KME-0584 / Kurome - LARVOL DELTA

Kme-0584, a Highly Potent IRAK1/IRAK4/panFLT3 Inhibitor, Is a Promising Clinical Candidate for Hypomethylating Agent Plus Venetoclax Resistant AML/MDS Patients (ASH 2023) - "In primary patient cell lines from FLT3 wildtype (WT) patients, KME-0584 inhibits leukemia stem cell progenitor function as measured by the colony formation assay in methylcellulose with higher potency than IRAK4 inhibitor compounds that lack IRAK1 activity such as CA-4948 (Emavusertib)...Given that monocytic-like subtypes of AML are resistant to Venetoclax plus Azacitidine (VEN/AZA) (S Pei et...KME-0584 exhibits superior potency and efficacy to gilteritinib in the FLT3-ITD (D835Y) xenograft model after QD oral dosing, with sufficient PK and oral bioavailability across multiple species to support QD or BID dosing in the clinic. KME-0584 does not inhibit any of the major or minor cytochrome P450 enzymes at anticipated clinical concentrations and early indication from ongoing GLP toxicology studies suggest that it could be safely administered in humans. A clinical study of KME-0584 in relapsed/refractory AML and HR-MDS is currently planned to start in 1H 2024."

Clinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Pediatrics • FLT3 • GLI2 • IRAK4 • PDGFRB • SF3B1 • U2AF1

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) (Businesswire) - "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."

IND • New P1 trial • Acute Myelogenous Leukemia • Myelodysplastic Syndrome