Curis, Inc., a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 and FLT3 inhibitor, has reached an important enrolment milestone in its TakeAim CLL study in patients with chronic lymphocytic leukaemia (CLL).
Previously, Curis announced that 11 clinical sites had opened for enrolment in the study and 10 patients had been consented in that study.
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 five-10 patients in December 2026.
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 said to be 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).
The TakeAim CLL Study is an open label phase 2 study of emavusertib in combination with zanubrutinib in patients with CLL. 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.
