Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), a leading biopharmaceutical company based in China, has announced the first dosing in a Phase I clinical study for AU409, an oral small molecule drug. The drug was discovered by Auransa Inc. using the AI platform SMarTR Engine and will be manufactured by Lee’s Pharma. The single-arm, open, dosage escalation Phase I study aims to evaluate the safety and pharmacokinetics of AU409 in patients with advanced hepatocellular carcinoma (HCC) who have not responded to standard first-line treatment. The study will determine the maximum tolerable dosage and the recommended dosage for Phase II.
Preclinical studies have demonstrated that AU409 has the unique ability to alter the transcription of specific genes, leading to changes in the gene expression profile of liver cancer cells. This distinct mechanism of action sets it apart from other liver cancer drugs currently in clinical use. The molecule received clearance for clinical trials in the US in 2022, marking a significant step towards bringing this innovative therapy to patients.- Flcube.com
