9MW-2821

SHANGHAI, May 24, 2024 /PRNewswire/ -- Mabwell (688062.SH), an innovation-driven biopharmaceutical company, announced the data and latest progress of the Phase I/II clinical study of 9MW2821, a novel Nectin-4-targeting ADC for multiple advanced solid tumors, which will be reported as an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. As of April 1, 2024, among 240 patients in the 1.25 mg/kg dose group in the Phase II clinical trial: >> Urothelial Carcinoma (UC) Of the 37 patients evaluable for efficacy assessment, the objective response rate (ORR) and disease control rate (DCR) were 62.2% and 91.9%, respectively, with median progression-free survival (mPFS) was 8.8 months and median overall survival (mOS) was 14.2 months. >> Cervical Cancer (CC) Of the 53 patients evaluable for efficacy assessment, 51% were previously treated with platinum-based doublet chemotherapy and bevacizumab, and 58% received platinum-based doublet chemotherapy and immune checkpoint inhibitor, with ORR and DCR were 35.8% and 81.1%, respectively. The mPFS was 3.9 months, with mOS not reached. Of the patients with Nectin-4 tumor cell staining intensity 3+, the ORR was 43.6% among the 39 evaluable patients. >> Esophageal Cancer (EC) Of the 39 patients evaluable for efficacy assessment, ORR and DCR were 23.1% and 69.2%, respectively, with mPFS of 3.9 months and mOS of 8.2 months; 37 of them were treated with platinum-based chemotherapy and immunotherapy previously. >> Triple-negative Breast Cancer (TNBC) Of the 20 patients with locally advanced or metastatic triple-negative breast cancer and evaluable for efficacy assessment, the ORR and DCR were 50.0% and 80.0% respectively. The mPFS was 5.9 months, and the mOS was not yet reached, with one patient achieved complete response (CR) and had been in CR for 20 months and is currently sustained to be CR. >> Safety Profile To date, the most common treatment-related adverse events (all grade, ≥grade 3) in the 240 patients in the 1.25 mg/kg dose group were white blood cell count decreased (50.8%, 23.3%), neutrophil count decreased (46.3%, 27.9%), anemia (43.8%, 8.3%), aspartate aminotransferase increased (42.1%, 2.9%), alanine aminotransferase increased (35.4%, 2.1%), asthenia (32.1%, 2.9%), rash (30.0%, 5.0%), decreased appetite (28.8%, 1.3%), nausea (26.7%, 0%), hyperglycemia (25.4%, 2.1%), platelet count decreased (24.2%, 4.6%), alopecia (24.2%, 0%), hypoaesthesia (22.5%, 1.7%), constipation (21.3%, 0%), vomiting (20.9%, 1.3%), hypertriglyceridemia (20.4%, 2.1%), and gamma glutamyl aminotransferase increased (15.8%, 5.4%). The data suggest that 9MW2821 has a manageable safety profile. About 9MW2821 9MW2821 is the first site-specific conjugated novel Nectin-4-targeting ADC developed by Mabwell using ADC platform and automated high-throughput hybridoma antibody molecular discovery platform, and is the first drug candidate to enter clinical study among the Nectin-4-targeting ADCs developed by Chinese companies, and the first therapeutic drug candidate targeting Nectin-4 in the world to reveal clinical efficacy data of cervical cancer, esophageal cancer and breast cancer. 9MW2821 has been granted Fast Track Designation (FTD) and Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma and esophageal cancer in Feb. 2024 and May 2024, respectively. 9MW2821 achieves site-specific modification of antibody through proprietary conjugate technology linkers and optimized ADC conjugation process. After injection, 9MW2821 can specifically bind to Nectin-4 on the cell membrane surface, be internalized and release cytotoxic drug, and induce the apoptosis of tumor cells. About Mabwell Mabwell (688062.SH) is an innovation-driven biopharmaceutical company with the entire value chain of the pharmaceutical industry. We provide more effective and accessible therapy and innovative medicines to fulfill global medical needs. Since 2017, an advanced R&D system which covers target discovery, early discovery, druggability, preclinical, clinical research and manufacturing transformation was established. Mabwell has 14 pipeline products in different stages based on a world-class and state-of-the-art R&D engine, including 10 novel drug candidates and 4 biosimilars. We focus on the therapeutic areas of oncology, auto-immune diseases, metabolic disorders, ophthalmologic diseases and infectious diseases, etc. Of these, 3 products have been approved and commercialized, 1 product has been filed for MA approval, 3 products are in pivotal trials. We have also undertaken 1 national major scientific and technological special project for "Significant New Drugs Development", 2 projects for National Key R&D Programmes, and multiple provincial and municipal science and technological innovation projects. Mabwell's Taizhou factory possesses robust in-house manufacturing capability compliant with international GMP standards regulated by the NMPA, FDA and EMA, and has passed the EU QP Audit. The large-scale manufacturing base located in Shanghai is under construction. Our mission is "Explore Life, Benefit Health" and our vision is "Innovation, from ideas to reality". For more information, please visit . Forward-Looking Statements This press release contains forward-looking statements including, but not limited to, the potential safety, efficacy, regulatory review or approval and commercial success of our product candidates and those relating to the Company's product development, clinical studies, clinical and regulatory milestones and timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. "Forward-looking statements" are statements that are not historical facts and involve a number of risks and uncertainties, which may cause actual results to be materially different from any future results expressed or implied in the forward-looking statements. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would," and similar expressions and the negatives of those terms. Forward-looking statements are based on the Company's current expectations and assumptions. Forward-looking statements are subject to a number of risks, uncertainties, and other factors, many of which are beyond the Company's control, including, but not limited to: environment; politic; economy; society; legislation; our dependence on our product candidates, most of which are still in preclinical or various stages of clinical development; our reliance on third-party vendors, such as contract research organizations and contract manufacturing organizations; the uncertainties inherent in clinical testing; our ability to complete required clinical trials for our product candidates and obtain approval from regulatory authorities for our product candidates; our ability to protect our intellectual property; the potential impact of COVID-19; the loss of any executive officers or key personnel. In case one or more of these risks or uncertainties deteriorate, or any assumptions are incorrect, the actual results may be seriously inconsistent with the stated results. The Company cautions all the persons not to place undue reliance on any such forward-looking statements, which speaks only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the applicable Stock authority to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. All forward-looking descriptions, figures and assumptions in this press release are applicable to this statement. SOURCE Mabwell

▎药明康德内容团队报道5月23日，迈威生物宣布将于2024年美国临床肿瘤学会（ASCO）年会上，以口头报告形式展示靶向Nectin-4的ADC创新药9MW2821的1/2期临床研究数据及最新进展，包括尿路上皮癌、宫颈癌、食管癌、三阴性乳腺癌等多种晚期实体瘤。9MW2821为迈威生物开发的一款靶向Nectin-4的定点偶联ADC新药。该药注射入体内后，可与肿瘤细胞表面的Nectin-4结合并进入细胞，通过酶解作用，定向释放细胞毒素，从而实现对肿瘤的精准杀伤。2024年2月、2024年5月，9MW2821先后获得美国FDA授予的快速通道资格和孤儿药资格，分别用于治疗晚期、复发或转移性食管鳞癌和食管癌。2024年5月，该药再次获得美国FDA授予快速通道资格，用于治疗既往接受过含铂化疗方案治疗失败的复发或转移性宫颈癌。截至2024年4月1日，在2期临床1.25mg/kg剂量组的240例患者中，针对不同癌种患者的数据分别如下：尿路上皮癌：37例可评估疗效的患者中，客观缓解率（ORR）为62.2%，疾病控制率（DCR）为91.9%，中位无进展生存期（mPFS）为8.8个月，中位总生存期（mOS）为14.2个月。宫颈癌：53例可评估疗效的患者中，51%受试者既往接受过含铂双药化疗及贝伐单抗治疗，58%受试者既往接受过含铂双药化疗及免疫检查点抑制剂治疗，ORR为35.8%，DCR为81.1%，mPFS为3.9个月，mOS尚未达到。Nectin-4肿瘤细胞染色强度3+的患者中，39例可评估疗效的患者ORR为43.6%。食管癌：39例可评估疗效的患者中，ORR为23.1%，DCR为69.2%，mPFS为3.9个月，mOS为8.2个月；其中37例接受过铂类化疗及免疫治疗。三阴性乳腺癌：20例可评估疗效的局部晚期或转移性三阴性乳腺癌患者中，ORR为50.0%，DCR为80.0%，mPFS为5.9个月，mOS尚未达到；其中，1例完全缓解（CR）患者已持续治疗20个月，目前仍持续完全缓解。安全性数据。截至目前，1.25 mg/kg剂量组240例患者中，最常见的治疗相关不良事件和≥3级治疗相关不良事件是白细胞计数降低、中性粒细胞减少、贫血、天门冬氨酸氨基转移酶升高、丙氨酸氨基转移酶升高、虚弱、皮疹、食欲减退、恶心、高血糖症、血小板计数降低、脱发、感觉减退、便秘、呕吐、高甘油三酯血症、γ谷氨酰氨基转移酶升高 。研究认为，这些数据表明9MW2821具有可控的安全性。参考资料：[1]  迈威生物 9MW2821 将于 2024 ASCO 年会以口头报告形式展示的临床数据及最新进展. Retrieved May 23 , 2024, from https://mp.weixin.qq.com/s/CC84t2vBwdvOl4Q6Weh8VQ本文由药明康德内容团队根据公开资料整理编辑，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。转发授权请在「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。