Patient Screening is Underway at Rocky Mountain Cancer Centers, Part of the US Oncology Network and Sarah Cannon Research Institute; Astera Cancer Care, Part of the OneOncology Network; and Norton Cancer Institute

美国肿瘤学网络和莎拉·坎农研究所（SarahCannonResearch Institute）的一部分，落基山癌症中心（Rocky Mountain Cancer Center）正在进行患者筛查；Astera癌症护理，OneOncology网络的一部分；和诺顿癌症研究所

ALPHA3 Will be the First Pivotal Trial to Offer CAR T as Part of First Line (1L) Treatment at Community Cancer Centers, Where 80% of Patients Receive Care

ALPHA3将是第一个在社区癌症中心提供CAR T作为一线（1L）治疗一部分的关键试验，80%的患者在社区癌症中心接受治疗

ALPHA3 Expected to Complete Enrollment in 1H 2026; Potential BLA Submission in 2027

；2027年可能提交的BLA

SOUTH SAN FRANCISCO, Calif., July 01, 2024 (GLOBE NEWSWIRE) -- Allogene Therapeutics Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune disease, today announced that Rocky Mountain Cancer Centers (RMCC), part of the US Oncology Network and Sarah Cannon Research Institute (SCRI); Astera Cancer Care (ACC), a multi-specialty community oncology practice and part of the OneOncology network; and Norton Cancer Institute, are open for enrollment in the pivotal Phase 2 ALPHA3 trial..

；Astera癌症护理（ACC），一个多专业的社区肿瘤学实践和OneOncology网络的一部分；和诺顿癌症研究所（Norton Cancer Institute）开放参加关键的2期ALPHA3试验。。

The ALPHA3 trial is evaluating the use of cemacabtagene ansegedleucel (cema-cel) as part of the first line (1L) consolidation treatment regimen for newly diagnosed and treated large B-cell lymphoma (LBCL) patients who remain positive for minimal residual disease (MRD). Detection of MRD will be done using the Foresight CLARITY™ Investigational Use Only (IUO) MRD test, powered by PhasED-Seq™.

ALPHA3试验正在评估使用cemacabtagene ansegedleucel（cema-cel）作为一线（1L）巩固治疗方案的一部分，用于新诊断和治疗的微小残留病（MRD）阳性的大B细胞淋巴瘤（LBCL）患者。MRD的检测将使用Foresight CLARITY™仅供研究使用（IUO）MRD测试进行，该测试由PhasED Seq™提供支持。

When given as a “7th cycle” of frontline treatment to eligible patients with MRD, consolidation treatment with cema-cel has the potential to meaningfully improve 1L cure rates for patients with LBCL who are likely to relapse..

当作为一线治疗的“第7周期”给予符合条件的MRD患者时，cema-cel巩固治疗有可能显着提高可能复发的LBCL患者的1L治愈率。。

“We believe community physicians have been waiting for a trial like ALPHA3 that offers cutting-edge CAR T without the inherent complexities associated with autologous therapies,” said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. “The differentiated attributes of cema-cel eliminate many of the complex logistics that have hindered CAR T adoption in the community setting.

Allogene总裁、首席执行官兼联合创始人、医学博士David Chang表示：“我们相信社区医生一直在等待类似ALPHA3的试验，该试验可以提供尖端的CAR T，而不需要与自体疗法相关的固有复杂性。”。“cema cel的差异化属性消除了许多阻碍CAR T在社区环境中采用的复杂物流。

The fact that community-based practices are the first sites to open for enrollment in the ALPHA3 trial is a significant symbolic step forward in expanding patient access to this powerful modality and will serve as a catalyst for our cema-cel development program.”.

以社区为基础的实践是第一个开放注册ALPHA3试验的网站，这是扩大患者使用这种强大模式的重要象征性步骤，并将成为我们cema cel开发计划的催化剂。”。

RMCC is the largest multidisciplinary practice in Colorado with 19 locations across the state dedicated solely to providing care for patients with cancer and diseases of the blood. RMCC is a part of SCRI, a combination of two nationally recognized oncology research institutes – US Oncology and SCRI.

RMCC是科罗拉多州最大的多学科实践机构，在全州有19个地点专门为癌症和血液疾病患者提供护理。RMCC是SCRI的一部分，SCRI是美国肿瘤学和SCRI两个国家认可的肿瘤学研究机构的组合。

This combination creates a leading oncology research organization participating in community-based clinical trials. Patients undergoing treatment for newly diagnosed LBCL throughout the RMCC network will be considered for enrollment in ALPHA3..

这种结合创造了一个领先的肿瘤学研究组织，参与基于社区的临床试验。在整个RMCC网络中接受新诊断LBCL治疗的患者将被考虑参加ALPHA3。。

“Current 1L chemoimmunotherapy is effective in most patients, but the reality is that 30% will relapse,” said John M. Burke, M.D., a Blood Cancer Specialist at RMCC. “The ALPHA3 trial will be answering two key questions. First, can measuring circulating tumor DNA in the blood be used to select lymphoma patients destined to relapse for early intervention? And second, does treating these high-risk lymphoma patients with cema-cel increase cure rates compared with conventional surveillance? These are critically important questions that have the potential to change the lymphoma treatment paradigm.”.

“目前的1L化学免疫疗法对大多数患者都是有效的，但事实是30%的患者会复发，”RMCC的血癌专家约翰·M·伯克医学博士说。“ALPHA3试验将回答两个关键问题。首先，能否通过测量血液中的循环肿瘤DNA来选择注定要复发的淋巴瘤患者进行早期干预？其次，与常规监测相比，用cema-cel治疗这些高危淋巴瘤患者是否能提高治愈率？这些都是至关重要的问题，有可能改变淋巴瘤治疗模式。”。

ACC is an independent and physician-owned multi-specialty community oncology practice serving more than 22,000 new patients annually in Central New Jersey. The practice is part of the OneOncology platform which is a partnership of over 20 independent community oncology practices nationally. Astera’s specialists practice at 13 distinct locations in Middlesex, Somerset, Bergen, Hudson, Hunterdon, Mercer and Monmouth counties in New Jersey and Langhorne, Pennsylvania and have a robust clinical trial platform for cancer therapy with one of the only community-based clinical trial programs in CAR T cell therapies in the nation.

ACC是一家独立的医生拥有的多专业社区肿瘤学诊所，每年在新泽西州中部为22000多名新患者提供服务。该实践是OneOncology平台的一部分，该平台是全国20多个独立社区肿瘤学实践的合作伙伴。Astera的专家在新泽西州米德尔塞克斯县、萨默塞特县、卑尔根县、哈德逊县、亨特顿县、默瑟县和蒙茅斯县以及宾夕法尼亚州兰霍恩县的13个不同地点开展业务，拥有强大的癌症治疗临床试验平台，是全国唯一一个基于社区的CAR T细胞治疗临床试验项目。

Patients undergoing treatment for newly diagnosed LBCL throughout the ACC network will be considered for enrollment in ALPHA3..

在整个ACC网络中接受新诊断LBCL治疗的患者将被考虑参加ALPHA3。。

According to Edward J. Licitra, M.D., PhD, oncologist and Chairman and Chief Executive Officer at ACC, relapsed LBCL is much more difficult to treat, and physicians often consider enrollment in clinical trials to allow access to promising therapies. “I have watched with interest the acceleration of CAR T research in LBCL, but because most patients live more than two hours from the nearest treatment center, it’s not feasible for them to participate.

根据肿瘤学家兼ACC主席兼首席执行官Edward J.Licitra医学博士的说法，复发性LBCL更难治疗，医生经常考虑参加临床试验以获得有希望的治疗方法。“我饶有兴趣地观看了LBCL加速进行的CAR T研究，但由于大多数患者距离最近的治疗中心超过两个小时，因此他们不可能参加。

Having access to an “off-the-shelf” CAR T product with a manageable safety profile changes that equation dramatically for me, and my patients. We are excited to help define a new treatment standard in LBCL. An approved “off-the-shelf” CAR T product would allow for greater access to cutting edge technologies for patients in their local communities and this could improve outcomes for many more cancer patients.”.

。我们很高兴能帮助确定LBCL的新治疗标准。批准的“现成”CAR T产品将为当地社区的患者提供更多的尖端技术，这可以改善更多癌症患者的预后。”。

With more than 21 locations serving Louisville, Kentucky and Southern Indiana, Norton Cancer Institute (NCI) treats more than 4,000 newly diagnosed cancer patients each year. NCI’s network of multidisciplinary clinics offers patients the latest treatments and access to more than 100 clinical trials..

诺顿癌症研究所（NCI）每年治疗4000多名新诊断的癌症患者，为路易斯维尔、肯塔基州和印第安纳州南部服务的地点超过21个。NCI的多学科诊所网络为患者提供最新的治疗方法，并提供100多项临床试验。。

“Kentucky has one of the highest cancer death rates in the United States1 and a big contributor to this is lack of patient access to cutting-edge treatments,” said Don A. Stevens, M.D., a hematologist-oncologist at Norton Cancer Institute. “Offering investigational cema-cel to our first line patients has the potential to improve cure rates for the 30% we know will relapse after chemoimmunotherapy.

诺顿癌症研究所（Norton cancer Institute）的血液肿瘤学家唐·史蒂文斯（Don a.Stevens）医学博士说：“肯塔基州是美国癌症死亡率最高的州之一，造成这种情况的一个重要原因是患者无法获得尖端治疗。”。“为我们的一线患者提供研究性cema-cel有可能提高30%的治愈率，我们知道化学免疫治疗后会复发。

This could change how we treat these patients in the future.”.

这可能会改变我们未来治疗这些患者的方式。”。

About Cemacabtagene Ansegedleucel (cema-cel)

关于Cemacabtagene Ansegedleucel（cema cel）

Cemacabtagene ansegedleucel, or cema-cel, is a next generation anti-CD19 AlloCAR T™ investigational product for the treatment of large B cell lymphoma (LBCL). In June 2022, the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) designation to cema-cel in third line (3L) r/r LBCL.

Cemacabtagene ansegedleucel或cema-cel是用于治疗大B细胞淋巴瘤（LBCL）的下一代抗CD19 AlloCAR T™研究产品。2022年6月，美国食品和药物管理局授予cema cel第三线（3L）r/r LBCL再生医学高级治疗（RMAT）称号。

The ALPHA3 pivotal Phase 2 trial in first line (1L) consolidation for the treatment of LBCL launched in June 2024. Allogene has oncology rights to cema-cel in the US, EU and UK with options for rights in China and Japan..

用于治疗LBCL的一线（1L）巩固治疗的ALPHA3关键性2期试验于2024年6月启动。Allogene在美国、欧盟和英国拥有cema cel的肿瘤学权利，在中国和日本拥有权利选择权。。

About the ALPHA3 Trial

关于ALPHA3试验

Over 60,000 patients are expected to be treated for LBCL annually in the US, the EU and the UK. While first line (1L) R-CHOP or other chemoimmunotherapy is effective for most patients, approximately 30% will relapse and require subsequent treatment. The current standard of care (SOC) after 1L treatment has been simply to “watch and wait” to see if the disease relapses.

在美国、欧盟和英国，预计每年有超过60000名患者接受LBCL治疗。虽然一线（1L）R-CHOP或其他化学免疫疗法对大多数患者有效，但大约30%的患者会复发并需要随后的治疗。目前1L治疗后的护理标准（SOC）只是“观察和等待”，看看疾病是否复发。

The pivotal Phase 2 ALPHA3 study takes advantage of cema-cel as a one-time, off-the-shelf treatment that can be administered immediately upon discovery of MRD following six cycles of R-CHOP or other chemoimmunotherapy, positioning it to become the standard “7th cycle” of frontline treatment available to all eligible patients with MRD..

关键的2期ALPHA3研究利用cema-cel作为一次性现成的治疗方法，可以在六个周期的R-CHOP或其他化学免疫治疗后发现MRD后立即进行治疗，使其成为所有符合条件的MRD患者可用的一线治疗的标准“第七周期”。。

About Allogene Therapeutics

Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients.

总部位于南旧金山的Allogene Therapeutics是一家临床阶段生物技术公司，率先开发用于癌症和自身免疫性疾病的同种异体嵌合抗原受体T细胞（AlloCAR T™）产品。在具有丰富细胞治疗经验的管理团队的带领下，Allogene正在开发一系列“现成”CAR T细胞候选产品，目标是按需、更可靠、更大规模地向更多患者提供现成的细胞治疗。

For more information, please visit www.allogene.com, and follow Allogene Therapeutics on X (formerly Twitter) and LinkedIn..

有关更多信息，请访问www.allogene.com，并在X（以前的Twitter）和LinkedIn上关注allogene Therapeutics。。

Cautionary Note on Forward-Looking Statements for Allogene

关于Allogene前瞻性声明的警示说明

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. This press release may, in some cases, use terms such as “believes,” “potential,” “likely to,” “expect,” “can,” “become,” “may,” “could,” or “will,” including alternative forms thereof, or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements.

本新闻稿包含1995年《私人证券诉讼改革法案》安全港条款的前瞻性声明。在某些情况下，本新闻稿可能会使用“相信”、“潜在”、“可能”、“期望”、“可以”、“成为”、“可能”、“可以”或“将”等术语，包括其替代形式，或其他表达未来事件或结果不确定性的词语来识别这些前瞻性陈述。

Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: ALPHA3 being a pivotal trial and the extent to which it will support regulatory approval of cema-cel; the potential for the ALPHA3 trial or the ability for Foresight’s minimal residual disease test to identify patients with LBCL who are likely to relapse following standard 1L treatment; the potential for cema-cel to become the standard “7th cycle” of frontline treatment; the timing for completion of ALPHA3 enrollment or cema-cel BLA submission; delivery of cema-cel with fewer complexities associated with autologous therapies; expanding patient access to cutting edge technologies such as CAR T; the extent to which patients throughout various networks will be considered for enrollment in ALPHA3; the incidence of LBCL including the extent to which patients will relapse and require subsequent treatment; the potential for our product candidates to be approved; the potential benefits of the ALPHA3 trial and of AlloCAR T™ products, including the potential for ALPHA3 to change the lymphoma treatment paradigm, define a new LBCL treatment standard, or improve cure rates or patient outcomes; cema-cel’s safety profile; the ability of ALPHA3 to answer various questions; our a.

前瞻性声明包括关于意图、信念、预测、前景、分析或当前期望的声明，其中包括：ALPHA3是一项关键试验，它将在多大程度上支持cema cel的监管批准；ALPHA3试验的潜力或Foresight最小残留病测试的能力，以确定标准1L治疗后可能复发的LBCL患者；cema-cel成为一线治疗标准“第7周期”的潜力；完成ALPHA3注册或cema cel BLA提交的时间；cema细胞的递送与自体治疗相关的复杂性较低；扩大患者对尖端技术（如CAR T）的访问；各种网络中的患者将被考虑参加ALPHA3的程度；LBCL的发生率，包括患者复发和需要后续治疗的程度；我们的候选产品获得批准的可能性；；cema cel的安全简介；ALPHA3回答各种问题的能力；我们的a。

The Foresight CLARITY™ MRD test, powered by PhasED-Seq™ is for investigational use only.

Foresight CLARITY™MRD测试由PhasED Seq™提供支持，仅供研究使用。

AlloCAR T™ is a trademark of Allogene Therapeutics, Inc.

AlloCAR T™是Allogene Therapeutics，Inc.的商标。

CLARITY™ and PhasED-Seq™ are trademarks of Foresight Diagnostics.

CLARITY™和PhasED Seq™是Foresight Diagnostics的商标。

Allogene’s investigational AlloCAR T™ oncology products utilize Cellectis technologies. These products are developed based on an exclusive license granted by Cellectis to Servier. Servier, which has an exclusive license to the anti-CD19 AlloCAR T™ investigational products from Cellectis, has granted Allogene exclusive rights to these products in the U.S., all EU Member States and the United Kingdom..

Allogene的研究性AlloCAR T™肿瘤学产品利用Cellectis技术。这些产品是根据Cellectis授予Servier的独家许可证开发的。施维雅拥有Cellectis抗CD19 AlloCAR T™研究产品的独家许可证，并已在美国、所有欧盟成员国和英国授予这些产品的异基因独家权利。。

Media/Investor Contacts:

媒体/投资者联系人：

Christine Cassiano

克里斯汀·卡西亚诺

EVP, Chief Corporate Affairs & Brand Strategy Officer

执行副总裁、首席企业事务与品牌战略官

Christine.Cassiano@allogene.com

Christine.Cassiano@allogene.com

Leslie Bryant

莱斯利·布莱恩特

Senior Communications Consultant

高级沟通顾问

Leslie.Bryant@Allogene.com

Leslie.Bryant@Allogene.com

1 US News & World Report. You’re More Likely to Die of Cancer if You Live in This State (usnews.com). Accessed 25June2024.

1《美国新闻与世界报道》。如果你生活在这种状态，你更有可能死于癌症（usnews.com）。2024年6月25日访问。