Curis Unveils Groundbreaking Data from the TakeAim Leukemia Clinical Trial

Introduction
Curis, Inc., a pioneering biotechnology firm specializing in the development of innovative treatments for hematological malignancies, recently shared compelling new insights from the TakeAim Leukemia study (CA-4948-102) during the prestigious 66th annual meeting of the American Society of Hematology (ASH). The study is primarily centered on emavusertib (CA-4948), an oral small molecule that targets IRAK4, which has shown significant promise in treating patients with relapsed/refractory acute myeloid leukemia (R/R AML).

The Study Findings
The latest findings presented involved 21 patients diagnosed with a FLT3 mutation and who had previously undergone fewer than three lines of therapy. These patients were administered emavusertib as a monotherapy at the recommended phase 2 dose (RP2D) of 300 mg twice daily (BID). Notably, this expanded the total number of patients treated at this dose bracket from 12 to 21.

In these 19 evaluable patients, a striking 10 objective responses were recorded, highlighting the drug’s efficacy. Among these responses, there were six instances of complete remission (CR), combined with two cases where patients achieved CR with incomplete hematological recovery (CRi) or partial hematological recovery (CRh). Furthermore, two patients were reported to be in a morphologic leukemia-free state (MLFS).

Notably, prior therapies among these responders included venetoclax in five cases, hypomethylating agents (HMA) in six cases, and FLT3 inhibitors in six cases, showcasing the potential of emavusertib as a leading therapy in an ecosystem where existing treatment options often fall short.

Two of the patients who achieved complete remission and CRi have subsequently proceeded to undergo allogenic stem cell transplantation, illustrating the transformative potential of emavusertib in this patient demographic. Rapid responses were a notable feature of the treatment, with seven out of ten responses noted at the first assessment during Cycle 2, Day 1.

Expert Insights
James Dentzer, the President and CEO of Curis, expressed the company’s enthusiasm regarding the monotherapy data derived from patients suffering R/R AML with FLT3 mutations. He stated, “We are pleased with our ongoing findings and inherently believe that these outcomes further delineate the groundbreaking potential of emavusertib’s mechanism as it addresses a critical unmet need in AML patients.”

About Curis, Inc.
Curis, Inc. continues its commitment to bring innovative therapies to market, focusing primarily on emavusertib's application across various studies. Beyond its involvement in the TakeAim Leukemia study, emavusertib is currently being evaluated in combination with the BTK inhibitor ibrutinib in the Phase 1/2 TakeAim Lymphoma study (CA-4948-101) for patients diagnosed with relapsed/refractory primary central nervous system lymphoma (PCNSL). Additionally, it is being tested as a frontline combination therapy with azacitidine and venetoclax for patients suffering from AML, showcasing the versatility and promise of this compound in treating a wide array of hematological malignancies.

The drug has garnered Orphan Drug Designation from the U.S. FDA aimed at treating both AML and myelodysplastic syndromes (MDS), alongside similar recognitions from the European Commission for its application in PCNSL. Curis holds exclusive licensing rights to emavusertib, having entered into a collaboration with Aurigene in 2015.

Conclusion
The compelling data from the TakeAim Leukemia study reinforces Curis's position as a forward-thinking leader in the biotechnology space focused on addressing critical treatment gaps in hemato-oncology. The ongoing development of emavusertib symbolically resonates with hope for patients who have burned through traditional treatment modalities and now seek effective alternatives.