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Recently, Simnova, a company focused on developing innovative immunocyte therapies, announced that its self-developedTargeted CD19 in vivo CAR-T Product (SNC116), at the Cancer Hospital of the Chinese Academy of Medical SciencesOfficially Launch Clinical Research, and successfully completed the enrollment of the first patient. This move marks that CAR-T therapy has officially entered a new phase from "ex vivo preparation" to "in vivo generation," which is expected to provide a more convenient and accessible disruptive treatment option for patients with hematological tumors.Unlike traditional CAR-T therapies that require complex and time-consuming ex vivo preparation processes, Simnova's in vivo technology platform delivers a viral vector carrying the CAR gene in a single infusion, directly "arming" T cells within the patient’s body to express chimeric antigen receptors targeting CD19. This innovative approach greatly simplifies the treatment process and is expected to drive CAR-T therapy from the era of "personalized customization" into a new age of "standardized medication."Simnova, with its proprietary viral vector platform, has launched a new generation of in vivo CAR-T therapy. This technology utilizes T cell-specific promoters and transfection systems, akin to "precision guidance," ensuring efficient and specific expression of the CAR gene in vivo. Its next-generation dual-target design aims to enhance the clearance of target cells, pursuing deeper therapeutic effects. Meanwhile, the successful advancement of this therapy is attributed to the company's long-term technical沉淀 in lentiviral modification and CMC, securing a significant first-mover advantage in process development and scalable production.Simnova CEO Dr. Cao Zhuoxiao stated:"We are extremely proud to join hands with the top team at the Cancer Hospital of the Chinese Academy of Medical Sciences to open a new clinical chapter in in vivo CAR-T therapy. The successful enrollment of the first patient is a key milestone in bringing this disruptive technology from concept to clinical validation."The principal investigator (PI) of this study, Dean Li Ning from the Cancer Hospital of the Chinese Academy of Medical Sciences, pointed out: "The in vivo CAR-T technology represents the future direction of development. It is expected to address the core bottlenecks of accessibility and timeliness in current CAR-T therapies. The successful enrollment of the first patient marks a good start, and we will advance this research with a rigorous scientific attitude."Simnova is a cell therapy biotechnology company at 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. Simnova has research centers in Shanghai, China, and Boston, USA. The company is currently focusing on developing globally competitive universal CAR-NK therapies while actively advancing clinical research on in vivo cell therapy. Through collaboration with the renowned biotechnology company ORNA, Simnova has positioned itself to develop next-generation universal in vivo cell therapy products based on circular mRNA and targeted delivery platforms. Additionally, its self-developed in vivo CAR-T therapy based on lentivirus is about to enter the clinical validation stage. This technology will become another disruptive form of universal cell therapy drug alongside CAR-NK, holding tremendous potential for widespread application in treating cancer, autoimmune diseases, and other conditions.Source: Simnova
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