SinoBiopharm's Innovative Dual-Arm BiTE-Armored CAR-T Therapy SNC109 Receives FDA Orphan Drug Designation for Malignant Glioma

On January 23, Simnova announced that it had received an official response from the U.S. FDA, granting its self-developed SNC109 injection "Orphan Drug Designation" (ODD) for the treatment of malignant glioma.

Image Source: Simnova

SNC109 Injection is a dual-CAR-T cell therapy with a dual-arm BiTE armor independently developed by Simnova based on its BiTE CAR-T platform. Previously, the product received clinical tacit approval from China's CDE on December 26, 2023.

Image Source: CDE Official Website

According to the press release, the CAR-T cell surface carries two CAR molecules, targeting IL13Rα2 and HER2, which are expressed in glioblastoma. Meanwhile, this CAR-T therapy can also 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 by a flexible fusion linker, which can activate the cytotoxic effects of the body's own T cells.

Glioblastoma is the most malignant glioma among astrocytic tumors, with rapid growth. The course of disease for 70%-80% of patients is 3-6 months, and only 10% of patients have a course exceeding one year. The main treatment methods include surgery, radiotherapy, chemotherapy, tumor electric field therapy, and other comprehensive treatments, with significant unmet clinical needs.

About Simnova

Simnova was founded in 2019 as a cell therapy biotechnology company currently in the clinical development stage. Originally a subsidiary of Simcere Pharmaceutical, it was spun off into an independently operated company in 2021.

Currently, Simnova is focused on developing globally competitive off-the-shelf cell therapy products while actively advancing the clinical research and regulatory submissions for several distinct solid tumor therapies. The NK cell injection genetically modified with chimeric antigen receptors targeting CD19 is being investigated for the treatment of various diseases. The drug's clinical trial application for treating relapsed or refractory B-cell acute lymphoblastic leukemia, as well as for adult patients with relapsed and/or refractory large B-cell lymphoma who have received at least two prior lines of systemic therapy, has been approved by the CDE. Additionally, the clinical trial application for this drug to treat moderate to severe refractory systemic lupus erythematosus was accepted by the CDE in 2023.

Image Source: Simnova

In addition, Simnova has partnered with ORNA, a leading international biotechnology company, to develop next-generation universal in vivo cell therapy products based on circular mRNA and targeted delivery platforms. Simnova stated that this technology will become another disruptive form of universal cell therapy drug alongside CAR-NK, holding tremendous potential for wide application in treating cancers, autoimmune diseases, and other conditions.

Editor: Mu Mian

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