Curis Announces Positive Updated Data from Ongoing Phase 1/2 Study of CA-4948 Monotherapy in Patients with Relapsed or Refractory Acute Myeloid Leukemia and Myelodysplastic Syndromes
June 11, 2021 at 07:00 am EDT
Share
Curis, Inc. announced updated data from its ongoing Phase 1/2 open-label, single arm, dose escalation and expansion trial of CA-4948, a novel, small molecule IRAK4 kinase inhibitor, in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS) at the European Hematology Association 2021 Virtual Congress (EHA). The reported data are from Curis's ongoing open-label, single arm Phase 1/2 dose escalation 3+3 study of orally administered CA-4948 monotherapy in adult patients with AML or high-risk MDS. A total of 22 patients (11 with high-risk MDS, 11 with AML) were enrolled across dose cohorts of 200 mg BID, 300 mg BID, 400 mg BID, and 500 mg BID. The primary objective of the study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for CA-4948 based on safety and tolerability, dose-limiting toxicities (DLT), and any biologic activity, pharmacokinetic (PK), and pharmacodynamic (PD) findings from the trial population. Additional objectives include characterization of CA-4948's pharmacokinetic parameters and biomarker correlations.
Curis, Inc. is a biotechnology company. The Company is focused on the development of emavusertib (CA-4948), an orally available, small molecule inhibitor of Interleukin-1 receptor associated kinase (IRAK4). Emavusertib is undergoing testing in the Phase I/II TakeAim Lymphoma study in patients with relapsed/refractory primary central nervous system lymphoma (PCNSL) in combination with the BTK inhibitor ibrutinib, as a monotherapy in the Phase I/II TakeAim Leukemia study in patients with relapsed/refractory acute myeloid leukemia (AML) and relapsed/refractory high risk myelodysplastic syndrome (hrMDS). Its other clinical programs include Fimepinostat and CA-170. Fimepinostat is an oral, dual inhibitor of histone deacetylase (HDAC), and phosphotidyl-inositol 3 kinase (PI3K) enzymes. CA-170 is an oral small molecule drug candidate that is designed to selectively target V-domain Ig Suppressor of T-cell Activation (VISTA) and PDL1 immune checkpoint proteins.
Curis Announces Positive Updated Data from Ongoing Phase 1/2 Study of CA-4948 Monotherapy in Patients with Relapsed or Refractory Acute Myeloid Leukemia and Myelodysplastic Syndromes