Onatasertib

Oral Presentation：a Phase II study of ATG-008 (mTORC1/2 Inhibitor) combined with PD-1 antibody in patients with cervical cancer Three Poster presentations: Phase I/II studies of ATG-031 (anti-CD24 monoclonal antibody), ATG-022 (Claudin 18.2 antibody-drug conjugate), and selinexor (XPO1 Inhibitor) Journal Publication: the first-in-human Phase I dose-escalation study of ATG-017 (ERK1/2 inhibitor) in patients with advanced solid tumors SHANGHAI and HONG KONG, May 23, 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 one oral presentation, three poster presentations and a journal publication at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 31st to June 4th at the McCormick Place Convention Center in Chicago, IL, the United States. Details of the Oral Presentation: ATG-008 (mTORC1/2 Inhibitor) Title: A phase I/II study of the TORC1/2 inhibitor onatasertib combined with toripalimab in patients with advanced solid tumors: Cervical cancer cohort Abstract: 5509 Session: Clinical Science Symposium – Stronger Together: Novel Combinations Across the Gynecologic Cancer Spectrum Date: June 1, 2024 Time: 1:15 PM - 2:45 PM (Central Daylight Time) 2:15 AM - 3:45 AM, June 2, 2024 (Beijing Time) 31 checkpoint inhibitor (CPI)-naïve cervical cancer patients who previously had at least one systemic line of chemotherapy were enrolled in the TORCH-2 study as of Oct 20th 2023. ATG-008 (Onatasertib; oral TORC1/2 inhibitor) combined with toripalimab (anti-PD-1 antibody) showed promising anti-tumor activity and acceptable tolerability in cervical cancer patients, achieving an overall response rate (ORR) of 53.3% and a disease control rate of 86.7%. In general, ATG-008 in combination with toripalimab are very well tolerated. The most common grade ≥ 3 treatment-related adverse events (TRAEs) included rash (12.9%), decreased lymphocyte count (9.7%), and decreased platelet count (6.5%). Encouraging response rates and disease stabilization were observed in patients, regardless of PD-L1 expression, with further data being collected in an ongoing expansion cohort for CPI-treated cervical cancer. Details of the Poster Presentations: ATG-031 (anti-CD24 monoclonal antibody) Title: A first-in-human phase I study of ATG-031, anti-CD24 antibody, in patients with advanced solid tumors or B-cell non-Hodgkin lymphomas (PERFORM) Abstract: TPS2691 Session: Developmental Therapeutics—Immunotherapy Date: June 1, 2024 Time: 9:00 AM - 12:00 PM (Central Daylight Time) 10:00 PM, June 1 - 1:00 AM, June 2, 2024 (Beijing Time) ATG-031 is a first-in-class CD24 antibody that promotes cancer cell phagocytosis and T cell activity by disrupting the CD24-Siglec-10 interaction on macrophages, while also triggering antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). The Phase I PERFORM study is designed to evaluate the safety and preliminary efficacy of ATG-031 in patients with advanced solid tumors or B-cell non-Hodgkin's lymphoma, employing a dose-escalation phase with a Bayesian Optimal Interval (BOIN) design and a dose-expansion phase with two or more dose levels to determine the recommended phase II dose (RP2D). As of April 2024, the study is underway in 4 U.S. sites, and the first dose level has been cleared. ATG-022 (Claudin 18.2 Antibody-drug Conjugate) Title: An open-label, multicenter, phase I study of ATG-022 in patients with advanced/metastatic solid tumors (CLINCH) Abstract: 3032 Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology Date: June 1, 2024 Time: 9:00 AM - 12:00 PM (Central Daylight Time) 10:00 PM, June 1 - 1:00 AM, June 2, 2024 (Beijing Time) ATG-022 is a Claudin 18.2 (CLDN 18.2)-targeting antibody-drug conjugate (ADC) with sub-nM high affinity that showed promising tumor inhibition activity in vitro and in vivo. The CLINCH Phase I trial is assessing its safety, tolerability, and efficacy in patients with advanced/metastatic solid tumors. As of October 9th, 2023, 10 patients have been enrolled, receiving doses ranging from 0.3 to 2.4 mg/kg. The most common grade ≥ 3 TRAEs included nausea, vomiting, and decreased appetite, each occurring in 30% of patients. No dose-limiting toxicities (DLTs) were reported. Preliminary efficacy data among 7 gastric cancer patients across multiple doses in the Phase I dose escalation demonstrated one complete response (CR) in a patient with gastric cancer (2.4 mg/kg, CLDN 18.2-negative) and one partial response (PR) in another patient (1.8 mg/kg, CLDN 18.2 expression undetermined). ATG-022 demonstrated tolerability, safety, and potential anti-tumor activity. A Phase II trial is currently enrolling patients with gastric cancer and other solid tumors. Selinexor (XPO1 Inhibitor) Title: Selinexor combined with tislelizumab in patients with relapsed or refractory extranodal NK/T-cell lymphoma (R/R ENKTL): Results of dose-escalation of cohort C, from a multicenter, single-arm, phase I/II study (TOUCH) Abstract: 7065 Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia Date: June 3, 2024 Time: 9:00 AM - 12:00 PM (Central Daylight Time) 10:00 PM, June 3 - 1:00 AM, June 4, 2024 (Beijing Time) The Phase I/II TOUCH study is investigating selinexor combined with different drugs in relapsed/refractory extranodal NK/T-cell lymphoma (R/R ENKTL). Cohort C of the study aims to evaluate the safety, tolerability and preliminary efficacy of selinexor in combination with anti-PD-1 antibody tislelizumab. As of December 25th, 2023, 12 patients were enrolled, with no DLTs observed, and the maximum tolerated dose (MTD) was not reached. The most common adverse events included asthenia, neutropenia, and nausea/vomiting. Grade ≥ 3 adverse events occurred in 58.3% of patients. The ORR was 72.7% among 11 efficacy evaluable patients, including a CR rate of 36.4%. The combination showed a tolerable safety profile and promising efficacy. Details of the Journal Publication: ATG-017 (ERK1/2 Inhibitor) Title: Results of a first-in-human, dose-escalation phase I study of the ERK1/2 inhibitor ATG-017 in patients with advanced solid tumors Abstract: e15114 Session: Publication Only: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology ATG-017, an oral and selective ERK1/2 inhibitor, was evaluated in a Phase I study to assess safety, pharmacokinetics, and MTD in patients with refractory advanced solid tumors. At the 20 mg BID level, no DLTs were observed, and pharmacokinetic analysis revealed effective ERK inhibition at this dose. Common treatment-emergent adverse events (TEAEs) were consistent with previously reported toxicities with other ERK pathway inhibitors (gastrointestinal, skin, and ocular adverse events). Efficacy data showed that one patient (4.8%) achieved a PR, while 8 patients (38%) achieved stable disease (SD). 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 10 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

▎药明康德内容团队报道2024年美国临床肿瘤学会（ASCO）年会将于5月31日至6月4日（美国当地时间）在美国芝加哥举行。根据ASCO年会官网，今年有5000+摘要入选。近日，许多中国公司也发表新闻稿，宣布了其入选本届ASCO大会的新药研究，其中包括多项口头报告。本文将结合各公司新闻稿，分享部分入选本届ASCO大会的中国新药口头报告，仅供读者参阅（本文为不完全统计，按照公司名字首字母排序）鞍石生物：伯瑞替尼肠溶胶囊作用机制：MET抑制剂适应症：胶质母细胞瘤根据鞍石生物新闻稿，其全资子公司浦润奥生物研发的伯瑞替尼肠溶胶囊的2项临床研究入选今年ASCO年会，其中一项获口头报告。获口头报告的是一项2/3期临床试验，评估了伯瑞替尼治疗经治、携带PTPRZ1-MET融合基因（FUGEN）的继发性胶质母细胞瘤/IDH突变型胶质母细胞瘤患者的疗效和安全性。就在几天前（4月23日），伯瑞替尼在中国获批新适应症，用于既往治疗失败的具有PTPRZ1-MET融合基因的IDH突变型星形细胞瘤（WHO 4级）或有低级别病史的胶质母细胞瘤成人患者。博生吉：PA3-17注射液作用机制：自体CD7-CAR-T产品适应症：T淋巴母细胞白血病/淋巴瘤根据博生吉新闻稿，该公司研发的自体CD7-CAR-T产品PA3-17注射液治疗复发/难治T淋巴母细胞白血病/淋巴瘤（T-ALL/LBL）的1期临床研究入选本次ASCO大会快速口头报告。T-ALL/LBL是高度侵袭性的恶性血液肿瘤，复发/难治性患者的预后一直很差。CD7在复发/难治性T-ALL/LBL中过表达高达100%，是有吸引力的治疗靶点。PA3-17是一款基于CD7纳米抗体的CAR-T细胞注射液，已经在复发/难治T-ALL/LBL患者中显示出良好的安全性和令人鼓舞的疗效。德琪医药：ATG-008作用机制：mTORC1/2抑制剂适应症：宫颈癌根据德琪医药新闻稿，该公司有4项研究入选本次ASCO年会，其中mTORC1/2抑制剂ATG-008联合抗PD-1单抗特瑞普利单抗在宫颈癌患者中的2期临床研究数据获选口头报告。ATG-008（onatasertib）可靶向抑制mTOR的活性，进而诱导肿瘤细胞凋亡并降低肿瘤细胞增殖。德琪医药曾在2023年ASCO大会上报告了该产品治疗晚期实体瘤的临床结果，本次将口头报告来自宫颈癌队列的数据。迪哲医药：舒沃替尼作用机制：EGFR-TKI适应症：非小细胞肺癌（NSCLC）迪哲医药宣布，将于本届ASCO年会上公布其高选择性EGFR酪氨酸激酶抑制剂（TKI）舒沃替尼片针对EGFR20号外显子插入（exon20ins）突变型晚期NSCLC的两项最新研究成果。其中，舒沃替尼针对经治EGFR exon20ins突变型NSCLC的全球注册临床研究“悟空1B部分”（WU-KONG1 Part B）的研究数据将以口头报告形式全球首发。据悉，这是一项开放标签、国际多中心的2期临床研究，旨在评估舒沃替尼在含铂化疗失败或不耐受的EGFR exon20ins突变型NSCLC患者中的疗效和安全性，该研究目前正在美国、欧洲、中国等全球10个国家和地区开展。加科思：glecirasib、JAB-3312作用机制：KRAS G12C抑制剂，SHP2抑制剂适应症：非小细胞肺癌根据加科思新闻稿，该公司将在本次ASCO大会以口头报告形式公布glecirasib（KRAS G12C抑制剂）和JAB-3312（SHP2抑制剂）联用一线治疗非小细胞肺癌患者的安全性和有效性数据更新。加科思曾在2023年欧洲肿瘤内科学会（ESMO）大会上发布过这项试验的初步数据，此次将更新长期随访数据。此外，glecirasib针对携带KRAS G12C突变的非小细胞肺癌患者进行的2期单臂注册性临床研究，也将在5月1日举行的ASCO Plenary Series会议中的线上口头报告专场展示。精准生物：C-13-60细胞制剂作用机制：靶向CEA的CAR-T细胞产品适应症：CEA阳性晚期实体肿瘤根据精准生物新闻稿，该公司将在本次ASCO大会上以口头汇报形式展示其自主研发的靶向CEA的CAR-T细胞（C-13-60细胞制剂）治疗CEA阳性晚期实体肿瘤的临床试验数据。这是一项低氧反应性CEA CAR-T细胞通过腹腔或静脉输注治疗重度预处理实体瘤患者的1期试验。据精准生物新闻稿介绍，C-13-60细胞制剂特有的腹腔局部用药方式可突破传统静脉输注方式的局限性，建立循环持久的免疫力，可增强对实体瘤的杀伤并防止复发，同时可能降低脱靶效应带来的风险。康方生物：依沃西、卡度尼利单抗作用机制：PD-1/VEGF双抗、PD-1/CTLA-4双抗适应症：非小细胞肺癌、胃或胃食管交界处腺癌康方生物宣布，该公司将在今年ASCO年会上以口头报告形式首次发布其PD-1/VEGF双抗新药依沃西的一项注册性3期临床研究数据。这是一项随机、双盲、多中心3期临床研究，旨在评估依沃西联合化疗对比安慰剂联合化疗用于经EGFR-TKI治疗进展的EGFR突变的局部晚期或转移性非鳞非小细胞肺癌的效果。目前，依沃西关于该适应症的新药上市申请已被中国NMPA受理，并获得优先审评。此外，康方生物还将以快速口头报告形式公布一项PD-1/CTLA-4双特异性抗体卡度尼利单抗的多中心、随机、双盲试验结果，该研究旨在评估卡度尼利单抗联合普络西单抗和紫杉醇二线治疗免疫联合化疗治疗失败的晚期胃或胃食管交界处（G/GEJ）腺癌患者的疗效和安全性。科济药业：CT041作用机制：靶向Claudin18.2的CAR-T适应症：胃肠道肿瘤根据科济药业新闻稿，该公司靶向Claudin18.2的自体CAR-T细胞候选产品CT041的摘要已入选今年ASCO年会的口头报告，这是一项治疗胃肠道肿瘤患者的1期CT041-CG4006研究的最终结果。CT041拟被开发治疗Claudin18.2阳性实体瘤，该产品曾被美国FDA授予再生医学先进疗法（RMAT）认定和孤儿药资格，分别用于治疗Claudin18.2阳性的晚期胃癌/食管胃结合部腺癌，以及治疗胃癌/食管胃结合部腺癌。乐普生物：MRG004A、MRG003、普特利单抗作用机制：抗组织因子ADC、靶向EGFR的ADC、抗PD-1单抗适应症：实体瘤乐普生物宣布该公司将在本届ASCO年会上展示3项最新临床试验进展，其中包括2项口头报告，分别为：评价MRG004A在实体瘤患者中的安全性和有效性的1/2期临床研究结果；以及普特利单抗与MRG003联合治疗EGFR阳性实体瘤患者的安全性和有效性的1/2期研究的初步结果。其中，MRG004A是一款靶向组织因子（TF）的抗体偶联药物（ADC），已于今年3月获得FDA授予治疗胰腺癌的快速通道资格。MRG003是一款靶向EGFR的ADC，其针对复发/转移性鼻咽癌的申请已被NMPA纳入突破性治疗品种，并获得FDA授予治疗晚期鼻咽癌的孤儿药资格。普特利单抗是一款抗PD-1单抗，已在中国获批治疗不可切除或转移性的MSI-H或dMMR的晚期实体瘤患者。迈威生物：9MW2821作用机制：靶向Nectin-4的ADC适应症：晚期实体瘤根据迈威生物新闻稿，该公司将在本次ASCO年会以口头报告形式公布靶向Nectin-4的ADC产品9MW2821用于多项晚期实体瘤的1/2期临床研究结果。目前，9MW2821单药治疗经铂类化疗和PD-(L)1抑制剂治疗的局部晚期或转移性尿路上皮癌的3期临床研究已正式启动，与PD-1抑制剂联合用药的1/2期临床研究也在推进中，均已完成首例受试者入组。该产品还于今年2月获FDA授予快速通道资格，用于治疗晚期、复发或转移性食管鳞癌。信达生物：IBI389、信迪利单抗、他雷替尼等作用机制：CLDN18.2/CD3双抗、抗PD-1抗体、ROS1抑制剂等适应症：胃癌、胰腺导管腺癌、宫颈癌等根据信达生物新闻稿，该公司将在今年ASCO年会上公布约20项最新临床研究数据，包括一系列单抗、双抗及ADC在研管线，以及奥雷巴替尼、他雷替尼（ROS1抑制剂）等创新肿瘤药物。其中，8项研究将以口头报告或快速口头报告形式展示，分别为：1）评估抗CLDN18.2/CD3双特异性抗体IBI389在实体瘤和胃或胃食管肿瘤患者中的安全性和初步疗效的一项1期剂量递增和扩展研究；2）评估抗CLDN18.2/CD3双抗IBI389在晚期胰腺导管腺癌患者中的安全性和疗效的1期研究的初步结果；3）评估抗CTLA-4抗体IBI310联合抗PD-1抗体信迪利单抗对微卫星高度不稳定性（MSI-H）/错配修复缺陷(dMMR)结直肠癌患者的新辅助治疗的一项随机、开放标签的1b期研究结果；4）评估ROS1抑制剂他雷替尼在晚期或转移性ROS1阳性非小细胞肺癌患者中的疗效和安全性的2期TRUST-I研究；5）评估抗PD-1单抗信迪利单抗联合紫杉醇和顺铂新辅助治疗局部晚期宫颈癌的疗效和安全性的一项2期研究；6）评估新辅助信迪利单抗联合含铂双药化疗后进行经口机器人手术治疗HPV相关可切除口咽癌的单臂、2期临床研究；7）评估信迪利单抗联合阿霉素和异环磷酰胺作为晚期未分化多形性肉瘤、滑膜肉瘤、粘液样脂肪肉瘤和去分化脂肪肉瘤患者的一线治疗疗效和安全性的单臂2期研究；8）奥雷巴替尼治疗酪氨酸激酶抑制剂（TKI）耐药的琥珀酸脱氢酶缺陷型（SDH-）胃肠道间质瘤（GIST）和副神经节瘤患者的最新疗效数据。亚盛医药：奥雷巴替尼作用机制：第三代BCR-ABL抑制剂适应症：胃肠道间质瘤和副神经节瘤亚盛医药宣布，该公司有三个新药的4项临床研究入选2024年ASCO年会，其中一项获口头报告。这3个药物分别为第三代BCR-ABL抑制剂奥雷巴替尼（HQP1351）、Bcl-2选择性抑制剂APG-2575和FAK/ALK/ROS1三联抑制剂APG-2449。其中，奥雷巴替尼治疗酪氨酸激酶抑制剂（TKI）耐药的琥珀酸脱氢酶缺陷型（SDH-）胃肠道间质瘤（GIST）和副神经节瘤患者的最新疗效数据入选了口头报告。宜明昂科：IMM01（timdarpacept)作用机制：新一代CD47靶向分子适应症：经典型霍奇金淋巴瘤、骨髓增生异常综合征宜明昂科宣布该公司今年共有5篇创新药研究结果被ASCO大会介绍，其中新一代CD47靶向分子IMM01有两项研究入选了口头报告，分别为：一项名为IMM01-04的开放标签、多中心、2期研究，旨在评估IMM01联合替雷利珠单抗治疗既往抗PD-1治疗失败的经典型霍奇金淋巴瘤的安全性和初步抗肿瘤活性；另一项为IMM01联合阿扎胞苷作为高风险骨髓增生异常综合征成人患者一线治疗的2期研究最新结果。值得一提的是，4月17日，宜明昂科刚宣布，IMM01联合抗PD-1单抗替雷利珠单抗已在中国获批一项3期临床试验，拟开发用于抗PD-(L)1单抗难治的经典霍奇金淋巴瘤患者治疗。正大天晴：安罗替尼作用机制：酪氨酸激酶抑制剂适应症：腺泡状软组织肉瘤正大天晴宣布，该公司将在今年ASCO大会上公布51项最新临床研究和基础研究数据，包括安罗替尼（小分子多靶点受体酪氨酸激酶抑制剂）、艾贝格司亭α（第三代双分子G-CSF）、派安普利单抗（PD-1抑制剂），以及在研创新项目贝莫苏拜单抗（TQB2450，PD-L1抑制剂）、TQB3617、TQB3728、TQB2930等多款创新肿瘤药物。其中，安罗替尼的一项2期研究入选了快速口头报告，该研究旨在评估安罗替尼联合抗PD-L1抗体治疗腺泡状软组织肉瘤的效果，本次将公布的是该研究的扩展队列的结果。一年一度的ASCO年会是全球肿瘤领域的学术交流盛会之一，将展示当前国际前沿的临床肿瘤学科研成果和肿瘤治疗技术。除了上述研究，还有很多其它中国新药研究也入选了本届ASCO大会，限于篇幅，本文不再一一介绍。我们将会持续跟踪本届ASCO会议的信息，为大家分享更多癌症研究领域的前沿动态。参考资料：[1]2024年ASCO大会官网. From https://conferences.asco.org/am/attend[2]各公司公开新闻稿本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「医药观澜」微信公众号留言联系我们。其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。