Curis doses first five patients in CLL study, eyes December data

Curis, Inc. (NASDAQ: CRIS) announced it has dosed the first five patients in its TakeAim CLL study, a phase 2 trial evaluating emavusertib in combination with zanubrutinib in patients with Chronic Lymphocytic Leukemia (CLL).

The Lexington, Mass.-based biotechnology company said the milestone meets a previously stated enrollment goal. Curis reaffirmed its expectation to report initial data from 5 to 10 patients in December 2026.

The TakeAim CLL study is an open-label phase 2 trial in which participants must be in a partial response or partial response with lymphocytosis, with measurable residual disease as determined by the clonoSEQ assay, and must have been actively taking zanubrutinib for at least 12 months.

Emavusertib is an orally available small molecule IRAK4 and FLT3 inhibitor. The study combines it with zanubrutinib, a BTK inhibitor, with the goal of blocking both the TLR and BCR pathways that drive NF-kB dysregulation in CLL.

Curis Chief Medical Officer Ahmed Hamdy said the combination "appears to be well tolerated and may be demonstrating early evidence of deepening responses in CLL patients," while noting the study remains in early stages with a small patient count.

Curis previously reported that 11 clinical sites had opened for enrollment and 10 patients had been consented in the study.

The company also disclosed in the press release that, based on available cash resources, it does not have sufficient cash on hand to support current operations within the next 12 months and will require substantial additional funding.

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