Luminary Therapeutics Announces FDA Clearance of IND for LMY-920, a Novel BAFF CAR T-Cell Therapy to Treat Systemic Lupus Erythematosus (SLE).

MINNEAPOLIS, MN, UNITED STATES, December 20, 2023 /EINPresswire.com/ -- Luminary Therapeutics ("Luminary"), a cell therapy company with the mission of engineering first in class cell therapies for serious autoimmune diseases and solid tumors, today announced the clearance of its first Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial of LMY-920 (A BAFF CAR), a novel therapy for the treatment of systemic lupus erythematosus (SLE).

"We are pleased with the FDA's clearance of our IND application for our lead candidate LMY-920 (a BAFF CAR) for the treatment of refractory SLE. This is a huge achievement for Luminary and another indication of the promise for CAR-T therapies to treat autoimmune disease." noted Jeff Liter, Luminary’s CEO.

SLE, more commonly referred to as lupus, causes severe inflammation throughout the body and can impact multiple organ systems, especially the kidneys, lungs, and skin. A significant portion of patients will experience severe organ inflammation, eventually leading to end-stage kidney disease, requiring dialysis or a kidney transplant. Aside from modest efficacy, current treatments expose these patients to the well-demonstrated detrimental consequences of chronic treatment with corticosteroids and other powerful immunosuppressants. At the present, there is no cure and sustained remission requires a lifetime of pharmaceutical intervention.

About LMY-920
LMY-920 is an autologous version of a novel, fully human clinical-stage ligand-based BAFF CAR T cell construct with properties well-suited for use in SLE and multiple other B cell-driven autoimmune diseases. LMY-920’s proprietary CAR design targets 3 receptors on B cells, allowing for clearance of long-lived plasma cells in the bone marrow suspected to play a key role in disease pathology. Importantly, these plasma cells do not express CD19 and are undetectable to current CD19 CAR T therapies. Thus, we expect LMY-920 to provide a more durable response then the current CD19 CAR T products being applied in the autoimmune space.

About Luminary Therapeutics
Luminary is a clinical stage company developing CAR T therapies for the treatment of autoimmune disease and cancers. This is the third cleared IND for LMY-920. The company is currently in clinical trials using LMY-920 for the treatment of Relapsed/Refractory Non-Hodgkin Lymphoma and Multiple Myeloma. Luminary expects to submit an IND application with this same CAR construct on an allogeneic gamma delta manufacturing platform in mid-2024.

Jeff S Liter
Luminary Therapeutics, Inc.
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