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Atara Biotherapeutics Announces Submission of Investigational New Drug Application for ATA3219 for Treatment of Lupus Nephritis
ATA3219 is an Allogeneic CAR T-Cell Therapy Targeting CD19+ B Cells to Potentially Address the Root Cause of Lupus Nephritis (LN) ATA3219 Is Designed to
About this update from Atara Biotherapeutics, Inc.
[{"type":"text","content":"\nATA3219 is an Allogeneic CAR T-Cell Therapy Targeting CD19+ B Cells to Potentially Address the Root Cause of Lupus Nephritis (LN)\n\n\nATA3219 Is Designed to Combine the Natural Biology of Unedited T Cells and the Benefits of an Allogeneic CAR T Approach With Preclinical Data Demonstrating Potential Efficacy in LN\n\n\nSecond IND Submission for ATA3219, Following Non-Hodgkin’s Lymphoma (NHL) IND Clearance Received in Q3 2023\n\n\n THOUSAND OAKS, Calif.--(BUSINESS WIRE)--\nAtara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today announced its recent submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the use of ATA3219 as a monotherapy for the treatment of systemic lupus erythematosus (SLE) with kidney involvement (lupus nephritis [LN]).\n\n\n“Despite therapeutic advances, there remains high unmet need in lupus nephritis, where standard of care and approved therapies have limited efficacy that often rely on multi-year, if not lifelong immune suppression,” said Rajani Dinavahi, Chief Medical Officer at Atara. “We are dedicated to advancing medical breakthroughs with innovative cell therapies that truly make a difference. We look forward to working with the FDA to initiate this study and advance ATA3219 into the clinic to potentially bring a new disease-modifying option for patients suffering from this chronic disease.”\n\n\nATA3219 is an allogeneic anti-CD19 chimeric antigen receptor (CAR) T-cell therapy. ATA3219 consists of allogeneic EBV T cells that express a CAR targeting CD19 antigen, which is present on the cell surface of most B cells involved in B-cell mediated autoimmune diseases. Key features of ATA3219 include clinically validated technologies designed for T-cell memory phenotype and associated durability, optimized expansion and mitigated exhaustion from a novel 1XX costimulatory domain, and retained endogenous T-cell receptor as a key survival signal that contributes to cell persistence. Using an allogeneic approach may address the significant technical, operational, manufacturing cost, and access challenges seen with autologous CAR T products, permitting the rapid treatment ...