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 that the U.S. Food and Drug Administration (FDA) has agreed to an amendment to the Company’s Investigational New Drug (IND) application to evaluate ADI-001 in idiopathic inflammatory myopathy (IIM) and stiff person syndrome (SPS) as part of the ongoing Phase 1 trial in autoimmune diseases.

加利福尼亚州红木市和波士顿——（商业新闻短讯）——临床阶段生物技术公司Adicet Bio，Inc.（纳斯达克：ACET）今天宣布，美国食品和药物管理局（FDA）同意修订该公司的研究性新药（IND）申请，以评估ADI-001在特发性炎症性肌病（IIM）和僵硬人综合征（SPS）中的作用，作为正在进行的自身免疫性疾病第一阶段试验的一部分。

The Company plans to initiate enrollment for IIM and SPS patients in the first quarter of 2025. This announcement follows the FDA’s recent agreements on amendments to the Company’s ADI-001 IND application to evaluate three additional indications beyond lupus nephritis (LN), including systemic lupus erythematosus (SLE), systemic sclerosis (SSc) and anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV)..

该公司计划在2025年第一季度开始IIM和SPS患者的登记。本公告发布之前，FDA最近同意修改公司的ADI-001 IND申请，以评估狼疮性肾炎（LN）以外的三个其他适应症，包括系统性红斑狼疮（SLE），系统性硬化症（SSc）和抗中性粒细胞胞质自身抗体（ANCA）相关血管炎（AAV）。

“The FDA’s acceptance of our IND amendment to evaluate ADI-001 in patients with IIM and SPS builds on our recent momentum in autoimmune diseases, expanding our efforts to six autoimmune indications as we aim to bring our differentiated gamma delta T cell therapy candidates to more patients in need of new treatment options,” said Chen Schor, President and Chief Executive Officer at Adicet Bio.

Adicet Bio总裁兼首席执行官陈绍尔（Chen Schor）表示：“FDA接受我们的IND修正案，以评估IIM和SPS患者的ADI-001，这建立在我们最近在自身免疫性疾病方面的势头基础上，将我们的努力扩展到六个自身免疫适应症，因为我们的目标是将我们分化的γδT细胞治疗候选药物带给更多需要新治疗选择的患者。”。

“Following our recent announcement highlighting clinical biomarker data which demonstrated robust B-cell depletion and preferential trafficking to tissues and organs, we believe in ADI-001’s best-in-class potential for the treatment of autoimmune diseases, and we look forward to initiating patient enrollment in IIM and SPS in the first quarter of 2025 in our ongoing Phase 1 clinical program.”.

“在我们最近宣布强调临床生物标志物数据显示出强大的B细胞耗竭和优先运输到组织和器官之后，我们相信ADI-001在治疗自身免疫性疾病方面具有同类最佳的潜力，我们期待在2025年第一季度在我们正在进行的第一阶段临床计划中启动IIM和SPS的患者登记。”。

The ADI-001 Phase 1 program in autoimmune diseases will have four separate arms, enrolling LN and SLE patients into one arm, SSc patients into a second arm, AAV patients into a third arm, and IIM and SPS patients into a fourth arm. The fourth cohort combines several rare autoimmune muscle diseases into a single dose-finding population, including SPS and the following IIM subtypes: dermatomyositis, anti-synthetase syndrome, immune-mediated necrotizing myopathy, polymyositis, and overlap myositis.

自身免疫性疾病的ADI-001第一阶段计划将有四个独立的部门，将LN和SLE患者纳入一个部门，将SSc患者纳入第二部门，将AAV患者纳入第三部门，将IIM和SPS患者纳入第四部门。第四个队列将几种罕见的自身免疫性肌肉疾病合并为一个单剂量发现人群，包括SPS和以下IIM亚型：皮肌炎，抗合成酶综合征，免疫介导的坏死性肌病，多发性肌炎和重叠肌炎。

Enrolled patients will receive a single dose of ADI-001. The dose-limiting toxicity window is 28 days with response and safety assessments conducted on Day 28 and during the follow up period on months 3, 6, 9, 12, 18, and 24. The primary objectives of the study are to evaluate the safety and tolerability of ADI-001.

入选患者将接受单剂量的ADI-001。剂量限制性毒性窗口为28天，在第28天和随访期间在第3、6、9、12、18和24个月进行反应和安全性评估。该研究的主要目的是评估ADI-001的安全性和耐受性。

Secondary objectives include measuring cellular kinetics, pharmacodynamics, changes in autoantibody titers, and appropriate disease activity scores in each indication..

次要目标包括测量细胞动力学、药效学、自身抗体滴度的变化以及每个适应症中适当的疾病活动评分。

About Idiopathic Inflammatory Myopathy

关于特发性炎性肌病

Idiopathic inflammatory myopathy (IIM, or myositis) refers to a group of rare autoimmune disorders characterized by chronic muscle inflammation and progressive muscle weakness. IIM primarily affects skeletal muscles but can also involve other organs such as the lungs, heart, and skin. Five of the main subtypes include dermatomyositis, anti-synthetase syndrome, immune-mediated necrotizing myopathy, polymyositis, and overlap myositis, all of which can lead to significant functional impairment and have the potential to be life threatening.

特发性炎性肌病（IIM或肌炎）是指一组罕见的自身免疫性疾病，其特征是慢性肌肉炎症和进行性肌无力。IIM主要影响骨骼肌，但也可能涉及其他器官，如肺，心脏和皮肤。五种主要亚型包括皮肌炎，抗合成酶综合征，免疫介导的坏死性肌病，多发性肌炎和重叠肌炎，所有这些都可能导致严重的功能障碍，并有可能危及生命。

There is no available cure for IIM and many patients on current treatments have refractory disease and may experience significant side effects..

IIM没有可用的治疗方法，目前治疗的许多患者患有难治性疾病，可能会出现明显的副作用。。

About Stiff Person Syndrome

关于僵硬人综合征

Stiff person syndrome (SPS) is a rare neurological autoimmune disorder characterized by severe muscle stiffness and spasms, primarily affecting the torso and limbs. Muscle stiffness caused by SPS often impairs mobility, making it difficult for patients to walk, bend, or perform daily activities. Muscle spasms can be triggered by sudden stimuli such as loud noises, physical contact, or emotional distress, and can result in a 'statue-like' posture when severe.

僵硬人综合征（SPS）是一种罕见的神经系统自身免疫性疾病，其特征是严重的肌肉僵硬和痉挛，主要影响躯干和四肢。由SPS引起的肌肉僵硬通常会损害活动能力，使患者难以行走，弯曲或进行日常活动。肌肉痉挛可能由突然的刺激引起，如噪音、身体接触或情绪困扰，严重时可能导致“雕像般”的姿势。

Due to its rarity and overlapping symptoms with other conditions, SPS is frequently misdiagnosed, often as an anxiety disorder or movement disorder. There is currently no available cure for SPS..

由于其罕见且症状与其他疾病重叠，SPS经常被误诊为焦虑症或运动障碍。目前尚无可用的SPS治疗方法。。

About ADI-001

关于ADI-001

ADI-001 is an investigational allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapy targeting CD20 for the treatment of autoimmune diseases. ADI-001 was granted Fast Track Designation by the FDA for the treatment of relapsed/refractory class III or class IV lupus nephritis (LN), and the ongoing Phase 1 study is also evaluating ADI-001 for the treatment of systemic lupus erythematosus (SLE), systemic sclerosis (SSc), anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV), idiopathic inflammatory myopathy (IIM, or myositis), and stiff person syndrome (SPS).

ADI-001是一种针对CD20的研究性同种异体γ-δ嵌合抗原受体（CAR）T细胞疗法，用于治疗自身免疫性疾病。ADI-001被FDA授予治疗复发/难治性III类或IV类狼疮性肾炎（LN）的快速通道指定，正在进行的1期研究也正在评估ADI-001治疗系统性红斑狼疮（SLE），系统性硬化症（SSc），抗中性粒细胞胞质自身抗体（ANCA）相关血管炎（AAV），特发性炎性肌病（IIM或肌炎）和僵硬人综合征（SPS）。

In the Phase 1 GLEAN trial, ADI-001 was shown to target B-cells via an anti-CD20 CAR and demonstrated robust exposure and complete CD19+ B-cell depletion both in peripheral blood and secondary lymphoid tissue..

在第一阶段GLEAN试验中，ADI-001显示通过抗CD20 CAR靶向B细胞，并在外周血和次级淋巴组织中表现出强烈的暴露和完全的CD19+B细胞耗竭。。

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。