THOUSAND OAKS, Calif.--(

加利福尼亚州千橡树--(

BUSINESS WIRE

商业热线

)--

)--

Atara Biotherapeutics, Inc.

Atara生物治疗公司。

(Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on Atara’s active Investigational New Drug (IND) applications.

（纳斯达克：ATRA）是T细胞免疫疗法的领导者，利用其新型同种异体爱泼斯坦-巴尔病毒（EBV）T细胞平台为癌症和自身免疫性疾病患者开发转化疗法，今天宣布美国食品和药物管理局（FDA）已在临床上搁置Atara的积极研究性新药（IND）应用。

These INDs include the EBVALLO.

这些IND包括EBVALLO。

TM

TM公司

(tabelecleucel) program as monotherapy treatment for adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD), as well as ATA3219, an allogeneic CD19-targeted CAR-T therapy, for the treatment of non-Hodgkin’s lymphoma and systemic lupus erythematosus.

（tabelecleucel）计划作为单一疗法治疗2岁及以上患有爱泼斯坦-巴尔病毒阳性移植后淋巴增生性疾病（EBV+PTLD）的成人和儿科患者，以及用于治疗非霍奇金淋巴瘤和系统性红斑狼疮的同种异体CD19靶向CAR-T疗法ATA3219。

Specifically identified subjects currently enrolled in the clinical studies who have the potential to derive clinical benefit may continue to receive treatment in accordance with the ongoing study protocols. Screening and enrollment of new participants in both programs have been paused..

目前参加临床研究的特定受试者可能会继续根据正在进行的研究方案接受治疗，这些受试者可能会获得临床益处。两个项目的新参与者的筛选和登记都已暂停。。

The clinical hold for EBVALLO is directly linked to inadequately addressed GMP compliance issues identified during the pre-license inspection of the third-party manufacturing facility referenced in the Complete Response Letter (CRL) for EBVALLO that was announced on January 16, 2025. While ATA3219 drug product is manufactured at a separate, fully compliant GMP-certified facility, the starting materials used in its production are affected by the compliance issues at the same third-party facility referenced in the CRL.

EBVALLO的临床封存与2025年1月16日宣布的EBVALLO完整回复函（CRL）中提及的第三方制造设施许可证前检查期间发现的GMP合规问题没有得到充分解决直接相关。。

These issues, which underlie both the CRL and the clinical hold, are specific to the referenced third-party manufacturing facility and do not affect Atara’s second third-party manufacturer, FUJIFILM Diosynth Biotechnologies (FDB) facility in Thousand Oaks, California. The FDB facility remains a critical component of Atara’s long-term manufacturing strategy for both assets..

这些问题是CRL和临床封存的基础，特定于参考的第三方制造工厂，不影响Atara的第二家第三方制造商FUJIFILM Diosynch Biotechnologies（FDB）在加利福尼亚州千橡树市的工厂。FDB设施仍然是Atara两项资产长期制造战略的关键组成部分。。

Atara and FDA have discussed and agreed upon the actions necessary to release the clinical holds. The FDA has confirmed its commitment to working collaboratively and expeditiously with Atara to resolve the clinical holds.

Atara和FDA已经讨论并同意了释放临床扣留所需的行动。FDA已确认其承诺与Atara合作并迅速解决临床问题。

“

“

We intend to work closely with the FDA to address these issues as expeditiously as possible,” said Cokey Nguyen, Ph.D., President and Chief Executive Officer of Atara. “

我们打算与FDA密切合作，尽快解决这些问题，”Atara总裁兼首席执行官Cokey Nguyen博士说。“”

We are encouraged with ongoing correspondence with the Agency and a potential path to submitting the necessary data to release the clinical hold. Patient safety remains our priority and maintaining the highest standards for our programs.”

我们对与该机构的持续通信以及提交必要数据以发布临床封存的潜在途径感到鼓舞。患者安全仍然是我们的首要任务，并保持我们计划的最高标准。”

About Atara Biotherapeutics, Inc.

关于Atara Biotherapeutics，Inc。

Atara is harnessing the natural power of the immune system to develop off-the-shelf cell therapies for difficult-to-treat cancers and autoimmune conditions that can be rapidly delivered to patients from inventory. With cutting-edge science and differentiated approach, Atara is the first company in the world to receive regulatory approval of an allogeneic T-cell immunotherapy.

Atara正在利用免疫系统的天然力量开发现成的细胞疗法，用于治疗难以治疗的癌症和自身免疫性疾病，这些疾病可以从库存中快速传递给患者。凭借尖端科学和差异化方法，Atara是世界上第一家获得同种异体T细胞免疫疗法监管批准的公司。

Our advanced and versatile T-cell platform does not require T-cell receptor or HLA gene editing and forms the basis of a diverse portfolio of investigational therapies that target EBV, the root cause of certain diseases, in addition to next-generation AlloCAR-Ts designed for best-in-class opportunities across a broad range of hematological malignancies and B-cell driven autoimmune diseases.

。

Atara is headquartered in Southern California. For more information, visit .

阿塔拉总部位于南加州。有关更多信息，请访问。

atarabio.com

网站 atarabio.com

and follow

并遵循

@Atarabio

@阿塔拉比奥

on

在

X

十

and

和

LinkedIn

LinkedIn

.

.

Forward-Looking Statements

前瞻性声明

This press release contains or may imply 'forward-looking statements' within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, forward-looking statements include statements regarding: (1) the development, timing and progress of tab-cel, including the BLA and potential indications, the timing for FDA review of any resubmission of the BLA, the potential characteristics and benefits of tab-cel, the tab-cel clinical trials; (2) the development, timing and progress of Atara’s AlloCAR-T programs (including ATA3219 and ATA3431), including the clinical trials; and (3) Atara’s ability to address the FDA’s concerns and to complete the activities necessary to release the clinical hold.

本新闻稿包含或可能暗示1933年《证券法》第27A节和1934年《证券交易法》第21E节所指的“前瞻性声明”。例如，前瞻性陈述包括以下方面的陈述：（1）tab-cel的发展，时机和进展，包括BLA和潜在适应症，FDA对BLA重新提交的时间，tab-cel的潜在特征和益处，tab-cel临床试验；（2） Atara的AlloCAR-T计划（包括ATA3219和ATA3431）的开发，时间和进展，包括临床试验；（3）Atara解决FDA担忧并完成释放临床封存所需活动的能力。

Because such statements deal with future events and are based on Atara’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Atara could differ materially from those described in or implied by the statements in this press release.

由于此类声明涉及未来事件，并基于Atara当前的预期，因此会面临各种风险和不确定性，Atara的实际结果、业绩或成就可能与本新闻稿中所述或暗示的结果、业绩或成就存在重大差异。

These forward-looking statements are subject to risks and uncertainties, including, without limitation, risks and uncertainties associated with the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success; risks related to FDA feedback and the ability of Atara and its third-party manufacturer to address the issues identified in the CRL and the clinical hold; our ability to access capital; the sufficiency of Atara’s cash resources and need for and ability to obtain additional capital on favorable terms or at all; risks and uncertainties related to Atara’s financial close and audit procedures; the timing of the strategic review process; whether Atara will pursue any strategic a.

这些前瞻性陈述具有风险和不确定性，包括但不限于与昂贵且耗时的药品开发过程相关的风险和不确定性以及临床成功的不确定性；与FDA反馈相关的风险以及Atara及其第三方制造商解决CRL和临床封存中确定的问题的能力；我们获取资本的能力；Atara现金资源充足，需要并有能力以优惠条件或根本不需要额外资本；与Atara财务结算和审计程序相关的风险和不确定性；战略审查过程的时间安排；阿塔拉是否会寻求任何战略援助。

Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of the Company’s most recently filed periodic reports on Form 10-K and Form 10-Q and subsequent filings and in the documents incorporated by reference therein. Except as otherwise required by law, Atara disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise..

管理层对财务状况和经营成果的讨论和分析”公司最近提交的定期报告中的表格10-K和表格10-Q以及随后的文件以及其中引用的文件中的章节。除法律另有规定外，Atara不承担任何更新或修订任何前瞻性声明的意图或义务，无论是由于新信息、未来事件或情况或其他原因，这些前瞻性声明仅在本协议日期发表。。