11 Mar 2024
Phase 1IND
DOVER, Del., March 11, 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, today announced that Eilean Therapeutics Australia Pty, Ltd, received clearance from the Human Research Ethics Committee in Australia to begin a Phase 1 trial of balamenib (ZE63-0302) under the Clinical Trial Notification (CTN) scheme of the Australian Therapeutics Goods Administration (TGA). The Phase 1 program includes a single ascending dose trial in healthy volunteers to evaluate the safety, pharmacokinetics and target engagement profile of balamenib, a highly selective inhibitor of the meninKMT2A binding interaction.
"The first-in-human study of balamenib in Australia represents another important milestone for Eilean Therapeutics, as we progress, with an accelerated development of our portfolio of best-in-class agents targeting hematological malignancies," stated Iain Dukes, Chief Executive Officer of Eilean Therapeutics. "The highly differentiated pre-clinical profile of balamenib emphasizes important advantages over molecules in the same class in safety, tolerability and feasibility of outpatient treatment, enabling our drug to safely treat AML patients alone and in combination with our other targeted therapies."
About Balamenib
Balamenib (ZE63-0302) is an oral small molecule inhibitor of the menin-KMT2A interaction. In vitro studies with KMT2Ar specific cell lines and in vivo studies using xenograft models demonstrated that balamenib is a potent menin inhibitor when administered both as a stand-alone agent or in combination with other compounds used for the treatment of r/rAML, in particular with eiletoclax (ZE50-0134), and lomonitinib (ZE46-0134), Eilean Therapeutics' BCL-2 selective inhibitor and pan FLT3/IRAK4 inhibitorFLT3/IRAK4 inhibitor, respectively. Balamenib demonstrates improved safety compared to other molecules in the same class, with an absence of QTc prolongation and is neither a substrate nor inducer of cytochrome P450 3A4 metabolism. Furthermore, balamenib shows significantly reduced susceptibility to "hot spot" menin mutations currently being encountered in the clinic with other menin inhibitors.
Eilean Therapeutics LLC is a pharmaceutical 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/ML platform (Expert Systems Inc.), leveraging its key partners proprietary data, chem-bio platforms, knowledge and expertise to choose highly valuable molecular mechanisms of pathology; to precisely design and accelerate the execution of discovery and 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
[email protected]
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