Gracell Biosciences announced that the U.S. FDA has approved the Investigational New Drug Application (IND) for FasTCAR-T GC012F

　　Gracell Biosciences announced that the U.S. FDA has approved the Phase 1 Investigational New Drug (IND) application for FasTCAR-T GC012F for the early treatment of multiple myeloma

　　Further expanding the clinical development of FasTCAR-T GC012F in multiple myeloma in the U.S., following the ongoing clinical trial for relapsed/refractory multiple myeloma (RRMM).

　　Gracell Biotech Group (NASDAQ: GRCL; Gracell Therapeutics or the "Company") is a global, clinical-stage biopharmaceutical company dedicated to the development of innovative and highly effective cell therapies for the treatment of cancer and autoimmune diseases. Today, the company announced that the U.S. Food and Drug Administration (FDA) has granted approval to a Phase 1 clinical trial of GC012F in the U.S. for the early line of multiple myeloma (ELMM).

　　"At the beginning of the new year, we welcome the great news that the company's core candidate product FasTCAR-T GC012F has received the third US IND approval; As a result, we have further expanded the clinical exploration of GC012F for multiple myeloma to early-line treatment. Dr. Wei Cao, Founder, Chairman and Chief Executive Officer of Gracell, said, "This IND approval is another significant milestone in the clinical development of GC012F. With its unique dual-target design and FasTCAR manufacturing technology, GC012F has the potential to fill the huge clinical needs in the early treatment stage of multiple myeloma due to its unique dual-target design and FasTCAR manufacturing technology, which has demonstrated a deeper and more durable therapeutic response in previous clinical studies, as well as superior safety performance. With the initiation of relevant clinical trials, we will obtain more safety and efficacy data of GC012F in patients with early-stage multiple myeloma (ELMM), better explore and define the significance of this innovative cell therapy in early line treatment, and hope to provide more efficient and durable treatment options for the current clinical treatment status that needs to be improved urgently." ”

　　GC012F is a dual-target autologous CAR-T product candidate based on Gracell's proprietary FasTCAR next-day manufacturing platform. This approval is the third IND approval granted to GC012F by the U.S. FDA. In addition to the clinical trial for the treatment of early-line multiple myeloma (ELMM), the company is conducting a Phase 1b/2 IND clinical trial of GC012F for the treatment of RRMM in the United States, and will initiate a Phase 1/2 IND clinical trial of GC012F for the treatment of refractory systemic lupus erythematosus (rSLE) this year. In addition, four investigator-initiated clinical trials (IITs) are currently evaluating the clinical efficacy of the therapy in rSLE, RRMM, newly diagnosed multiple myeloma (NDMM), and B-cell non-Hodgkin lymphoma (B-NHL).

　　At the 65th Annual Meeting of the American Society of Hematology held in December 2023, the company presented the latest clinical results of GC012F for the treatment of NDMM IIT, which showed an overall response rate (ORR) of 100% and a negative strict complete response rate (MRD-sCR) of 95.5% for minimal residual disease.

　　About GC012F

　　GC012F is a BCMA/CD19 dual-target autologous CAR-T cell therapy based on Gracell's proprietary FasTCAR technology platform, which has the potential to revolutionize the treatment of cancer and autoimmune diseases with rapid, deep and long-lasting results with differentiated safety advantages. At present, the company is conducting a number of clinical studies of FasTCAR-T GC012F, covering a variety of hematologic malignancies and autoimmune diseases. Clinical data shows that the drug has consistently demonstrated excellent efficacy and safety in clinical studies. The Company has initiated a Phase 1b/2 IND trial evaluating GC012F in relapsed/refractory multiple myeloma (RRMM) in the U.S. and a Phase 1/2 IND trial for the same indication in China. In addition, both the US FDA and the Chinese NMPA have approved the IND application for GC012F for refractory systemic lupus erythematosus (rSLE); At the same time, an investigator-initiated clinical trial for the same indication has also been initiated. Recently, the U.S. FDA once again approved the IND application for GC012F for the early line treatment of multiple myeloma.

　　About FasTCAR:

　　FasTCAR is a groundbreaking next-day autologous CAR-T cell technology platform launched in 2017 by Gracell Biosciences, which aims to significantly improve patient outcomes by enhancing efficacy, reducing manufacturing costs, and improving access to CAR-T therapies, which is expected to usher in a new era of cancer and autoimmune disease treatment. The FasTCAR platform dramatically accelerates the cell production cycle from traditional weeks to next-day completion, potentially significantly reducing patient waiting times and reducing the risk of disease progression. What's more, FasTCAR-T cells have a younger phenotype compared to cells prepared by the traditional CAR-T process, which allows them to have better in vivo expansion and more efficient tumor killing ability. With its outstanding contribution to overcoming industry problems, the FasTCAR technology platform has won the [2022 Fierce Life Sciences Biotechnology Innovation Award] and the [2023 BioTech Breakthrough Awards].

　　About Gracell Biotech

　　Gracell Biosciences (Grabit) is a global, clinical-stage biopharmaceutical company dedicated to the discovery and development of breakthrough cell therapies for the treatment of cancer and autoimmune diseases. Leveraging its groundbreaking FasTCAR and TruUCAR technology platforms, as well as the SMART CARTTM technology module, Gracell is developing a broad pipeline of clinical-stage autologous and allogeneic cell therapies. These product candidates are expected to overcome major industry challenges that persist in CAR-T therapies, including bottlenecks such as long manufacturing times, suboptimal product cell quality and high treatment costs, as well as the lack of long-term and efficient treatments for solid tumors and autoimmune diseases. The core product BCMA/CD19 dual-target FasTCAR-T GC012F is currently in a series of clinical trials to explore its therapeutic efficacy in multiple myeloma, B-cell non-Hodgkin lymphoma and systemic lupus erythematosus.