Company: ATRA
Filing Date: 2025-03-07
Form Type: 10-K
Source: 0000950170-25-035507
Chunk: 24

Company: Atara Biotherapeutics, Inc.
Filing Date: 2025-03-07
Form: 10-K
Item: Item 1
Chunk 24
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  The elimination of LD is designed to further simplify the treatment regimen and to potentially provide a differentiated safety profile to patients without compromising efficacy which may improve patient access. 

In January 2025, the FDA placed a clinical hold on Atara’s active IND applications.  These INDs include ATA3219 for the treatment of non-Hodgkin’s lymphoma and systemic lupus erythematosus.  The clinical hold is directly linked to inadequately addressed GMP compliance issues referenced in the Response Letter.  While ATA3219 drug product is manufactured at a separate 

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facility, the starting materials used in its production are affected by the compliance issues at the same third-party facility referenced in the Response Letter.

In March 2025, we announced our decision to pause the development of our allogeneic CAR-T cell programs and to discontinue all CAR T operations, including terminating the clinical trials evaluating ATA3219.  We expect to complete wind-down activities for the ATA3219 program by the end of the first quarter of 2025.

Additional Programs 

ATA3431 is an allogeneic, bispecific CAR directed against CD19 and CD20 for B-cell malignancies and autoimmune disease, leveraging our 1XX CAR co-stimulatory domain and EBV T-cell platform and does not require gene TCR or HLA gene editing. Preclinical data presented at the American Society of Hematology 2023 demonstrated potential for potent antitumor activity, long-term persistence, and superior tumor growth inhibition compared to an autologous CD19/CD20 CAR T benchmark.  In March 2025, we announced our decision to pause the development of our allogeneic CAR-T cell programs and discontinue all development operations, including ATA3431.  We expect to complete wind-down activities for the ATA3431 program by the end of the first quarter of 2025. 

We have also discontinued some programs and will return the programs to our collaborators. For example, in March 2024, we returned the ATA2271 and ATA3271 programs targeting mesothelin to MSK. We are in discussions with QIMR Berghofer to return rights to ATA188 and the EBV vaccine to QIMR Berghofer.

We believe our platform will have utility beyond the current set of targets to which it has been directed. 

Competition

The biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary products. We face