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DOVER, Del., April 4, 2024 /PRNewswire/ -- Eilean Therapeutics LLC, a biopharmaceutical company dedicated to discovering and developing best-in-class and first-in-class small molecule inhibitors to target escape mutations in hematologic and solid malignancies, is pleased to announce the clearance from the Human Research Ethics Committee in Australia for lomonitinib (ZE46-0134) allowing the company to proceed with a Phase I clinical trial in relapsed/refractory (R/R) AML. Lomonitinib is a highly potent and selective plan-FLT3/IRAK4 inhibitor that targets clinically relevant FLT3 mutations and putative escape pathways.

"This is a major milestone for the Eilean team, as we continue to progress an accelerated development of lomonitinib," stated Iain Dukes, Chief Executive Officer of Eilean Therapeutics. "Given the safety profile, extended half-life and target engagement demonstrated in a healthy volunteer study, we look forward to initiating our clinical trial and testing our approach in R/R AML patients."

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: the FLT3-ITD-F691L mutation deemed the "gatekeeper" mutation that confers resistance to all currently approved FLT3 inhibitors and the activation of the IRAK4 escape pathway. Lomonitinib inhibits both resistance mechanisms.

About the Phase 1 Clinical Trial
The Phase I study will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of lomonitinib as monotherapy in R/R AML patients with FLT3 mutations (ITD, TKD or gatekeeper). The study will include a dose escalation and an expansion phase with up to 60 total participants. Eilean Therapeutics is planning to initiate the study in Q2 2024 across multiple investigative sites in Australia.

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
aburd@eileanther.com

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SOURCE Eilean Therapeutics