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June 30, 2022

Ascentage Phase I cancer therapy trial receives FDA IND clearance

Dose-limiting toxicity, maximum tolerated dose and recommended Phase II dose of oral APG-5918 will be analysed in the trial.

Ascentage Pharma has received the US Food and Drug Administration (FDA) clearance for the Investigational New Drug (IND) application to commence the Phase I clinical trial of APG-5918 in people with solid tumours or haematologic malignancies.

Discovered and developed by the company, APG-5918 is an orally active, small-molecule embryonic ectoderm development (EED) protein inhibitor with greater binding affinity. 

It selectively attaches to the EED protein as an allosteric inhibitor. 

APG-5918 has the ability to overcome tumour resistance and provide broad and lasting tumour regression by regulating tumour microenvironment and epigenetics.

The first-in-human open-label, multicentre trial will assess the safety, pharmacokinetics and initial efficacy of APG-5918 in patients with solid tumours or haematologic malignancies.

Furthermore, the trial will analyse the dose-limiting toxicity, maximum tolerated dose and recommended Phase II dose (RP2D) of oral APG-5918. 

Ascentage Pharma chief medical officer Dr Yifan Zhai said: “In preclinical studies, APG-5918 showed potent binding activity with the EED protein, in vitro antiproliferative activity, and in vivo antitumour activity.”

Yale Cancer Center Early Drug Development Program clinical director professor Joseph Paul Eder will be the trial’s principal investigator.

In December 2020, the company announced plans to commence a Phase IIa clinical trial of its novel APG-115 to treat relapsed/refractory T-cell prolymphocytic leukaemia (r/r T-PLL) patients. 

Ascentage has a pipeline of eight clinical therapy candidates, including highly potent Bcl-2 and dual Bcl-2/Bcl-xL inhibitors, and candidates that target IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors (TKIs). 

Currently, the company is carrying out over 50 Phase I/II trials in the US, Australia, Europe, and China.

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