Curis Doses First Five Patients in TakeAim CLL Study
Rhea-AI Summary
Curis (NASDAQ: CRIS) reported an enrollment milestone in its TakeAim CLL study evaluating emavusertib, an oral IRAK4/FLT3 inhibitor, in Chronic Lymphocytic Leukemia. The company has now dosed the first five patients, after previously opening 11 sites and consenting 10 patients.
Curis reaffirmed its expectation to present initial data from 5–10 CLL patients in December 2026. The study combines emavusertib with the BTK inhibitor zanubrutinib to achieve dual NF-kB pathway blockade (BCR and TLR), aiming for deeper responses, complete remissions and undetectable minimal residual disease. According to Curis, the regimen appears well tolerated so far, with possible early signs of deepening responses, although patient numbers remain small.
Positive
- First five CLL patients dosed in TakeAim CLL, meeting stated enrollment milestone
- Initial data timing reaffirmed for 5–10 CLL patients in December 2026
- Early tolerability and response signals reported for emavusertib plus zanubrutinib combination in CLL
Negative
- None.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jul 22 | Emavusertib update | Positive | +4.0% | Updated PCNSL responses and higher CLL data guidance preceded a positive reaction. |
| Jul 06 | CLL enrollment update | Positive | -14.3% | First six CLL patients were consented, but shares declined after the update. |
| Jun 26 | CLL study update | Positive | +56.0% | Eleven sites opened, dosing guidance reaffirmed, and reverse-split approval were reported. |
| May 12 | Quarterly business update | Negative | -9.2% | Net loss, no revenue, and increased other expense accompanied the quarterly business update. |
| May 05 | Earnings scheduling notice | Neutral | +8.2% | Curis scheduled first-quarter results and a conference call for May 12. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
CRIS had three positive and two negative 24-hour reactions across the five recent news events, including a divergence after a prior CLL enrollment update.
Key Terms
irak4 medical
flt3 medical
measurable residual disease medical
objective response medical
undetectable minimal residual disease medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Previously, Curis announced that 11 clinical sites had opened for enrollment in the TakeAim CLL study and 10 patients had been consented in that study. Today, 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 5-10 patients in December 2026.
"We are encouraged by our progress in the CLL study as patient enrollment continues to exceed expectations," said James Dentzer, Chief Executive Officer of Curis. "The excitement among clinicians and patients reflects the clear unmet need in CLL, where emavusertib has the potential to change the treatment landscape when combined with approved BTK inhibitors."
"BTK inhibitors have improved outcomes for patients with CLL; however, most patients still achieve only partial response and continue to have measurable residual disease (MRD) despite continuous, indefinite BTKi therapy," said Ahmed Hamdy, Chief Medical Officer of Curis. "This chronic BTKi dosing can lead to BTKi resistance, bleeding risk, cardiovascular events, and eventual CLL relapse. Combining emavusertib with an approved BTKi offers the potential to deepen responses, promote conversion to complete remission, undetectable MRD, and the potential for fixed-duration treatment. While we are still in the early days of the study, and the number of patients is small, we are greatly encouraged that the combination of emavusertib and zanubrutinib appears to be well tolerated and may be demonstrating early evidence of deepening responses in CLL patients."
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 the current standard of care in CLL. In the registrational study for the BTKi zanubrutinib,
About the TakeAim CLL Study
The TakeAim CLL Study is an open label phase 2 study of emavusertib in combination with zanubrutinib in patients with CLL (CA-4948-203, NCT07271667). 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.
About Curis, Inc.
Curis is a biotechnology company focused on the development of emavusertib, an orally available, small molecule IRAK4 and FLT3 inhibitor. Emavusertib is currently being evaluated in the TakeAim Lymphoma Phase 1/2 study (CA-4948-101) of emavusertib in combination with the BTK inhibitor, ibrutinib, in patients with relapsed/refractory primary central nervous system lymphoma (PCNSL) and in the TakeAim CLL Phase 2 study (CA-4948-203) of emavusertib in combination with the BTK inhibitor, zanubrutinib, in chronic lymphocytic leukemia (CLL). The Company's monotherapy and combination studies in acute myeloid leukemia (AML) are substantially complete, with additional funding the Company plans to continue development of emavusertib in AML. Emavusertib has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of PCNSL, AML and MDS and from the European Commission for the treatment of PCNSL. Curis, through its 2015 collaboration with Aurigene Discovery Technologies Limited, has the exclusive license to emavusertib (CA-4948). For more information, visit Curis's website at www.curis.com.
Cautionary Note Regarding Forward-Looking Statements:
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, including, without limitation, statements concerning Curis's expectations with respect to the initial data from the TakeAim CLL study. Forward-looking statements may contain the words "believes," "expects," "anticipates," "plans," "intends," "seeks," "estimates," "assumes," "predicts," "projects," "targets," "will," "may," "would," "could," "should," "likelihood", "continue," "potential," "opportunity," "focus," "strategy," "mission," or similar expressions. These forward-looking statements are not guarantees of future performance and involve risks, uncertainties, assumptions and other important factors that may cause actual results to be materially different from those indicated by such forward-looking statements. Curis may experience adverse results, delays and/or failures in its drug development programs and may not be able to successfully advance the development of its drug candidates in the time frames it projects, if at all. Curis's drug candidates may cause unexpected toxicities, fail to demonstrate sufficient safety and efficacy in clinical studies and/or may never achieve the requisite regulatory approvals needed for commercialization. Favorable results seen in preclinical studies and early clinical trials of Curis's drug candidates may not be replicated in later trials. Curis is dependent on the success of emavusertib and any delays in the development of emavusertib could have a material adverse effect on its business. There can be no guarantee that the collaboration agreement with Aurigene or the CRADA with NCI will continue for their full terms, that Curis or its collaborators will each maintain the financial and other resources necessary to continue financing its portion of the research, development and commercialization costs, or that the parties will successfully discover, develop or commercialize drug candidates under the collaboration. Curis will require substantial additional capital to fund its business. Based on its available cash resources, it does not have sufficient cash on hand to support current operations within the next 12 months from the date of this press release. Curis will require substantial additional funding to fund the development of emavusertib through regulatory approval and commercialization, and to support its continued operations. If it is not able to obtain sufficient funding, it will be forced to delay, reduce in scope or eliminate the development of emavusertib, including related clinical trials and operating expenses, potentially delaying the time to market for, or preventing the marketing of, emavusertib, which could adversely affect its business prospects and its ability to continue operations, and would have a negative impact on its financial condition and its ability to pursue its business strategies. Curis faces substantial competition. Curis and its collaborators face the risk of potential adverse decisions made by the FDA, EMA and other regulatory authorities, investigational review boards, and publication review bodies. Curis may not obtain or maintain necessary patent protection and could become involved in expensive and time-consuming patent litigation and interference proceedings. Unstable market and economic conditions, natural disasters, public health crises, political crises and other events outside of Curis's control, including its ability to regain and maintain its listing on the Nasdaq Capital Market, could significantly disrupt its operations or the operations of third parties on which Curis depends and could adversely impact Curis's operating results and its ability to raise capital. Other important factors that may cause or contribute to actual results being materially different from those indicated by forward-looking statements include the factors set forth under the captions "Risk Factor Summary" and "Risk Factors" in our most recent Form 10-K, and the factors that are discussed in other filings that Curis periodically makes with the Securities and Exchange Commission. In addition, any forward-looking statements represent the views of Curis only as of today and should not be relied upon as representing Curis's views as of any subsequent date. Curis disclaims any intention or obligation to update any of the forward-looking statements after the date of this press release whether as a result of new information, future events or otherwise, except as may be required by law.
1 Bennett, Curr Opin Hematol. 2022
2 Zanubrutinib USPI.
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SOURCE Curis, Inc.