Suzhou Evopoint Biosciences Co., Ltd., a China-based pharmaceutical company, has announced receiving approval from the Center for Drug Evaluation (CDE) to conduct a Phase I/II clinical study for its antibody-drug conjugate (ADC), XNW27011. The study will focus on locally advanced unresectable or metastatic malignant solid tumors expressing Claudin 18.2 (CLDN18.2). Sinovent had previously secured an Investigational New Drug (IND) approval from the US FDA for XNW27011 for the same indication.
XNW27011 Targets Claudin 18.2 in Multiple Cancer Types
XNW27011 is designed to target CLDN18.2, a potential anti-tumor target that is abnormally expressed in various cancers, including gastric cancer, pancreatic ductal adenocarcinoma, esophageal cancer, ovarian cancer, lung cancer, colon cancer, and biliary tract cancer. This ADC has demonstrated promising anti-tumor activity in both low and high-expression pharmacological models of CLDN18.2 and has shown good safety characteristics in preclinical studies.
Potential Impact and Clinical Progress
The approval for the Phase I/II clinical study is a significant step forward in the development of XNW27011 as a potential treatment for CLDN18.2-expressing tumors. Sinovent’s progress with XNW27011 highlights the company’s commitment to advancing targeted therapies for patients with limited treatment options.-Fineline Info & Tech
