Eilean Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for Lomonitinib for the Treatment of Acute Myeloid Leukemia (AML)

2024-06-10

临床申请临床1期

DOVER, Del., June 10, 2024 /PRNewswire/ -- Eilean Therapeutics LLC, is pleased to announce that the U.S. Food and Drug Administration (FDA) has cleared the IND for lomonitinib (ZE46-0134), allowing the company to proceed with a Phase 1 clinical trial in FLT3 mutated relapsed/refractory (R/R) AML. While the Phase 1 study has already initiated in Australia, clearance from the FDA will allow the trial to be initiated in the US. Lomonitinib is a highly potent and selective pan-FLT3/IRAK4 inhibitor that targets clinically relevant FLT3 mutations and putative escape pathways. "This is a major milestone for Eilean Therapeutics and validates our rational drug discovery approach with our collaborator Expert Systems," commented Iain Dukes, Chief Executive Officer of Eilean Therapeutics. "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."

About Lomonitinib

Lomonitinib is a highly potent and selective inhibitor of FLT3 ITD, TKD and other clinically relevant FLT3 mutations, as well as IRAK4. FLT3 mutations are the most frequently identified mutations in AML. There are two main mechanisms of resistance to FLT3 inhibitors FLT3 inhibitors: the FLT3-ITD-F691L mutation deemed the "gatekeeper" mutation that confers resistance to all currently approved FLT3 inhibitors FLT3 inhibitors and the activation of the IRAK4 escape pathway. Lomonitinib inhibits both resistance mechanisms. Given the excellent safety profile (with no cytological changes) and ability to rapidly reach steady state, target engagement exposures in a healthy volunteer study, it is anticipated that lomonitinib will have a deeper response (i.e. more CR/CRh) and longer duration of response in R/R AML patients, and eventually expand to be the best-in-class FLT3 inhibitor FLT3 inhibitor.

About Eilean Therapeutics

Eilean Therapeutics LLC is a biopharmaceutical company co-founded by OrbiMed, Torrey Pines Investment and Dr. John C. Byrd, focused on the discovery and development of best-in-class and first-in-class small molecule inhibitors that target escape mutations in hematologic and solid cancers. The company is utilizing a proprietary hybrid AI (Expert Systems Inc.), leveraging its key partners proprietary data, chem/bio tools, knowledge and expertise to choose highly valuable molecular mechanism of pathology, to rationally design, accelerate discovery and optimize development of best-in-class and first-in-class therapies. Eilean Therapeutics' goal is to utilize its capabilities and platform to become a leader in developing novel breakthrough medicines to maximize the clinical benefit when treating hematologic and solid malignancies. For more information visit

www.eileanther.com

Media Contact:

Amy Burd

CSO

[email protected]

SOURCE Eilean Therapeutics

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