REDWOOD CITY, Calif.--(BUSINESS WIRE)--Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, today announced that it will present clinical data in a poster presentation from its Phase 1 study (abstract #4825) of anitocabtagene autoleucel (anito-cel) in patients with relapsed or refractory multiple myeloma (RRMM); preliminary clinical data in an oral presentation from its iMMagine-1 study (abstract #1031) in patients with RRMM; and a health-related quality of life systematic literature review and meta-analysis (abstract #4721) in patients with RRMM in a poster presentation at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition taking place December 7-10, 2024, in San Diego, California.

加利福尼亚州红木市——（商业新闻短讯）——Arcellx，Inc.（纳斯达克：ACLX），一家生物技术公司，通过为癌症和其他不治之症患者开发创新的免疫疗法来重新想象细胞疗法，今天宣布，它将在其复发或难治性多发性骨髓瘤（RRMM）患者的anitocabtagene autoleucel（anito-cel）第一阶段研究（摘要#4825）的海报展示中展示临床数据；RRMM患者iMMagine-1研究（摘要#1031）口头介绍的初步临床数据；2024年12月7日至10日，在加利福尼亚州圣地亚哥举行的第66届美国血液学会（ASH）年会和博览会上，RRMM患者的健康相关生活质量系统文献综述和荟萃分析（摘要#4721）。

Additionally, an abstract (#6962) describing the treatment patterns and outcomes in triple-class exposed patients with RRMM will be published in a supplemental issue of Blood in November 2024. The company will also have a medical affairs booth (#1615) in Hall E of the San Diego Convention Center..

此外，描述RRMM三级暴露患者治疗模式和结果的摘要（#6962）将于2024年11月在《血液》的补充期刊上发表。该公司还将在圣地亚哥会议中心E厅设立一个医务室（#1615）。。

Phase 2 Registrational Study of Anitocabtagene Autoleucel for the Treatment of Patients With Relapsed and/or Refractory Multiple Myeloma: Preliminary Results From the iMMagine-1 Trial (abstract #1031)

As detailed in the abstract (#1031) as of June 1, 2024, 58 patients had received anito-cel infusion with ≥2 months of follow-up after infusion, with a median follow-up of 10.3 months (range, 2.0-17.8). The median age was 66 years (range, 38-77). Patients had received a median of four prior lines of treatment (range, 3-8) with 26 patients (45%) having received only three prior lines of treatment.

如摘要（#1031）所述，截至2024年6月1日，58例患者接受了anito-cel输注，输注后随访≥2个月，中位随访时间为10.3个月（范围2.0-17.8）。中位年龄为66岁（范围38-77）。患者接受了中位数为四个治疗方案（范围3-8），其中26名患者（45%）仅接受了三个治疗方案。

Forty patients (69%) were triple-class refractory and 20 (34%) were penta-class refractory..

40例（69%）为三级难治性，20例（34%）为五级难治性。。

Investigator-assessed overall response rate (ORR) per International Myeloma Working Group (IMWG) criteria was 95% (55/58) with a complete response/stringent complete response (CR/sCR) rate of 62% (36/58). Of those evaluable for minimal residual disease (MRD) testing (n=39), 36 (92%) achieved MRD negativity at least to the level of 10-5.

。在可评估最小残留病（MRD）检测的患者中（n=39），36例（92%）达到MRD阴性至少10-5。

The Kaplan–Meier-estimated 6-month progression-free survival (PFS) and overall survival (OS) rates (95% CI) were 90% (77-96) and 95% (85-98), respectively. Median (mPFS) and median OS have not yet been reached..

Kaplan-Meier估计6个月无进展生存率（PFS）和总生存率（OS）分别为90%（77-96）和95%（85-98）。尚未达到中位数（mPFS）和中位数OS。。

No delayed neurotoxicities, including no parkinsonism, no cranial nerve palsies, and no Guillain-Barré syndrome have been observed to date. Forty-six patients (79%) had either no cytokine release syndrome (CRS) (n=9, 16%) or Grade (Gr) 1 CRS (n=37, 64%). Thirty-one patients (53%) had no fever or CRS in the first four days of anito-cel.

迄今为止，尚未观察到迟发性神经毒性，包括帕金森氏症，颅神经麻痹和格林-巴利综合征。46名患者（79%）没有细胞因子释放综合征（CRS）（n=9，16%）或1级（Gr）CRS（n=37，64%）。31名患者（53%）在anito cel的前四天没有发烧或CRS。

Any Grade CRS was observed in 49 patients (84%; Gr3/4 0%). Any Grade ICANS was observed in 5 patients (9%; Gr3 2%), with all cases resolved without sequelae. Three deaths occurred due to adverse events (AEs) (both related and unrelated; retroperitoneal hemorrhage, CRS, and fungal infection). No additional treatment or therapy-related deaths or Grade ≥3 CRS or ICANs events have occurred to date.

49例患者（84%；Gr3/4 0%）观察到任何级别的CRS。在5例患者（9%；Gr3 2%）中观察到任何级别的ICAN，所有病例均无后遗症。由于不良事件（AE）（相关和不相关；腹膜后出血，CRS和真菌感染）发生了三例死亡。迄今为止，尚未发生其他治疗或治疗相关死亡或≥3级CRS或ICANs事件。

Cytopenias were the most common Grade ≥3 treatment-emergent AEs; 36 patients (62%) had Grade ≥3 neutropenia, 15 (26%) had Grade ≥3 thrombocytopenia, and 15 (26%) had Grade ≥3 anemia..

血细胞减少症是最常见的≥3级治疗出现的AE；36例（62%）中性粒细胞减少≥3级，15例（26%）血小板减少≥3级，15例（26%）贫血≥3级。。

Conclusions

结论

Preliminary results from the first 58 patients in the Phase 2 iMMagine-1 study demonstrate deep and durable responses and manageable safety in a high-risk fourth line or higher (4L+) RRMM population including triple- and penta-class refractory disease. Notably, no delayed neurotoxicities, including no cranial nerve palsies, Guillain-Barré syndrome, or Parkinsonian-like symptoms have been observed with anito-cel to date.

在第二阶段iMMagine-1研究中，前58名患者的初步结果表明，在高风险的四线或更高（4L+）RRMM人群中，包括三级和五级难治性疾病，具有深度和持久的反应以及可控的安全性。值得注意的是，迄今为止，anito-cel尚未观察到迟发性神经毒性，包括无颅神经麻痹，格林-巴利综合征或帕金森病样症状。

Updated Phase 2 data with a more recent data cut will be presented at the oral presentation during ASH..

更新的第二阶段数据和最新的数据切割将在ASH期间的口头演示中呈现。。

Presentation details:

演示详细信息：

Speaker: Ciara Freeman, M.D., Ph.D., H. Lee Moffitt Cancer Center

演讲者：Ciara Freeman，医学博士，博士，H.Lee Moffitt癌症中心

Session Name: 655. Multiple Myeloma: Cellular Therapies: Unleashing Cell Therapies Against Myeloma

会话名称：655。多发性骨髓瘤：细胞疗法：释放针对骨髓瘤的细胞疗法

Session Date: Monday, December 9, 2024

会议日期：2024年12月9日，星期一

Session Time: 4:30 p.m. - 6:00 p.m.

会议时间：下午4:30至6:00。

Presentation Time: 5:30 p.m.

演讲时间：下午5:30。

Location: Marriott Marquis San Diego Marina, Pacific Ballroom Salons 24-26

地点：圣地亚哥马奎斯万豪酒店，太平洋宴会厅沙龙24-26

Publication Number: 1031

出版编号：1031

Submission ID: 198499

提交编号：198499

Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM) (abstract #4825)

Anitocabtagene Autoleucel治疗复发和/或难治性多发性骨髓瘤（RRMM）患者的1期研究（摘要#4825）

In the Phase 1 study, 40 patients were enrolled and 38 patients received anito-cel. All 38 patients demonstrated investigator-assessed clinical response per 2016 IMWG criteria, (ORR, 100%) with 30 CR/sCR (≥CR rate, 79%), 5 very good partial response (≥VGPR rate, 92%), and 3 partial response (PR). Of those evaluable for MRD testing (n=28), 25 (89%) achieved MRD negativity at 10-5.

在第一阶段研究中，招募了40名患者，38名患者接受了anito-cel。所有38例患者均按照2016年IMWG标准（ORR，100%）表现出研究者评估的临床反应，其中30例CR/sCR（≥CR率，79%），5例非常好的部分反应（≥VGPR率，92%）和3例部分反应（PR）。在可评估MRD测试的患者中（n=28），25名（89%）在10-5时达到MRD阴性。

With a median follow-up of 38.1 months, median OS was not reached and median PFS was 30.2 months. The safety profile was manageable with no delayed neurotoxicities observed to date, including no parkinsonism, no cranial nerve palsies, and no Guillain-Barré syndrome. Further investigations of anito-cel are ongoing in 4L+ RRMM (iMMagine-1, NCT05396885) and in earlier lines (iMMagine-3, NCT06413498)..

中位随访38.1个月，中位OS未达到，中位PFS为30.2个月。安全性是可控的，迄今为止没有观察到延迟的神经毒性，包括没有帕金森病，没有颅神经麻痹，也没有格林-巴利综合征。anito cel的进一步研究正在4L+RRMM（iMMagine-1，NCT05396885）和早期品系（iMMagine-3，NCT06413498）中进行。。

Presentation details:

演示详细信息：

Speaker: Michael R. Bishop, M.D., The University of Chicago

演讲者：芝加哥大学医学博士迈克尔·毕晓普

Session Name: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities

会话名称：704。

Session Date: Monday, December 9, 2024

会议日期：2024年12月9日，星期一

Presentation Time: 6:00 p.m. - 8:00 p.m.

演示时间：下午6:00至8:00。

Location: San Diego Convention Center, Halls G-H

地点：圣地亚哥会议中心G-H厅

Publication Number: 4825

出版编号：4825

Submission ID: 201080

提交编号：201080

Health Related Quality of Life (HRQoL) in Relapsed/Refractory Multiple Myeloma (RRMM): A Systematic Literature Review (SLR) and Meta-Analysis (abstract #4721)

复发/难治性多发性骨髓瘤（RRMM）的健康相关生活质量（HRQoL）：系统文献综述（SLR）和荟萃分析（摘要#4721）

Quantifying pre-treatment HRQoL burden is important as a reference for contextualizing baseline patient burden as emerging therapies for RRMM continue to evolve. This SLR synthesized studies that reported data for key multiple myeloma HRQoL instruments. It found that patients with RRMM had clinically meaningful impairments from population norms in important domains, such as Global Health Status and cognitive, physical, and emotional functioning.

随着RRMM新兴疗法的不断发展，量化治疗前HRQoL负担作为基线患者负担的参考非常重要。该SLR综合了报告关键多发性骨髓瘤HRQoL仪器数据的研究。研究发现，RRMM患者在重要领域（例如全球健康状况以及认知，身体和情绪功能）的人群规范中存在临床意义上的损害。

The SLR also found that pre-treatment HRQoL worsened with increasing lines of therapy..

SLR还发现，随着治疗方案的增加，治疗前HRQoL恶化。。

Presentation details:

演示详细信息：

Speaker: Rahul Banerjee, M.D., Fred Hutchinson Cancer Center

演讲者：医学博士Rahul Banerjee，弗雷德·哈钦森癌症中心

Session Name: 653. Multiple Myeloma: Clinical and Epidemiological: Poster III

会话名称：653。多发性骨髓瘤：临床和流行病学：海报III

Session Date: Monday, December 9, 2024

会议日期：2024年12月9日，星期一

Presentation Time: 6:00 p.m. - 8:00 p.m.

演示时间：下午6:00至8:00。

Location: San Diego Convention Center, Halls G-H

地点：圣地亚哥会议中心G-H厅

Treatment Patterns and Outcomes in Triple-Class Exposed Patients with Relapsed and Refractory Multiple Myeloma: Findings from the Flatiron Database (abstract #6962)

复发性和难治性多发性骨髓瘤三级暴露患者的治疗模式和结果：来自Flatiron数据库的发现（摘要#6962）

In order to understand the contemporary unmet need in the rapidly evolving treatment landscape for patients with triple-class exposed RRMM - those exposed to immunomodulatory drugs, proteasome inhibitors, and anti-CD38 monoclonal antibodies - in the 4L+ setting, a retrospective cohort study using the Flatiron Health electronic health record (HER) was conducted (sample size=594).

为了了解在4L+环境中，三类暴露RRMM患者（暴露于免疫调节药物，蛋白酶体抑制剂和抗CD38单克隆抗体的患者）在快速发展的治疗领域中的当代未满足需求，进行了一项回顾性队列研究使用Flatiron Health电子健康记录（HER）（样本量=594）。

This study found no clear standard of care in the 4L+ setting, and suboptimal health outcomes under the current treatment landscape (ORR=34%, PFS=4.1 months, and OS=15.4 months), emphasizing an urgent need for more effective and durable therapies for patients in this setting..

。。

This abstract will be published in a supplemental issue of Blood in November 2024.

该摘要将于2024年11月在《血液》的补充期刊上发表。

Webcast Event:

网络广播活动：

Arcellx will host a live webcast event with an expert panel of clinicians to discuss the clinical results on Monday, December 9, 2024 at 8:30 p.m. PT. The event will be accessible from Arcellx's website at www.arcellx.com in the Investors section. A webcast replay will be archived and available for 30 days following the event..

。网络广播重播将存档，并在活动结束后30天内可用。。

About Multiple Myeloma

关于多发性骨髓瘤

Multiple Myeloma (MM) is a type of hematological cancer in which diseased plasma cells proliferate and accumulate in the bone marrow, crowding out healthy blood cells and causing bone lesions, loss of bone density, and bone fractures. These abnormal plasma cells also produce excessive quantities of an abnormal immunoglobulin fragment, called a myeloma protein (M protein), causing kidney damage and impairing the patient's immune function.

多发性骨髓瘤（MM）是一种血液系统癌症，其中患病的浆细胞在骨髓中增殖并积聚，挤出健康的血细胞并引起骨损伤，骨密度降低和骨折。这些异常浆细胞还产生过量的异常免疫球蛋白片段，称为骨髓瘤蛋白（M蛋白），导致肾脏损伤并损害患者的免疫功能。

Multiple myeloma is the third most common hematological malignancy in the United States and Europe, representing approximately 10% of all hematological cancer cases and 20% of deaths due to hematological malignancies. The median age of patients at diagnosis is 69 years with one-third of patients diagnosed at an age of at least 75 years.

多发性骨髓瘤是美国和欧洲第三大最常见的血液系统恶性肿瘤，约占所有血液系统癌症病例的10%，占血液系统恶性肿瘤死亡的20%。诊断时患者的中位年龄为69岁，三分之一的患者被诊断为至少75岁。

Because MM tends to afflict patients at an advanced stage of life, patients often have multiple co-morbidities and toxicities that can quickly escalate and become life-endangering..

由于MM倾向于在生命的晚期折磨患者，因此患者通常会出现多种合并症和毒性，这些疾病和毒性会迅速升级并危及生命。。

About Anitocabtagene Autoleucel (anito-cel)

关于Anitocabtagene Autoleucel（anito cel）

Anitocabtagene autoleucel (anito-cel, previously ddBCMA) is the first BCMA-directed CAR T-cell therapy to be investigated in multiple myeloma that utilizes Arcellx’s novel and compact binder known as the D-Domain. Anito-cel has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the U.S.

。Anito cel已被美国授予快速通道、孤儿药和再生医学高级治疗称号。

Food and Drug Administration..

美国食品药品监督管理局。。

About iMMagine-3, A Global Phase 3 Randomized Controlled Clinical Study

关于iMMagine-3，一项全球3期随机对照临床研究

iMMagine-3 is a global Phase 3, randomized controlled study designed to compare the efficacy and safety of anitocabtagene autoleucel (anito-cel) with standard of care in patients with relapsed and/or refractory multiple myeloma (RRMM) who have received one to three prior lines of therapy, including an immunomodulatory drug (lMiD) and an anti-CD38 monoclonal antibody..

iMMagine-3是一项全球3期随机对照研究，旨在比较anitocabtagene autoleucel（anito-cel）与标准治疗对复发和/或难治性多发性骨髓瘤（RRMM）患者的疗效和安全性，这些患者接受了一到三种治疗方案，包括免疫调节药物（lMiD）和抗CD38单克隆抗体。。

iMMagine-3 will enroll approximately 450 adult patients. Prior to randomization, investigator’s choice of SOC regimens include: pomalidomide, bortezomib, and dexamethasone (PVd); daratumumab, pomalidomide, and dexamethasone (DPd); carfilzomib, daratumumab, and dexamethasone (KDd); or carfilzomib and dexamethasone (Kd).

iMMagine-3将招募大约450名成年患者。在随机化之前，研究者选择的SOC方案包括：pomalidomide，硼替佐米和地塞米松（PVd）；达拉木单抗，pomalidomide和地塞米松（DPd）；卡非佐米，达拉木单抗和地塞米松（KDd）；或卡非佐米和地塞米松（Kd）。

Patients in the anito-cel arm will undergo leukapheresis and optional bridging therapy (with the SOC regimen selected by the investigator prior to randomization) followed by lymphodepleting chemotherapy (fludarabine 30 mg/m2/d and cyclophosphamide 300 mg/m2/d for 3 days) and one infusion of anito-cel (115×106 CAR+ T cells) on Day 1..

anito-cel组的患者将接受白细胞分离术和可选的桥接治疗（在随机化之前由研究者选择SOC方案），然后进行淋巴清除化疗（氟达拉滨30 mg/m2/d和环磷酰胺300 mg/m2/d，持续3天），并在第1天输注anito-cel（115×106 CAR+T细胞）。。

The primary endpoint is progression-free survival (PFS) per blinded independent review according to the 2016 IMWG uniform response criteria for MM with the hypothesis that anito-cel will prolong PFS compared to SOC. Key secondary endpoints include complete response rate (CR/sCR), minimal residual disease negativity, overall survival, and safety..

根据2016年IMWG MM统一反应标准，主要终点是每个盲法独立评估的无进展生存期（PFS），假设anito-cel与SOC相比会延长PFS。关键的次要终点包括完全缓解率（CR/sCR），最小残留疾病阴性，总生存期和安全性。。

The iMMagine-3 study initiated in the second half of 2024 at approximately 130 study sites across North America, Europe, and the rest of the world.

iMMagine-3研究于2024年下半年在北美、欧洲和世界其他地区的大约130个研究地点启动。

About Arcellx and Kite Collaboration

关于Arcellx和Kite的合作

Arcellx and Kite, a Gilead Company, formed a global strategic collaboration and license agreement to co-develop and co-commercialize anito-cel for patients with relapsed or refractory multiple myeloma, RRMM. Anito-cel is currently being developed in a Phase 2 registrational pivotal study and a global Phase 3 randomized controlled study for RRMM.

Arcellx和Gilead公司Kite达成了全球战略合作和许可协议，共同开发和共同商业化anito cel，用于复发或难治性多发性骨髓瘤RRMM患者。anito cel目前正在进行RRMM的2期注册关键研究和全球3期随机对照研究。

Kite and Arcellx will jointly commercialize the anito-cel asset in the United States, and Kite will commercialize the product outside the United States..

Kite和Arcellx将在美国共同将anito cel资产商业化，Kite将在美国境外将产品商业化。。

About Arcellx, Inc.

关于Arcellx，Inc。

Arcellx, Inc. is a clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. Arcellx believes that cell therapies are one of the forward pillars of medicine and Arcellx's mission is to advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible.

Arcellx，Inc.是一家临床阶段生物技术公司，通过为癌症和其他无法治愈的疾病患者设计创新的免疫疗法，重新想象细胞疗法。Arcellx认为细胞疗法是医学的前沿支柱之一，Arcellx的使命是通过开发更安全，更有效和更广泛的细胞疗法来促进人类。

For more information on Arcellx, please visit www.arcellx.com. Follow Arcellx on X @arcellx and LinkedIn..

有关Arcellx的更多信息，请访问www.Arcellx.com。在X@Arcellx和LinkedIn上关注Arcellx。。

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements in this press release that are not purely historical are forward-looking statements, including Arcellx’s plans for the clinical development of its product candidates; anticipated announcements of additional data; anito-cel tolerability and toxicity trends; Arcellx’s competitive positioning; expectations regarding manufacturing time; the potential commrical launch of anito-cel, subject to FDA approval; and the potential impact of Arcellx’s product candidates and platforms on patients and cell therapy.

本新闻稿包含经修订的《1933年证券法》第27A节和经修订的《1934年证券交易法》第21E节所指的前瞻性声明。本新闻稿中所有不纯粹是历史性的声明都是前瞻性的声明，包括Arcellx的候选产品临床开发计划；其他数据的预期公告；anito细胞耐受性和毒性趋势；Arcellx的竞争定位；对制造时间的期望；anito cel的潜在商业推出，需经FDA批准；以及Arcellx的候选产品和平台对患者和细胞治疗的潜在影响。

The forward-looking statements contained herein are based upon Arcellx’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including those set forth in Part II, Item 1A (Risk Factors) in the Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, filed with the Securities and Exchange Commission (SEC) on August 8, 2024, and the other documents that Arcellx may file from time to time with the Securities and Exchange Commission.

。这些前瞻性声明既不是承诺，也不是保证，具有多种风险和不确定性，包括2024年8月8日提交给证券交易委员会（SEC）的截至2024年6月30日的季度报表10-Q中第二部分第1A项（风险因素）中规定的风险和不确定性，以及Arcellx可能不时向证券交易委员会提交的其他文件。

These forward-looking statements are made as of the date of this press release, and Arcellx assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law..

这些前瞻性声明是在本新闻稿发布之日做出的，Arcellx没有义务更新或修改任何前瞻性声明，无论是由于新信息、未来事件还是其他原因，除非法律要求。。