By Fineline Cube Suzhou-based Ascentage Pharma (HKG: 6855) has announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct a multi-center, open-label, dose escalation and expansion Phase I study. The study will assess the safety, pharmacokinetics, and efficacy of its embryonic ectoderm development (EED) inhibitor APG-5918. The drug candidate is being evaluated for its potential use against a range of advanced solid tumors and hematological malignancies. APG-5918 previously obtained clinical trial approval in the US for the same indications.
APG-5918 Profile
APG-5918 is an investigational, oral, potent, and selective small molecule EED inhibitor. As an allosteric inhibitor, the product can selectively bind to EED proteins. It is expected to overcome tumor resistance and achieve complete and durable tumor regression by modulating tumor epigenetics and the tumor microenvironment. Preliminary data has shown that APG-5918 produces anti-tumor cell proliferation activity in multiple tumor cell lines and tumor models, highlighting its potential as a novel therapeutic agent.
Clinical Development and Future Prospects
The Phase I study approved by the CDE will provide valuable insights into the drug’s safety and efficacy in treating advanced cancers. This marks a significant step forward in the clinical development of APG-5918, with the potential to address unmet needs in oncology and hematology. Ascentage Pharma’s commitment to advancing innovative therapies underscores its role in the global fight against cancer.-Fineline Info & Tech