Curis Opens Eleven Clinical Sites for Phase 2 TakeAim CLL Study of Emavusertib–Zanubrutinib Combination
核心洞察
Curis has activated eleven clinical sites for patient enrollment in its Phase 2 TakeAim CLL study evaluating emavusertib combined with zanubrutinib in chronic lymphocytic leukemia (搜索).
The company reaffirmed guidance that the initial five patients will be dosed by the end of July 2026, with initial data expected in December 2026.
The combination strategy targets dual blockade of NF-kB (搜索), a key driver of CLL, by pairing an IRAK4 (搜索)/FLT3 (搜索) inhibitor with a BTK (搜索) inhibitor.
Curis, Inc. announced on June 26, 2026 that eleven clinical sites have been initiated and are now open for patient enrollment in its Phase 2 TakeAim CLL study, which is evaluating the company's lead candidate emavusertib (CA-4948) in combination with zanubrutinib in patients with chronic lymphocytic leukemia (搜索) (CLL). The Lexington, Massachusetts-based biotechnology company also reaffirmed its expectation to dose the initial five patients by the end of July 2026, with data anticipated in December 2026.
The operational update reflects what Curis President and CEO James Dentzer described as strong investigator interest in the combination approach. "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," Dentzer said, "and we look forward to building on those successes in the weeks and months to come."
Dual NF-kB (搜索) Blockade Strategy
Emavusertib is an orally available, small molecule inhibitor targeting both IRAK4 (搜索) and FLT3 (搜索). The TakeAim CLL study pairs this mechanism with zanubrutinib, a BTK (搜索) inhibitor, to achieve dual blockade of NF-kB (搜索) signaling — a pathway identified as a key driver of CLL disease. The rationale builds on the premise that combining an IRAK4 inhibitor with a BTK inhibitor may provide more complete suppression of this critical oncogenic pathway than either agent alone.
The open-label Phase 2 study (CA-4948-203, NCT07271667) enrolls patients who are in a partial response (PR) or partial response with lymphocytosis (PR-L), are measurable residual disease positive (MRD+) as determined by the ClonoSEQ assay, and have been actively taking zanubrutinib for at least 12 months.
Broader Development Program
Beyond the TakeAim CLL study, emavusertib is also being evaluated in the TakeAim Lymphoma Phase 1/2 study (CA-4948-101) in combination with the BTK (搜索) inhibitor ibrutinib in patients with relapsed/refractory primary central nervous system lymphoma (搜索) (PCNSL). The company's monotherapy and combination studies in acute myeloid leukemia (搜索) (AML) are substantially complete, and Curis plans to continue development of emavusertib in AML contingent on additional funding.
Emavusertib has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of PCNSL, AML, and myelodysplastic syndromes (搜索) (MDS), and from the European Commission for PCNSL. Curis holds the exclusive license to emavusertib through its 2015 collaboration with Aurigene Discovery Technologies Limited (搜索).
Corporate Developments
At a special meeting of stockholders held on June 25, 2026, Curis shareholders approved a proposal to amend the company's Restated Certificate of Incorporation to effect a reverse stock split of its issued and outstanding common stock at a ratio ranging from 1-for-5 to 1-for-25. The move is intended to help the company regain compliance with Nasdaq's $1.00 bid price rule. The final ratio will be determined at the discretion of Curis's Board of Directors, and the company intends to announce the specific ratio and effective date in advance of the reverse stock split becoming effective. Curis shares will continue to trade on the Nasdaq Capital Market under the ticker symbol "CRIS."
The company has acknowledged in its forward-looking statements 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 to advance emavusertib through regulatory approval and commercialization.