On April 26, 2023 Gracell Biotechnologies Inc. ("Gracell" or the "Company", NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, reported that it will present updated clinical data on GC012F, the Company’s FasTCAR-enabled autologous CAR-T cell therapy dual-targeting B-cell maturation antigen (BCMA) and CD19, from ongoing investigator-initiated trials (IIT) in relapsed-refractory multiple myeloma (RRMM) and B-cell non-Hodgkin’s lymphoma (B-NHL) at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held June 2-6, 2023, in Chicago and online (Press release, Gracell Biotechnologies, APR 26, 2023, View Source [SID1234630565]).
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"We are looking forward to sharing updated results from our ongoing studies evaluating GC012F in relapsed/refractory multiple myeloma and B-cell non-Hodgkin’s lymphoma. We are particularly encouraged by the recognition of our long-term follow-up data of GC012F in RRMM, which will be presented at an oral session. We believe for these hematological cancers, there is critical need for transformational treatment options with strong efficacy, favorable safety profiles and rapid manufacturing," said Dr. Wendy Li, Gracell’s Chief Medical Officer. "With plans to commence clinical trials in the U.S. and China following the receipt of regulatory clearance of Investigational New Drug applications, 2023 is a critical year for both GC012F and Gracell. We plan to showcase the latest data to our peers in cancer research at the ASCO (Free ASCO Whitepaper) Annual Meeting that augments the clinical validation of the FasTCAR platform in a wide array of indications, emphasizing the importance of the dual-targeted approach and the potential benefits of enhanced T cell quality and accelerated delivery of the therapy to patients thanks to Gracell’s FasTCAR next-day manufacturing technology."
BCMA/CD19 Dual-Targeting FasTCAR-T GC012F for the Treatment of RRMM
Longer-term follow-up data from a multicenter investigator-initiated trial evaluating GC012F for the treatment of RRMM in heavily pretreated patients will be presented as an oral abstract session.
Oral presentation details are as follows:
Abstract title: Updated results of a phase I, open-label study of BCMA/CD19 dual-targeting fast CAR-T GC012F for patients with relapsed/refractory multiple myeloma (RRMM)
Abstract number: 8005
Session title: Hematologic Malignancies – Plasma Cell Dyscrasia
Session type: Oral Abstract Session
Presentation time: Saturday, June 3 at 1:15 PM – 4:15 PM CDT
BCMA/CD19 Dual-Targeting FasTCAR-T GC012F for the Treatment of B-NHL
A separate poster presentation will highlight updated clinical results from an ongoing IIT evaluating GC012F for the treatment of relapsed/refractory B-NHL. While CD19-directed CAR-T has proven effective for the treatment of NHL[i],[ii], the CD19/BCMA dual-targeting approach is novel for this indication. Additionally, this study further validates the FasTCAR platform.
Poster presentation details are as follows:
Abstract title: Updated clinical results of first-in-human study of CD19/BCMA dual-targeting fast CAR-T GC012F for patients with relapsed/refractory B-cell non-Hodgkin’s lymphoma
Abstract number: 7562
Session title: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Session type: Poster Abstract Session
Session date & time: Monday, June 5 at 8:00 – 11:00 AM CDT
Full abstracts will be released on May 25, 2023 at 5 PM EDT. Additional information about the presentation and the ASCO (Free ASCO Whitepaper) Annual Meeting is available on the ASCO (Free ASCO Whitepaper) website.
About GC012F
GC012F is Gracell’s FasTCAR-enabled BCMA/CD19 dual-targeting autologous CAR-T cell therapy, which aims to transform cancer treatment by driving fast, deep and durable responses with improved safety profile. GC102F is currently being evaluated in investigator-initiated trials in multiple myeloma and B-cell non-Hodgkin’s lymphoma (B-NHL), and has demonstrated a consistently strong efficacy and safety profile. In February 2023, Gracell announced regulatory clearance of Investigational New Drug applications in the U.S. and China to commence clinical trials evaluating GC012F for the treatment of relapsed/refractory multiple myeloma.
About FasTCAR
Introduced in 2017, FasTCAR is Gracell’s revolutionary next-day autologous CAR-T cell manufacturing platform. FasTCAR is designed to lead the next generation of cancer therapy and improve outcomes for patients by enhancing efficacy, reducing costs, and enabling more patients to access critical CAR-T treatment. FasTCAR drastically shortens cell production from weeks to overnight, potentially reducing patient wait times and probability for their disease to progress. Furthermore, FasTCAR T-cells appear younger and are more robust than traditional CAR-T cells, making them more proliferative and effective at killing cancer cells. In November 2022, FasTCAR was named the winner of the Biotech Innovation category of the 2022 Fierce Life Sciences Innovation Awards for its ability to address major industry obstacles.