THOUSAND OAKS, Calif. - Atara Biotherapeutics, Inc. (NASDAQ: NASDAQ:ATRA), a pioneer in T-cell immunotherapy, has announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for ATA3219, a novel therapy for patients with systemic lupus erythematosus (SLE) and kidney involvement, known as lupus nephritis (LN). This submission follows the company's previous IND clearance for ATA3219 in treating non-Hodgkin's lymphoma received in Q3 2023.
ATA3219 is an allogeneic anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, harnessing the natural biology of unedited T cells and the advantages of an allogeneic approach. It is designed to address the high unmet need in lupus nephritis, where existing treatments often require long-term immune suppression with limited efficacy. The therapy aims to provide a more accessible and cost-effective alternative to autologous CAR T products, with the potential for rapid treatment delivery from finished product inventory.
The company's Chief Medical Officer, Rajani Dinavahi, expressed commitment to advancing medical breakthroughs that significantly impact patients' lives. Atara aims to initiate clinical studies to explore ATA3219 as a new disease-modifying option for those suffering from this chronic condition.
Preclinical data suggest ATA3219 may offer a differentiated profile with potential for deep and durable remission. The therapy incorporates multiple clinically validated technologies, including a novel 1XX costimulatory domain to optimize expansion and mitigate exhaustion, and retains the endogenous T-cell receptor, which contributes to cell persistence.
The IND submission for ATA3219 includes robust in vitro data demonstrating the CD19 antigen-specific functional activity of ATA3219 and its efficacy against B cells from SLE patients, showing near-complete CD19-specific B-cell depletion.
Lupus nephritis is a severe complication of SLE, affecting a significant proportion of the 200,000+ SLE patients in the U.S. Current treatments yield low response rates, with many patients being refractory to standard immunosuppressive therapies, highlighting the need for novel therapeutic approaches.
Atara Biotherapeutics is focused on developing off-the-shelf cell therapies for cancers and autoimmune diseases, leveraging its Epstein-Barr virus (EBV) T-cell platform. The company's approach does not require T-cell receptor or HLA gene editing, aiming to provide a diverse portfolio of investigational therapies targeting EBV and next-generation AlloCAR-Ts.
The information in this article is based on a press release statement from Atara Biotherapeutics, Inc.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.