Eilean Therapeutics Joins LLS's Beat AML® Clinical Trial

Eilean Therapeutics AU Pty Ltd, a biopharmaceutical company focused on small molecule inhibitors for treating hematologic and solid malignancies, has joined The Leukemia & Lymphoma Society (LLS) in the Beat AML® Master Clinical Trial. This collaborative trial aims to transform the treatment of acute myeloid leukemia (AML) through a targeted approach. Eilean's investigational agent, lomonitinib (ZE46-0134), has been chosen for a new trial arm targeting patients with FLT3 mutated relapsed/refractory (R/R) AML. Lomonitinib is a potent and selective pan-FLT3/IRAK4 inhibitor designed to address resistance pathways in AML treatment.

Lomonitinib has shown a promising safety profile in preliminary studies and the ability to engage its targets quickly, with no cytological changes. These attributes make it a strong candidate for providing deeper and longer-lasting responses in R/R AML patients, potentially making it the best-in-class FLT3 inhibitor. The upcoming trial marks Beat AML's first phase 1 sub-study and its inaugural precision medicine study for patients whose AML has relapsed or not responded to other therapies.

Iain Dukes, the CEO of Eilean Therapeutics, highlighted the significance of the Beat AML Master Trial as a platform to advance scientific understanding and evaluate lomonitinib's potential in treating FLT3 mutated R/R AML. Beat AML® is one of the pioneering cancer clinical trials sponsored by a nonprofit organization, uniting top clinicians, cancer centers, pharmaceutical companies, and technology partners globally. The trial has already demonstrated superior survival rates and improved quality of life for patients receiving targeted treatments matched to their genetic mutations, compared to standard chemotherapy.

Ashley Yocum, Ph.D., the executive research lead for Beat AML at LLS, expressed enthusiasm about the partnership with Eilean. She emphasized that collaborations like this are crucial for accelerating the development of new treatments for both newly diagnosed and previously treated AML patients.

Lomonitinib is particularly noteworthy for its dual inhibition of FLT3 ITD, TKD, and other FLT3 mutations, as well as the IRAK4 escape pathway. This dual action targets the two main resistance mechanisms in AML, specifically the FLT3-ITD-F691L mutation, known as the "gatekeeper" mutation, and the activation of the IRAK4 pathway. These mutations are frequent in AML and pose significant challenges for existing FLT3 inhibitors.

Eilean Therapeutics was co-founded by OrbiMed, Torrey Pines Investment, and Dr. John C. Byrd. The company utilizes a proprietary hybrid AI platform to accelerate the discovery and development of novel therapies. By leveraging proprietary data, chem/bio tools, and expertise, Eilean aims to design and develop best-in-class and first-in-class treatments for both hematologic and solid cancers. The ultimate goal is to lead the field in creating breakthrough medicines that provide maximum clinical benefits.

The Leukemia & Lymphoma Society (LLS) is a global leader in the fight against blood cancer, dedicated to curing leukemia, lymphoma, Hodgkin's disease, and myeloma, and improving the quality of life for patients and their families. Founded in 1949, LLS funds critical blood cancer research worldwide, offers free support services, and advocates for patient access to quality care. LLS operates throughout the United States and Canada, continuing its mission to combat blood cancers through research, education, and advocacy.