China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received the green light from the US FDA to conduct a clinical study for its bispecific antibody (BsAb), NBL-028, which targets CLDN6 and CD137. The initial focus of the study will be on advanced tumors with CLDN6 expression, including testicular cancer, ovarian cancer, non-small cell lung cancer, and endometrial cancer.
NBL-028’s Mechanism of Action and Preclinical Success
NBL-028 is designed to selectively activate the CD137 co-excitation pathway in T cells and other immune cells when it binds to the tumor cell surface antigen CLDN6 within the tumor microenvironment (TME). This targeted approach aims to achieve selective killing of tumor cells. Preclinical studies have demonstrated that NBL-028 possesses excellent efficacy and safety, making it a promising candidate for clinical development.
NovaTE Platform and Its Clinical Potential
NBL-028 represents NovaTE’s first project to reach the clinical stages. NovaTE is CSPC Pharma’s proprietary T cell adapter platform, designed as a next-generation T cell co-excitation platform for the treatment of cancer, with a particular focus on solid tumors. The platform has been optimized to induce sustained effector T cell activation, alleviate immune suppression within the TME, and minimize the risk of systemic toxicity, including cytokine release syndrome (CRS), immune cell-associated neurotoxicity (ICAN), and hepatotoxicity.-Fineline Info & Tech
