REDWOOD CITY, Calif. & BOSTON--(BUSINESS WIRE)--Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today announced ADI-001 clinical biomarker data from the Phase 1 GLEAN trial which further reinforces the potential of ADI-001 as a best-in-class allogeneic cell therapy for autoimmune diseases.

加利福尼亚州红木市和波士顿——（商业新闻短讯）——Adicet Bio，Inc.（纳斯达克：ACET），一家临床阶段生物技术公司，发现并开发用于自身免疫性疾病和癌症的同种异体γ-δT细胞疗法，今天宣布了来自第一阶段GLEAN试验的ADI-001临床生物标志物数据，该数据进一步增强了ADI-001作为同类最佳同种异体细胞疗法治疗自身免疫性疾病的潜力。

Notably, ADI-001 demonstrated robust tissue trafficking resulting in high levels of ADI-001, significant chimeric antigen receptor (CAR) T cell activation, and complete CD19+ B cell depletion in secondary lymphoid tissue. These data will be presented by Dr. Blake Aftab, Chief Scientific Officer, at the 9th Annual CAR-TCR Summit on Thursday, September 19, 2024 in Boston, MA..

值得注意的是，ADI-001表现出强大的组织运输，导致高水平的ADI-001，显着的嵌合抗原受体（CAR）T细胞活化，以及次级淋巴组织中CD19+B细胞的完全消耗。这些数据将由首席科学官布莱克·阿夫塔布博士在2024年9月19日（星期四）于马萨诸塞州波士顿举行的第九届CAR-TCR年度峰会上提交。。

“These results clearly support the potential of ADI-001 and Adicet’s off-the-shelf gamma delta CAR T cell platform, by demonstrating robust trafficking and complete B cell depletion in tissue, while providing superior exposure of ADI-001 in secondary lymphoid tissue compared to published third-party data reported for alpha-beta CAR T therapies,” said Blake Aftab, Ph.D., Chief Scientific Officer of Adicet Bio.

Adicet Bio首席科学官Blake Aftab博士说：“这些结果清楚地支持了ADI-001和Adicet现成的γδCAR T细胞平台的潜力，证明了组织中强大的运输和完全的B细胞耗竭，同时与已发表的第三方报告的α-βCAR T治疗数据相比，在次级淋巴组织中提供了更好的ADI-001暴露。”。

“Together, the totality of our findings provide multiple levels of evidence highlighting the significant advantages of our approach and present a compelling opportunity for ADI-001 to extend B cell targeting into tissues, as we look to address a range of autoimmune diseases in the clinic.”.

“总之，我们的全部发现提供了多个层面的证据，突出了我们方法的显着优势，并为ADI-001将B细胞靶向扩展到组织中提供了一个令人信服的机会，因为我们希望在临床上解决一系列自身免疫性疾病。”。

A summary of the results is reported below:

结果总结如下：

ADI-001 demonstrated significant levels of CAR T cell activation and tissue exposure in lymph node biopsies in the GLEAN trial, with a mean exposure of 236,701 CAR T cells per million across all dose levels, representing a range of 27-64% of total cellular material detected by ddPCR in evaluable biopsies at the 1E9 dose, and exceeding levels previously reported for patients who received autologous alpha-beta CAR T therapies.

在GLEAN试验中，ADI-001在淋巴结活检中显示出显着水平的CAR T细胞活化和组织暴露，在所有剂量水平下，平均暴露量为236701个CAR T细胞/百万，占通过ddPCR在1E9剂量的可评估活组织检查中检测到的总细胞材料的27-64%，并且超过了先前报道的接受自体α-βCAR T疗法的患者的水平。

CAR T cells detected in tissues also demonstrated a robust activation profile, based on in situ detection of granzyme B..

基于颗粒酶B的原位检测，在组织中检测到的CAR T细胞也表现出强大的激活谱。。

Recently published studies have demonstrated depletion of CD19+ plasmablasts, memory B cells and naïve B cells in peripheral blood using anti-CD20 targeted antibodies, however, these CD20-targeted antibody modalities failed to deplete B cells within secondary lymphoid tissues.

最近发表的研究表明，使用抗CD20靶向抗体可以消耗外周血中的CD19+浆母细胞，记忆B细胞和幼稚B细胞，然而，这些CD20靶向抗体模式未能消耗次级淋巴组织中的B细胞。

Concurrent with ADI-001 tissue trafficking and activation, complete depletion of CD19+ B cells within analyzed secondary lymphoid tissue was also observed. These results support ADI-001’s potential for achieving complete B-cell depletion in peripheral blood and within tissues.

在ADI-001组织运输和激活的同时，还观察到分析的次级淋巴组织中CD19+B细胞的完全消耗。这些结果支持ADI-001在外周血和组织内实现完全B细胞耗竭的潜力。

Adicet is advancing the ADI-001 clinical program in lupus nephritis, systemic lupus erythematosus, systemic sclerosis and anti-neutrophil cytoplasmic autoantibody associated vasculitis (AAV) and expects to report initial clinical data in the first half of 2025.

Adicet正在推进狼疮性肾炎、系统性红斑狼疮、系统性硬化症和抗中性粒细胞胞浆自身抗体相关性血管炎（AAV）的ADI-001临床计划，并预计在2025年上半年报告初步临床数据。

Company webcast information

公司网络广播信息

A listen-only webcast with an accompanying presentation by Dr. Aftab is accessible under Presentations & Events | Adicet Bio in the Investors section of Adicet Bio’s website. The archived webcast will be available for 30 days.

Adicet Bio网站投资者部分的Presentations&Events | Adicet Bio下提供了一个仅供收听的网络广播，并附有Aftab博士的演示。存档的网络广播将持续30天。

About the GLEAN trial

关于GLEAN审判

The Phase 1 GLEAN study was an open-label, multi-center study of ADI-001 enrolling adults diagnosed with B-cell malignancies who have either relapsed, or are refractory to, at least two prior regimens.

第一阶段GLEAN研究是一项开放标签的多中心研究，ADI-001招募了被诊断患有B细胞恶性肿瘤的成年人，这些成年人至少有两种先前的方案复发或难治。

About Adicet Bio, Inc.

关于Adicet Bio，股份有限公司。

Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients.

Adicet Bio，Inc.是一家临床阶段生物技术公司，发现并开发用于自身免疫性疾病和癌症的同种异体γδT细胞疗法。Adicet正在推进一条“现成”γδT细胞的管道，该细胞由嵌合抗原受体（CAR）设计，以促进患者的持久活动。

For more information, please visit our website at https://www.adicetbio.com..

欲了解更多信息，请访问我们的网站https://www.adicetbio.com..

Forward-Looking Statements

This press release contains 'forward-looking statements' of Adicet within the meaning of the Private Securities Litigation Reform Act of 1995 relating to the business and operations of Adicet. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,”, “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

本新闻稿包含1995年《私人证券诉讼改革法案》所指的Adicet的“前瞻性声明”，涉及Adicet的业务和运营。“预期”，“相信”，“继续”，“可能”，“估计”，“预期”，“打算”，“可能”，“计划”，“潜力”，“预测”，“项目”，“应该”，“目标”，“会”等词语旨在识别前瞻性陈述，尽管并非所有前瞻性陈述都包含这些识别词。

These forward-looking statements include, but are not limited to, express or implied statements regarding the potential safety, tolerability and efficacy of ADI-001 multiple autoimmune indications; the potential for ADI-001 to be best-in-class allogenic cell therapy for autoimmune diseases and differentiation from existing therapies; the clinical development of ADI-001 in lupus nephritis, systemic lupus erythematosus, systemic sclerosis and anti-neutrophil cytoplasmic autoantibody associated vasculitis; and the planned announcement of initial clinical data from ADI-001 in four autoimmune indications in the first half of 2025.

；ADI-001成为自身免疫性疾病最佳同种异体细胞疗法的潜力以及与现有疗法的区别；ADI-001在狼疮性肾炎，系统性红斑狼疮，系统性硬化症和抗中性粒细胞胞浆自身抗体相关性血管炎中的临床发展；计划在2025年上半年公布ADI-001在四种自身免疫适应症中的初步临床数据。

Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including without limitation, the effect of global economic conditions and public health crises on the Company’s business and financial results, including with respect to disruptions to its preclinical and clinical studies, business operations, employee hiring and retention, and ability to raise additional capital; Adicet's abi.

本新闻稿中的任何前瞻性陈述均基于管理层当前对未来事件的预期和信念，并受到许多风险和不确定性的影响，这些风险和不确定性可能导致实际结果与此类前瞻性陈述中所述或暗示的结果产生重大不利影响，包括但不限于全球经济状况和公共卫生危机对公司业务和财务结果的影响，包括对其临床前和临床研究、业务运营、员工招聘和保留以及筹集额外资本能力的干扰；Adicet的abi。