Prulacabtagene Leucel

γδ T 细胞是先天性与适应性免疫的“桥梁”细胞，具有 MHC非依赖性识别肿瘤的能力；   它们能直接杀伤肿瘤细胞，并分泌 IFN-γ、TNF-α 等细胞因子，重塑肿瘤微环境。 part 1 γδ T 细胞的基本特征 1 分类与组织分布 γδ T 细胞根据 TCR δ 链 分为：Vδ1、Vδ2、Vδ3 及少量 Vδ5；Vγ9Vδ2 T 细胞是外周血中最主要的亚群；Vδ1 和 Vδ3 T 细胞在外周血中较少，但在组织（黏膜、皮肤、肠道等）中富集。 2 单细胞转录组学揭示的异质性 Vδ2 T 细胞：存在三个胸腺发育阶段（早期 → 效应 → 细胞毒性），功能编程主要发生在出生后胸腺，外周扩增有限。   Vδ1 T 细胞：在胎儿和婴儿期占主导，克隆多样性极高；成人后受 CMV 等感染驱动，向寡克隆/私有种型转化，呈现适应性记忆特征。   组织特异性：乳腺、肺、肝脏中的 Vδ1 细胞呈现组织驻留记忆表型（CD69⁺ CD103⁺），不依赖 TCR 即可快速响应细胞因子（IL-12、IL-18）。 3 γδ T 细胞的关键抗肿瘤特性 part 2 γδ T 细胞 如何识别肿瘤？ 01   Vγ9Vδ2 T 细胞的        识别机制 识别磷抗原（如 IPP），通过 BTN3A1 和 BTN2A1 家族分子介导； 磷抗原结合 BTN3A1 的 B30.2 结构域，诱导构象变化，促使 BTN2A1 与 Vγ9 TCR 链结合； AMPK 激动剂可上调 BTN2A1/BTN3A1，增强肿瘤杀伤； Vγ9Vδ2 T 细胞高表达 CD16，可介导 ADCC。 02   Vδ1⁻ T 细胞（Vδ1、Vδ3、Vδ5）的识别机制 Vδ1 TCR 多样性高，呈现适应性免疫特征； 识别 MICA、CD1家族、MR1 等 MHC 样分子； 识别 EphA2、annexin A2、EPCR 等肿瘤相关分子； 依赖 NK 受体（如 NKG2D、DNAM-1、NKp30）识别应激配体。 03  NK 受体的作用 NKG2D 识别 MICA/B、ULBP，直接激活 γδ T 细胞； DNAM-1 识别 PVR/CD155、nectin-2/CD112，对 AML 和 CRC 靶向至关重要； NKp30/44/46 在特定刺激下诱导表达，增强肿瘤识别。 part 3 γδ T 细胞在癌症中 的功能角色 1 抗肿瘤作用（多数研究） 小鼠模型：γδ T 细胞缺失增加化学诱导肿瘤发生率； 人类肿瘤中高丰度 γδ T 细胞（尤其是 Vδ1）与良好预后相关： 三阴性乳腺癌、非小细胞肺癌、肝细胞癌、卵巢癌、胃癌、头颈癌、膀胱癌、结直肠癌等； 机制：分泌 IFN-γ、TNF-α、穿孔素、颗粒酶 B、TRAIL。 2 促肿瘤作用的罕见情况 IL-17⁺ γδ T 细胞在部分模型中促进肿瘤进展； 在 CRC 中，早期以 IFN-γ⁺ 为主（抗肿瘤），晚期向 IL-17⁺ 转化（促肿瘤）； 人 γδ T 细胞以 IFN-γ⁺ 细胞毒性表型为主，与小鼠差异显著； CRC 微环境中 γδ T 细胞可被重编程为 AREG⁺ 伤口愈合表型，促进肿瘤进展。 part 4 γδ T 细胞疗法 01 关键发现 肿瘤浸润 γδ T 细胞（尤其是 Vδ1）高表达 PD-1、TIGIT、TIM-3，但仍保留效应功能； 这些细胞不呈现典型耗竭特征，与 CD8⁺ T 细胞不同； 在肾癌、黑色素瘤、CRC 中，PD-1⁺ γδ T 细胞仍具增殖和杀伤能力。 02 ICB 对 γδ T 细胞的        增强作用 PD-L1/PD-1 或 TIGIT 阻断可增强 γδ T 细胞杀伤功能； 在卵巢癌、黑色素瘤、Merkel 细胞癌中，PD-1⁺ γδ T 细胞与ICB 治疗响应正相关； 正在进行的临床试验：NCT06212388、NCT06364800、NCT06404281。 03  生物制剂靶向    γδ T 细胞 抗 BTN3A 单抗 ICT01 可激活 Vγ9Vδ2 T 细胞，联合阿扎胞苷/维奈克拉在 AML 中显示良好耐受性与高缓解率（EVICTION 试验）。双特异性 T 细胞衔接分子（如 LAVA-1207 靶向 Vδ2×PSMA）已在转移性前列腺癌进入 I/II 期试验；Vδ1×EGFR 双特异性分子处于临床前阶段。此外，利用 γδ T 细胞高表达 CD16 的特性，可联合抗 GD2 抗体（dinutuximab）诱导 ADCC 治疗神经母细胞瘤。 04  过继 γδ T 细胞治疗 早期使用氨磷酸盐联合 IL-2 扩增 Vδ2 T 细胞的策略因扩增效率低和细胞耗竭而临床反应有限。异体 γδ T 细胞可避免 GVHD 实现“现货型”治疗，其中化疗耐药的 INB-100 在移植后患者中达 100% 一年无复发生存。课题组开发的 Vδ1 富集 DOT 细胞扩增超 1000 倍，依赖 DNAM-1/PVR 识别 AML，已进入 I/II 期试验；在结直肠癌模型中联合丁酸盐或抗 PD-1/抗 TIGIT 可进一步增强疗效。 05  CAR-γδ T 细胞与其他工程化策略 CAR-γδ T 细胞兼具 TCR 和 NK 受体的广谱识别能力，可减少免疫逃逸并实现异体现货化治疗。代表性产品包括靶向 CD20 的 ADI-001（I 期，7/9 完全缓解）、靶向 CD70 的 ADI-270（I/II 期肾癌）等。新型工程化策略包括 AbTCR（降低 CRS 风险）、TEG 细胞（将 γδ TCR 转入 αβ T 细胞）以及 CAR 与 BiTE 或 IL-15 联合的双靶向武装。 part 5 γδ T流式 1 human 外周血 2 mouse 外周淋巴结 vs 2耳皮肤 part 6 结论与展望 1 优势总结 MHC 非限制性，适用于 HLA 缺陷肿瘤； 组织归巢能力强，适合上皮来源肿瘤； 快速、广谱、多功能的免疫响应； 异体可用，便于规模化生产。 2 挑战与未来方向 实体瘤中 TME 免疫抑制（如 PGE2、IDO、galectin）需联合靶向； 需优化 CAR 信号模块以更好适配 γδ T 细胞生物学； 需开发 Vδ1 特异性衔接分子； 需更多临床数据验证持久性、安全性、抗肿瘤活性。 参考文献 https://doi.org/10.1146/annurev-immunol-083024-024653 DOI: 10.1002/eji.202170126 联系我们 7*24 h快速响应+专业技术解答，双重保障让您无后顾之忧！欢迎有实验服务/产品需求的老师随时联系（4008-526413） END 加入社群 关于福麦斯

Clinical update anticipated in mid-2026 for Phase 1 autoimmune program evaluating prulacabtagene leucel (prula-cel, formerly ADI-001) with at least 20 lupus nephritis (LN) and systemic lupus erythematosus (SLE) patients with a minimum of six months follow-up U.S. Food and Drug Administration (FDA) interaction to inform potential pivotal trial design for prula-cel expected in 2Q/2026 On track to submit regulatory filing for ADI-212 in metastatic castration-resistant prostate cancer (mCRPC) in 3Q/2026; enrollment expected to begin 4Q/2026, pending regulatory clearance Continued advancement of cell therapy programs and differentiated in vivo CAR-T platform targeting multiple indications REDWOOD CITY, Calif. --(BUSINESS WIRE)--May 13, 2026-- 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 reported financial results and operational highlights for the first quarter ended March 31, 2026 . “Adicet is approaching a key inflection point as we prepare to report Phase 1 data for prula-cel in mid-year 2026, including data from at least 20 LN and SLE patients with a minimum of six months of follow-up,” said Chen Schor , President and Chief Executive Officer of Adicet Bio . “Reaching this important inflection point builds on the collaboration of our employees and a global network of investigators and clinical sites advancing a comprehensive Phase 1 trial of a potential first-in-class gamma delta 1 CAR-T cell therapy in autoimmune diseases.” Mr. Schor continued, “In parallel, we are continuing to build our portfolio with ADI-212, a gene-edited and armored product candidate designed to enhance clinical activity in solid tumors and deliver multiple anti-tumor mechanisms of action to the tumor microenvironment. We are also advancing our ongoing preclinical programs and activities focused on a differentiated in vivo CAR-T platform targeting heme malignancies.” First Quarter 2026 and Recent Operational Highlights: Autoimmune diseases Phase 1 prula-cel clinical update in LN and SLE patients anticipated in mid-2026. The Company plans to provide its next clinical update in mid-2026 for its ongoing Phase 1 clinical trial evaluating prula-cel across multiple autoimmune conditions. Adicet also intends to meet with the FDA in the second quarter of 2026 to inform potential pivotal trial design. Subject to regulatory clearance to proceed, the Company expects to initiate start up activities for a pivotal program in LN or LN and SLE patients in the second half of 2026. In addition, following alignment with the FDA in November 2025 , LN and SLE patients in the ongoing Phase 1 study and future studies may be dosed with prula-cel in the outpatient setting. The Company plans to provide a clinical update in patients with systemic sclerosis in the second half of 2026. Ongoing Phase 1 trial of prula-cel in treatment-refractory rheumatoid arthritis (RA) to assess reduced conditioning regimens. The Phase 1 trial of prula-cel in RA is designed to assess two lymphodepletion approaches, cyclophosphamide alone and in combination with fludarabine. Primary objectives include evaluating safety and tolerability, with secondary assessments focused on cellular kinetics, pharmacodynamic markers, and disease activity measures. The next update on this trial is expected in the second half of 2026. Solid tumor indications Regulatory submission for ADI-212 planned for the third quarter of 2026 with Phase 1 start anticipated in the fourth quarter of 2026 pending regulatory clearance. Adicet continues to advance its next-generation gene-edited, armored cell therapy candidate targeting prostate-specific membrane antigen (PSMA). ADI-212 is engineered to express a novel CAR binder designed to support enhanced tolerability and tumor specific recognition. It integrates membrane tethered IL-12 armoring, and CRISPR/Cas9-mediated disruption of subunit 12 (MED12) to enhance potency in solid tumors and deliver multiple anti-tumor mechanisms of action within the tumor microenvironment. Adicet expects to submit a regulatory filing for ADI-212 for the treatment of mCRPC in the third quarter of 2026, with initiation of Phase 1 enrollment anticipated in the fourth quarter of 2026, subject to regulatory clearance. Additional early-stage programs (CAR and other technologies) Advancing innovation through a differentiated cell therapy platform. Adicet's pipeline also includes additional early-stage gamma delta CAR-T cell therapy programs for autoimmune diseases, hematological malignancies and solid tumors. Additionally, Adicet has ongoing preclinical programs and activities focused on a differentiated in vivo CAR-T platform targeting heme malignancies. Financial Results for First Quarter 2026: Three months ended March 31, 2026 Research and Development (R&D) Expenses: R&D expenses were $17.5 million for the three months ended March 31, 2026 , compared to $22.8 million during the same period in 2025. The decrease in R&D expenses was primarily due to a $3.6 million decrease in payroll and personnel expenses due to lower headcount, a $1.4 million decrease in expenses related to lab supplies and materials, a $0.5 million decrease related to lower CRO expenses and a $0.2 million decrease in allocated facility-related expenses. The decrease was partially offset by a $0.4 million increase in professional fees. General and Administrative (G&A) Expenses: G&A expenses were $4.1 million for the three months ended March 31, 2026 , compared to $7.1 million during the same period in 2025. The decrease in G&A expenses was due to a $1.4 million decrease in payroll and personnel-related expenses primarily due to a decrease in stock-based compensation and lower headcount, a $1.0 million decrease in allocated facility-related expenses and a $0.6 million decrease in professional fees. Net Loss: Net loss for the three months ended March 31, 2026 was $20.2 million , or a net loss of $1.88 per basic and diluted share, including non-cash stock-based compensation expense of $1.3 million , as compared to a net loss of $28.2 million , or a net loss of $4.96 per basic and diluted share, including non-cash stock-based compensation expense of $3.2 million during the same period in 2025. Cash Position: Cash, cash equivalents and short-term investments were $137.6 million as of March 31, 2026 , compared to $158.5 million as of December 31, 2025 . The Company expects that current cash, cash equivalents and short-term investments as of March 31, 2026 , will be sufficient to fund its operating expenses into the second half of 2027. About Adicet Bio, Inc. 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. For more information, please visit our website at 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. These forward-looking statements include, but are not limited to, express or implied statements regarding: clinical development of Adicet’s product candidates, including future plans or expectations for prula-cel in autoimmune diseases and the potential safety, tolerability and efficacy for the treatment of autoimmune diseases and cancer; timing and success of the Phase 1 clinical trial of prula-cel in multiple autoimmune indications, including timing and expectations for enrollment and future data releases; expectations regarding the timing and initiation of a pivotal study for prula-cel in LN or LN and SLE patients; the ongoing Phase 1 trial of prula-cel in RA; the preclinical and clinical development of ADI-212, including the timing of regulatory filings, clinical startup activities, clinical updates and future data releases; the timing of initiation of enrollment of a Phase 1 trial for ADI-212 in mCRPC; expectations regarding the potential potency of ADI-212; ongoing preclinical programs and activities relating to autoimmune diseases, hematological malignancies and solid tumors; and expectations regarding Adicet’s uses of capital, expenses and financial results, including the expected cash runway. 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 emergencies on Adicet’s business and financial results, including with respect to disruptions to our preclinical and clinical studies, business operations, employee hiring and retention, and ability to raise additional capital; Adicet’s ability to execute on its strategy including obtaining the requisite regulatory approvals on the expected timeline, if at all; that positive results, including interim results, from a preclinical or clinical study may not necessarily be predictive of the results of future or ongoing studies; clinical studies may fail to demonstrate adequate safety and efficacy of Adicet’s product candidates, which would prevent, delay, or limit the scope of regulatory approval and commercialization; and regulatory approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities are lengthy, time-consuming, and inherently unpredictable; and Adicet’s ability to meet production and product release expectations. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Adicet’s actual results to differ from those contained in the forward-looking statements, see the section titled “Risk Factors” in Adicet’s most recent annual report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in Adicet’s other filings with the U.S. Securities and Exchange Commission, including its quarterly report on Form 10- Q. All information in this press release is as of the date of the release, and Adicet undertakes no duty to update this information unless required by law. ADICET BIO, INC. Consolidated Statements of Operations and Comprehensive Income (in thousands, except share and per share amounts) (Unaudited) For the Three Months Ended March 31 , 2026 2025 Operating expenses: Research and development $ 17,487 $ 22,814 General and administrative 4,083 7,071 Total operating expenses 21,570 29,885 Loss from operations (21,570 ) (29,885 ) Interest income 1,342 1,683 Interest expense (23 ) — Other expense, net 7 (12 ) Loss before income tax provision (20,244 ) (28,214 ) Income tax provision — — Net loss $ (20,244 ) $ (28,214 ) Net loss per share, basic and diluted $ (1.88 ) $ (4.96 ) Weighted-average common shares used in computing net loss per share, basic and diluted 10,744,621 5,691,965 Other comprehensive income Unrealized loss on treasury securities, net of tax (139 ) (25 ) Total other comprehensive income (139 ) (25 ) Comprehensive loss $ (20,383 ) $ (28,239 ) ADICET BIO, INC. Consolidated Balance Sheets Information (in thousands) (Unaudited) March 31 , December 31 , 2026 2025 Cash, cash equivalents, and short-term investments in treasury securities $ 137,592 $ 158,530 Working capital 121,773 139,395 Total assets 169,382 192,355 Accumulated deficit (634,941) (614,697) Total stockholders’ equity 140,065 159,210 View source version on businesswire.com: https://www.businesswire.com/news/home/20260513189157/en/ Adicet Bio, Inc. Investor and Media Contacts Anne Bowdidge abowdidge@adicetbio.com Penelope Belnap Precision AQ Penelope.belnap@precisionaq.com Source: Adicet Bio, Inc.