An Open-Label, Multicenter, Phase Ib Dose Randomization Study of Bulumtatug Furvedotin (BFv; 9MW2821) in Subjects With Recurrent or Metastatic Triple-Negative Breast Cancer Previously Treated With Antibody-Drug Conjugates

The goal of this clinical trial is to investigate if treatment with bulumtatug fuvedotin is effective in triple-negative breast cancer patients who have previously received treatment with an antibody-drug conjugates.

开始日期2025-05-01

申办/合作机构

迈威（上海）生物科技股份有限公司

NCT06926998

/ Not yet recruiting临床1/2期

An Open-Label, Multicenter Phase Ib/ll Clinical Study Evaluating the Safety and Efficacy of 9MW2821 Combined With Other Antitumor Drugs in Patients With Advanced Gynecological Tumors

To evaluate the safety, tolerability, and preliminary efficacy of 9MW2821 in combination with other anti-tumor agents in patients with advanced gynecological malignancies.

开始日期2025-04-15

申办/合作机构

迈威（上海）生物科技股份有限公司

NCT06947226

/ Not yet recruiting临床1/2期

A Phase Ib/ll Clinical Study of Safety and Efficacy of 9MW2821 Monotherapy or Combined With Other Anticancer Therapy in Advanced Solid Tumors

This study is a Phase Ib/ll, open-label, multicenter study designed to evaluate the safety and efficacy of 9MW2821 monotherapy or combined with other anticancer therapy in advanced solid tumors.

开始日期2025-04-01

申办/合作机构

迈威（上海）生物科技股份有限公司

100 项与 Bulumtatug fuvedotin 相关的临床结果

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100 项与 Bulumtatug fuvedotin 相关的转化医学

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100 项与 Bulumtatug fuvedotin 相关的专利（医药）

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574

项与 Bulumtatug fuvedotin 相关的文献（医药）

2025-12-31·mAbs

A bispecific antibody-drug conjugate targeting pCAD and CDH17 has antitumor activity and improved tumor-specificity

作者: Gesner, Thomas ; Logel, Claude ; Xie, Kathleen T. ; Cebe, Regis ; Wu, Nila C. ; Li, Xun ; Shi, Xingyi ; Velazquez, Roberto ; Simmons, Quincey ; Tschantz, William R. ; Barzaghi-Rinaudo, Patrizia ; Korn, Joshua ; Sagar, Vivek ; Hainzl, Dominik ; Malamas, Anthony ; Mercan, Samuele ; Green, Andrew ; McLaughlin, Margaret ; Huber, Thomas ; Mueller, Kathrin ; Synan, Alyssa ; D’Alessio, Joseph A.

P-cadherin (pCAD) and LI-cadherin (CDH17) are cell-surface proteins belonging to the cadherin superfamily that are both highly expressed in colorectal cancer.This co-expression profile presents a novel and attractive opportunity for a dual targeting approach using an antibody-drug conjugate (ADC).In this study, we used a unique avidity-driven in vitro screening approach to generate pCAD x CDH17 bispecific antibodies that selectively target cells expressing both antigens over cells expressing only pCAD or only CDH17.Based on in vitro binding and inhibition of cell proliferation results, we selected a lead bispecific antibody to link to the cytotoxic payload monomethyl auristatin E (MMAE) to generate a pCAD x CDH17 bispecific MMAE ADC.In in vivo dual flank mouse models, we demonstrated antitumor activity of the bispecific ADC in tumors expressing both antigens but not in tumors expressing only pCAD or only CDH17.Overall, the preclin. data presented here support the proof-of-concept bispecific antibody discovery approach, demonstrating a rational design for screening antibodies by prioritizing cross-arm avid IgGs to target dual-pos. cells.

2025-05-12·ACS Biomaterials Science & Engineering

Enhanced Targeted Drug Delivery System to Control Avidity and Drug Encapsulation Using E2 Nanocages and SpyTag/SpyCatcher

Article

作者: Gone, Geetanjali B. ; Jeong, Myeong Seon ; Park, Sun Hee ; Chung, Sang J. ; Cho, Younghun ; Lee, Yeong Geun ; Ahn, Dohee

Although antibody-drug conjugates offer advanced targeted anticancer therapy that overcomes the limitations of conventional chemotherapy and therapeutic antibodies, they are restricted in their capacity to carry multiple hydrophobic payloads. Protein nanocages have emerged as versatile therapeutic platforms for targeted drug delivery, offering advantages like precise molecular assembly, biocompatibility, and multivalent targeting. This study presents the development of engineered E2 nanocages functionalized with anti-HER2 single-chain variable fragments (scFv) using the SpyTag/SpyCatcher ligation system to achieve controlled scFv display valency. The results demonstrate that increasing anti-HER2 scFv valency enhances HER2 binding affinity via avidity effects, with the highest valency nanocages showing the highest binding avidity. Furthermore, cysteine residues were introduced into the E2 nanocages to enable conjugation with monomethyl auristatin E (MMAE) through maleimide chemistry, achieving efficient drug loading. The resulting MMAE-conjugated nanocages displayed potent, subnanomolar cytotoxicity in HER2-positive SKBR3 and BT-474 cell lines while sparing HER2-negative MDA-MB-231 cells at concentrations up to 1 nM. These results underscore the critical role of scFv valency in enhancing HER2 targeting and highlight the potential of E2 protein nanocages as specific, potent platforms for targeted cancer therapy. In this study, we developed an enhanced targeted drug delivery system using E2 nanocages and scFv with SpyCatcher/SpyTag ligation to regulate binding avidity and encapsulate hydrophobic drugs. The modular design and pH-sensitive dissociation of these nanocages establish a foundation for next-generation precision medicine strategies.

2025-04-16·BIOCONJUGATE CHEMISTRY

Mechanistic Characterization of the Potency of THIOMAB Antibody–Drug Conjugates Targeting Staphylococcus aureus and ETbR-Expressing Tumor Cells Using Quantitative LC-MS/MS Analysis of Intracellular Drug Accumulation

Article

作者: Hernandez-Barry, Hilda ; Asundi, Jyoti ; Vandlen, Richard ; Zhang, Donglu ; Pillow, Thomas ; Loyet, Kelly M. ; Hazenbos, Wouter L.W. ; Liu, Yichin ; dela Cruz-Chuh, Josefa ; Wu, Cong ; Kozak, Katherine R. ; Kajihara, Kimberly K.

THIOMAB drug conjugate (TDC) technology provides site-specific conjugation of linker drugs to antibodies, allowing for targeted delivery of the payload. While a direct measurement of TDC cytotoxic potency allows efficient screening and confirmation that new drugs conjugated to antibodies result in proper processing in cells, additional mechanistic characterization is often needed to provide information-rich data to guide further optimization of TDC design. For example, a quantitative understanding of how TDCs are processed intracellularly can help determine which processing step is impacting payload delivery and thereby inform the basis of the TDC efficacy. Here, we measure the cellular accumulation of two different TDC drug payloads: MAPK (mitogen-activated protein kinase) pathway inhibitor targeting ETbR-expressing tumor cells and an antibiotic active against Staphylococcus aureus with an in vitro cell-based drug release LC-MS/MS assay in a 96-well format. This assay allowed us to correlate the cellular potency of each unconjugated molecule with the amount of payload that accumulated inside the cell. In the case of the pathway inhibitor drug, the biochemical characterization of TDC processing by cathepsin B and purified human liver enzyme extract demonstrated a correlation between the efficiency of the linker drug cleavage and intracellular payload accumulation. For the antibody-antibiotic conjugate, kinetic analysis of intracellular free drug retention provided valuable insight into the chemistry modifications needed for an efficient TDC. Taken together, we demonstrated the utility of quantitative LC-MS/MS assays as one tool in guiding the design of more effective TDCs via the mechanistic release characterization of two distinct payloads.

118

项与 Bulumtatug fuvedotin 相关的新闻（医药）

2025-05-26

·药渡

ASCO 2025热点速递 | 多款国产新药披露亮眼临床数据

2025年美国临床肿瘤学会（ASCO）年会将于5月30日至6月3日在美国芝加哥举行。4月底，ASCO官网已经公布所有中选的摘要标题。据药研网不完全统计，国内ADC领域已有28款产品的36项研究在ASCO上披露，涵盖HER2、EGFR、TROP2等热门靶点。5月22日，ASCO年会摘要全文公布，多款国产新药披露了亮眼的临床数据。科伦博泰四川科伦博泰将在本次大会公布其TROP2 ADC芦康沙妥珠单抗（sac-TMT）、抗PD-L1单抗塔戈利单抗（A167）以及RET抑制剂KL590586（A400/EP0031）的六项临床研究结果：其中2项研究数据详细介绍：在III期OptiTROP-Lung03研究中，共纳入137例EGFR突变、经EGFR-TKI及铂类化疗后进展的晚期非小细胞肺癌（NSCLC）患者。研究数据显示，在中位随访12.2个月时：芦康沙妥珠单抗组经独立影像评估委员会（BIRC）评估的客观缓解率（ORR）为45.1%，显著优于对照组多西他赛（15.6%，单侧p=0.0004）；中位无进展生存期（PFS）为6.9个月 vs 2.8个月，HR=0.30（单侧p<0.0001）；研究者评估下PFS分别为7.9个月和2.8个月，HR=0.23；尽管多西他赛组中有36.4%的患者在疾病进展后交叉接受芦康沙妥珠单抗治疗，中位总生存期（OS）在两组中尚未达到；经保秩结构失效时间（RPSFT）模型调整后，芦康沙妥珠单抗组中位OS仍未达到，对照组为9.3个月，HR=0.36，提示其潜在生存获益。在II期OptiTROP-Breast05研究中，共纳入41例既往未接受治疗的不可切除局部晚期或转移性三阴性乳腺癌（a/m TNBC）患者，其中43.9%为ECOG PS评分1分，78.0%的PD-L1 CPS评分<10。截至中位随访18.6个月时，研究结果显示：客观缓解率（ORR）达70.7%，疾病控制率（DCR）为92.7%；缓解持续时间（DoR）中位数为12.2个月；中位无进展生存期（PFS）为13.4个月；在PD-L1 CPS<10的32例患者中，ORR为71.9%，DCR为93.8%，中位PFS为13.1个月，提示其疗效与PD-L1表达水平关联不强。迈威生物丨9MW2821在2025年ASCO年会上，迈威生物展示了的多项临床研究成果。其中，首次以口头报告形式发布其Nectin-4 ADC 9MW2821联合PD-1抗体特瑞普利单抗（Toripalimab）的Ib/II期研究结果。迈威生物自主研发的9MW2821在晚期或转移性尿路上皮癌（la/mUC）治疗中展现出强劲疗效。研究共纳入40例既往未经系统治疗的la/mUC患者，接受9MW2821（1.25 mg/kg）联合特瑞普利单抗（Toripalimab, 240 mg）治疗。截止至2024年12月19日，数据显示该联合治疗方案的客观缓解率（ORR）为87.5%，经确认的ORR为80%，疾病控制率（DCR）达92.5%。中位无进展生存期（PFS）和缓解持续时间（DoR）尚未达到，显示出持久的治疗潜力。值得注意的是，研究中未观察到任何新的与9MW2821或特瑞普利单抗相关的安全性信号，表明该联合方案在疗效和耐受性之间具备良好平衡。泽璟制药|ZG006在此项II期研究中，ZG006单药（剂量为10 mg或30 mg，每两周一次）用于治疗既往接受过至少二线标准系统治疗的小细胞肺癌（SCLC）患者，显示出良好的初步疗效。截至2024年12月31日，共有40例患者入组，其中27例可评估疗效。结果显示，18例患者实现部分缓解（PR），其中5例已确认，其余尚待确认，初步客观缓解率（ORR）达到66.7%，疾病控制率（DCR）为92.6%。在剂量分组中，10 mg组的ORR为53.8%（7/13），DCR为84.6%；30mg组的ORR高达78.6%（11/14），DCR为100%。治疗反应的持续时间（DoR）及无进展生存期（PFS）尚未成熟，仍需进一步随访。在21例DLL3表达水平较低（17例）或中等表达（4例）的患者中，ZG006仍展现出良好的抗肿瘤活性，15例患者实现PR，ORR为71.4%，提示该药物在DLL3表达水平较低的患者中依然具有潜在疗效。安全性方面，治疗相关不良事件（TRAE）发生率为87.5%（35/40），其中3级及以上TRAE发生率为12.5%（5/40），严重不良事件（SAE）发生率同样为12.5%，未观察到因TRAE导致的停药或死亡事件，整体安全性可控。这些结果为ZG006在SCLC后线治疗中的进一步开发奠定了基础。恒瑞医药|SHR-1501在一项针对高危非肌层浸润性膀胱癌（NMIBC）患者的I/II期临床研究中，研究人员评估了SHR-1501单药或联合卡介苗（BCG）的安全性、耐受性及初步疗效。I期研究包括Ia期的单药SHR-1501剂量递增部分（n=8）和Ib期的SHR-1501联合BCG治疗部分（n=6），结果显示未观察到剂量限制性毒性（DLT），也未达到最大耐受剂量（MTD），为后续研究奠定了安全基础。II期研究中，SHR-1501（600μg）联合BCG的治疗进一步在三个患者队列中展开评估：队列A为初次接受BCG治疗的NMIBC患者（n=29），队列B为对BCG治疗无应答的原位癌患者（n=17），队列C则为BCG无应答的非原位高级别Ta/T1期NMIBC患者（n=24）。在队列B中，有效性评估结果显示，在可评估疗效的患者中，3个月或6个月的完全缓解（CR）率高达90.9%（10/11）。队列A和C的12个月无疾病生存期（DFS）数据尚未成熟，但在中期分析中，9个月DFS率分别为94.4%和53.9%，显示出积极的临床趋势。安全性方面，SHR-1501单药治疗组的治疗相关不良事件（TRAE）发生率为50.0%（4/8），而联合BCG治疗组为69.7%（53/76）。3级及以上TRAE的发生率分别为12.5%（1/8）和9.2%（7/76）。研究过程中未出现4-5级TRAE，也无严重不良事件（SAE）报告，整体治疗耐受性良好。药渡媒体商务合作媒体公关 | 新闻&会议发稿张经理：18600036371（微信同号）点击下方“药渡“，关注更多精彩内容免责声明“药渡”公众号所转载该篇文章来源于其他公众号平台，主要目的在于分享行业相关知识，传递当前最新资讯。图片、文章版权均属于原作者所有，如有侵权，请及时告知，我们会在24小时内删除相关信息。微信公众号的推送规则又双叒叕改啦，如果您不点个“在看”或者没设为"星标"，我们可能就消散在茫茫文海之中~点这里，千万不要错过药渡的最新消息哦！👇👇👇

ASCO会议临床结果抗体药物偶联物临床1期临床2期

2025-05-26

·抗体圈

手握BIC，科创Biotech被严重低估

2025 ASCO大会公布的国产创新分子数据百花齐放，但要说其中真正超出市场预期的数据，迈威生物的Nectin4 ADC（9MW2821）要算其中之一。9MW2821联用PD-1特瑞普利单抗在一线尿路上皮癌的1b/2期中，其疗效数据展现出了优于Padcev联用K药的疗效，同类最佳的属性非常突出。在这一轮的创新药行情中，迈威生物作为国内创新研发能力突出的Biotech来说，公司明显滞涨于其他同行业Biotech（截至5月26日收盘年度累积涨幅仅12.43%），这或许存在一定的不合理性。从迈威生物的全方位布局审视，公司不仅有生物类似药全球布局作为基本盘，同时在ADC平台层面有极强的海外授权预期，以及在大分子抗体领域有出色差异化布局，这些都将成为公司未来市值催化的潜在助力。尽管短期的处罚瑕疵会影响市场判断，但长期价值必将回归。01生物类似药基本盘与大部分未有商业化产品的Biotech相比，迈威生物拥有生物类似药的基本盘，在未来几年将为公司提供源源不断的现金流，以对冲大量研发投入带来的现金流失。目前，迈威生物拥有三款生物类似药产品在市，包括君迈康（阿达木单抗）、迈利舒和迈卫健（以上两款均为地舒单抗），2025年长效G-CSF（8MW0511）有望获批上市且抗VEGF眼科药物（9MW0813）有望申报BLA，公司生物类似药商业化管线梯队进一步夯实。2024年及2025年一季度，迈威生物药品销售收入分别为1.45亿元和4472.07 万元，同比增长243.53%和149.77%。目前公司在市产品中最大的增长来源于地舒单抗，2024年收入为1.39亿，占全年药品销售收入的95.86%。地舒单抗的原研方为安进，其对应的Prolia（骨质疏松）和Xgeva（肿瘤骨转移）合计销售额在2023年、2024年分别为61.6亿美元和43.74亿（专利到期）。据财通证券数据，2024年Xgeva中国销售收入约2.24亿美元，同比增长141.7%。据弗若斯特沙利文的分析，2025年中国地舒单抗市场规模预计达到37.41亿元，2030年中国市场规模将达到106.61亿元。目前来看，国内地舒单抗市场安进一家独大（2024H1市占率高达94.21%），而生物类似药中有迈威生物、齐鲁制药和博安生物，国产厂商除了替代空间十足之外，人口老龄化和骨质疏松诊出率提升也加速地舒单抗市场的快速增长。（迈威生物地舒单抗市占率情况）从目前的放量趋势来看，迈威生物地舒单抗产品未来在国内取得至少10-15%的市场份额是可以预见的，国内销售峰值保守预计在10-15亿。该产品的潜力不局限于国内，迈威生物在海外多个国家和地区达成了对外合作，包括与俄罗斯药企Binnopharm Group、巴西及哥伦比亚Legrand、巴基斯坦Searle以及泰国Innobic等的合作，未来海外市场放量将进一步打开单品天花板。从迈威生物现有在市产品和短期内有望上市生物类似药产品来看，阿达木单抗国内市场较卷，预计可能有小几亿的销售峰值；而长效升白药和眼科VEGF单抗市场较大，竞争对手也不少，两款药物销售合计峰值可能同样在10-15亿；整体来看，预计迈威生物的生物类似药总盘子未来的体量有可能在30-35亿的范围。（图源：迈威生物公告）02ADC平台倍产潜力分子迈威生物ADC平台的价值日益凸显，在这次2025 ASCO大会上，市场不仅更加笃定9MW2821是潜在的BIC，而且还看到了B7H3、Trop-2靶点ADC的一些初步潜力。Nectin4 ADC管线9MW2821显然是迈威生物的ADC管线的“头号炸子鸡”，目前在国内已经推进至临床三期，全球进度仅次于辉瑞的Padcev，目前在各线尿路上皮癌（UC）治疗中已经展现出BIC潜力。Padcev是尿路上皮癌领域的重磅炸弹，于2019获批二线后尿路上皮癌，并在2023年底联用K药获批一线治疗尿路上皮癌，2024年销售高达15.88亿美元，2025Q1更是单季销售增至4.26美元（Yoy+25%），不可小觑其市场扩张力。在2024年公布9MW2821单药治疗晚期后线UC的I/II期临床研究中，1.25 mg/kg剂量组的客观缓解率（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（OS）为14.2个月。安全性方面，9MW2821在274例患者中≥3级的TRAEs发生率为57.7%，主要为血液毒性，导致停药比例为3.9%，不过市场关注的皮肤毒性和眼部毒性≥3级的TRAEs发生率罕见，分别为5.1%和0.8%；对比Padcev，其带有严重皮肤毒性的黑框警告，且带有周围神经病变、眼疾病、肺炎等特殊毒性。最新的2025 ASCO大会公布的数据，9MW2821联用特瑞普利单抗一线治疗尿路上皮癌1b/2期临床数据显示，在40例患者中ORR为87.5%，cORR为80%，DCR为92.5%，而PFS、DoR未成熟；非头对头对比下，Padcev联用K药治疗尿路上皮癌3期研究，cORR为67.5%，mPFS为12.5个月，mOS为33.8个月。值得注意的是，Nectin4除了在UC上显著高表达外，其在三阴乳腺癌（TNBC）、宫颈癌（CC）、等多个实体瘤中亦高表达，9MW2821目前在TNBC、CC和食管癌（EC）亦进行早期临床探索，未来有望成为一个广谱性的创新大药。除了9MW2821之外，基于迈威生物新一代ADC定点偶联技术（IDDC™）和采用创新载荷的非P-糖蛋白（P-gp）底物的MF-6平台开发的7MW3711（B7H3 ADC）、9MW2921（Trop2 ADC）也在2025 ASCO大会上公布了初步数据，以B7H3 ADC管线7MW3711为例，在入组了16例小细胞肺癌（SCLC） I/II 期临床研究中，患者的ORR和DCR分别为62.5%和100.0%，非头对头对比数据对比目前在研的B7H3 ADC数据下，也具备极强的竞争力。另外，胃肠道肿瘤创新靶点CDH17的ADC管线7MW4911中美双报IND也在路上，亦存在较强的未来海外授权预期。03手握呼吸科潜力大药管线迈威生物9MW1911作为国内首个获批临床的ST2单抗，其下半年I/II期COPD（慢肺阻）临床数据读出备受期待。过去IL-33/ST2通路在呼吸系统疾病的作用逐渐被验证，尤其与COPD的发生、发展及急性加重密切相关，比如IL-33表达水平与中重度COPD患者急性加重风险和疾病严重程度正相关。目前ST2单抗全球已有临床领先的分子初步证明了成药性，以罗氏全球同类首创ST2单抗Astegolimab的IIa期临床数据显示，接受治疗的中重度慢阻肺病患者急性加重发生率降低22%，并且相比高嗜酸性粒细胞患者，低嗜酸性粒细胞患者（≤170细胞/μL）亚组中慢阻肺病急性加重发生率降幅更大，为31%；安全性方面，stegolimab的治疗相关不良事件与安慰剂组相似，未发现安全性问题。（图源：呼吸界）ST2单抗相对于已获批COPD的IL4Rα度普利尤单抗和IL-33单抗有差异化优势：度普利尤单抗只适用于2型炎症的慢阻肺患者（血嗜酸性粒细胞≥300个细胞/μL），而IL-33单抗itepekimab则目前暂时被证明对过往吸烟史患者有效，ST2单抗更差异化针对低嗜酸性粒细胞COPD人群（流行病学显示COPD以嗜酸性粒细胞计数小于300个细胞/μL的患者居多，而一项研究显示这类患者约占COPD总人数的31%）。赛诺菲/再生元对其IL-33单抗Itepekimab销售峰值预估高达22亿美元，而协同度普利尤单抗在COPD的适应症潜力合计销售峰值高达50亿美元。据《中国吸烟危害健康报告2022》，中国40岁以上人群COPD患病率高达13.7%，推测估算潜在患者可能接近1亿人，可见COPD药物市场空间巨大。9MW1911在Ib/IIa期阶段性结果显示，患者急性加重率呈下降趋势，且FEV1（用力呼气容积）在部分患者中观察到改善趋势；安全性方面，未报告严重不良事件（SAE），常见不良反应为轻度头痛（8%）和注射部位反应（5%）。9MW1911作为国内进度第一和全球第二的ST2单抗，如若I/II期数据顺利验证，显然具备较大的出海潜力；同时，迈威生物的IL-11单抗9MW3811也进入了临床阶段（特发性肺纤维化），同样为国内第一、全球第一梯队的产品。结语：迈威生物在各个药物和疾病领域的研发能力正在被市场逐步验证，除了文中提到的几大重磅药物外，公司还有治疗真性红细胞增多症和β-地中海贫血的TMPRSS6单抗（国内首家进入临床），并且在2025年AACR大会上公布了其TCE双/三特异性抗体平台，可开发1+1、1+2、2+2等多种TCE形式，未来有望倍产FIC管线。对于迈威生物这种既有中短期有望快速放量的商业化品种的Biotech，公司又手握数个潜力重磅创新药管线（Nectin4 ADC和一众平台分子，以及ST2单抗等特色管线）有强烈海外授权预期，同时公司新一代ADC平台和TCE在未来能源源不断产出优质创新药管线，目前的市值显然是被严重低估的。据太平洋医药模型测算，公司合理估值预估在134亿人民币。识别微信二维码，添加抗体圈小编，符合条件者即可加入抗体圈微信群！请注明：姓名+研究方向！本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

生物类似药抗体药物偶联物专利到期财报ASCO会议

2025-05-23

·PRNewswire

Mabwell Announces Clinical Data of Multiple ADCs to be presented at 2025 ASCO Annual Meeting

SHANGHAI, May 23, 2025 /PRNewswire/ -- Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, announced multiple clinical research results to be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, including phase Ib/II clinical study data of 9MW2821 (Bulumtatug Fuvedotin, BFv), a novel Nectin-4 targeting ADC, in combination with Toripalimab in locally advanced or metastatic uroepithelial carcinoma to be presented as oral presentation, and clinical study data of 7MW3711 and 9MW2921, a novel B7-H3 targeting ADC and a novel Trop-2 targeting ADC respectively, to be presented as poster presentations. The study of 9MW2821 was the only selected Chinese oral presentation in the field of urothelial carcinoma at this meeting. Nectin-4 ADC (9MW2821): In the phase Ib/II clinical study of 9MW2821 in combination with Toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma (la/mUc), a total of 40 patients with previously untreated for la/mUC were enrolled in the study and were treated with 9MW2821 (1.25 mg/kg) and Toripalimab (240 mg). As of December 19, 2024, the objective response rate (ORR) was 87.5% and the confirmed ORR was 80%. The disease control rate (DCR) was 92.5%. Median progression-free survival (PFS) and duration of response (DoR) have not been achieved. No new safety signals of 9MW2821 or Toripalimab were observed in this study. 9MW2821 stands out as the first clinical-stage drug candidate among Chinese companies for this specific target. And it's the first Nectin-4 targeting ADC to disclose clinical efficacy data in cervical, esophageal, and breast cancers. Currently, 3 Phase III pivotal clinical trials are ongoing. Its monotherapy and combination therapy with Toripalimab for urothelial carcinoma have been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. It has also been granted Fast Track Designations (FTD) for 3 indications and Orphan Drug Designation (ODD) for 1 indication by the U.S. Food and Drug Administration (FDA). B7-H3 ADC (7MW3711): 7MW3711 has enrolled 43 patients as of January 2, 2025 in a phase I/II clinical study in patients with advanced solid tumors. During the dose-escalation phase, dose-limiting toxicity (DLT) was not observed and the maximum tolerated dose (MTD) has not been reached. In patients evaluated at doses of 4.5 mg/kg or higher, the ORR for esophageal cancer, ovarian cancer, and prostate cancer was 33.3%, 60.0%, and 50.0%, respectively, and the DCR was 100%. In the phase I/II clinical study in lung cancer patients, 37 lung cancer patients were enrolled as of January 8, 2025, including 16 small cell lung cancer (SCLC) patients and 21 non-small cell lung cancer (NSCLC) patients. Common grade ≥3 adverse reactions were neutrophil count decreased, white blood cell count decreased, anemia, lymphocyte count decreased, and platelet count decreased. Among the 25 patients who received 7MW3711 at a dose of 4.5 mg/kg or greater and completed at least one tumor evaluation, the ORR was 36.0% and the DCR was 96.0%; of these, the ORR and DCR were 62.5% and 100.0%, respectively, for patients with small-cell lung cancer at a dose of 4.5 mg/kg. Among squamous lung cancer (Sq-NSCLC) patients with a B7-H3 H-score >5, the ORR and DCR were 37.5% and 87.5%, respectively. The study results suggest that 7MW3711 has a tolerable safety profile and good anti-tumor activity in patients with advanced tumors such as lung, esophageal, prostate and ovarian cancers. 7MW3711 was developed with Mabwell's Interchain-Disulfide Drug Conjugate (IDDC™) platform. It consists of an innovative antibody molecule, a novel linker, and a novel payload: Mtoxin™, which is a topoisomerase I inhibitor. It has been granted ODD by the FDA for the treatment of SCLC. Trop-2 ADC (9MW2921): In the first-in-human clinical study in patients with advanced solid tumors, a total of 39 patients were enrolled as of November 12, 2024. The most common ≥3 grade adverse were stomatitis, anemia, white blood cell count decreased, neutropenia, lymphocyte count decreased, etc. The ORR of 3.0 mg/kg dose group was 42.1% and the DCR was 84.2%. Under this dose level, the ORR and DCR was 75% and 100% for endometrial cancer, 50% and 75% for HR+/HER2- breast cancer, 50% and 100% for gastric cancer, 25% and 100% for non-squamous non-small cell lung cancer. The study result suggests that 9MW2921 has a tolerable safety profile and good anti-tumor activity in patients with advanced tumors. 9MW2921 was developed with Mabwell's Interchain-Disulfide Drug Conjugate (IDDC™) platform. It consists of an innovative antibody molecule, a novel linker, and a novel payload: Mtoxin™, which is a topoisomerase I inhibitor. 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 16 pipeline products in different stages based on a world-class and state-of-the-art R&D engine, including 12 novel drug candidates and 4 biosimilars. We focus on the therapeutic areas of oncology, immunology, bone disorders, ophthalmology, hematology and infectious diseases, etc. Of these, 3 products have been approved and commercialized, 1 product has been filed for market 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 in Shanghai and the ADC commercialized manufacturing base in Taizhou are 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 WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

快速通道ASCO会议临床结果孤儿药突破性疗法

100 项与 Bulumtatug fuvedotin 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
子宫颈转移癌	临床3期	中国	迈威（上海）生物科技股份有限公司	2024-09-10
宫颈癌	临床3期	中国	江苏迈威康新药研发有限公司	2024-09-10
膀胱尿路上皮癌	临床3期	中国	迈威（上海）生物科技股份有限公司	2024-08-22
子宫内膜癌	临床2期	中国	江苏迈威康新药研发有限公司	2025-03-26
卵巢癌	临床2期	中国	江苏迈威康新药研发有限公司	2025-03-26
肾盂和输尿管尿路上皮癌	临床2期	中国	迈威（上海）生物科技股份有限公司	2025-01-17
复发性尿路上皮癌	临床2期	中国	迈威（上海）生物科技股份有限公司	2025-01-17
晚期三阴性乳腺癌	临床2期	中国	迈威（上海）生物科技股份有限公司	2024-07-26
转移性三阴性乳腺癌	临床2期	中国	迈威（上海）生物科技股份有限公司	2024-07-26
晚期恶性实体瘤	临床2期	中国	迈威（上海）生物科技股份有限公司	2022-06-11

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05216965 (9MW2821, Pubmed \| Ann Oncol)	临床1/2期	晚期恶性实体瘤 Nectin-4	274	9MW2821 0.33mg/kg	構糧衊憲顧築醖築壓遞(獵餘築醖顧遞鑰願鏇遞) = 繭簾窪鹽構願艱衊膚築鏇選鑰餘襯糧糧觸廠鬱 (鹹獵製遞鑰獵齋獵遞範 ) 更多	积极	2025-04-01
NCT05216965 (9MW2821, Pubmed \| Ann Oncol)	临床1/2期	晚期恶性实体瘤 Nectin-4	274	9MW2821 1.5mg/kg	構糧衊憲顧築醖築壓遞(獵餘築醖顧遞鑰願鏇遞) = 顧築鬱積範鬱範繭壓鹽鏇選鑰餘襯糧糧觸廠鬱 (鹹獵製遞鑰獵齋獵遞範 ) 更多	积极	2025-04-01
NCT06079112 (PRNewswire) 人工标引	临床3期	不可切除的尿路上皮癌一线	40	9MW2821 + Toripalimab	夢鏇獵衊鑰鹽衊選積構(築壓艱衊淵築齋鬱鬱鹽) = 蓋鹹蓋衊鏇艱獵遞網鏇醖夢淵艱襯顧鏇襯願憲 (鏇膚廠夢鹹鑰鬱鑰顧齋 ) 更多	积极	2025-01-09
PRNewswire 人工标引	N/A	宫颈癌 PVRL4	53	9MW2821	範顧選願壓選遞鹽繭襯(蓋選繭夢鑰遞構繭鏇壓) = 淵願鹽範積願鹹夢築餘鑰簾蓋獵鹽獵繭壓鏇網 (窪膚簾鬱糧壓艱簾餘鹽 ) 更多	积极	2024-08-23
PRNewswire 人工标引	N/A	宫颈癌 PVRL4	53	9MW2821 (Nectin-4 IHC 3+)	範顧選願壓選遞鹽繭襯(蓋選繭夢鑰遞構繭鏇壓) = 廠鹹窪憲膚夢鏇選遞築鑰簾蓋獵鹽獵繭壓鏇網 (窪膚簾鬱糧壓艱簾餘鹽 )	积极	2024-08-23
NCT05216965 (NEWS \| ASCO2024) 人工标引	临床1/2期	食管癌 \| 晚期恶性实体瘤 \| 三阴性乳腺癌 ... 一线 Nectin-4 positive 更多	240	9MW2821 at 1.25mg/kg or above (UC)	窪鹹淵窪壓網窪願蓋鏇(衊鬱醖構憲製願鏇顧築) = 繭願鏇積膚壓繭蓋餘選築構齋範淵淵壓築膚夢 (蓋壓鑰獵鏇簾簾築構窪, 44.76 ~ 77.54) 更多	积极	2024-05-25
NCT05216965 (NEWS \| ASCO2024) 人工标引	临床1/2期	食管癌 \| 晚期恶性实体瘤 \| 三阴性乳腺癌 ... 一线 Nectin-4 positive 更多	240	9MW2821 at 1.25mg/kg or above (CC)	窪鹹淵窪壓網窪願蓋鏇(衊鬱醖構憲製願鏇顧築) = 窪憲壓鹹遞願艱壓淵遞築構齋範淵淵壓築膚夢 (蓋壓鑰獵鏇簾簾築構窪, 23.77 ~ 53.46) 更多	积极	2024-05-25
NCT05216965 (PRNewswire) 人工标引	临床1/2期	转移性三阴性乳腺癌 \| 晚期三阴性乳腺癌	20	9MW2821	糧廠繭艱選簾築顧鏇糧(範繭窪壓蓋窪構膚選構) = 獵選鑰淵齋窪鹹簾製製製憲構獵築願鬱衊積夢 (選齋願鹽蓋壓衊鏇鏇鬱 ) 更多	积极	2024-05-13
Corporate Publications 人工标引	临床1/2期	宫颈癌 NECTIN4 Positive	40	9MW2821	憲餘憲淵糧鹹鹹積糧鹽(簾顧廠觸繭鹽壓膚鬱夢) = 醖窪鹹壓淵壓夢簾夢構網範衊餘構鬱衊窪鹹鑰 (窪選廠鑰構築淵選衊繭 ) 更多	积极	2024-03-18
NEWS 人工标引	临床2期	尿路上皮癌	-	9MW2821 1.25mg/kg	獵憲繭遞衊膚餘膚壓齋(膚夢獵積鹽廠蓋艱齋膚) = 淵餘衊鑰構襯蓋構鹹齋窪衊襯糧遞廠淵願鹹網 (膚餘蓋網獵構繭築製顧, 44.8 ~ 77.5) 更多	积极	2023-12-07
NCT05216965 (ESMO 12023 \| ESMO 22023) 人工标引	临床1/2期	实体瘤	-	9MW2821	艱構膚繭願夢壓壓製製(遞遞繭鹹選鑰襯鏇鹹範) = 願繭壓鬱範壓觸蓋範憲網廠夢選夢鹽壓淵願夢 (願襯窪獵鏇選製淵範膚 ) 更多	积极	2023-10-23