Curis has opened enrolment at 11 clinical sites for its Phase II TakeAim CLL trial to assess the oral small molecule inhibitor emavusertib, along with zanubrutinib, for patients with chronic lymphocytic leukaemia (CLL).
The company also reaffirmed that dosing of the initial five patients is on track to take place by the end of July 2026, with study data anticipated in December 2026.
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The open-label trial will examine the dual inhibition strategy targeting nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB), which is considered a key driver in CLL pathology.
Curis stated that participants are required to be in a partial response or partial response with lymphocytosis, must test as measurable residual disease positive using the ClonoSEQ assay and must have been on zanubrutinib treatment for at least 12 months.
Curis president and CEO James Dentzer said: “We are pleased with both our operational progress in the CLL study and the strong support from our shareholders as we work to regain compliance with the NASDAQ bid price listing requirement, and we look forward to building on those successes in the weeks and months to come.”
In parallel, Curis reported stockholder approval of a reverse stock split proposal during its special meeting.
At the special meeting, stockholders approved an amendment to the company’s Restated Certificate of Incorporation for a reverse stock split of issued and outstanding shares at a ratio between 1-for-5 and 1-for-25.
The company’s board of directors will determine the final ratio. Curis announced its intention to disclose the specific ratio and effective date before the split is implemented. Shares will continue to be traded on the Nasdaq Capital Market as ‘CRIS’.
Curis is also conducting the TakeAim Lymphoma Phase I/II trial of emavusertib with ibrutinib in relapsed or refractory primary central nervous system lymphoma and has ongoing studies in acute myeloid leukaemia and myelodysplastic syndromes.
Emavusertib previously received orphan drug designation for several indications from regulatory authorities in the European Commission and the US.
Curis has an exclusive licence for emavusertib under a 2015 agreement with Aurigene Discovery Technologies.
