Shanghai Simcere Biologics' SNC109, a Bispecific BiTE-Armored Dual CAR-T Therapy for Glioblastoma, Receives IND Acceptance from CDE

SNC-109 Injection is a CAR-T cell specifically targeting glioblastoma, featuring dual CAR-T cells armed with bispecific BiTE.CAR-T cells specifically express chimeric antigen receptors (CAR) targeting IL13R⍺2 and HER2 on their surface, and can secrete bispecific T-cell engagers (BiTE) targeting EGFR and EGFRvIII.

CAR-T cells carry two CAR molecules on their surface, targeting IL13R⍺2 and/or HER2 antigens on the surface of glioblastoma cells. IL13R⍺2 and HER2 are highly overexpressed on the surface of glioblastoma cells but are not expressed in normal brain tissue.

The BiTE molecule secreted by CAR-T cells consists of two nanobodies (VHH) and a single-chain variable fragment (scFv), connected in tandem via a flexible fusion linker. The scFv of the BiTE can recognize the CD3ε protein on the surface of its own T cells, while the other two nanobodies (VHH) can recognize EGFR and/or EGFRvIII antigens on the surface of glioblastoma cells. Thus, the BiTE can activate its own T cells to exert cytotoxic effects.

Simnova is a cell therapy biotechnology company at the clinical development stage. Established in 2019, it was originally a subsidiary of Simcere Pharmaceutical Group and became an independently operated company after being spun off in 2021. Simnova has research centers in Shanghai, China, and Boston, USA. The company is currently focused on developing competitive universal CAR-NK therapies while actively advancing clinical research and regulatory submissions for its innovative BiTE CAR-T technology platform targeting solid tumors. Additionally, through collaboration with ORNA, a leading biotechnology company, Simnova is also developing next-generation universal in vivo cell therapy products based on circular mRNA and targeted delivery platforms. This technology represents another disruptive form of universal cell therapy beyond CAR-NK, with significant potential for broad applications in treating cancer, autoimmune diseases, and more.