Recently，Simnova's Self-Developed SNC109 Injection Granted Clinical Trial Approval by China’s National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE). SNC109 Injection is a dual-CAR-T cell therapy developed independently by Simnova based on its BiTE CAR-T platform. This therapy features a dual-arm BiTE armor and is used to treat recurrent glioblastoma. The CAR-T cells carry two CAR molecules on their surface, targeting IL13Rα2 and HER2, which are expressed in glioblastoma. Additionally, this CAR-T therapy can secrete multispecific antibodies (BiTE) targeting EGFR and EGFRvIII. The BiTE molecule consists of two nanobodies (VHH) and a single-chain variable fragment (scFv), connected in tandem via flexible fusion linkers, capable of activating the body's own T cells to exert cytotoxic effects. Glioblastoma is the most malignant type of astrocytic tumor, characterized by rapid growth. The disease duration for 70%-80% of patients is 3-6 months, with only 10% surviving beyond one year. Current treatment options include surgery, radiotherapy, chemotherapy, tumor-treating fields, and other comprehensive therapies, yet there remains a significant unmet clinical need.
Another core platform of Simnova, the universal allogeneic CD19 CAR-NK cell injection, received implied approval for clinical trials in non-Hodgkin's lymphoma (NHL) and B-cell acute lymphoblastic leukemia (ALL) in July and August this year, respectively. This marks the first CD19-targeted universal NK cell therapy in China to enter clinical trials. Additionally, this product is expanding into autoimmune indications, with a clinical application for moderate to severe refractory systemic lupus erythematosus submitted in November, which has also been accepted.
Simnova is a cell therapy biotechnology company in 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. The company is currently focused on developing globally competitive universal cell therapy products while actively advancing the clinical research and application of multiple differentiated solid tumor products. Additionally, through collaboration with ORNA, a prominent foreign biotechnology company, Simnova has positioned itself to develop 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 tremendous potential for broad applications in treating cancer, autoimmune diseases, and more.
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Disclaimer: The content is sourced from Simnova. This article aims to share knowledge, and all content is for reference only, not constituting any advice.
