored research agreement with Immune-Onc Therapeutics.
This publication is an outcome of multi-year research collaborations between UT Southwestern, UTHealth and Immune-Onc, which has exclusive global rights to develop and commercialize novel biotherapeutics stemming from the sponsored research, including product candidates targeting LILRB4. Leveraging these strategic partnerships with UT Southwestern and UTHealth together with the company’s drug development expertise, Immune-Onc aims to bring much needed new medicines to patients with acute myeloid leukemia and other cancers.
“This pioneering study is a significant milestone in what continues to be a fruitful multi-year collaboration,” said Charlene Liao, Ph.D., co-founder and chief executive officer of Immune-Onc Therapeutics, and a co-author of the Nature publication. “We are proud of this discovery and excited to continue advancing our program toward the clinic on behalf of cancer patients.”
“We are enthusiastic about the research and the potential for new treatment approaches in acute myeloid leukemia,” said Dr. Zhiqiang An, Professor of Molecular Medicine, the Robert A. Welch Distinguished University Chair in Chemistry, and Director of the Texas Therapeutics Institute (TTI) at the Brown Foundation Institute of Molecular Medicine for the Prevention of Human Diseases at McGovern Medical School at UTHealth in Houston. “While immune checkpoint blockade therapies have worked in other cancers, the same benefits have not yet been seen in leukemia. Inhibition of LILRB4 signaling may represent a novel treatment strategy for acute myeloid leukemia.”
About Acute Myeloid Leukemia (AML)
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. Approximately 103,000 new cases of acute myeloid leukemia were diagnosed globally in 2016 [1] and 19,520 new cases are expected to be diagnosed in the United States in 2018 [2]. Despite advances in treatment, only about 27 percent of acute myeloid leukemia patients are alive five years after initial diagnosis [2].
About UT Southwestern Medical Center
UT Southwestern, one of the premier academic medical centers in the nation, integrates pioneering biomedical research with exceptional clinical care and education. The institution’s faculty has received 6 Nobel Prizes, and includes 22 members of the National Academy of Sciences, 16 members of the National Academy of Medicine, and 15 Howard Hughes Medical Institute Investigators. The faculty of more than 2,700 is responsible for groundbreaking medical advances and is committed to translating science-driven research quickly to new clinical treatments. UT Southwestern physicians provide care in about 80 specialties to more than 105,000 hospitalized patients, nearly 370,000 emergency room cases, and oversee approximately 2.4 million outpatient visits a year.
About University of Texas Health Science Center at Houston (UTHealth)
Established in 1972 by The University of Texas System Board of Regents, The University of Texas Health Science Center at Houston (UTHealth) is Houston’s Health University and Texas’ resource for health care education, innovation, scientific discovery and excellence in patient care. The most comprehensive academic health center in the UT System and the U.S. Gulf Coast region, UTHealth is home to Jane and Robert Cizik School of Nursing, John P. and Kathrine G. McGovern Medical School, and schools of biomedical informatics, biomedical sciences, dentistry and public health. UTHealth includes The University of Texas Harris County Psychiatric Center, as well as the growing clinical practices UT Physicians, UT Dentists and UT Health Services. The university’s primary teaching hospitals are Memorial Hermann-Texas Medical Center, Children’s Memorial Hermann Hospital and Harris Health Lyndon B. Johnson Hospital. For more information, visit www.uth.edu.
About Immune-Onc Therapeutics, Inc.
Immune-Onc Therapeutics, Inc. (“Immune-Onc”) is a privately held cancer immunotherapy company dedicated to the discovery and development of novel biologic treatments for cancer patients. The company aims to translate unique scientific insights in the tumor microenvironment and immune suppressive pathways to develop first-in-class biotherapeutics. 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. Its lead program, an antibody targeting LILRB4, is being developed to treat acute myeloid leukemia and other cancers. 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.
Media Contact
UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER
Communications
news@utsouthwestern.edu
214-648-3404
THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT HOUSTON (UTHEALTH)
Media Relations
Robert.Cahill@uth.tmc.edu
713-500-3042
IMMUNE-ONC THERAPEUTICS, INC.
Tara Cooper
Cooper Communication Group
media@immuneonc.com
650-303-7306
References
1. Global Burden of Disease Cancer Collaboration. Global, Regional, and National Cancer Incidence, Mortality, Years of Life Lost, Years Lived With Disability, and Disability-Adjusted Life-Years for 29 Cancer Groups, 1990 to 2016: A Systematic Analysis for the Global Burden of Disease Study. JAMA Oncology. Published online June 2, 2018. doi:10.1001/jamaoncol.2018.2706.
2. National Cancer Institute. SEER Cancer Stat Facts: Leukemia – Acute Myeloid Leukemia (AML). Available at https://seer.cancer.gov/statfacts/html/amyl.html. Accessed July 31, 2018.