Immune-Onc Therapeutics Selected for Oral Presentation at American Society of Hematology (ASH) Annual Meeting to Showcase New Data from Phase 1b Study of IO-202 in Chronic Myelomonocytic Leukemia
PALO ALTO, CA, November 5, 2024 -- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a private clinical-stage biopharmaceutical company advancing novel therapies in immunology and oncology by targeting myeloid cell inhibitory receptors, today announced that the latest data from the Phase 1b expansion cohort of its first-in-class anti-LILRB4 antibody, IO-202, in combination with azacitidine (AZA) for the treatment of chronic myelomonocytic leukemia (CMML), has been selected for an oral presentation at the 2024 American Society of Hematology (ASH) Annual Meeting, to be held December 7-10 in San Diego, California.
CMML is a rare and aggressive form of leukemia with limited treatment options and poor survival outcomes. Currently, the only approved therapies for CMML are hypomethylating agents (HMAs), including AZA, which yield a 7-17% complete remission (CR) rate.2 IO-202, a humanized monoclonal antibody that targets leukocyte immunoglobulin-like receptor B4 (LILRB4, also known as ILT3), offers a promising therapeutic option for this patient population.
“We are pleased with the positive interim data for IO-202 in CMML patients,” said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. “These results highlight the potential of IO-202 to redefine treatment for CMML, a disease with very limited therapeutic options. We look forward to working closely with regulators to explore its potential as a frontline therapy for this underserved patient population.”
New data beyond what was published in the ASH abstract #1008 will be included in the oral presentation on December 9, 2024.
Oral presentation details:
Publication Number: 1008
Title: IO-202, a Novel Anti-LILRB4 Antibody, with Azacitidine for Hypomethylating Agent-Naive Chronic Myelomonocytic Leukemia: Phase 1b Expansion Cohort Results
Presenter: Gabriel N. Mannis, M.D., associate professor of medicine, division of hematology, Stanford Cancer Institute, Stanford University
Session Name: 637. Myelodysplastic Syndromes: Clinical and Epidemiological: Defining and Treating Chronic Myelomonocytic Leukemia
Session Date and Time: Monday, December 9, 2024: 4:30 PM - 6:00 PM PT
Presentation Time: 5:45 PM PT
Room: Manchester Grand Hyatt San Diego, Grand Hall D
ABOUT CHRONIC MYELOMONOCYTIC LEUKEMIA (CMML)
CMML is a rare form of blood cancer, occurring in 4 of every 1,000,000 people in the United States each year,2 or about 1,100 annual cases.3 CMML is characterized by a high monocyte count (>1x109/L peripheral monocytes with monocytes ≥ 10% of white blood count) and dysplastic features in the bone marrow.1 Current FDA-approved therapies for CMML are all hypomethylating agents, including azacitidine, only achieving a 7-17% complete response rate.2
ABOUT LILRB4 (also known as ILT3)
LILRB4, also known as ILT3, is an immune-modulatory transmembrane protein found on monocytes and monocyte-derived cells. LILRB4 is expressed on certain hematologic cancer cells, such as myelomonocytic leukemia blasts, and on certain pathogenic cells involved in autoimmunity and inflammatory processes.
ABOUT IO-202
IO-202 is a first-in-class IgG1 antibody with specific, high-affinity binding to LILRB4 and depletes LILRB4 positive cells via antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis. As such, IO-202 is a targeted therapy with broad potential in blood cancers and autoimmune and inflammatory diseases.
IO-202 has completed the dose escalation part of the first-in-human, multicenter, open-label Phase 1 study in the U.S., and the data was presented at the European Hematology Association (EHA) Congress in 2023. This Phase 1 trial has advanced to the dose expansion stage to evaluate IO-202 in combination with azacitidine (NCT04372433) in patients with newly diagnosed chronic myelomonocytic leukemia (CMML) who have not received any hypomethylating agents (HMA).
The U.S. Food and Drug Administration granted IO-202 Fast Track Designations for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) and relapsed or refractory CMML, respectively. The FDA has also granted IO-202 Orphan Drug Designations for the treatment of AML and CMML, respectively.
ABOUT IMMUNE-ONC THERAPEUTICS, INC.
Immune-Onc Therapeutics Inc. (“Immune-Onc”) is a private, clinical-stage biopharmaceutical company developing novel therapies in immunology and oncology by targeting myeloid cell inhibitory receptors.
Immune-Onc has a differentiated pipeline with a current focus on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB). Immune-Onc’s focused platform approach has led to the development of several promising therapeutics across various stages of development. Those include IO-108, an antagonist antibody targeting LILRB2 (also known as ILT4), in Phase 1b/2 clinical development for solid tumors, and IO-202, a first-in-class antibody targeting LILRB4 (also known as ILT3), in Phase 1b clinical development for the treatment of acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML). Additional assets in Immune-Onc’s pipeline include IO-312 (a novel bispecific antibody targeting LILRB4 and CD3), IO-106 (first-in-class antagonist antibody targeting LAIR1), and undisclosed immunology and oncology programs.
Immune-Onc has established agreements with leading biopharmaceutical companies, including BeiGene, Regeneron, and Roche, to support its global product development plans for IO-108 and IO-202. It has received research grants from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) and the California Institute for Regenerative Medicine (CIRM) and investment from The Leukemia & Lymphoma Society Therapy Acceleration Program® (LLS TAP®). Headquartered in Palo Alto, California, Immune-Onc has assembled a diverse team with deep expertise in drug development and proven track records of success at leading biopharmaceutical companies. For more information, please visit www.immune-onc.com and follow us on X and LinkedIn.
MEDIA CONTACT
Tara Cooper
The Grace Group
tara@gracegroup.us
media@immuneonc.com
650-303-7306
Consensus proposal for revised International Working Group 2023 response criteria for higher-risk myelodysplastic syndromes. Blood 2023; 141 (17): 2047–2061. doi.org/10.1182/blood.2022018604
Chronic myelomonocytic leukemia: 2022 update on diagnosis, risk stratification, and management. Am J Hematol. 2022; 97(3):352-372. doi: 10.1002/ajh.26455.
Epidemiology of myelodysplastic syndromes and chronic myeloproliferative disorders in the United States, 2001-2004, using data from the NAACCR and SEER programs. Blood. 2008; 112(1):45-52. doi: 10.1182/blood-2008-01-134858
