Gracell Biotechnologies Receives IND Approval From China NMPA For GC019F, A FasTCAR-Enabled CAR-T Therapy For The Treatment Of Relapsed Or Refractory

Gracell Biotechnologies Receives IND Approval From China NMPA For GC019F, A FasTCAR-Enabled CAR-T Therapy For The Treatment Of Relapsed Or Refractory

By, Admin 20 January 2021

SUZHOU and SHANGHAI, China, Jan. 19, 2021 /PRNewswire/ -- Gracell Biotechnologies Inc. (NASDAQ: GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, today announced that the National Medical Products Administration (NMPA) in China has approved an investigational new drug (IND) application to study GC019F, a FasTCAR-enabled chimeric antigen receptor (CAR)-T therapy in patients with relapsed or refractory adult B-cell acute lymphoblastic leukemia (B-ALL).GC019F is an autologous CAR-T therapy currently in development for adult B-ALL patients who are relapsed from or refractory to prior therapies. With the therapy, a patient's own T cells are genetically modified to express CD19-specific CAR. GC019F is manufactured on Gracell's FasTCAR technology platform, which significantly reduces manufacturing time from an industry norm of two to six weeks down to 22 to 36 hours. "This marks the first IND approval for a product candidate manufactured on Gracell 's FasTCAR platform and sets an important milestone for furthering therapies manufactured on this platform. We are excited to bring this new therapy to adult B-ALL patients, who - once relapsed from or refractory to therapy - remain a high unmet medical need with limited treatment options in China," commented Dr. Martina Sersch, M.D., Ph.D., Chief Medical Officer of Gracell. [1] https://www.cancer.org/cancer/acute-lymphocytic-leukemia/about/key-statistics.html [2] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5055577/ About GC019F GC019F is an autologous investigational CD19-targeted CAR-T cell therapy, directed to eradicate CD19 positive leukemia cells. About FasTCAR FasTCAR-manufactured CAR-T cells appear younger, less exhausted and show enhanced proliferation, persistence, bone marrow migration and tumor cell clearance activities as demonstrated in preclinical studies. With next-day manufacturing (22 to 36 hours), FasTCAR is able to significantly improve cell production efficiency which may result in meaningful cost savings, increasing the accessibility of cell therapies for cancer patients.

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