Ascentage Pharma Announces IND Approval in China for Phase I Study of APG-5918 in Patients with Advanced Solid Tumors or Hematologic Malignancies – QNT Press Release

SUZHOU, China and ROCKVILLE, Md., Nov. 9, 2022 /PRNewswire/ — Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that its novel inhibitor of the embryonic ectoderm development ( EED) protein, APG-5918, has been approved by the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) to enter a Phase I study in patients with advanced solid tumors or hematologic malignancies. Following the recent clearance for the study in the US, this approval in China marks another milestone for the company’s strategy of simultaneous clinical development in the two countries. APG-5918 is the first domestically developed novel EED inhibitor entering clinical development in China.

This multicenter, open-label Phase I dose-escalation and dose-expansion study is designed to assess the safety, pharmacokinetics, and efficacy of orally administered APG-5918 in patients with advanced solid tumors or hematologic malignancies. Prof. Ruihua XuPresident and Director of Sun Yat-Sen University Cancer Center, and President of the Chinese Society of Clinical Oncology, will be the principal investigator of this study.

EZH2, which is highly expressed in multiple tumors in humans, was found to promote the development and progression of tumors, and targeted inhibition of EZH2’s methyltransferase activity has already proved to be an effective mechanistic approach for cancer treatment. However, the secondary mutation of EZH2 may lead to acquired drug resistances, while the homologous EZH1 also has methyltransferase (MTase) activity that could limit the effects of EZH2 inhibitors. Studies have shown that the PRC2 complex’s component proteins and EZH2’s histone (MTase; HMTase) activities are highly dependent on the scaffold and modulating effects of EED. Compounds with inhibitory effects …

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