Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, today announced initial combination study data from its TakeAim Lymphoma trial including 5 primary CNS lymphoma (PCNSL) patients.
“We are very pleased with the initial emavusertib/ibrutinib combination data from the TakeAim Lymphoma study. We are particularly excited about the activity in relapsed/refractory PCNSL and the meaningful benefit emavusertib may provide in combination with BTKi,” said James Dentzer, President and Chief Executive Officer of Curis.
As of October 12th, the TakeAim Lymphoma trial has enrolled and treated 19 Non-Hodgkin Lymphoma (NHL) patients, with a combination of emavusertib and ibrutinib; with emavusertib doses ranging from 100 mg to 300 mg BID. The initial data reveal encouraging efficacy, demonstrating multiple objective responses in both BTK-naïve and BTK-experienced patients.
Patients with PCNSL who had a history of failed BTKi therapy showed a particularly noteworthy response: 3 out of 5 evaluable PCNSL patients achieved a Complete Response (CR), with durability ranging from 0.3 – 8.9 months. These data underscore the potential of emavusertib to re-sensitize patients to BTKi therapy, marking a significant advancement in Non-Hodgkin Lymphoma treatment.
Consistent with our previous findings, the emavusertib/ibrutinib combination demonstrates a manageable and acceptable safety profile, with no observed dose-limiting toxicities (DLTs) in the 200 mg cohort and 2 reversible DLTs (stomatitis and syncope) in the 300 mg cohort.
About emavusertib (CA-4948)
Emavusertib is a small molecule IRAK4 inhibitor. IRAK4 plays an essential role in the toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) signaling pathways, which are frequently dysregulated in patients with cancer. TLRs and the IL-1R family signal through the adaptor protein MYD88, which results in the assembly and activation of IRAK4, initiating a signaling cascade that induces cytokine and survival factor expression mediated by the NF-κB protein complex. Preclinical studies targeting IRAK1/4 in combination with FLT3 have demonstrated the ability to overcome the adaptive resistance incurred when targeting FLT3 alone. Further, emavusertib has shown anti-tumor activity across a broad range of hematologic malignancies including monotherapy activity in patient-derived xenografts and synergy with both azacitidine and venetoclax.
About TakeAim Lymphoma Study
TakeAim Lymphoma Study (NCT03328078) – study is open for enrollment.
