FDA Clears Eilean Therapeutics' IND Application for Lomonitinib in AML Treatment

Eilean Therapeutics LLC, a biopharmaceutical enterprise based in Dover, Delaware, has achieved a significant milestone with the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA). This clearance pertains to their novel drug, lomonitinib (ZE46-0134), which will proceed to a Phase 1 clinical trial targeting FLT3 mutated relapsed or refractory acute myeloid leukemia (AML) in the United States. While the Phase 1 study has already commenced in Australia, the FDA’s approval now paves the way for trials to begin in the U.S.

Lomonitinib is a robust and selective pan-FLT3/IRAK4 inhibitor designed to address clinically significant FLT3 mutations and potential escape pathways. These mutations are predominantly observed in cases of AML. Eilean Therapeutics' CEO, Iain Dukes, underscores the importance of this development, stating that it validates the company’s drug discovery approach, which is executed in collaboration with Expert Systems. Dukes expressed enthusiasm about initiating the clinical trial in the U.S. and enhancing their global efforts to target FLT3 mutated AML.

Lomonitinib specifically targets FLT3 ITD and TKD mutations along with other clinically relevant FLT3 mutations and the IRAK4 pathway. FLT3 mutations are the most frequently identified in AML. Resistance to FLT3 inhibitors often results from the FLT3-ITD-F691L "gatekeeper" mutation and the activation of the IRAK4 escape pathway. Lomonitinib is engineered to inhibit both these resistance mechanisms. Its excellent safety profile, with no observed cytological changes, and its rapid achievement of steady-state target engagement in healthy volunteer studies, suggest that lomonitinib could offer deeper and more sustained responses in R/R AML patients. This positions lomonitinib to potentially become the leading FLT3 inhibitor in the market.

Eilean Therapeutics LLC was co-founded by OrbiMed, Torrey Pines Investment, and Dr. John C. Byrd. The company’s focus is on developing best-in-class and first-in-class small molecule inhibitors that target escape mutations in hematologic and solid cancers. Eilean Therapeutics leverages a hybrid AI platform developed in collaboration with Expert Systems Inc. This platform integrates proprietary data, chemical and biological tools, and specialized knowledge to identify valuable molecular mechanisms involved in pathology. This strategic approach aims to accelerate the discovery, design, and optimization of groundbreaking therapies.

The overarching ambition of Eilean Therapeutics is to lead in the development of novel medicines that provide maximum clinical benefit for patients with hematologic and solid malignancies. The company’s innovative platform and dedicated partnerships aim to deliver first-in-class and best-in-class therapies, transforming the landscape of cancer treatment.

This progress highlights Eilean Therapeutics’ commitment to advancing cancer treatment options through scientific innovation and strategic collaboration, aiming to bring new hope to patients with challenging cancer types.