LEXINGTON, Mass., July 30, 2026
Curis, Inc. has reached an important clinical milestone by successfully dosing the first five patients in its Phase 2 TakeAim CLL study, evaluating emavusertib (CA-4948) in combination with the BTK inhibitor zanubrutinib for the treatment of Chronic Lymphocytic Leukemia (CLL). The biotechnology company also reaffirmed its expectation to report initial clinical data from 5–10 patients in December 2026, highlighting continued momentum as patient enrollment surpasses expectations. The milestone follows the opening of 11 clinical sites and the successful consent of the first 10 patients into the study. Curis believes the investigational combination therapy has the potential to deepen treatment responses beyond current standards of care by targeting complementary biological pathways involved in CLL progression, offering hope for improved remission rates and potential fixed-duration treatment strategies for patients living with the disease.
TakeAim Phase 2 Trial Reaches Key Enrollment Milestone
The TakeAim CLL study is an open-label Phase 2 clinical trial evaluating emavusertib in combination with zanubrutinib in patients with Chronic Lymphocytic Leukemia who have achieved only a partial response after receiving BTK inhibitor therapy. The successful dosing of the first five participants represents a critical advancement in the study and demonstrates strong enrollment momentum across participating clinical centers. Curis reported that patient recruitment continues to exceed internal expectations, reinforcing physician and patient interest in developing new therapeutic approaches for CLL. The company expects to release the first efficacy and safety data later this year, providing an early indication of the combination therapy’s potential clinical benefit. The trial is designed to evaluate whether adding emavusertib to standard BTK inhibitor treatment can improve treatment responses while addressing persistent measurable residual disease (MRD) that often remains despite long-term therapy.
Dual Pathway Targeting Could Improve CLL Treatment Outcomes
Unlike conventional treatment strategies, emavusertib is an orally available small-molecule IRAK4 and FLT3 inhibitor that targets the Toll-Like Receptor (TLR) signaling pathway, while zanubrutinib inhibits the B-cell receptor (BCR) pathway. Together, the combination aims to deliver a dual blockade of NF-κB signaling, a central driver of CLL disease progression. Although current BTK inhibitors have significantly improved patient outcomes, many individuals achieve only partial remission and continue to harbor measurable residual disease, increasing the risk of resistance, disease progression, cardiovascular complications, and bleeding events associated with prolonged therapy. Curis believes that combining emavusertib with zanubrutinib could deepen clinical responses, increase rates of complete remission, achieve undetectable minimal residual disease (uMRD), and potentially enable fixed-duration treatment, reducing the need for indefinite BTK inhibitor therapy. Early observations suggest the combination has been well tolerated, providing encouraging preliminary support for continued clinical evaluation.
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Clinical Development Strengthens Curis’ Oncology Pipeline
The TakeAim CLL study represents one of several ongoing clinical development programs evaluating emavusertib across multiple hematologic malignancies. In addition to CLL, the investigational therapy is being studied in primary central nervous system lymphoma (PCNSL) and has previously demonstrated encouraging activity in acute myeloid leukemia (AML). Emavusertib has also received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of PCNSL, AML, and myelodysplastic syndromes (MDS), reflecting its potential importance in addressing rare and difficult-to-treat blood cancers. As Curis advances enrollment and prepares to report initial clinical data later this year, the company continues strengthening its oncology pipeline with targeted therapies designed to improve outcomes for patients with hematologic malignancies. The successful dosing milestone further reinforces the growing clinical interest in combination approaches capable of delivering deeper and more durable responses in Chronic Lymphocytic Leukemia.
Source: Curis press release
