Eilean Therapeutics LLC, a biopharmaceutical company focusing on discovering and developing small molecule inhibitors for hematologic and solid malignancies, has announced a significant milestone. Its Australian subsidiary, Eilean Therapeutics Australia Pty Ltd, has received clearance from the Human Research Ethics Committee in Australia to commence a Phase 1 trial of balamenib (ZE63-0302) under the Australian Therapeutics Goods Administration's Clinical Trial Notification (CTN) scheme. This Phase 1 trial will involve evaluating the safety, pharmacokinetics, and target engagement profile of balamenib through escalating single doses administered to healthy volunteers.

Iain Dukes, CEO of Eilean Therapeutics, expressed enthusiasm about this development, emphasizing its importance in advancing the company's portfolio of therapies targeting hematological malignancies. He highlighted balamenib's unique preclinical profile, noting its potential advantages over similar molecules in terms of safety, tolerability, and outpatient treatment feasibility.

Balamenib, also known as ZE63-0302, is an oral small molecule inhibitor designed to target the menin-KMT2A interaction. Preclinical studies have shown its efficacy both as a standalone treatment and in combination with other compounds for treating relapsed or refractory Acute Myeloid Leukemia (r/rAML). Specifically, it has demonstrated promising results in combination with eiletoclax (ZE50-0134) and lomonitinib (ZE46-0134), two other compounds developed by Eilean Therapeutics. Balamenib also boasts improved safety profiles compared to similar compounds, showing no QTc prolongation and lacking substrate or inducer activity of cytochrome P450 3A4 metabolism. Additionally, it exhibits reduced susceptibility to "hot spot" menin mutations commonly encountered in clinical settings with other menin inhibitors.

 

Source: prnewswire.com

 

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