Immune-Onc to Present IO-202 Phase 1b Interim CMML Data at 2024 EHA Congress

Immune-Onc Therapeutics, Inc. ("Immune-Onc"), a clinical-stage biopharmaceutical company focused on innovative therapies in immunology and oncology, has shared promising interim Phase 1b data for IO-202 in patients with chronic myelomonocytic leukemia (CMML). The findings are set to be presented at the 2024 European Hematology Association (EHA) Annual Meeting, occurring virtually and in Madrid, Spain, from June 13 to 16.

In the ongoing Phase 1b expansion study, early responses are encouraging. Specifically, 4 out of 5 efficacy evaluable patients, who had not previously been treated with hypomethylating agents, achieved complete remission (CR) using the preliminary recommended Phase 2 dose of IO-202 in combination with azacitidine (AZA). Hypomethylating agents, including AZA, currently represent the only FDA-approved treatment for CMML but have a relatively low CR rate of 7-17%. The interim data suggest that IO-202 is well tolerated when combined with azacitidine. All patients who achieved CR showed high baseline LILRB4 expression on bone marrow blasts, reinforcing the mechanism of action of IO-202 as a targeted therapy.

Dr. Charlene Liao, CEO of Immune-Onc, expressed optimism about the early complete responses seen in the study. She highlighted the potential of IO-202, in combination with azacitidine, to transform CMML treatment, a disease with limited treatment options and poor prognosis.

The poster presentation at the EHA meeting is titled "Targeting LILRB4 (ILT3) Using IO-202 in Patients with Chronic Myelomonocytic Leukemia (CMML): Interim Efficacy, Safety, and Mechanism of Action Data from the Phase 1b Expansion Cohort." It will be presented by Dr. Ahmed Aribi, an assistant professor in the Division of Leukemia at City of Hope in Duarte, CA, on June 14.

CMML is a rare type of blood cancer that affects approximately 1,100 people annually in the United States. It is characterized by high monocyte counts and dysplastic features in the bone marrow. Current FDA-approved therapies, including azacitidine, only achieve a complete response rate of 7%-17%.

LILRB4, also known as ILT3, is an immune-modulatory protein found on monocytes and some hematologic cancer cells, including myelomonocytic leukemia blasts. IO-202 is a first-in-class IgG1 antibody that specifically binds to LILRB4 with high affinity and induces the depletion of LILRB4-positive cells through antibody-dependent cellular cytotoxicity and phagocytosis.

The Phase 1 trial of IO-202, which began with dose escalation, has now progressed to the dose expansion stage. This stage is assessing IO-202 in combination with azacitidine in newly diagnosed CMML patients who have not been treated with hypomethylating agents. The U.S. Food and Drug Administration has granted IO-202 Fast Track Designations for treating relapsed or refractory acute myeloid leukemia (AML) and CMML, as well as Orphan Drug Designations for both conditions.

Immune-Onc, headquartered in Palo Alto, California, is dedicated to discovering and developing novel therapies that target myeloid cell inhibitory receptors. Their pipeline includes several promising therapeutic candidates, such as IO-108 and IO-202, in various stages of clinical development. The company has partnerships with leading biopharmaceutical companies like BeiGene, Regeneron, and Roche, and has received support from notable institutions like the National Cancer Institute and the California Institute for Regenerative Medicine.

In summary, the interim Phase 1b data for IO-202 in combination with azacitidine show significant promise for treating CMML, potentially bringing new hope to patients suffering from this challenging disease.