Kurome Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for KME-0584 for the Treatment of Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndromes (MDS)

February 15, 2024 |

3 min read

Kurome Therapeutics Inc. is pleased to announce that the U.S. Food and Drug Administration has cleared the IND for KME-0584, allowing the company to proceed with a Ph1 clinical trial in relapsed/refractory AML and high-risk MDS patients.

Entering the clinic in the second half of 2024, KME-0584, an IRAK1/4/panFIt3 Inhibitor is a first in class investigational drug for relapsed/refractory AML and high-risk MDS patients

CINCINNATI--(BUSINESS WIRE)-- 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.

Forward-Looking Statements
This press release contains forward-looking statements as defined in the private Securities Litigation Reform Act of 1995, including, without limitation, statements made by Jan Rosenbaum, Ph.D. in this press release, statements regarding the development, plans and expectations for our KME-0584 development program, our plans to initiate a Phase 1 clinical trial in patients with R/R AML and HR-MDS, and anticipated benefits of KME-0584. While Kurome Therapeutics believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company’s beliefs only as of the date of this press release and there are several risks and uncertainties that could cause actual events or results to differ materially from those expressed in forward-looking statements. These include but are not limited to Kurome’s need for, and the availability of, substantial capital in the future to fund its operations and research and development program, that data from an initial limited number of patients may not be indicative of final clinical results, that Kurome’s compounds may not successfully complete clinical trials or be granted regulatory approval to be sold and marketed in the United States and elsewhere. You should not place undue reliance on these statements. Kurome Therapeutics undertakes no obligation to update the information contained in this press release as new information becomes available.