ROCKVILLE, Md. and SHANGHAI, Dec. 7, 2023 /PRNewswire/ -- AbelZeta Pharma Inc. (the Company, or AbelZeta), a global clinical-stage biopharmaceutical company focused on the discovery and development of innovative cell therapies for cancer, inflammatory and immunological diseases, today announced an agreement with AstraZeneca to co-develop C-CAR031, an autologous, armored GPC3-targeting chimeric antigen receptor T Cells (CAR-T) therapy, in hepatocellular carcinoma (HCC).

罗克维尔，马里兰州和上海，2023年12月7日/PRNewswire/--AbelZeta Pharma Inc.（该公司或AbelZeta），一家全球临床阶段的生物制药公司，专注于发现和开发针对癌症，炎症和免疫疾病的创新细胞疗法，今天宣布与阿斯利康（AstraZeneca）达成协议，共同开发C-CAR031，一种自体，在肝细胞癌（HCC）中靶向嵌合抗原受体T细胞（CAR-T）的装甲GPC3治疗。

C-CAR031 is based on a novel GPC3-targeting CAR-T (AZD5851) designed by AstraZeneca using their transforming growth factor-beta receptor II (TGFβRII) dominant negative armoring discovery platform, and is manufactured by AbelZeta in China..

C-CAR031基于阿斯利康使用其转化生长因子β受体II（TGFβRII）显性负铠装发现平台设计的新型GPC3靶向CAR-T（AZD5851），由AbelZeta在中国制造。。

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HCC is one of the most common cancers and major causes of cancer deaths in China1, with 466 thousand new cases each year, accounting for about 50% of the total global new cases. Approximately 45% of deaths worldwide from HCC occur in greater China.2

HCC是中国最常见的癌症之一，也是癌症死亡的主要原因1，每年新增46.6万例，约占全球新增病例总数的50%。全世界大约45%的HCC死亡发生在大中华地区

'We are pleased to collaborate with AstraZeneca in pursuing this novel CAR-T treatment for solid tumors.'

“我们很高兴与阿斯利康合作，寻求这种新型的实体瘤CAR-T治疗方法。”

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Under the terms of the agreement, AbelZeta will receive an upfront payment from AstraZeneca for the co-development and commercialization of C-CAR031 in China. AbelZeta is also eligible to receive milestone payments and royalties for the global development of AZD5851, which is being solely developed, manufactured and commercialized by AstraZeneca outside of China..

根据协议条款，阿贝尔泽塔将从阿斯利康获得预付款，用于C-CAR031在中国的共同开发和商业化。AbelZeta也有资格获得AZD5851全球开发的里程碑付款和版税，AZD5851由阿斯利康在中国境外独家开发、制造和商业化。。

At AACR 2023, the Company presented preliminary safety, efficacy, pharmacokinetics (PK) and pharmacodynamic (PD) data from an investigator-initiated trial (IIT) in China showing promising anti-tumor activity and robust PK/PD profiles for C-CAR031 in patients with advanced HCC.'We are pleased to collaborate with AstraZeneca in pursuing this novel CAR-T treatment for solid tumors,' said Tony (Bizuo) Liu, Chairman and CEO of AbelZeta.

在AACR 2023上，该公司提交了来自中国研究者发起的试验（IIT）的初步安全性，有效性，药代动力学（PK）和药效学（PD）数据，显示C-CAR031在晚期HCC患者中具有良好的抗肿瘤活性和强大的PK/PD谱AbelZeta董事长兼首席执行官Tony（Bizuo）Liu说，我们很高兴与阿斯利康合作，寻求这种新型的实体瘤CAR-T治疗方法。

'The treatment of advanced HCC has always been a great challenge, and I believe this CAR-T therapy has the potential to redefine therapeutic paradigms in HCC and other GPC3-expressing solid tumors.'Mark Cobbold, Vice President, Head Cell Therapy, Oncology R&D, AstraZeneca said: 'This agreement with AbelZeta accelerates the investigation of our innovative armoring CAR-T platform in solid tumors and advances our ambition to bring novel cell therapies to more people living with hard-to-treat cancers.'About HCCLiver cancer is the third-leading cause of cancer death and the sixth most commonly diagnosed cancer worldwide.3,4 Several types of primary liver cancer occur in adults, HCC being the most common form.

“晚期HCC的治疗一直是一个巨大的挑战，我相信这种CAR-T疗法有可能重新定义HCC和其他表达GPC3的实体瘤的治疗模式。”阿斯利康（AstraZeneca）肿瘤研发部头细胞治疗副总裁马克·科博德（Mark Cobbold）表示：“与阿贝尔·泽塔（AbelZeta）达成的这项协议加速了我们在实体瘤中创新铠装CAR-T平台的研究，并推进了我们为更多难以治疗的癌症患者带来新型细胞疗法的雄心。”关于HCCLiver癌症是导致癌症死亡的第三大原因，也是全球第六大最常诊断的癌症[3,4]。成人中发生几种类型的原发性肝癌，HCC是最常见的形式。

About 75% of all primary liver cancers in adults are HCC.3 Liver cancers are categorized based on the originating cell type. Hepatocellular carcinoma begins in the liver as either a single tumor or several small nodules and at this local stage can be treated by locally targeted or surgical methods. However, most patients are diagnosed at advanced-stage, or their disease progresses to advanced-stage HCC when the prognosis is poor, with a 5-year survival rate of only 7% and a median survival of ~20 months.5.

成人中约75%的原发性肝癌是HCC[3]。肝癌根据起源细胞类型进行分类。肝细胞癌在肝脏中以单个肿瘤或几个小结节开始，在这个局部阶段可以通过局部靶向或手术方法治疗。然而，大多数患者被诊断为晚期，或预后不良时疾病进展为晚期HCC，5年生存率仅为7%，中位生存期约为20个月。

Chinese Clinical Oncology Vol 2, No 4 (December 16, 2013)

《中国临床肿瘤学》第2卷第4期（2013年12月16日）

Frontiers in Public Health doi: 10.3389/fpubh.2022.801981

公共卫生前沿doi:10.3389/fpubh.2022.801981

ASCO. Liver Cancer: View All Pages. Available at: https://www.cancer.net/cancer-types/liver-cancer/view-all. Accessed November 2023.

ASCO公司。肝癌：查看所有页面。网址：https://www.cancer.net/cancer-types/liver-cancer/view-all.2023年11月访问。

WHO. Liver Cancer Fact Sheet. Available at: https://gco.iarc.fr/today/data/factsheets/cancers/11-Liver-fact-sheet.pdf. Accessed November 2023.

谁。肝癌概况。网址：https://gco.iarc.fr/today/data/factsheets/cancers/11-liver-fact-sheet.pdf.2023年11月访问。

NEJM Evid 2022;1(8) DOI: 10.1056/EVIDoa2100070 and N Engl J Med 2020; 382:1894-1905 DOI: 10.1056/NEJMoa1915745

NEJM Evid 2022；1（8）DOI:10.1056/EVIDoa2100070和N Engl J Med 2020；382:1894-1905 DOI:10.1056/NEJMoa1915745

About AbelZeta Pharma, Inc.AbelZeta Pharma is a global clinical-stage biopharmaceutical company with centers of excellence in Rockville, Maryland and Shanghai, China. The Company is focusing on developing innovative and proprietary cell-based therapeutic products, and is committed to ushering in bespoke treatments that harness the body's own immune system to fight against hematological malignancies and solid tumors, as well as inflammatory and immunological diseases.

关于AbelZeta Pharma，Inc.AbelZeta Pharma是一家全球临床阶段生物制药公司，在马里兰州罗克维尔和中国上海设有卓越中心。该公司专注于开发创新和专有的基于细胞的治疗产品，并致力于推出定制的治疗方法，利用人体自身的免疫系统来对抗血液系统恶性肿瘤和实体瘤，以及炎症和免疫疾病。

The Company advances research and development in its own research and GMP facilities at its centers of excellence for early-stage clinical studies, with a pipeline comprised of CAR-T and TIL therapies.Forward-Looking StatementsStatements in this communication relating to plans, strategies, specific activities, and other statements that are not descriptions of historical facts are forward-looking statements.

该公司在其早期临床研究卓越中心推进其自身研究和GMP设施的研发，其管道由CAR-T和TIL疗法组成。前瞻性陈述本通讯中与计划、战略、具体活动和其他非历史事实描述的陈述有关的陈述是前瞻性陈述。

Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors, which include any risks detailed from time to time in the Company's reports. Such statements are based on the management's current beliefs and expectations and are subject to significant risks and uncertainties outside of management and the Company's control.

前瞻性信息固有地受到风险和不确定性的影响，由于多种因素，实际结果可能与目前预期的结果存在重大差异，其中包括公司报告中不时详述的任何风险。此类声明基于管理层当前的信念和期望，并受到管理层和公司控制之外的重大风险和不确定性的影响。

Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as otherwise required by law, the Company does not undertake any obligation, and expressly disclaims any obligation, to update, alter or otherwise revise any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise.Company Contac.

鉴于这些不确定性，您不应过度依赖这些前瞻性声明，这些声明仅在本协议签署之日起生效。除法律另有规定外，本公司不承担任何义务，也明确否认任何义务，更新、更改或以其他方式修改可能不时做出的任何前瞻性声明，无论是书面还是口头，无论是由于新信息、未来事件还是其他原因。公司联系人。