China-based Antengene Corporation Limited (HKG: 6996) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase I study assessing its ATG-037, a small molecule inhibitor of CD73, in patients with locally advanced or metastatic solid tumors. This marks a significant step forward in the development of innovative cancer therapies.
Study Objectives
The primary objective of the Phase I study is to assess the safety, pharmacological properties, tolerability, and preliminary efficacy of ATG-037 both as a monotherapy and in combination with pembrolizumab. The study aims to determine the optimal dosage for a Phase II study and evaluate the drug’s preliminary efficacy. The secondary objective is to establish the pharmacological profile of ATG-037.
Mechanism of Action
CD73 generates adenosine, a highly immunosuppressive molecule that enhances the proliferation of cancer cells by downregulating IFN-γ, NK cells, and CD8+ T cells. Tumors often exploit multiple CD73-mediated pathways to evade immune responses. ATG-037, a highly potent and selective inhibitor of CD73, has demonstrated significant potential as a monotherapy and in combination with other drugs against various tumor types. Preclinical data have shown that ATG-037 exhibits immune-mediated, single-agent activity in syngeneic mouse tumor models. Additionally, drug toxicology studies have indicated that the drug has a wide therapeutic window.
Future Development
The NMPA approval underscores Antengene’s commitment to advancing innovative cancer treatments. By evaluating ATG-037 in clinical trials, Antengene aims to further explore its potential as a novel therapeutic option for patients with advanced solid tumors.-Fineline Info & Tech
