China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received approval from China’s National Medical Products Administration (NMPA) to conduct a clinical study for its investigational bispecific antibody (BsAb) NBL-028. The drug targets CLDN6 and CD137, focusing initially on advanced tumors with CLDN6 expression, such as testicular cancer, ovarian cancer, non-small cell lung cancer, and endometrial cancer.
Mechanism of Action and Target Selection
NBL-028 is designed to selectively activate the CD137 co-stimulation pathway in T cells and other immune cells when binding to the tumor cell surface antigen CLDN6 in the tumor microenvironment (TME). Claudin 6 (CLDN6), a tight junction protein, is highly expressed in various human malignant tumors but minimally expressed in normal tissues. CD137 (or 4-1BB), a member of the tumor necrosis factor receptor (TNFR) superfamily, plays a crucial role in T cell proliferation, survival, cytotoxic activity, and memory formation.
Preclinical Efficacy and Safety
Preclinical studies have demonstrated that NBL-028 exhibits excellent efficacy and safety. As the first project from NovaTE’s proprietary T cell adapter platform to reach clinical stages, NBL-028 represents a significant milestone for CSPC Pharmaceutical in advancing innovative cancer therapies.-Fineline Info & Tech
