Kurome Therapeutics Announces FDA Clearance of IND Application for KME-0584 in Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndromes

Cincinnati, Ohio – Kurome Therapeutics Inc. is pleased to announce that the U.S. Food and Drug Administration (FDA) has cleared the IND for KME-0584, allowing the company to proceed with a Ph1 clinical trial in relapsed/refractory (R/R) AML and high-risk (HR) MDS patients. Kurome plans to initiate the clinical trial in the latter half of 2024.

“This is a major milestone for the Kurome team and our collaborators and validates our unique approach to AML and MDS as well as the suitability of KME-0584 for initial clinical testing,” said Jan Rosenbaum, Ph.D., CEO and CSO at Kurome. “We look forward to getting our clinical trial underway and testing our approach of targeting dysregulated immune signalling in the setting of AML and HR-MDS by targeting both IRAK1 and IRAK4 together to improve efficacy in this difficult to treat R/R patient population.”

 

About KME-0584
KME-0584 is a potent and highly selective small molecule inhibitor of interleukin 1 receptor associated kinases (IRAK)1, IRAK4, and all mutations of FMS-like receptor tyrosine kinase-3 (FLT3), for the treatment of R/R AML or HR-MDS. KME-0584 is intended for oral administration as a monotherapy, and as combination therapy with azacitidine or venetoclax.

 

About the Phase 1 Clinical Trial
The Phase I study will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of KME-0584 alone or in combination with venetoclax or azacitidine in patients with AML and HR MDS. The study will include a dose escalation and an expansion phase with up to 100 total participants. Kurome Therapeutics is planning to start the study in 2024 across multiple investigative sites in the US.

 

About Kurome Therapeutics
Kurome^® Therapeutics is a privately held clinical stage biotechnology company developing novel therapies that target dysregulated immune signalling in cancer. Founded on research and intellectual property developed at Cincinnati Children’s in collaboration with the National Center for Advancing Translational Sciences (NCATS), Kurome is developing a series of combined IRAK1/4 inhibitors to target cancer cells that have co-opted IRAK1/4-mediated immune signalling pathways to survive and maintain a more primitive cancer cell phenotype.