SinoBiomics Submits IND Application for Universal CAR-NK Therapy Targeting CD19 in Moderate-to-Severe Refractory Systemic Lupus Erythematosus

Nov 18, 2023 09:08 CST Updated 09:08

Simnova

Innovative Cell Therapy Product Developer

2023Year11Month17Day，Simnova Submits TargetedCD19Chimeric Antigen Receptor Gene-ModifiedNKClinical trial application for cell injection solution approved by the Center for Drug Evaluation of the National Medical Products Administration (NMPA) in China.CDE) has been accepted, with the indication for moderate to severe refractory systemic lupus erythematosus. This isSLEIndication is the first in ChinaNKProduct AvailabilityINDAcceptance.

Systemic Lupus Erythematosus (SLE) is a complex autoimmune disease that can cause damage to multiple organs and tissues throughout the body. It is estimated that currently, there are approximately100Ten ThousandSLEPatient. In recent years,SLEAlthough the long-term survival of patients has improved, the inevitable recurrence of the disease and the resulting irreversible organ damage remain.SLEAn important cause of patient death.SLEThe mortality rate of patients is3-4Times. Therefore, there is an urgent need for innovative treatment methods to achieve continuous relief of disease symptoms, control organ damage, and improve patients' long-term survival. The development of cell therapy providesSLEPatients bring a brand-new, safe, and effective treatment option. Simnova focuses on the development of universal-typeCAR-NKTherapy, significantly reduces the economic burden on patients compared to other innovative cell therapy products and is readily available.NKThe innate safety advantages of cells allowNKThe therapy is expected to stand out in the evolving field of autoimmune diseases.

During the product development process, Simnova adopted an innovative design with independent intellectual property rights.CARStructure, demonstrated superior results in preclinical studies compared to similarCARDesign more effective activity. Meanwhile, Simnova has mature and stable large-scale universal typeNKCell PreparationCMCAbility.NKofCARThe transduction efficiency, amplification level, and cell viability after cryopreservation and recovery have reached industry-leading levels.

Simnova is a cell therapy biotechnology company at the clinical development stage. Founded in2019Year, originally a subsidiary of Simnova,2021Year split into an independently operated company. Simnova has research centers in Shanghai, China, and Boston, USA. The company is currently focusing on developing globally competitive universal-typeCAR-NK, and is also actively promoting innovativeBiTE CAR-TTechnical Platform for Clinical Research and Application of Solid Tumors, Meanwhile Simnova Also Cooperates with Star Biotechnology CompaniesORNA's collaboration layout is based on circularmRNAand the development of next-generation universal in vivo cell therapy products with targeted delivery platforms,This technology will becomeCARNKAnother disruptive universal cell therapy drug format with significant potential for wide application in treating tumors, autoimmune diseases, and other disease areas.

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