德琪医药在中国和澳大利亚启动Claudin 18.2抗体偶联药物的II期剂量扩展...

中国上海和香港，2024年3月20日–致力于研发，生产和销售同类首款及/或同类最优血液及实体肿瘤疗法的商业化阶段领先创新生物制药公司–德琪医药有限公司（简称“德琪医药”，香港交易所股票代码：6996.HK）今日宣布，公司正式在中国和澳大利亚启动旨在评估ATG-022（Claudin 18.2抗体偶联药物）单药治疗晚期或转移性实体瘤患者的II期CLINCH研究的剂量扩展阶段。此前，正在进行中的CLINCH研究已经取得了优异的初步临床数据，患者达到部分缓解（PR）和完全缓解（CR）。

CLINCH研究是一项在晚期或转移性实体瘤患者中开展的多中心、开放性I/II期试验，分为剂量递增和剂量扩展两个阶段。该试验的主要目的为评估ATG-022单药的安全性和耐受性，以确认ATG-022的最大耐受剂量（MTD）和II期试验的使用剂量（RP2D）。次要目的为评估ATG-022的药理特性和初步疗效。

该研究的剂量扩展阶段计划入组胃癌和其他实体瘤患者。2023年5月，美国食品药品监督管理局（FDA）接连授予ATG-022两项孤儿药资格认定（ODD），分别用于治疗胰腺癌和胃癌。

张晓静

德琪医药首席医学官

“非常高兴在中国和澳大利亚成功启动ATG-022的II期CLINCH研究的剂量扩展阶段。其临床前和初步临床数据令我们备受鼓舞，两位晚期转移性胃癌患者已分别达到PR和CR。紧随这一重要研究阶段的启动，德琪医药将继续保持与监管部门及临床研究人员间的密切合作，在充分评估ATG-022的临床潜力之路上不断探索前行。”

关于ATG-022  

ATG-022是一款作用于紧密连接蛋白18.2（Claudin 18.2）的抗体偶联药物。紧密连接蛋白是在细胞间形成紧密连接的粘附分子，它可形成调节细胞渗透性的屏障。肿瘤细胞中的细胞极性变化可在细胞表面产生紧密连接蛋白表达。在胃癌、食道癌、胆管癌和胰腺癌在内的多种原发性肿瘤都常见Claudin 18.2的过度表达。

在2022年美国癌症研究协会年会（2022 AACR）上发布的基于病人来源胃癌异种移植模型的临床前数据显示，ATG-022对于Claudin 18.2具有低纳摩尔级别的亲和力以及强效的体外和体内抗肿瘤活性。这就意味着ATG-022有望为具有不同Claudin 18.2表达水平的胃癌患者带来临床获益。此外，ATG-022还在药物非临床研究质量管理规范（GLP）毒理研究中显示了良好的安全性。

关于德琪医药   

德琪医药有限公司（简称“德琪医药”，香港交易所股票代码：6996.HK）是一家以研发为驱动，并已进入商业化阶段的生物制药领先企业，以“医者无疆，创新永续”为愿景，德琪医药专注于血液及实体肿瘤领域的同类首款和同类最优疗法的早期研发、临床研究、药物生产及商业化，致力于通过提供突破性疗法，改善全球患者生活质量。

自2017年以来，德琪医药现已建立起一条拥有9款从临床延展至商业化阶段的肿瘤药物资产研发管线，其中，6款产品具有全球权益，3款产品具有亚太权益。公司已在美国及多个亚太市场获得29个临床批件（IND），并递交了11个新药上市申请（NDA）。目前，希维奥（塞利尼索片）已获得中国大陆、中国台湾、中国香港、中国澳门、韩国、新加坡和澳大利亚的新药上市批准。

前瞻性陈述   

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Antengene Initiates Phase II Dose Expansion Study of Claudin 18.2 ADC ATG-022 in China and Australia

Shanghai and Hong Kong, PRC, March 20, 2024 — Antengene Corporation Limited (“Antengene” SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, today announced that it has initiated the dose expansion portion of the Phase II CLINCH study of ATG-022 (Claudin 18.2 antibody-drug conjugate[ADC]) in China and Australia. Prior to this, the CLINCH trial has already produced promising preliminary clinical results with partial response (PR) and compete response (CR).

The CLINCH trial, consists of a dose escalation portion and a dose expansion portion, is a multi-center, open-label Phase I/II study of ATG-022 monotherapy in patients with advanced or metastatic solid tumors. The primary objective of the study is to evaluate the safety and tolerability of ATG-022 and to determine important dosing parameters including maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of ATG-022 monotherapy. The secondary objective is to characterize the pharmacology and evaluate the preliminary efficacy of ATG-022.

The dose expansion portion of the study will enroll patients with gastric cancer or other solid tumors. In May 2023, the U.S. Food and Drug Administration (FDA) consecutively granted two Orphan Drug Designations (ODDs) to ATG-022 for the treatment of pancreatic cancer and gastric cancer, separately.

Dr. Amily Zhang, Antengene’s Chief Medical Officer, said, “We are excited that the dose expansion portion of the Phase II study of ATG-022 in China and Australia. The Phase I/II CLINCH trial is supported by strong preclinical data and has already made encouraging early observations with one PR and CR in two patients with metastatic gastric cancer. With the trial entering its next critical phase, we will continue working closely with regulators and investigators to fully explore the clinical potential of ATG-022.”

About ATG-022 

ATG-022 is an antibody-drug-conjugate targeting Claudin 18.2. Claudins are cell adhesion molecules normally expressed within the tight junctions between cells to form a barrier that regulates cell permeability. In cancer, Claudins are expressed at the cell surface due to changes in cell polarity. The Claudin 18.2 is often overexpressed in various primary malignant tumors including gastric, esophageal, cholangiocarcinoma and pancreatic cancers.

Data from preclinical studies, including results from gastric cancer-patient derived xenograft models presented at the 2022 American Association for Cancer Research (2022 AACR), showed that ATG-022 binds to Claudin 18.2 with low nanomolar affinity and demonstrated potent in vitro and in vivo antitumor effects, including in vivo efficacy demonstrated in Claudin 18.2 low expression models. This could pave the way for broad clinical utility of ATG-022 in gastric cancer patients with a wide range of Claudin 18.2 expression levels. ATG-022 demonstrated an excellent safety profile in Good Laboratory Practice (GLP) toxicology studies.

About Antengene   

Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK) is a leading commercial-stage R&D-driven global biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative first-in-class/best-in-class therapeutics for the treatment of hematologic malignancies and solid tumors, in realizing its vision of “Treating Patients Beyond Borders”.

Since 2017, Antengene has built a pipeline of 9 oncology assets at various stages going from clinical to commercial, including 6 with global rights, and 3 with rights for the APAC region. To date, Antengene has obtained 29 investigational new drug (IND) approvals in the U.S. and Asia, and submitted 11 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for XPOVIO (selinexor) already approved in Mainland of China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore and Australia.

Forward-looking statements   

The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, please see the other risks and uncertainties described in the Company’s Annual Report for the year ended December 31, 2022, and the documents subsequently submitted to the Hong Kong Stock Exchange.

(德琪医药-B)