Business
Curis Provides Second Quarter 2023 Business Update
Removal of partial clinical hold – enrolling patients at confirmed RP2D in the TakeAim Leukemia Study Enrolling patients in the TakeAim Lymphoma Study in
About this update from Curis, Inc.
[{"type":"text","content":"Removal of partial clinical hold – enrolling patients at confirmed RP2D in the TakeAim Leukemia Study\nEnrolling patients in the TakeAim Lymphoma Study in combination with ibrutinib\nStrong balance sheet with $77.4 million in cash and investments; cash runway into 2025\nManagement to host conference call today at 4:30 p.m. ET\nLEXINGTON, Mass., Aug. 3, 2023 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib, an orally available, small molecule IRAK4 inhibitor for the treatment of hematologic malignancies, today reported its business update and financial results for the second quarter ended June 30, 2023.\n\n \n \n \n \n \n \n\n \n\"We are very pleased with our progress this quarter, as we were able to work with the FDA to remove the partial clinical hold on the TakeAim Leukemia study a quarter ahead of schedule. In that process, we also gained alignment with FDA in confirming 300 mg BID as the RP2D for monotherapy, which we believe is the optimal monotherapy dose. We appreciate the strong support of our clinical investigators during our discussions with FDA and we are excited to expand patient enrollment in the TakeAim Leukemia study at the RP2D,\" said James Dentzer, President and CEO of Curis.\nSecond Quarter 2023 and Recent Operational Highlights\nPrecision Oncology, Emavusertib (IRAK4 Inhibitor)\nTakeAim Leukemia\nIn July, the Company announced that the U.S. Food and Drug Administration (FDA) removed the partial clinical hold on the TakeAim Leukemia Phase 1/2 study of emavusertib. Further, the recommended phase 2 dose (RP2D) for emavusertib as a monotherapy has been confirmed at 300 mg BID in patients with Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndromes (MDS).The Company is currently enrolling relapsed or refractory (R/R) AML patients with FLT3 mutation or a spliceosome mutation (U2AF1 or SF3B1 mutation) who have received ≤ 2 prior lines of treatment in the monotherapy study.The Company is also planning a combination study of emavusertib with azacitidine and venetoclax to treat AML patients in the front-line setting.TakeAim Lymphoma\nThe Company is focusing its lymphoma clinical development efforts on Primary CNS lymphoma (PCNSL), a rare form of extranodal non-Hodgkin lymphoma for which there are limited treatment options. The Company is currently enrol...