A Phase 1 dosage expansion clinical trial combining IO-202 with azacitidine is presently enrolling newly diagnosed CMML patients who have not yet taken any hypomethylating medications
An image of CMML on peripheral blood film. (Credit: Simon Caulton from Wikimedia Commons)
Immune-Onc Therapeutics has received the orphan drug designation from the US Food and Drug Administration (FDA) for IO-202 to treat chronic myelomonocytic leukaemia (CMML).
IO-202 is a first-in-class antagonist humanised IgG1 antibody. It has a specific, high affinity binding to Leukocyte Immunoglobulin-Like Receptor subfamily B4 (LILRB4).
It is being assessed as a potential targeted therapy in blood cancers and autoimmune and inflammatory diseases.
The therapy has received Fast Track Designation to treat relapsed or refractory CMML in 2023.
Additionally, the FDA granted fast track and orphan drug designations for the treatment of acute myeloid leukaemia (AML) in 2022 and 2020, respectively.
Immune-Onc CEO and board chair Charlene Liao said: “Although current therapeutic options for CMML can improve a patient’s quality of life, there is a high unmet need for effective disease-modifying approaches that are potentially curative.
“We are very proud that the FDA has granted IO-202 Orphan Drug Designation for the treatment of CMML. We look forward to continued collaborations with our investigators and the FDA as we work to bring this potentially important therapy to patients with hard-to-treat blood cancers.”
A Phase 1 dosage expansion clinical trial combining IO-202 with azacitidine (AZA) is presently enrolling newly diagnosed CMML patients who have not yet taken any hypomethylating medications (HMA).
After a dose-escalation trial, IO-202 demonstrated clinical efficacy as a monotherapy or in combination with AZA for treating relapsed or refractory AML and CMML.
The therapy has proven to be well tolerated in every patient treated so far.
Headquartered in California, US, Immune-Onc has signed agreements with biopharmaceutical firms like BeiGene, Regeneron, and Roche to support the global product development plans of IO-202.