New Study Launched to Tackle Refractory SLE with GC012F: Gracell Biotechnologies Takes Aim at Systemic Lupus Erythematosus.

Gracell Biotechnologies Inc. (NASDAQ: GRCL), a global biopharmaceutical company dedicated to revolutionizing the treatment of cancer and autoimmune diseases, is delighted to announce the launch of an investigator-initiated trial (IIT) in China utilizing GC012F, the Company’s autologous FasTCAR therapeutic candidate. This innovative therapy dual-targets B cell maturation antigen (BCMA) and CD19, with the aim of effectively treating even the most refractory cases of Systemic Lupus Erythematosus (SLE).

Gracell is thrilled to announce the launch of a clinical trial evaluating the efficacy and safety of GC012F, its lead cell therapy candidate, in the treatment of refractory Systemic Lupus Erythematosus (SLE).

GC012F, which leverages several next-generation CAR-T technologies including CD19/BCMA dual-targeting and FasTCAR next-day manufacturing, has shown strong efficacy and favorable safety in the treatment of hematological malignancies. With the launch of the SLE clinical trial, Gracell is hopeful that the potentially curative treatment option will be extended to patients suffering from autoimmune diseases.

SLE is an incurable, autoimmune disease that affects over three million people worldwide. It is particularly devastating to young women, as its symptoms can lead to permanent organ damage and even death.

Despite immunosuppressants being the current standard of care, SLE remains a challenging condition to manage and significantly impacts quality of life. As such, there is an urgent need for more effective, and even curative, treatments, particularly to help manage refractory SLE.

Gracell’s GC012F CAR-T therapy has been studied in over 50 patients across three hematological malignancy indications, with remarkable results. In two studies conducted on relapsed/refractory multiple myeloma (RRMM) and newly-diagnosed multiple myeloma (NDMM), GC012F showed fast, deep and durable responses, achieving an overall response rate of 93.1% and 100% respectively.

Gracell is now turning its attention to Systemic Lupus Erythematosus (SLE), where recent clinical research suggests CAR-T therapy may be a promising treatment, being “feasible, tolerable, and highly effective” in this indication.

GC012F is breaking new ground in the treatment of refractory Systemic Lupus Erythematosus with its novel approach of dual-targeting CAR-T. By targeting both CD19 and BCMA, GC012F has the potential to provide a deeper and wider depletion of autoantibody-producing B-cells and plasma cells, leading to improved clinical outcomes compared to CD19-only approaches. This pioneering therapy is set to revolutionize the way SLE is treated.

GC012F has demonstrated a remarkable safety profile in patients with RRMM, NDMM and B-NHL, with no neurotoxicity or ICANs reported. Notably, 75% of NDMM patients did not experience any CRS, while RRMM patients generally experienced mild CRS. This impressive track record has been confirmed across three clinical trials.

The FasTCAR next-day manufacturing platform technology brings tremendous advantages to SLE patients: shorter wait times, enhanced CAR-T cell fitness, and reduced costs. This revolutionary platform is revolutionizing the way patients receive care, making it easier and more affordable than ever before.

About GC012F

Gracell’s GC012F FasTCAR-enabled autologous CAR-T cell therapy is revolutionizing cancer and immunology treatment, offering patients fast, deep, and durable responses with an improved safety profile.

Cleared by regulators in the U.S. and China in February 2023, GC012F is being evaluated in clinical trials for multiple myeloma and B-cell non-Hodgkin’s lymphoma (B-NHL). Encouraging efficacy and safety data has already been observed, and an investigator-initiated trial is now underway to assess GC012F’s potential for treating systemic lupus erythematosus (SLE).

About FasTCAR

Introducing FasTCAR – Gracell’s revolutionary next-day autologous CAR-T cell manufacturing platform. FasTCAR is designed to revolutionize cancer and autoimmune therapy and improve patient outcomes, with enhanced efficacy, reduced costs, and greater access to critical CAR-T treatment.

Unlike traditional CAR-T cells, FasTCAR drastically shortens the cell production process from weeks to overnight, potentially reducing patient wait times and the risk of disease progression.

Additionally, FasTCAR T-cells are younger and more robust, allowing them to be more proliferative and effective at killing cancer cells. In November 2022, FasTCAR was recognized for its impact in the industry, being awarded the Biotech Innovation category of the 2022 Fierce Life Sciences Innovation Awards.

About Refractory SLE

Systemic lupus erythematosus (SLE) is a chronic autoimmune disorder that is estimated to affect over 3 million people worldwide, with a disproportionate burden of disease seen among young women. This devastating condition causes the body’s immune system to attack healthy tissues, resulting in widespread inflammation and tissue damage that can affect the joints, skin, brain, lungs, kidneys and blood vessels. Although immunosuppressants are the current standard of care for SLE, exciting new research is suggesting that CAR-T cell therapy may be a promising treatment option.

About Gracell

Gracell Biotechnologies Inc. is revolutionizing the field of cell and gene therapy with its pioneering FasTCAR and TruUCAR technology platforms and SMART CARTM technology module. Gracell is developing a comprehensive clinical-stage pipeline of autologous and allogeneic product candidates that have the potential to overcome the various major challenges that are present in conventional CAR-T therapies such as long manufacturing times, subpar cell quality, high therapy costs, and lack of effective CAR-T therapies for solid tumors.

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