お知らせ • Jul 22
Curis, Inc. Announces Positive Updated Clinical Data In TakeAim Lymphoma Study And Provides Updated Guidance On Year-End Data In TakeAim CLL Study
Curis, Inc. announced that it will host a webcast 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). The PCNSL update includes data for 7 BTK-naïve patients and 39 BTKi-experienced patients. 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. 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. 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 response. 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). 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. 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. 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).