FDA Allows Patient Enrollment to Resume in Monotherapy Dose Escalation of Emavusertib in TakeAim Leukemia Study
August 30 2022 - 08:00AM
PR Newswire (US)
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Curis working with clinical sites to resume enrollment
Preliminary clinical data update expected in 2023
LEXINGTON, Mass., Aug. 30, 2022 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has notified Curis that it may resume enrollment of additional patients in the monotherapy phase of the TakeAim Leukemia study.
(PRNewsfoto/Curis, Inc.)
Previously, Curis announced that the FDA had placed partial clinical holds on the TakeAim Leukemia and TakeAim Lymphoma studies in April 2022. On August 18, 2022, Curis reported that the partial clinical hold on the TakeAim Lymphoma study was lifted. After review of the comprehensive data package submitted by Curis, the FDA has notified Curis that it may resume enrollment of additional patients in the monotherapy dose finding phase (Phase 1a) of the TakeAim Leukemia study, in which the company has agreed to enroll at least nine additional patients at the 200mg dose level. The partial hold remains in place for the combination therapy phase (Phase 1b) and the expansion phase (Phase 2a) of the study until Phase 1a is complete and the FDA approves proceeding to the next phases of the study.
Before lifting the restriction on patient enrollment, the FDA reviewed additional data provided by the company related to the risk of rhabdomyolysis, a side effect also associated with statins, as well as with cancer medications such as Odomzo® and Cotellic®. The FDA also reviewed the company's strategy for utilizing objective laboratory measurements, similar to those used with Odomzo and Cotellic, to identify rhabdomyolysis, as well as the company's strategy for managing rhabdomyolysis, if it is detected.
"We are pleased to announce the results of the FDA's review and to have addressed potential concerns about the identification and management of rhabdomyolysis," said James Dentzer, President and Chief Executive Officer of Curis. "We are working with our clinical sites to quickly resume enrollment of additional patients."
Similar to the TakeAim Lymphoma study, the Company is updating its timeline for clinical data release to reflect the availability of updated preliminary data from the TakeAim Leukemia study in 2023. In addition, Curis is proactively discussing the clinical plans for emavusertib in leukemia, including alignment on optimal dose and development path, with the FDA's leukemia division.
About Emavusertib (CA-4948)
Emavusertib is an IRAK4 kinase inhibitor and IRAK4 plays an essential role in the toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) signaling pathways, which are frequently dysregulated in patients with cancer. TLRs and the IL-1R family signal through the adaptor protein MYD88, which results in the assembly and activation of IRAK4, initiating a signaling cascade that induces cytokine and survival factor expression mediated by the NF-?B protein complex. Additionally, third parties have recently discovered that the long form of IRAK4 (IRAK4-L) is oncogenic and preferentially expressed in over half of patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The overexpression of IRAK4-L is believed to be driven by a variety of factors, including specific spliceosome mutations such as SF3B1 and U2AF1. In addition to inhibiting IRAK4, emavusertib was also designed to inhibit FLT3, a known oncologic driver, which may provide additional benefit in patients with AML and MDS.
About TakeAim Leukemia
The TakeAim Leukemia study (NCT04278768) is a Phase 1/2 open-label dose
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