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news.Atara Biotherapeutics has submitted an investigational new drug (IND) application to the US Food and Drug Administration (FDA) for its chimeric antigen receptor (CAR) T-cell therapy ATA3219 for treating lupus nephritis.
ATA3219 will be analysed to treat patients with lupus nephritis. Credit: Robina Weermeijer on Unsplash.
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ATA3219 utilises allogeneic T cells to act on the CD19 antigen found on B cells, which are implicated in B-cell mediated autoimmune diseases such as systemic lupus erythematosus (SLE).
It is designed to overcome the challenges linked to autologous CAR T products, including technical complexities and high manufacturing costs.
The allogeneic approach of ATA3219 could enable rapid treatment for thousands of high-risk patients by providing an off-the-shelf solution, eliminating the need for individual patient manufacturing and apheresis.
In an investigator-sponsored proof of concept study, the treatment with an autologous CD19-targeted CAR T therapy showed promising results, with 100% of lupus nephritis patients achieving drug-free, durable remission.
This approach successfully removed autoreactive B cells and aided the healthy B cells to return to normalcy, improving clinical symptoms.
The IND submission for ATA3219 includes comprehensive in vitro data showcasing the therapy’s specific activity against the CD19 antigen and its efficacy in depleting B cells from SLE patients.
The data indicated that ATA3219 led to near-complete elimination of CD19-specific B cells versus controls, supporting its potential as a transformative treatment for lupus nephritis.
Atara Biotherapeutics chief medical officer Rajani Dinavahi said: “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.
“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.”
