Pharma Focus America

Eilean Therapeutics Partners with the Leukemia & Lymphoma Society for the Beat AML® Master Clinical Trial

Wednesday, June 12, 2024

Eilean Therapeutics AU Pty Ltd, a biopharmaceutical firm committed to developing advanced small molecule inhibitors for hematologic and solid cancers, has partnered with The Leukemia & Lymphoma Society (LLS) on the innovative Beat AML® Master Clinical Trial.

Lomonitinib (ZE46-0134), Eilean’s experimental drug, has been chosen for a new trial segment focusing on patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) who have FLT3 mutations. Lomonitinib is designed as a powerful and selective inhibitor against FLT3/IRAK4, targeting significant FLT3 mutations and bypass pathways. Its promising safety profile and quick establishment of therapeutic levels, as observed in preliminary studies with healthy volunteers, suggest that lomonitinib could achieve deeper and more prolonged responses in R/R AML patients, potentially setting a new standard among FLT3 inhibitors.

This trial marks the first phase 1 sub-study of the Beat AML initiative, and represents its initial foray into precision medicine for AML patients who have not responded to previous therapies or have relapsed.

"The Beat AML Master Trial offers a valuable opportunity to advance our understanding of AML and evaluate the efficacy of lomonitinib in treating FLT3 mutated relapsed refractory AML," noted Iain Dukes, CEO of Eilean Therapeutics.

The Beat AML® trial is one of the pioneering cancer clinical trials supported by a nonprofit organization. It brings together a diverse group of experts, including clinicians, cancer centers, pharmaceutical companies, and partners in operations and technology, all united to transform the approach to AML treatment. The trial has produced significant results, showing improved survival rates and quality of life for patients receiving targeted therapies customized to their genetic mutations, as opposed to conventional chemotherapy.

"This partnership with Eilean is exactly what LLS envisioned when launching the Beat AML trial," commented Ashley Yocum, Ph.D., executive research lead for Beat AML at LLS. "Collaborating with innovative companies like Eilean to explore new and potentially groundbreaking treatments in the Beat AML framework will expedite the introduction of new therapies for both newly diagnosed patients and those who have received other treatments."

Lomonitinib is a potent and selective inhibitor targeting FLT3 ITD, TKD, and other relevant FLT3 mutations, as well as IRAK4. FLT3 mutations are among the most frequent in AML, with resistance mechanisms including the FLT3-ITD-F691L mutation, known as the "gatekeeper" mutation, and the activation of the IRAK4 escape pathway. Lomonitinib effectively addresses these resistance mechanisms.

The Leukemia & Lymphoma Society® (LLS) is a global leader in the fight against blood cancers. Its mission is to cure leukemia, lymphoma, Hodgkin's disease, and myeloma, while improving the quality of life for patients and their families. LLS funds vital blood cancer research globally, provides free information and support services, and advocates for accessible, quality, coordinated care for all blood cancer patients.



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