THOUSAND OAKS, Calif. - Atara Biotherapeutics, Inc. (NASDAQ:ATRA), has received U.S. Food and Drug Administration (FDA) clearance for an Investigational New Drug (IND) application for ATA3219. This is a new allogeneic anti-CD19 chimeric antigen receptor (CAR) T-cell therapy aimed at treating systemic lupus erythematosus (SLE), specifically lupus nephritis (LN), a kidney-related complication.
The company, known for its T-cell immunotherapy platform, announced the initiation of a Phase 1 trial for ATA3219.
The study will be an open-label, single-arm, dose-escalation trial assessing the safety and preliminary efficacy of the drug in subjects with LN. The trial is set to begin enrollment in the second half of 2024, with patients receiving a one-time infusion of ATA3219 after lymphodepletion treatment.
ATA3219 has been designed with the intention of providing a potentially curative off-the-shelf cell therapy option for patients with severe autoimmune diseases. The drug aims to eliminate the need for ongoing administration, which is a limitation of current therapies for LN, and to improve accessibility to treatment.
The IND submission for ATA3219 included in vitro data that showed the drug's specific activity against B cells from SLE patients, demonstrating robust B-cell depletion. This data builds upon earlier academic studies that showed promising results using autologous CD19-targeted CAR T therapy for LN, where patients achieved drug-free, durable remission.
Lupus nephritis is a severe complication of SLE, affecting up to 60% of adult patients with SLE and with up to 70% of patients being refractory to standard immunosuppressive therapies. The prevalence of SLE in the U.S. is estimated at 73 per 100,000 people, impacting over 200,000 U.S. patients.
Atara Biotherapeutics is leveraging its experience with allogeneic Epstein-Barr virus (EBV) T cells, having treated over 600 patients, to advance its pipeline in oncology and autoimmune disease. ATA3219 combines unedited T cells with allogeneic therapy benefits and incorporates multiple clinically validated technologies to offer a differentiated approach to treatment.
This news is based on a press release statement from Atara Biotherapeutics, Inc.
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