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PRESS RELEASE GRACELL Gracell Biotechnologies Reports Third Quarter 2021 Unaudited Financial Results and Provides Corporate Update SUZHOU , China and PALO ALTO , Calif . , Nov. 15 , 2021 ( GLOBE NEWSWIRE ) -- Gracell Biotechnologies Inc. ( NASDAQ : GRCL ) ( " Gracell " ) , a global clinical - stage biopharmaceutical company dedicated to discovering and developing highly efficacious and affordable cell therapies for the treatment of cancer , today reported its unaudited financial results for the third quarter of the year and provided recent business highlights . " We continue to deliver strong research and clinical execution across our pipeline this quarter , furthering our clinical programs as well as advancing innovative preclinical product candidates to clinical stage , " commented Dr. William ( Wei ) Cao , founder , Chairman , and CEO of Gracell . " Our autologous and allogeneic T cell therapies are designed to offer differentiated approaches that aim to provide significant improvements in manufacturing , production , efficacy , and cost . We remain focused on building solid clinical foundations across our lead programs , advancing R & D efforts and new preclinical candidates , and enhancing our manufacturing capabilities to provide therapies with reduced cost and increased accessibility to patients . " " Our lead FasTCAR candidate GC012F , a unique BCMA / CD19 dual - targeting autologous CAR - T cell therapy for the treatment of multiple myeloma developed using the next - day manufacturing FasTCAR platform , has demonstrated fast , deep and durable responses at all dose levels in a predominantly high risk , difficult to treat patient population . We continue advancing with the tech transfer to Lonza to support manufacturing of GC012F in the U.S. , an instrumental step towards our US IND filing targeting the first half of 2022. We continue expanding this program including into earlier lines of therapy . GC027 , our lead TruUCAR candidate , an off - the - shelf , allogeneic CAR - T cell therapy for the treatment of T - cell malignancies reported encouraging longer - term follow - up data at AACR , and we continue to enroll patients in our ongoing Phase I IIT trial in China for this candidate . We expanded our TruUCAR platform with GC502 , a CD19 / CD7 dual - directed allogeneic TruUCAR - enabled CAR - T therapy for the treatment of r / r B - ALL and B - NHL recently advancing to clinical stage with the initiation of an IIT study in China . GC502 leverages the unique dual CAR capabilities of the TruUCAR platform , with the CD7 CAR designed to suppress host versus graft rejection , and the second CAR that can have scFv swapped to target different tumor antigens such as CD19 , making TruUCAR platform widely applicable . GC502 comprehensively exemplifies the TruUCAR design that aims for optimized persistence without the need of being co - administered with additional immunosuppressive drugs . We look forward to highlighting the preclinical data that lead to advancing this program into the clinic in a poster presentation at ASH 2021. Our donor derived allogeneic CD19 - targeted CAR - T for B - ALL , GC007g , is currently being advanced to the second dose cohort in our pivotal IND Phase 1/2 study in China . " " We have actively expanded our SMART CART TM solid tumor program , including exploring CLDN 18.2 as a target in collaboration with Future Gen , and using preclinical learnings presented at SITC 2021 conference to inform on the optimization of second - generation CAR - T candidates entering clinical stage in the first half of 2022. Gracell's SMART CARTTM technology is designed to incorporate unique cytokine signaling to improve persistence , and reverse and turn immunosuppressive signals of the solid tumor microenvironment into stimulatory reactions of CAR - T cells . " " Lastly , we will also continue building a strong manufacturing and R & D foundation with the ongoing expansion of our US R & D capabilities and the development of a significantly larger facility for the commercial phase in Suzhou , China in addition to our state - of - the - art , 66,000 sq . ft . GMP manufacturing facility . These clinical , R & D and manufacturing developments will further support our abilities to deliver therapeutic solutions across hematological malignancies and solid tumors that have the potential for optimized cost - efficiency , faster manufacturing , and superior efficacy and safety , " Dr. Cao concluded . Third Quarter 2021 and Subsequent Highlights GC502 for the treatment of adult relapsed / refractory B - cell acute lymphoblastic leukemia and B cell non - Hodgkin lymphoma ( r / r B - ALL and B - NHL ) : GC502 is a TruUCAR - enabled CD19 / CD7 dual - directed allogeneic CAR - T cell therapy being studied in an ongoing Phase 1 IIT in China for the treatment of adult r / r B - ALL and B - NHL . GC502 is manufactured from T cells of non - human leukocyte antigen ( HLA ) -matched healthy donors . • Clinical IIT initiated . IIT study was initiated in China in adult patients with r / r B - ALL and B - NHL . • Preclinical data presentation at ASH . Preclinical data for GC502 will be featured as a poster presentation at ASH 2021. ( Press Release November 2021 ) GC007g for the treatment of B - ALL : GC007g is a donor - derived CD19 - targeted allogeneic CAR - T cell therapy for the treatment of r / r B - ALL patients who failed transplant and may not be eligible for autologous CAR - T therapy . The allogeneic approach , utilizing T - cells