Curis Provides Second Quarter 2024 Financial and Operating Update

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[{"type":"text","content":"EC Grants ODD to emavusertib in PCNSL\nManagement to host conference call and webcast today at 8:30 a.m. ET\nLEXINGTON, Mass., Aug. 1, 2024 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, today reported its financial and operating results for the second quarter ended June 30, 2024.\n\n \n \n \n \n \n \n\n \nOperational Highlights\nTakeAim Lymphoma\nIn July 2024, emavusertib was granted Orphan Drug Designation (ODD) by the European Commission (EC) for the treatment of patients with primary central nervous system lymphoma (PCNSL). To qualify for ODD in the European Union, among several requirements, emavusertib must be intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating and the prevalence of the condition must be fewer than 5 in 10,000 across the EU.\n\"We are extremely pleased that emavusertib has been granted ODD in the EU for the treatment of PCNSL. The designation is significant for the development of emavusertib in the EU and shows the high unmet need for this patient population,\" said Jonathan Zung, Chief Development Officer.\nIn addition to the EC ODD designation, Curis continues to progress the clinical development of emavusertib and expects to have initial data for 15-20 patients with R/R PCNSL by late 2024. \n\"We are pleased with our progress in the TakeAim Lymphoma study and look forward to providing updated data at the ASH conference in December. As we continue the expansion of clinical sites in our PCNSL study, we have initiated discussions with health authorities to align on a registrational development path for emavusertib in PCNSL. We are excited to take this next step in advancing a novel treatment for patients with PCNSL,\" said James Dentzer, President and Chief Executive Officer. \nTakeAim Leukemia \nIn May 2024, Curis released data for 25 new patients in the Relapsed/Refractory (R/R) FLT3 mutation (FLT3m) and U2AF1/SF3B1 Splicing Factor mutation (SFm) cohorts who had received fewer than 3 lines of prior therapy and were treated with emavusertib as monotherapy at the Recommended Phase 2 Dose (RP2D) of 300 mg BID. 12 R/R AML patients with FLT3m were treated with emavusertib. Preliminary data show 6 objective responses in ...

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