▎Edited by the WuXi AppTec content team

On January 23, Simnova announced that it had received formal feedback from the U.S. FDA, granting orphan drug designation to its self-developed SNC109 injection for the treatment of malignant glioma. Public information shows that SNC109 injection is a product independently developed by Simnova based on its BiTE CAR-T platform.Carrying two CAR moleculesofDual CAR-T Cell TherapyPreviously, the product had received clinical tacit approval from China's CDE.

Gliomas are tumors that originate from glial cells or precursor cells within the central nervous system (CNS). Among them, the majority of malignant gliomas areGlioblastoma（GBM), characterized by high malignancy and high mortality. Despite significant progress in the understanding of GBM in recent years, the current clinical treatment outcomes remain limited, with a 5-year survival rate of less than 10%.

According to the press release from Simnova, the CAR-T product SNC109 carries two CAR molecules on the cell surface.Targeting IL13Rα2 and HER2 expressed in GBM, respectively. At the same time, this CAR-T therapyCan also secrete targeting EGFR and EGFRvIIIofMultispecific Antibody（BiTE), BiTE molecules consist of two nanobodies (VHH) and a single-chain variable fragment (scFv), connected in tandem by flexible fusion linkers, capable of activating autologous T cells to exert cytotoxic effects.

ClinicalTrialsPlatform Information Display`, researchers`A Phase 1 study is currently being conducted in China to evaluate the safety, tolerability, and pharmacokinetics (PK) of SNC-109 in patients with recurrent GBM, while also providing a preliminary assessment of the product’s efficacy, immunogenicity, and the correlation between cytokine changes relative to baseline levels following cell infusion.

Simnova was founded in 2019 as a cell therapy biotechnology company currently in the clinical development stage. In addition to developing universal cell therapy products, the company is also actively advancing the clinical research and application of several highly differentiated solid tumor products. Furthermore, Simnova is collaborating with ORNA.CompanyThrough collaboration, Simnova has laid out the development of next-generation universal in vivo cell therapy products based on circular mRNA and targeted delivery platforms for the treatment of cancer and autoimmune diseases.etc.Field.

References:

[1] Simnova's Innovative CAR-T Therapy for Malignant Glioma Receives FDA Orphan Drug Designation. Retrieved Jan 23, 2024, from https://mp.weixin.qq.com/s/0t-DJlhvk4LDInl_bLhITg