FDA Clears Phase 1 Study of Lomonitinib for R/R AML Treatment in the US

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An investigational new drug application for lomonitinib has been cleared by the FDA for FLT3-mutated relapsed/refractory AML treatment, and a phase 1 trial evaluating the agent will begin in the US.

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  • The FDA cleared the investigational new drug application for lomonitinib (ZE46-0134) in FLT3-mutated relapsed/refractory acute myeloid leukemia (AML).
  • With this, a phase 1 clinical trial evaluating lomonitinib in this patient population can commence in the US.
  • Lomonitinib is a highly potent and selective inhibitor of FLT3 internal tandem duplication (ITD), tyrosine kinase domaine (TKD), and other clinically relevant FLT3 mutations, along with IRAK4.

The investigational new drug application for lomonitinib has been cleared by the FDA for the treatment of patients with FLT3-mutated relapsed/refractory AML.1

A phase 1 study of the agent has already been initiated in Australia. With this clearance from the FDA, a phase 1 trial evaluating lomonitinib may begin in the US.

"This is a major milestone for Eilean Therapeutics and validates our rational drug discovery approach with our collaborator Expert Systems," said Iain Dukes, chief executive officer of Eilean Therapeutics, in a press release. "We are looking forward to getting our clinical trial underway in the US and further expanding our global trial testing a targeted approach to treating FLT3-mutated AML."

White blood cells in leukemia, AI Generative: © Катерина Євтехова - stock.adobe.com

White blood cells in leukemia, AI Generative: © Катерина Євтехова - stock.adobe.com

Lomonitinib is a highly potent and selective pan-FLT3/IRAK4 inhibitor. The agent works by targeting clinically relevant FLT3 mutations and putative escape pathways. Lomonitinib inhibits both most frequent resistance mechanisms in AML: the FLT3-ITD-F691L mutation and the activation of the IRAK4 escape pathway.

The agent has shown to have an excellent safety profile with no cytological changes. Lomonitinib also can rapidly reach steady state and target engagement exposures. Further, lomonitinib is expected to have a deeper response and longer duration of response in patients with relapsed/refractory AML.

The phase 1 trial in Australia is investigating the safety, tolerability, pharmacokinetics, and antitumor activity of lomonitinib when used as a monotherapy in patients with relapsed/refractory AML harboring FLT3 mutations.2 The study consists of dose-escalation and dose-expansion phases and plans to include up to 60 total patients.

REFERENCES:
1. Eilean Therapeutics announces FDA clearance of investigational new drug (IND) application for lomonitinib for the treatment of acute myeloid leukemia (AML). News release. Eilean Therapeutics LLC. June 10, 2024. Accessed June 10, 2024. https://tinyurl.com/2u9j2vd5
2. Eilean Therapeutics receives clearance to initiate R/R AML trial with lomonitinib, a selective pan-FLT3/IRAK4 inhibitor. News release. Eilean Therapeutics LLC. April 4, 2024. Accessed June 10, 2024. https://tinyurl.com/4d829dta
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