REDWOOD CITY, Calif. & SANTA MONICA, Calif.--(BUSINESS WIRE)--Arcellx, Inc. (NASDAQ: ACLX) and Kite, a Gilead Company (NASDAQ: GILD), today announced several key operational updates on their partnered anitocabtagene autoleucel (anito-cel) multiple myeloma program. Anito-cel is the first BCMA CAR T to be investigated in multiple myeloma that utilizes Arcellx’s novel and compact D-Domain binder..

加利福尼亚州红木城和加利福尼亚州圣莫尼卡——（商业新闻短讯）——Arcellx公司（纳斯达克股票代码：ACLX）和吉列德公司Kite（纳斯达克股票代码：GILD）今天宣布了他们合作的anitocabtagene autoleucel（anito cel）多发性骨髓瘤项目的几项关键运营更新。Anito cel是第一个在多发性骨髓瘤中进行研究的BCMA CAR T，它利用了Arcellx新颖而紧凑的D结构域粘合剂。。

The companies shared the design of a global, Phase 3 randomized controlled clinical trial, iMMagine-3, which Kite expects to start in the second half of this year. The trial will compare the efficacy and safety of anito-cel randomized against the standard of care (SOC) 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..

这两家公司分享了一项全球性的3期随机对照临床试验iMMagine-3的设计，Kite预计该试验将于今年下半年开始。该试验将比较anito-cel随机对照标准治疗（SOC）对复发和/或难治性多发性骨髓瘤（rrMM）患者的疗效和安全性，这些患者曾接受过一至三种治疗方案，包括免疫调节药物（lMiD）和抗CD38单克隆抗体。。

Kite’s facility in Frederick, Maryland will manufacture anito-cel for this trial. This follows the completion of the technical transfer from a third-party contract manufacturing organization to Kite, as well as the transfer of the Investigational New Drug (IND) application for anito-cel, which has been cleared by the U.S.

Kite在马里兰州弗雷德里克的工厂将为这次试验生产anito cel。在此之前，第三方合同制造组织完成了向Kite的技术转让，以及anito cel的研究性新药（IND）申请的转让，该申请已获得美国的批准。

Food and Drug Administration..

美国食品药品监督管理局。。

“Our global iMMagine-3 trial will evaluate anito-cel as a second through fourth line treatment in patients with multiple myeloma who were previously exposed to both an immunomodulatory drug and an anti-CD38 monoclonal antibody,” said Rami Elghandour, Arcellx’s Chairman and Chief Executive Officer. “The iMMagine-3 study allows us to maximize the impact of anito-cel as it captures what will become the largest second line patient population based on the current treatment paradigm, as anti-CD38 therapies move to front line treatment.

Arcellx董事长兼首席执行官拉米·埃尔甘杜尔（Rami Elghandour）表示：“我们的全球iMMagine-3试验将评估anito cel作为多发性骨髓瘤患者的二线至四线治疗方法，这些患者之前曾接触过免疫调节药物和抗CD38单克隆抗体。”。“iMMagine-3研究使我们能够最大限度地发挥anito cel的影响，因为它捕获了基于当前治疗范式的最大二线患者群体，因为抗CD38治疗将转向一线治疗。

This population represents an emerging significant unmet clinical need allowing us to provide access to a unique patient population. In addition, the completion of the technical transfer to Kite allowed us to accelerate our development program and launch iMMagine-3 globally, which will enable broader and earlier patient access to anito-cel.”.

这一人群代表了一个新出现的重大未满足的临床需求，使我们能够提供对独特患者人群的访问。此外，完成对Kite的技术转让，使我们能够加速开发计划，并在全球推出iMMagine-3，这将使患者能够更广泛和更早地访问anito cel。”。

“We are pleased to start the Phase 3 pivotal trial, iMMagine-3, in the second half of this year given the tremendous unmet need that remains in patients with relapsed and/or refractory multiple myeloma,” said Cindy Perettie, Executive Vice President, Kite. “As we prepare for this pivotal program, we look forward to leveraging our manufacturing expertise to further position anito-cel as a potential best-in-class cell therapy.

Kite执行副总裁辛迪·佩雷蒂（CindyPerettie）表示：“鉴于复发和/或难治性多发性骨髓瘤患者的巨大需求尚未得到满足，我们很高兴在今年下半年开始进行第三阶段关键试验iMMagine-3。”。“在我们准备这一关键项目时，我们期待着利用我们的制造专业知识，进一步将anito cel定位为潜在的同类最佳细胞疗法。

We know manufacturing quality, reliability, and speed are critically important as every day matters for these patients.”.

我们知道制造质量、可靠性和速度对于这些患者来说至关重要。”。

About iMMagine-3 Global Phase 3 Randomized Controlled Clinical Trial

关于iMMagine-3全球3期随机对照临床试验

iMMagine-3 is a phase 3, randomized controlled trial designed to compare the efficacy and safety of anitocabtagene autoleucel (anito-cel) with SOC 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3期随机对照试验，旨在比较anitocabtagene autoleucel（anito-cel）与SOC在复发和/或难治性多发性骨髓瘤（rrMM）患者中的疗效和安全性，这些患者接受了一至三种治疗方案，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 trial is expected to initiate in the second half of 2024 at ~130 study sites across North America, Europe, and rest of world.

iMMagine-3试验预计将于2024年下半年在北美，欧洲和世界其他地区的约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 to co-develop and co-commercialize Arcellx's anito-cel candidate for the treatment of patients with relapsed or refractory multiple myeloma currently in a pivotal Phase 2 trial. Kite and Arcellx will jointly develop and commercialize the anito-cel asset in the United States, and Kite will commercialize the product outside the United States..

Arcellx和Gilead公司Kite建立了全球战略合作关系，共同开发和共同商业化Arcellx的anito cel候选药物，用于治疗目前处于关键的2期试验中的复发或难治性多发性骨髓瘤患者。Kite和Arcellx将在美国共同开发anito cel资产并将其商业化，Kite将在美国境外将该产品商业化。。

About anitocabtagene autoleucel (anito-cel)

关于anitocabtagene autoleucel（anito cel）

Anito-cel is a BCMA CAR T that utilizes a novel binder (or CAR) known as the D-Domain. Its small size (8kDa) facilitates high T-cell transduction and expression, resulting in more CAR positive cells and more CARs expressed per T-cell.

Anito cel是一种BCMA CAR T，它利用了一种称为D域的新型粘合剂（或CAR）。其小尺寸（8kDa）促进高T细胞转导和表达，导致更多的CAR阳性细胞和每个T细胞表达更多的CAR。

Anito-cel has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy designations by the U.S. Food and Drug Administration.

Anito cel已被美国食品和药物管理局授予快速通道、孤儿药和再生医学高级治疗称号。

About Kite

关于Kite

Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, focused on cell therapy to treat and potentially cure cancer. As the global cell therapy leader, Kite has treated more patients with CAR T-cell therapy than any other company. Kite has the largest in-house cell therapy manufacturing network in the world, spanning process development, vector manufacturing, clinical trial production, and commercial product manufacturing..

基列德公司Kite是一家总部位于加利福尼亚州圣莫尼卡的全球生物制药公司，专注于治疗和潜在治愈癌症的细胞疗法。作为全球细胞疗法的领导者，Kite治疗的CAR T细胞疗法患者比其他任何公司都多。Kite拥有世界上最大的内部细胞治疗制造网络，涵盖过程开发，载体制造，临床试验生产和商业产品制造。。

About Gilead Sciences

关于吉利德科学

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer.

吉利德科学公司（Gilead Sciences，Inc.）是一家生物制药公司，三十多年来一直致力于医学领域的突破，目标是为所有人创造一个更健康的世界。该公司致力于推进创新药物，以预防和治疗威胁生命的疾病，包括艾滋病毒、病毒性肝炎和癌症。

Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Gilead acquired Kite in 2017..

吉利德在全球35多个国家开展业务，总部位于加利福尼亚州福斯特城。吉利德于2017年收购了风筝公司。。

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。

Arcellx's lead product candidate, anito-cel (formerly CART-ddBCMA), is being developed for the treatment of relapsed or refractory multiple myeloma (rrMM) in a Phase 2 pivotal trial..

Arcellx的主要候选产品anito cel（以前称为CART-ddBCMA）正在进行2期关键试验，用于治疗复发或难治性多发性骨髓瘤（rrMM）。。

Arcellx is also developing its dosable and controllable CAR T therapy, ARC-SparX, through two Phase 1 programs, ACLX-001 for rrMM and ACLX-002 in relapsed or refractory acute myeloid leukemia and high-risk myelodysplastic syndrome. For more information on Arcellx, please visit www.arcellx.com. Follow Arcellx on X (Twitter) at @arcellx and LinkedIn..

Arcellx还通过两个第一阶段计划开发了其可剂量和可控的CAR T疗法ARC-SparX，用于rrMM的ACLX-001和用于复发或难治性急性髓细胞白血病和高危骨髓增生异常综合征的ACLX-002。有关Arcellx的更多信息，请访问www.Arcellx.com。关注X上的Arcellx（Twitter），网址为@Arcellx和LinkedIn。。

Arcellx Forward-looking Statements

Arcellx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 expectations regarding the timing, design and outcomes of clinical trials for its product candidates, including expected timing of presentation on clinical data and the breadth and uniqueness of the patient population being addressed; expectations around manufacturing; and the potential impact of its 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陈述都是前瞻性的陈述，包括Arcellx对其候选产品临床试验的时间，设计和结果的期望，包括临床数据的预期呈现时间以及所涉及患者群体的广度和独特性；对制造业的期望；以及其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 risks that may be found in the section entitled “Part II, Item 1A (Risk Factors) in the Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, filed with the Securities and Exchange Commission (SEC) on May 9, 2024, and other documents that Arcellx files from time to time with the SEC.

本文所含的前瞻性陈述基于Arcellx目前的预期，并涉及可能永远不会实现或可能被证明是不正确的假设。这些前瞻性声明既不是承诺，也不是担保，存在各种风险和不确定性，包括2024年5月9日提交给证券交易委员会（SEC）的截至2024年3月31日的季度报表10-Q中题为“第二部分第1A项（风险因素）”的部分中可能发现的风险，以及Arcellx不时向SEC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。。

Gilead Forward-Looking Statements

吉利德前瞻性声明

This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to realize the anticipated benefits from the collaboration with Arcellx; Gilead and Kite’s ability to increase its CAR T-cell therapy manufacturing capacity, timely manufacture and deliver such therapies (or otherwise reduce the time to manufacture such therapies), or produce an amount of supply sufficient to satisfy demand for such therapies, including the production of anito-cel for the iMMagine-3 clinical trial and any future commercial manufacturing; the ability of Gilead and Kite to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical studies, including those involving anito-cel; uncertainties relating to regulatory applications and related filing and approval timelines, including FDA approval of anito-cel for treatment of multiple myeloma; the risk that CAR T-cell therapy will not be broadly accepted by physicians, patients, hospitals, cancer treatment centers, payers and others in the medical community; and any assumptions underlying any of the foregoing.

本新闻稿包括1995年《私人证券诉讼改革法案》所指的前瞻性声明，这些声明受到风险、不确定性和其他因素的影响，包括吉利德实现与Arcellx合作预期收益的能力；Gilead和Kite能够提高其CAR T细胞疗法的制造能力，及时制造和提供此类疗法（或以其他方式减少制造此类疗法的时间），或产生足以满足此类疗法需求的供应量，包括为iMMagine-3临床试验和任何未来的商业制造生产anito cel；Gilead和Kite在目前预期的时间表内启动，进展或完成临床试验的能力，以及正在进行或其他临床研究（包括涉及anito cel的临床研究）产生不利结果的可能性；与监管申请和相关备案和批准时间表有关的不确定性，包括FDA批准anito cel治疗多发性骨髓瘤；CAR T细胞治疗不会被医生，患者，医院，癌症治疗中心，付款人和医学界其他人广泛接受的风险；以及基于上述任何一项的任何假设。

These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements.

这些以及其他风险、不确定性和因素在吉利德提交给美国证券交易委员会的截至2024年3月31日的季度10-Q表季度报告中有详细描述。这些风险、不确定性和其他因素可能导致实际结果与前瞻性声明中提及的结果存在重大差异。

All statements other than statements of historical fact are statements that could be deemed forward-looking statements..

除历史事实陈述外的所有陈述均为可被视为前瞻性陈述的陈述。。