Immune-Onc Therapeutics, the Hangzhou-based subsidiary of US company Immune-Onc Therapeutics Inc., has announced that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its drug candidate IO-202, which is being developed to treat chronic myelomonocytic leukemia (CMML). This potential first-in-class LILRB4 antagonist was granted fast-track status for its potential in treating CMML in 2023, building on its previous fast-track and ODD statuses for acute myeloid leukemia (AML) in the US.
The Phase I dosage expansion study for IO-202, which combines the drug with azacitidine (AZA), is currently enrolling newly diagnosed CMML patients who have not been previously treated with hypomethylating agents. IO-202 has completed a dosage escalation study, demonstrating clinical efficacy in recurrent or refractory AML and CMML, either as a monotherapy or in combination with AZA. The drug has also shown good tolerability across all patient groups.
This regulatory designation and the progress in clinical studies highlight the potential of IO-202 as a significant therapeutic option for patients with CMML and AML, underlining Immune-Onc Therapeutics’ commitment to advancing treatments for rare and challenging diseases.- Flcube.com
