Eilean Therapeutics Granted Approval to Launch Phase I R/R AML Clinical Trial Utilizing Lomonitinib, a Targeted FLT3/IRAK4 Inhibitor

April 4, 2024 — Eilean Therapeutics LLC, a biopharmaceutical firm specializing in the development of innovative small molecule inhibitors for hematologic and solid malignancies, has received approval from the Human Research Ethics Committee in Australia to commence a Phase I clinical trial for lomonitinib (ZE46-0134) in patients with relapsed/refractory acute myeloid leukemia (R/R AML).

Lomonitinib is a potent and selective FLT3/IRAK4 inhibitor designed to target key FLT3 mutations and potential escape pathways associated with resistance to current treatments. Iain Dukes, CEO of Eilean Therapeutics, expressed that the approval represents a significant milestone for the company, which is advancing lomonitinib's development with urgency. 

The drug has shown a promising safety profile, extended half-life, and target engagement in prior studies involving healthy volunteers. The Phase I clinical trial will assess the safety, tolerability, pharmacokinetics, and anti-tumor effects of lomonitinib as a monotherapy in R/R AML patients with specific FLT3 mutations. The study, set to include up to 60 participants, will be conducted in the second quarter of 2024 at various sites across Australia. 

Lomonitinib is distinguished by its ability to inhibit FLT3 ITD, TKD, and other clinically relevant FLT3 mutations, as well as IRAK4, which are common resistance mechanisms in AML. FLT3 mutations are prevalent in AML and are associated with a particularly aggressive form of the disease. By addressing these resistance mechanisms, lomonitinib has the potential to offer a new therapeutic option for patients with R/R AML. Eilean Therapeutics, co-founded by OrbiMed, Torrey Pines Investment, and Dr. John C. Byrd, is dedicated to discovering and developing novel small molecule inhibitors that target escape mutations in cancers. The company employs a proprietary hybrid AI platform to design and optimize therapies, aiming to lead in the development of breakthrough treatments for hematologic and solid malignancies.

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