LEXINGTON, Mass. — Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 and FLT3 inhibitor, today announced an important enrollment milestone in its TakeAim CLL study in patients with Chronic Lymphocytic Leukemia (CLL).
Previously, Curis announced that 11 clinical sites had opened for enrollment in the TakeAim CLL study and 10 patients had been consented in that study. Today, Curis is announcing that it has achieved the previously stated goal of dosing the first five patients in the TakeAim CLL study and reaffirmed its expectation to report initial CLL data in 5-10 patients in December 2026.
“We are encouraged by our progress in the CLL study as patient enrollment continues to exceed expectations,” said James Dentzer, Chief Executive Officer of Curis. “The excitement among clinicians and patients reflects the clear unmet need in CLL, where emavusertib has the potential to change the treatment landscape when combined with approved BTK inhibitors.”
“BTK inhibitors have improved outcomes for patients with CLL; however, most patients still achieve only partial response and continue to have measurable residual disease (MRD) despite continuous, indefinite BTKi therapy,” said Ahmed Hamdy, Chief Medical Officer of Curis. “This chronic BTKi dosing can lead to BTKi resistance, bleeding risk, cardiovascular events, and eventual CLL relapse. Combining emavusertib with an approved BTKi offers the potential to deepen responses, promote conversion to complete remission, undetectable MRD, and the potential for fixed-duration treatment. While we are still in the early days of the study, and the number of patients is small, we are greatly encouraged that the combination of emavusertib and zanubrutinib appears to be well tolerated and may be demonstrating early evidence of deepening responses in CLL patients.”
In CLL, disease is driven by NF-kB dysregulation, which is in turn driven by two biologic pathways: BCR and TLR1. The goal of combining emavusertib with a BTK inhibitor (BTKi) in the TakeAim CLL Study is to enable a dual blockade of NF-kB, by inhibiting both the BCR and TLR pathways. BTK inhibitors (BTKi) block the BCR pathway; emavusertib blocks the TLR pathway.
BTKi is the current standard of care in CLL. In the registrational study for the BTKi zanubrutinib, 93% of patients were able to achieve an objective response, but only 7% achieved complete response2. More recent clinical studies have demonstrated that adding emavusertib to a BTKi regimen, blocking both the TLR and BCR pathways, can enable patients with NHL to achieve deeper responses, including complete responses or undetectable minimal residual disease (uMRD).
About the TakeAim CLL Study
The TakeAim CLL Study is an open label phase 2 study of emavusertib in combination with zanubrutinib in patients with CLL (CA-4948-203, NCT07271667). Participants in the study must be in a partial response (PR) or partial response with lymphocytosis (PR-L), with measurable residual disease (MRD+) as determined by the clonoSEQ assay and actively taking zanubrutinib for at least 12 months.
About Curis, Inc.
Curis is a biotechnology company focused on the development of emavusertib, an orally available, small molecule IRAK4 and FLT3 inhibitor. Emavusertib is currently being evaluated in the TakeAim Lymphoma Phase 1/2 study (CA-4948-101) of emavusertib in combination with the BTK inhibitor, ibrutinib, in patients with relapsed/refractory primary central nervous system lymphoma (PCNSL) and in the TakeAim CLL Phase 2 study (CA-4948-203) of emavusertib in combination with the BTK inhibitor, zanubrutinib, in chronic lymphocytic leukemia (CLL). The Company’s monotherapy and combination studies in acute myeloid leukemia (AML) are substantially complete, with additional funding the Company plans to continue development of emavusertib in AML. Emavusertib has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of PCNSL, AML and MDS and from the European Commission for the treatment of PCNSL. Curis, through its 2015 collaboration with Aurigene Discovery Technologies Limited, has the exclusive license to emavusertib (CA-4948). For more information, visit Curis’s website at www.curis.com.
References
1 Bennett, Curr Opin Hematol. 2022
2 Zanubrutinib USPI.
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