Eilean Therapeutics Launches First Patient Trial for Menin Inhibitor Balamenib

Eilean Therapeutics LLC, a company specializing in biopharmaceutical innovations, announced that its Australian subsidiary has received approval from the Human Research Ethics Committee to begin a Phase 1 clinical trial of balamenib (ZE63-0302). This trial, conducted under the Clinical Trial Notification scheme of the Australian Therapeutics Goods Administration, aims to assess the safety, pharmacokinetics, and target engagement of this highly selective menin–KMT2A binding interaction inhibitor in healthy volunteers through a single ascending dose study.

CEO Iain Dukes emphasized that this first human study of balamenib in Australia signifies a significant milestone for the company, as it advances its portfolio of treatments targeting blood cancers. Balamenib boasts a unique pre-clinical profile that offers superior safety, tolerability, and outpatient treatment feasibility compared to similar drugs, enabling effective treatment of AML both independently and in combination with other therapies.

Balamenib (ZE63-0302) is an oral inhibitor focusing on the menin-KMT2A interaction. Pre-clinical studies have shown its potency against KMT2Ar specific cell lines and in xenograft models, either alone or when combined with Eilean Therapeutics' other treatments like eiletoclax and lomonitinib. It shows an improved safety profile, lacking QTc prolongation and avoiding interaction with cytochrome P450 3A4 metabolism, alongside significantly lower susceptibility to common menin mutations seen in clinical settings.

Eilean Therapeutics LLC, co-founded by Orbimed, Torrey Pines Investment, and Dr. John C. Byrd, is committed to discovering advanced small molecule inhibitors to target escape mutations in both blood and solid cancers. Utilizing a proprietary hybrid AI/ML platform from Expert Systems Inc., the company accelerates the development of groundbreaking therapies, aiming to become a leader in treating various malignancies.

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