Emavusertib

LEXINGTON, Mass., July 30, 2026 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 and FLT3 inhibitor, today announced an important enrollment milestone in its TakeAim CLL study in patients with Chronic Lymphocytic Leukemia (CLL). 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, 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). 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 . 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. SOURCE Curis, Inc. 21% more press release views with Request a Demo

Updated Clinical Data in PCNSL Increased Guidance on Year-End Data in CLL Company to Host Webcast at 8:30 a.m. ET LEXINGTON, Mass., July 22, 2026 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 and FLT3 inhibitor, today announced that it will host a webcast on Wednesday, July 22 at 8:30 a.m. ET to discuss positive updated clinical data in the TakeAim Lymphoma study, its ongoing registrational study in Primary CNS Lymphoma (PCNSL), and provide updated guidance on year-end data in the TakeAim CLL study, its ongoing Phase 2 study in Chronic Lymphocytic Leukemia (CLL). Participants may join the live audio webcast here or by dialing (800)-836-8184 from the United States or (646)-357-8785 from other locations or from the investor section of the Curis website. A replay of the conference call will be available at . Take Aim Lymphoma The PCNSL update includes data for 7 BTK-naïve patients and 39 BTKi-experienced patients: TakeAim CLL On June 26, 2026, Curis announced that eleven clinical sites had opened for enrollment in the TakeAim CLL study and on July 6, 2026, announced that it has consented the first six patients in that study. Today, the Company announced that the number of patients consented has increased to 10, with the first five expected to be dosed by the end of July. The company is also increasing its guidance for year-end CLL data from 5 patients to 5-10 patients in December 2026. "We are very encouraged by the updated data from the PCNSL study and by the support of clinicians and regulators for this novel treatment for patients with PCNSL. We are especially excited by the results in the BTKi-experienced patients for whom there are no approved therapies, where emavusertib has shown it can reverse disease progression in patients currently progressing on a BTK inhibitor and enable them to achieve objective responses," said James Dentzer, Chief Executive Officer of Curis. "We are also encouraged by the strong interest among clinical sites and key opinion leaders in our TakeAim CLL study that has enabled us to exceed expectations for site activation and enrollment." About PCNSL and CLL In PCNSL and 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 Lymphoma and TakeAim CLL Studies is to enable a dual blockade of NF-kB, by inhibiting both the BCR and TLR pathways. BTKi blocks the BCR pathway; emavusertib blocks the TLR pathway. BTKi is an established standard of care in Relapsed/Refractory (R/R) PCNSL. For BTKi-naïve patients, response rates can be 40%-70% and are typically partial responses. For those patients who progress on BTKi, outcomes are generally poor, with many patients proceeding directly to hospice or best supportive care. Initial clinical data have shown that adding emavusertib to a BTKi regimen, directly after a patient progresses on BTKi monotherapy, can enable patients to reverse their disease progression and achieve an objective response. BTKi is also standard of care in CLL, where outcomes are more favorable than in PCNSL. In the registrational study for the BTKi zanubrutinib in CLL, 93% of patients were able to achieve an objective response, though only 7% achieved complete response2. More recent clinical studies have shown 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 (MRD). About the TakeAim Lymphoma Study The TakeAim Lymphoma Study is a three-part study of emavusertib in combination with ibrutinib in patients with PCNSL (CA-4948-101, NCT03328078). Part A, the dose escalation part of the study, is complete. Part B is an ongoing single-arm study in BTKi-experienced patients. Part C is an ongoing randomized study in BTKi-naïve patients. In 2025, Curis announced that it completed meetings with the U.S. Food and Drug Administration (FDA) and European Medicines Agency's Committee for Medicinal Products for Human Use (EMA) to review initial clinical data from the Phase 1/2 single-arm study in PCNSL and received guidance that this ongoing study could support an application for accelerated approval in Relapsed/Refractory (R/R) PCNSL. 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. Curis expects to announce the dosing of the initial 5 patients in the TakeAim CLL study by the end of July, with initial data in 5-10 patients expected in December 2026. 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 . 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 the regulatory guidance on potential Conditional Marketing Authorization (CMA) from the EMA and potential NDA for Accelerated Approval from the FDA for emavusertib in the treatment of PCNSL, and Curis's expectations with respect to regulatory objectives; Curis's expectations with respect to enrollment of BTKi naïve and BTKi experienced populations in the TakeAim Lymphoma study; statements regarding updated PCNSL data and the timing of such data from the TakeAim Lymphoma study, the potential use thereof for regulatory submissions to support CMA and/or Accelerated Approval, and the therapeutic potential and tolerability of emavusertib in patients with PCNSL; expectations with respect to the number of patients consented in the TakeAim CLL study, the dosing of the first five patients and the timing thereof, the Company's increased guidance for year-end CLL data from five patients to five to ten patients, and the timing of and initial data from the TakeAim CLL study; statements concerning research, development, clinical trials and commercialization plans, timelines, anticipated results, use, safety, efficacy, rates and duration of responses, mutations or potential biomarkers, and potential benefits of emavusertib as a monotherapy and/or as a combination therapy. 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 SOURCE Curis, Inc. 21% more press release views with Request a Demo