Atara Biotherapeutics Submits Investigational New Drug Application for ATA3219 to Treat Lupus Nephritis

15 February 2024 | Thursday | News

Atara Biotherapeutics, a frontrunner in T-cell immunotherapy, has made a significant stride in combating lupus nephritis, a severe complication of systemic lupus erythematosus (SLE), with its latest submission of an Investigational New Drug (IND) application for ATA3219. This novel therapy aims to address the root cause of lupus nephritis by targeting CD19+ B cells.
Image Source : Public Domain

Image Source : Public Domain


Lupus nephritis, a condition affecting the kidneys, presents a challenging treatment landscape with limited efficacy from existing therapies. ATA3219, an allogeneic anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, holds promise in revolutionizing the treatment paradigm for this chronic autoimmune disease.

"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," stated Rajani Dinavahi, Chief Medical Officer at Atara Biotherapeutics. "We are dedicated to advancing medical breakthroughs with innovative cell therapies that truly make a difference."

ATA3219 combines the natural biology of unedited T cells with the advantages of an allogeneic CAR T approach, demonstrating potential efficacy in lupus nephritis through preclinical data. Notably, ATA3219 offers several key features, including T-cell memory phenotype, optimized expansion, and mitigated exhaustion, alongside the retention of the endogenous T-cell receptor for enhanced cell persistence.

"We are particularly excited to bring this allogeneic CD19 CAR T to the clinic as it has been designed to offer a differentiated profile by incorporating multiple clinically validated attributes," said Cokey Nguyen, Chief Scientific and Technical Officer at Atara. "Our goal is to demonstrate that ATA3219 can provide deep and durable remission, allowing the immune system to reset and potentially transform a new therapeutic area with an off-the-shelf CAR T approach."

The submission of the IND for ATA3219 follows the clearance received for non-Hodgkin's lymphoma (NHL) in Q3 2023, showcasing Atara Biotherapeutics' commitment to advancing innovative therapies across various disease areas.

With lupus nephritis affecting a significant portion of SLE patients, the potential of ATA3219 in providing a disease-modifying option holds promise for transforming patient outcomes in this challenging medical landscape. Atara Biotherapeutics looks forward to collaborating with the FDA to initiate clinical studies, aiming to bring this novel therapy to patients in need.


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