THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Atara Biotherapeutics, Inc. (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 its recent submission of an Investigational New Drug (IND) application to the U.S.

加利福尼亚州千橡树市（商业新闻短讯）--T细胞免疫治疗领域的领导者Atara Biotherapeutics，Inc.（纳斯达克：ATRA），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，今天宣布其最近向美国提交了一份研究性新药（IND）申请。

Food and Drug Administration (FDA) for the use of ATA3219 as a monotherapy for the treatment of systemic lupus erythematosus (SLE) with kidney involvement (lupus nephritis [LN])..

美国食品和药物管理局（FDA）使用ATA3219作为单一疗法治疗伴有肾脏受累的系统性红斑狼疮（SLE）（狼疮性肾炎[LN]）。。

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

Atara首席医疗官拉贾尼·迪纳瓦希（RajaniDinavahi）说：“尽管治疗取得了进展，但狼疮性肾炎的需求仍未得到满足，标准护理和批准的治疗效果有限，通常依赖于多年（如果不是终身）的免疫抑制。”。“我们致力于通过创新的细胞疗法推动医学突破，真正发挥作用。

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.”.

我们期待着与FDA合作启动这项研究，并将ATA3219推进临床，为患有这种慢性病的患者带来一种新的疾病缓解选择。”。

ATA3219 is an allogeneic anti-CD19 chimeric antigen receptor (CAR) T-cell therapy. ATA3219 consists of allogeneic EBV T cells that express a CAR targeting CD19 antigen, which is present on the cell surface of most B cells involved in B-cell mediated autoimmune diseases. Key features of ATA3219 include clinically validated technologies designed for T-cell memory phenotype and associated durability, optimized expansion and mitigated exhaustion from a novel 1XX costimulatory domain, and retained endogenous T-cell receptor as a key survival signal that contributes to cell persistence.

ATA3219是一种同种异体抗CD19嵌合抗原受体（CAR）T细胞疗法。ATA3219由表达CAR靶向CD19抗原的同种异体EBV T细胞组成，CD19抗原存在于参与B细胞介导的自身免疫疾病的大多数B细胞的细胞表面。ATA3219的关键特征包括针对T细胞记忆表型和相关耐久性设计的临床验证技术，优化的扩增和减轻新型1XX共刺激结构域的耗竭，以及保留内源性T细胞受体作为有助于细胞持久性的关键生存信号。

Using an allogeneic approach may address the significant technical, operational, manufacturing cost, and access challenges seen with autologous CAR T products, permitting the rapid treatment of potentially thousands of high-risk patients. Treatment will be facilitated for patients and physicians in avoiding apheresis and lengthy patient-by-patient manufacturing as ATA3219 would be rapidly available as an off-the-shelf treatment from finished product inventory..

使用同种异体方法可以解决自体CAR T产品所面临的重大技术，操作，制造成本和获取挑战，从而可以快速治疗潜在的数千名高危患者。由于ATA3219将作为成品库存中的现成治疗方法迅速提供，因此将有助于患者和医生避免单采血液和长时间的逐个患者制造。。

“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.”.

Atara首席科学技术官Cokey Nguyen说：“我们特别高兴能将这种同种异体CD19 CAR T带到诊所，因为它被设计为通过结合多种临床验证的属性来提供差异化的特征。”。“我们的目标是证明ATA3219可以提供深度和持久的缓解，使免疫系统能够重置，并可能通过现成的CAR T方法改变新的治疗领域。”。

Proof of concept for a CD19 CAR T approach in autoimmune disease was first demonstrated in early academic results from an investigator-sponsored study showing 100% (8/8) of LN patients rapidly attaining drug-free, durable remission with an autologous CD19-targeted CAR T therapy. The therapy eliminated the pathogenic, autoreactive B cells and allowed healthy B cells to return after treatment, enabling the patients’ immune system to function normally again with associated improvement of clinical symptoms.1 These early proof of concept clinical data with CD19 targeted CAR T support further development of CAR T for LN with differentiated and off-the-shelf allogeneic approaches..

CD19 CAR T方法在自身免疫性疾病中的概念验证首先在研究者赞助的一项研究的早期学术结果中得到证实，该研究显示100%（8/8）的LN患者通过自体CD19靶向CAR T治疗迅速获得无药物，持久缓解。该疗法消除了致病性，自身反应性B细胞，并使健康的B细胞在治疗后恢复，使患者的免疫系统恢复正常功能，并改善临床症状。这些以CD19为靶点的CAR T的早期概念验证临床数据支持通过分化和现成的同种异体方法进一步开发用于LN的CAR T。。

The ATA3219 IND submission includes robust in vitro data reflecting the CD19 antigen-specific functional activity of ATA3219 and CAR-mediated activity against B cells from SLE patients. ATA3219 led to near-complete CD19-specific B-cell depletion compared to controls.

ATA3219 IND提交包括强大的体外数据，反映了ATA3219的CD19抗原特异性功能活性和CAR介导的针对SLE患者B细胞的活性。与对照组相比，ATA3219导致接近完全的CD19特异性B细胞耗竭。

LN is a serious and most common complication of SLE, a chronic multisystem autoimmune disease. The prevalence of SLE in the U.S. is 73 per 100,000 people, afflicting more than 200,000 U.S. patients alone, and occurs in women much more commonly than men. Up to 60% of adult patients with SLE develop renal disease during the course of their illness, and up to 70% of patients with LN are refractory to standard immunosuppressive therapies.

LN是SLE（一种慢性多系统自身免疫性疾病）的严重且最常见的并发症。在美国，SLE的患病率为每10万人中有73人，仅在美国就有20多万患者患病，女性比男性更常见。高达60%的成年SLE患者在患病过程中会发生肾脏疾病，而高达70%的LN患者对标准免疫抑制疗法无效。

Despite recent advances in treatment strategies, the response rate using existing therapies remains low, with significant risk of long-term morbidity and mortality associated with refractory LN..

尽管治疗策略取得了最新进展，但使用现有疗法的缓解率仍然很低，与难治性LN相关的长期发病率和死亡率风险很大。。

About ATA3219

关于ATA3219

ATA3219 combines the natural biology of unedited T cells with the benefits of an allogeneic therapy. It consists of allogeneic Epstein-Barr virus (EBV)-sensitized T cells that express a second generation CD19 CAR construct for the treatment of CD19+ relapsed or refractory B-cell malignancies, including B-cell non-Hodgkin’s lymphoma and B-cell mediated autoimmune diseases including systemic lupus erythematosus (SLE) with kidney involvement (lupus nephritis [LN]).

ATA3219将未经编辑的T细胞的自然生物学与同种异体疗法的益处相结合。它由同种异体爱泼斯坦-巴尔病毒（EBV）致敏的T细胞组成，表达第二代CD19 CAR构建体，用于治疗CD19+复发或难治性B细胞恶性肿瘤，包括B细胞非霍奇金淋巴瘤和B细胞介导的自身免疫性疾病，包括伴有肾脏受累的系统性红斑狼疮（SLE）（狼疮性肾炎[LN]）。

ATA3219 has been optimized to offer a potential best-in-class profile, featuring off-the-shelf availability. It incorporates multiple clinically validated technologies like the modified CD3ζ signaling domain (1XX) that optimizes expansion and mitigates exhaustion, enrichment for a less differentiated memory phenotype for robust expansion and persistence and retains the endogenous T-cell receptor without gene editing as a key survival signal for T cells contributing to persistence..

ATA3219经过优化，提供了一个潜在的同类最佳配置文件，具有现成的可用性。它结合了多种经过临床验证的技术，如改良的CD3ζ信号传导结构域（1XX），可优化扩增并减轻衰竭，富集分化程度较低的记忆表型，以实现强大的扩增和持久性，并保留内源性T细胞受体，而无需基因编辑作为T细胞持久性的关键生存信号。。

Next-Generation Allogeneic CAR-T Approach

下一代同种异体CAR-T方法

Atara is focused on applying Epstein-Barr virus (EBV) T-cell biology, featuring experience in over 600 patients treated with allogeneic EBV T cells, and novel chimeric antigen receptor (CAR) technologies to meet the current limitations of autologous and allogeneic CAR therapies head-on by advancing a potential best-in-class CAR T pipeline in oncology and autoimmune disease.

Atara专注于应用爱泼斯坦-巴尔病毒（EBV）T细胞生物学，拥有600多名接受同种异体EBV T细胞治疗的患者的经验，以及新型嵌合抗原受体（CAR）技术，以满足目前自体和同种异体CAR治疗的局限性。通过推进肿瘤学和自身免疫性疾病领域潜在的一流CAR T管道，迎头赶上。

Unlike gene-edited approaches aimed at inactivating T-cell receptor (TCR) function to reduce the risk for graft-vs-host disease, EBV T cells maintain expression of native TCRs that promote in vivo functional persistence while also demonstrating inherently low alloreactivity due to their recognition of defined viral antigens and partial human leukocyte antigen (HLA) matching.

与旨在灭活T细胞受体（TCR）功能以降低移植物抗宿主病风险的基因编辑方法不同，EBV T细胞维持天然TCR的表达，其促进体内功能持久性，同时还表现出固有的低同种异体反应性，因为它们识别确定的病毒抗原和部分人类白细胞抗原（HLA）匹配。

A molecular toolkit of clinically-validated technologies—including the 1XX costimulatory domain designed for better cell fitness and less exhaustion while maintaining stemness—offers a differentiated approach to addressing significant unmet need with the next generation CAR T..

临床验证技术的分子工具包，包括1XX共刺激结构域，旨在改善细胞适应性和减少疲劳，同时保持干性，为解决下一代CAR T的重大未满足需求提供了一种不同的方法。。

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 within days. 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，这些疾病可以在几天内迅速传递给患者。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 Epstein-Barr virus (EBV) 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.

我们先进而通用的爱泼斯坦-巴尔病毒（EBV）T细胞平台不需要T细胞受体或HLA基因编辑，并且形成了针对EBV（某些疾病的根本原因）的多种研究疗法组合的基础，除了针对广泛的血液恶性肿瘤和B细胞驱动的自身免疫性疾病的最佳机会而设计的下一代AlloCAR Ts之外。

Atara is headquartered in Southern California. For more information, visit atarabio.com and follow @Atarabio on X and LinkedIn..

阿塔拉总部位于南加州。有关更多信息，请访问atarabio.com并在X和LinkedIn上关注@atarabio。。

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 the development, data, timing and progress, as applicable, of: (1) the ATA3219 program, including the progress of the IND for lupus nephritis; (2) the potential characteristics and benefits of ATA3219, including the potential safety, efficacy, tolerability and persistence of ATA3219, as well as the CD19 antigen-specific functional activity of ATA3219 and CAR-mediated activity against B cells from SLE patients; (3) the manufacture of ATA3219, including scalability; and (4) the Company’s planned clinical study of ATA3219 to treat lupus nephritis, including the timing thereof.

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，前瞻性陈述包括关于以下方面的发展，数据，时间和进展的陈述：（1）ATA3219计划，包括IND治疗狼疮性肾炎的进展；（2） ATA3219的潜在特征和益处，包括ATA3219的潜在安全性，有效性，耐受性和持久性，以及ATA3219的CD19抗原特异性功能活性和CAR介导的针对SLE患者B细胞的活性；（3） ATA3219的制造，包括可扩展性；（4）该公司计划对ATA3219进行治疗狼疮性肾炎的临床研究，包括时间安排。

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; the ongoing COVID-19 pandemic and the wars in Ukraine and the Middle East, which may significantly impact (i) our business, research, clinical development plans and operations, including our operations in Southern California and Denver and at our clinical trial sites, as well as the business or operations of our third-party manufacturer, contract research organizations or other third parties wit.

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；正在进行的新型冠状病毒肺炎大流行以及乌克兰和中东的战争可能会对（i）我们的业务、研究、临床开发计划和运营产生重大影响，包括我们在南加州和丹佛以及我们的临床试验地点的运营，以及我们的第三方制造商、合同研究组织或其他第三方的业务或运营。

1Mueller, F., et al. CD19-Targeted CAR-T Cells in Refractory Systemic Autoimmune Diseases: A Monocentric Experience from the First Fifteen Patients. Blood 2023; 142 (Supplement 1): 220.

1Mueller，F。等人。CD19靶向CAR-T细胞治疗难治性系统性自身免疫性疾病：前15名患者的单中心经验。血液2023；142（补编1）：220。