Benzinga | Apr 19, 2021 08:01AM EDT

Curis Receives FDA Orphan Drug Designation For CA-4948 For The Treatment Of AML and MDS

Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation for CA-4948, a first-in-class, small molecule inhibitor of IRAK4 and Curis's most advanced therapeutic in clinical development. CA-4948 targets IRAK4-L, the oncogenic isoform of IRAK4 preferentially expressed by the majority of patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) and has shown broad clinical activity in Phase 1 trials in patients with relapsed or refractory (R/R) AML/MDS.