Shanghai Simcere Biologics' BiTE CAR-T Therapy SNC109 Receives IND Acceptance from CDE for Recurrent Glioblastoma

Oct 09, 2023 17:32 CST Updated 17:32

Simnova

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Recently, according to the information on the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration, the IND application for Simnova's BiTE CAR-T cell therapy product SNC109 injection has been accepted by the CDE.

Public information shows that 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, used for treating recurrent glioblastoma.The CAR-T cell carries two CAR molecules on its surface, targeting IL13Rα2 and HER2, which are overexpressed in glioblastoma.At the same time, this CAR-T therapy can also secrete bispecific 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 autologous T cells.

Simnova was established in 2019 as a subsidiary of Simcere Pharmaceutical and became an independently operated company after being spun off in 2021. The company has research centers in Shanghai, China, and Boston, USA. Currently, Simnova is not only advancing the clinical research and application of its BiTE CAR-T technology platform for solid tumors but is also developing universally competitive off-the-shelf CAR-NK and next-generation mRNA-based in vivo cell therapy products.

In July this year, Simnova's self-developed CD19-targeted universal CAR-NK therapy received the tacit approval for registration clinical trials from the Center for Drug Evaluation of the National Medical Products Administration, becoming the first CD19-targeted universal NK cell therapy in China to be approved for clinical stage. In August, the product received tacit approval for clinical trials again, with the indication developed for the treatment of adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL).

Simnova Product Pipeline (Source: Simnova Official Website)

Another noteworthy point is that, as of todayIn January, Simnova announced a collaboration with Orna, a leading company in circular RNA. According to the agreement, Simnova will be responsible for the development and commercialization of Orna's in vivo cell therapy products in the Greater China region for oncology treatment, utilizing its breakthrough circular mRNA (oRNA) technology. This includes Orna’s primary program, the CD19-targeted in situ CAR (isCAR) project, ORN-101.

Text | MedValley

About Zhangjiang Cell and Gene Industry Park

Zhangjiang Cell and Gene Industry Park is the most innovative and dynamic cell and gene industry cluster in China.It is also the only cell and gene industry park in China that has achieved the "five-medical integration." According to incomplete statistics, as of January 2023, the cell and gene therapy registration clinical trial projects approved nationwide, Zhangjiang accounts for 3/5 of Shanghai and 1/4 of the whole country. It took the lead in launching the first and second CAR-T cell drugs in China and gave birth to the first gene CDMO stock on the STAR Market —— Origin Biosciences. At the same time, in the field of cell and gene therapy, many enterprises have strengthened their exploration in the fields of solid tumors, rare diseases, and autoimmune diseases.

Zhangjiang Cell and Gene Industry Park is currently building a comprehensive innovation acceleration platform that integrates source transformation, incubation, acceleration, and industry exchange. It has established the Sequoia Smart Healthcare Accelerator, NKCell Therapeutics Platform, and more. Additionally, it has successfully hosted three editions of the Zhangjiang Cell and Gene Industry International Summit, becoming an important platform for academic research, industrial transformation, and enterprise display within the industry. In the future, Zhangjiang Cell and Gene Industry Park will focus on the Zhangjiang Science City Shanghai International Medical Zone as its main carrier, concentrating on cell and gene therapy, genetic sequencing and molecular diagnostics, and CRO/CDMO in cell and gene therapy. The park aims to accelerate the gathering of leading enterprises and high-quality innovative projects in the cell and gene fields, expedite the creation of specialized facilities such as cell and gene incubation centers, public technology service platforms, biological laboratories, and animal experiment centers, forming a development system of "basic technology + source innovation + industrial cornerstone." Ultimately, it will be built into a technologically advanced, large-scale cell and gene industry cluster with global influence.

In 2023, Zhangjiang Gene Island, with a total construction area of 160,000 square meters, is about to open anew, attracting more cell and gene innovative technologies and companies to settle in the park.

Text | MedValley