CD24

Promising clinical activities and efficacies during dose escalations for four lead global rights programs targeting CD24, Claudin 18.2, CD73, and PD-L1/4-1BB Positive, differentiated cervical cancer data advancing mTORC1/2 inhibitor on registrational track for APAC markets RMB1.188 billion cash expected to support planned operations SHANGHAI and HONG KONG, March 22, 2024 /PRNewswire/ -- 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 medicines for cancer, today announced its full year results for the period ended December 31, 2023, and provided an update on the impressive progress of its clinical development pipeline over the last several months. "2023 has been a breakout year for Antengene, with excellent pipeline momentum across multiple first/best-in-class programs marked by encouraging clinical activities and efficacies during dose escalations for our four lead global-rights programs, namely ATG-031, ATG-022, ATG-037, and ATG-101 which are designed to target CD24, Claudin 18.2, CD73, and PD-L1/4-1BB. With respect to our APAC-rights programs, our second generation mTORC1/2 inhibitor ATG-008 has made steady progress towards registrational path for the indication of cervical cancer, complemented by the inclusion of XPOVIO® in the 2023 China National Reimbursement Drug List. Furthermore, we have entered into a partnership with Hansoh Pharma, a leading Chinese pharmaceutical company, for the commercialization of XPOVIO® in the Mainland of China," said Dr. Jay Mei, Antengene 's Founder, Chairman and C EO . "Looking into 2024 and beyond, we are confident that out four lead global rights programs will continue to deliver encouraging results and emerge as category leaders. Our current cash balance totaling RMB1.188 billion is expected to fund planned operations and product development. We look forward to report on our progress throughout the year, starting with the presentation of several abstracts at the American Association for Cancer Research Annual Meeting (AACR 2024)." 1. Momentous clinical development across four lead global-rights programs ATG-031 (anti-CD24 monoclonal antibody): Promising Activity at Starting Doses: ATG-031 is the first-in-class humanized anti-CD24 monoclonal antibody to enter the clinic for cancer in the U.S. ATG-031 acts by inhibiting the "don't eat me" signal while stimulating the "eat me" signal and enhances macrophage-mediated phagocytosis of cancer cells. Phase I "PERFORM" study: To date, a total of 5 late-stage cancer patients have been treated with ATG-031 in the Phase I dose escalation study. To date, no dose-limiting toxicities (DLTs) have been observed among the 5 patients. Tumor shrinkage based on CT scan was observed in one heavily pre-treated patient (7 prior lines of therapy). Key study sites include four major U.S. cancer centers: The University of Texas MD Anderson Cancer Center, the University of California San Francisco, the University of Colorado, and Yale University Cancer Center. Next ATG-031 Milestone: Completion of the dose escalation portion of the Phase I "PERFORM" Study in H1 2025. ATG-022 (Claudin 18.2 antibody-drug conjugate, "ADC"): Potential to Target Claudin 18.2 Low Expressors: ATG-022 is differentiated by its potential ability to be active across a range of Claudin 18.2 expression levels, including in low expressors. Antengene has also developed a companion diagnostic assay to support the clinical program. The ADC has been awarded two Orphan Drug Designations (ODD) by the U.S. Food and Drug Administration (FDA) for treatment of gastric and pancreatic cancers. Phase I "CLINCH" study: To date, 7 gastric cancer patients (without pre-screening patients' Claudin 18.2 expression levels) have been treated with ATG-022. Antengene has observed one complete response (CR) and one partial response (PR) in 2 patients with metastatic gastric cancer. In the 2.4 mg/kg dose cohort, one patient with extremely low expression of Claudin 18.2 achieved CR, while one patient from the 1.8 mg/kg dose cohort achieved PR. The study has already completed the dose escalation portion and initiated the dose expansion portion. Next ATG-022 Milestone: Clinical data readout of Phase I "CLINCH trial", including preliminary efficacy and safety in H2 2024. ATG-037 (CD73 small molecule inhibitor): Early Combination Activity Shown Potential in Reversing Prior PD-1 Resistance: Inhibiting CD73 is intended to stop the production of adenosine, a key immunosuppressive molecule in the tumor microenvironment. As a small molecule inhibitor of CD73, ATG-037 has demonstrated pre-clinically the ability to overcome the "hook effect" that can limit efficacy and is commonly seen in anti-CD73 antibodies. Antengene entered into a global clinical collaboration with MSD and is currently evaluating this molecule in combination with the anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with locally advanced or metastatic solid tumors. Phase I "STAMINA" study: In the dose escalation segment of ATG-037 combined with pembrolizumab, Antengene has observed PRs in two patients with melanoma and one patient with non-small cell lung cancer (NSCLC), all of whom were refractory to prior treatment with checkpoint inhibitors (CPIs). To date, 23 patients have been enrolled and received a first tumor assessment. Next ATG-037 Milestone: Completion of Phase I dose escalation and proceed to dose expansion in H1 2024. ATG-101 (PD-L1/4-1BB bispecific antibody): Durable Responses at Low Doses with No Off-Target Hepatotoxicity Observed and Efficacy in Cold Tumors: ATG-101's differentiated approach to targeting PD-L1 resistant cancers incorporates the T-cell co-stimulatory receptor 4-1BB. The bispecific antibody utilizes high PD-L1 affinity and conditional 4-1BB activation, to reduce the risk of hepatotoxicity. Phase I "PROBE" study: Antengene has observed a PR in a patient with metastatic colon adenocarcinoma (microsatellite stability biomarker [MSS], liver metastasis, and three prior lines of therapy). In addition, SD has been observed in two patients for longer than 1 year. Next ATG-101 Milestone: Completion of Phase I dose escalation and proceed to dose expansion in H1 2025. Progressing Early programs: Antengene continues to advance IND candidate, ATG-042 ( MTAPnull-selective PRMT5 Inhibitor), and the proprietary AnTenGagerTM "2+1" T cell engager platform. 2. Steadily progressing mid/late-stage clinical programs continue to demonstrate clinical potentials ATG-008 (mTORC1/2 small molecule inhibitor): Positive, Robust Cervical Cancer Data -The mTOR complex regulates different cellular processes and is upregulated in multiple tumors. mTORC1 and mTORC2 have to be inhibited simultaneously to maximize efficacy and minimize the development of resistance. ATG-008 was designed to inhibit both. Phase II "TORCH-2" study: ATG-008 has demonstrated positive Phase II results in cervical cancer that position the program to have a competitive profile compared to other agents approved across different global markets. The Phase II "TORCH-2" study is currently enrolling both checkpoint inhibitor (CPI)-naïve and CPI-pre-treated patients. Based on the latest data review as of March 14th, 2024, out of the 31 CPI-naïve patients who received treatment (30 had at least one tumor assessment), the objective response rate (ORR) was observed to be 53.3%, the disease control rate (DCR) was 86.7%. Among the 30 patients with prior CPI treatment (26 patients had at least one tumor assessment), the ORR was 23.1%, with a DCR of 84.6%. Next ATG-008 Milestone: Confirm registrational pathway in cervical cancer with health authorities. 3. Solidifying presence in APAC markets through accelerating commercialization Antengene and Hansoh Pharma entered into a collaboration for the commercialization of XPOVIO® in the Mainland of China in August 2023. XPOVIO® has been added to the NRDL (2023 Version) as announced on December 14th, 2023. The updated NRDL, taking effect on January 1st, 2024, will significantly improve the accessibility of XPOVIO® in Mainland of China. As of December 2023, Antengene has successfully secured XPOVIO® regulatory approvals in seven markets: Mainland of China, Taiwan China, Hong Kong China, Macau China, Australia, South Korea, and Singapore. National reimbursement has been secured in 3 markets: Mainland of China (NRDL), Australia (Pharmaceutical Benefits Scheme), and Singapore (Cancer Drug List). In June 2023, the coverage of XPOVIO® by the Australian Pharmaceutical Benefits Scheme (PBS) was extended from Xd to include both XVd and Xd regimens. . 4. Strong cash and bank balance enabling continuous growth As of December 31, 2023, the company's cash resources of about RMB1.188 billion, coupled with careful spending to support the continuous growth, development, and operations of Antengene. To learn more about the annual financial results of 2023, please see the full announcement on the "Investor Relations" section of the website. 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, 2023, and the documents subsequently submitted to the Hong Kong Stock Exchange. For more information, please contact: Investor Contacts: Donald Lung E-mail: [email protected] Mobile: +86 18420672158 PR Contacts: Peter Qian E-mail: [email protected] Mobile: +86 13062747000 SOURCE Antengene Corporation Limited

·ATN-031（又名ATG-031）是在美国进入肿瘤临床研究的首款抗CD24单克隆抗体药物。·正在美国的4个临床研究中心开展的I期PERFORM研究旨在评估ATN-031治疗晚期实体瘤或B细胞非霍奇金淋巴瘤（B-NHL）患者的安全性和初步疗效。美国宾夕法尼亚州多尔斯敦，2024年3月20日 – 德琪医药的美国全资子公司Antennova今日宣布，已完成抗CD24单克隆抗体药物ATN-031（又名ATG-031）的I期临床研究的首个剂量水平队列。这项剂量爬坡研究（NCT06028373）正在晚期实体瘤或B细胞非霍奇金淋巴瘤（B-NHL）患者中对ATN-031展开评估。PERFORM研究由MD安德森癌症中心牵头，其他三个美国临床研究中心共同参与开展。按照研究的贝叶斯最优区间（BOIN）设计，共有5例晚期癌症患者入组至第一剂量组。5例患者中均未观察到剂量限制毒性（DLT）。1例既往接受过7线治疗的患者已获得影像学确认的肿瘤体积缩小。德琪医药创始人、董事长兼首席执行官梅建明博士表示：“在美国开展针对首款治疗晚期癌症患者的抗CD24单抗的临床研究对于Antennova而言具有里程碑意义，我们非常感谢所有参与这项临床研究的患者和研究中心。临床评估和转化医学数据显示，研究已在这个既往接受过多线治疗的患者群体中观察到初步临床活性，这让我们对研究的前景充满信心。我们将继续与MD安德森癌症中心、旧金山加州大学、科罗拉多大学和耶鲁大学癌症中心的研究者们保持密切合作，并将在研究过程中定期公布阶段性进展，期待在国际学术会议上公布最新数据。”PERFORM研究是一项针对ATN-031用于治疗晚期实体瘤或B-NHL患者的首次人体、多中心、开放性I期剂量探索/剂量爬坡试验。该研究的主要目的为评估ATN-031单药的安全性和耐受性，并确定II期研究的使用剂量。该研究的次要目的为确定ATN-031的药理特性和免疫原性，并评估该药物的初步疗效。关于ATN-031ATN-031是一款可在抑制“别吃我”信号的同时激活“来吃我”信号并强化由巨噬细胞介导的肿瘤细胞吞噬的全球首创（first-in-class）人源化抗CD24单克隆抗体。肿瘤细胞通过过度表达让其免于被巨噬细胞发现和吞噬的“别吃我”细胞表面蛋白实现免疫逃逸。CD24是一个主要的 “别吃我” 信号，它通过抑制由巨噬细胞介导的肿瘤细胞吞噬，在肿瘤免疫逃逸中起着关键作用。与另一个“别吃我”靶点CD47相比，CD24具有更局限的健康组织分布和更高的肿瘤组织表达，在实体瘤中的表达尤为明显。此外，CD24并不在人红细胞上表达，这使得CD24靶向疗法具有更低的在靶脱瘤毒性以及更大的安全窗。作为一个新型固有免疫检查点，CD24通过与表达于肿瘤相关巨噬细胞（TAM）上的抑制受体Siglec-10（唾液酸结合性免疫球蛋白样凝集素10）的相互作用，实现肿瘤细胞的免疫逃逸。在2023年美国癌症研究协会年会（AACR 2023）和2022年癌症免疫治疗学会年会（SITC 2022）上公布的临床前数据显示，ATN-031可以纳摩尔级别亲和力与CD24特异性结合并阻断CD24与Siglec-10的互动。此外，ATN-031可诱导皮摩尔EC50水平的高效吞噬作用，并促进巨噬细胞分泌促炎细胞因子。关于Antennova德琪医药的美国全资子公司Antennova成立于美国特拉华州。作为一家已进入临床阶段的生物技术公司，Antennova致力于开发可改善肿瘤微环境、强化现有疗法疗效、逆转对于检查点抑制剂（CPI）耐药并可靶向作用于现有CPI药物不敏感的“冷肿瘤”的创新疗法。至今，Antennova已在推进抗CD24单克隆抗体药物ATN-031、CD73小分子抑制剂ATN-037、Claudin 18.2抗体偶联药物ATN-022和抗PD-L1/4-1BB双特异性抗体ATN-101这四款临床阶段资产的开发方面实现多项里程碑进展。此外，美国食品药品管理局（FDA）已授予ATN-101一项孤儿药资格认定，用于治疗胰腺癌；授予ATN-022一项孤儿药资格认定，用于治疗胰腺癌和胃癌。前瞻性陈述本文所作出的前瞻性陈述仅与本文作出该陈述当日的事件或资料有关。除法律规定外，于作出前瞻性陈述当日之后，无论是否出现新资料、未来事件或其他情况，我们并无责任更新或公开修改任何前瞻性陈述及预料之外的事件。请细阅本文，并理解我们的实际未来业绩或表现可能与预期有重大差异。本文内有关任何董事或本公司意向的陈述或提述乃于本文刊发日期作出。任何该等意向均可能因未来发展而出现变动。点击这里，更多了解德琪医药！

ATN-031 (also known as ATG-031), is the first anti-CD24 antibody to advance to the clinic in oncology in the United States The Phase I PERFORM trial, ongoing at four major U.S. cancer centers, is evaluating the safety and preliminary efficacy of ATN-031 in patients with advanced solid tumors or B-cell non-Hodgkin's lymphoma (B-NHL) DOYLESTOWN, Pa., March 20, 2024 /PRNewswire/ -- Antennova, a clinical-stage biotech company focused on oncology today announced completion of the first dosing cohort in the Phase I study for the anti-CD24 antibody, ATN-031 (also known as ATG-031). The dose escalation trial is evaluating ATN-031 in patients with advanced solid tumors or B-cell non-Hodgkin's lymphoma (B-NHL), (NCT06028373). The PERFORM trial is being conducted at four cancer centers in the U.S., led by The University of Texas MD Anderson Cancer Center. A total of five late stage cancer patients have been enrolled based on the Bayesian Optimal Interval (BOIN) design of the trial in the first dosing cohort. To date, no dose-limiting toxicities (DLTs) have been reported among the 5 patients. Tumor shrinkage based on CT scan was observed in one heavily pre-treated patient (7 prior lines of therapy). "Introducing the first anti-CD24 program for late stage cancer patients in the U.S. is a very important milestone for Antennova. We are especially grateful to the participation in the study by our patients and study centers, and encouraged to observe early clinical activity in this heavily pre-treated patient population based on clinical evaluation and translational data. We are working closely with study sites and investigators at MD Anderson, the University of California, San Francisco, the University of Colorado, and Yale University Cancer Center and look forward to providing periodic updates and presentations at major international medical conferences throughout the study." commented by Jay Mei, M.D., Ph. D., Founder and Chairman of the Board. The PERFORM trial is a first-in-human, multi-center, open-label, Phase I dose-finding/escalation study of ATN-031 in patients with advanced solid tumors or B-NHL. The study's primary objective is to evaluate the safety and tolerability of ATN-031 as a monotherapy, and determine the appropriate dose for Phase II studies. The secondary objective is to characterize the pharmacology, evaluate the immunogenicity, and assess the preliminary efficacy of ATN-031. About ATN-031 ATN-031 is a first-in-class humanized anti-CD24 monoclonal antibody which inhibits the "don't eat me" signal while stimulating the "eat me" signal, and enhances macrophage-mediated phagocytosis of cancer cells. Tumor cells evade the surveillance of the human immune system by over-expressing "don't eat me" surface proteins that signal macrophages to prevent the detection and phagocytosis of cancer cells. CD24 is a prominent "don't eat me" signal that plays a significant role in tumor immune evasion by suppressing macrophage-mediated phagocytosis. Compared to CD47, another "don't eat me" target, CD24, has a more markedly restricted distribution in normal tissues and higher expression in cancerous tissues, especially solid tumors. Importantly, CD24 is differentiated from CD47 because it is not expressed on human red blood cells, allowing for a wider therapeutic window and minimal on-target-off-tumor toxicity. CD24 acts as a novel innate immune checkpoint, orchestrating immune evasion through its interaction with the inhibitory receptor Siglec-10 (sialic-acid-binding Ig-like lectin 10), expressed on tumor-associated macrophages (TAMs). Preclinical data presented at the American Association for Cancer Research Annual Meeting in 2023 (AACR 2023) and the Society for Immunotherapy in Cancer Annual Meeting in 2022 (SITC 2022) demonstrated that ATN-031 can specifically bind to CD24 with nM affinity and block the interaction of CD24 and Siglec-10. Furthermore, ATN-31 induces efficient phagocytosis with a picomolar EC50 and stimulates the pro-inflammatory cytokines production by macrophages. About Antennova Antennova, a Delaware corporation and a subsidiary of Antengene (HKEX: 6996), is a clinical-stage biotech company specialized in developing innovative therapeutics that re-educate the tumor microenvironment, enhancing the effectiveness of standard therapies and reversing checkpoint inhibitor (CPI) resistance, as well as targeting "cold tumors" that are not responsive to the current CPI therapies. Antennova has achieved significant milestones which include advancing and developing 4 clinical stage programs: ATN-031: anti-CD24 monoclonal antibody; ATN-037: CD73 small molecule inhibitor; ATN-022: Claudin 18.2 ADC; and ATN-101: anti-PD-L1/4-1BB bispecific antibody. The U.S. Food and Drug Administration (FDA) awarded an Orphan Drug Designation to ATN-101, for pancreatic cancer; and to ATN-022, for gastric and pancreatic cancers. Forward-Looking Statements The forward-looking statements made in this document relate only to the events or information as of the date on which the statements are made in this document. 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 document completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this document, 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 document. Any of these intentions may alter in light of future development. Investor Relations Email: ir@antennova.com