Policy & Regulation
Ascentage Pharma's APG-5918 receives approval from FDA for first-in-human study
30 June 2022 -

Ascentage Pharma (6855.HK), a China-based, global biopharmaceutical company, announced on Wednesday that it has received approval from the US Food and Drug Administration (FDA) for its novel inhibitor of the embryonic ectoderm development (EED) protein, APG-5918, to enter a first-in-human (FIH) study that will evaluate the safety, pharmacokinetics, and preliminary efficacy of APG-5918 in patients with solid tumours or hematologic malignancies.

This multicentre, open-label Phase one study is aimed at evaluating the safety and tolerability, and determining the dose-limiting toxicity, maximum tolerated dose, and recommended Phase II dose (RP2D) of orally administered APG-5918. The Principal Investigator of this multicentric clinical trial is Prof Joseph Paul Eder, clinical director of the Early Drug Development Program at Yale Cancer Center.

APG-5918 is an orally active, potent, selective, small-molecule EED inhibitor with high binding affinity. It was discovered and developed by Ascentage Pharma. It selectively binds to the EED protein.