Neoaduvant chemotherapy woth FOLFOXIRI and anti-EGFR monoclonal antibody for colorectal cancer with liver metastasis - Neoaduvant chemotherapy woth FOLFOXIRI and anti-EGFR monoclonal antibody for colorectal cancer with liver metastasis

开始日期2011-05-01

申办/合作机构

The University of Tokushima

EUCTR2006-000899-32-DE / Not yet recruitingN/A

Randomized, phase II, open-label controlled study of two different doses and schedules of EMD 72000 (matuzumab) in combination with pemetrexed, or pemetrexed alone, as second-line treatment in subjects with Stage IIIB/IV non-smallcell lung cancer and progressive disease on or after first-line treatment with a platinum analogue in combination with either taxanes, gemcitabine or vinorelbine

开始日期2006-07-11

申办/合作机构-

EUCTR2005-001362-14-BE / Not yet recruitingN/A

Open-label, single-arm, multicenter phase II study of matuzumab in combination with irinotecan background chemotherapy in subjects with epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer that developed progressive disease while on therapy or within 4 weeks after termination of an irinotecan based regimen. - MAURICE

开始日期2005-09-15

申办/合作机构

Merck KGaA

100 项与马妥珠单抗相关的临床结果

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100 项与马妥珠单抗相关的转化医学

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100 项与马妥珠单抗相关的专利（医药）

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587

项与马妥珠单抗相关的文献（医药）

2024-09-04·MOLECULAR CANCER THERAPEUTICS

Enhancing Neutrophil Cytotoxicity of a Panel of Clinical EGFR Antibodies by Fc Engineering to IgA3.0

Article

作者: Olofsen, Patricia A. ; Leusen, Jeanette H.W. ; Valerius, Thomas ; Peipp, Matthias ; Verdonschot, Meggy E.L. ; Tsioumpekou, Maria ; van der Peet, Ida C. ; Hendriks, Ilona S.T. ; Nederend, Maaike ; Passchier, Elsemieke M. ; Jansen, J.H. Marco ; Klomp, Sharon A. ; Chan, Chilam

Abstract:

EGFR plays an essential role in cellular signaling pathways that regulate cell growth, proliferation, and survival and is often dysregulated in cancer. Several monoclonal IgG antibodies have been clinically tested over the years, which exert their function via blocking the ligand binding domain (thereby inhibiting downstream signaling) and inducing Fc-related effector functions, such as antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). However, these IgG antibodies do not optimally recruit neutrophils, which are the most abundant white blood cell population in humans. Therefore, we reformatted six therapeutic EGFR antibodies (cetuximab, panitumumab, nimotuzumab, necitumumab, zalutumumab, and matuzumab) into the IgA3.0 format, which is an IgA2 isotype adapted for clinical application. Reformatting these antibodies preserved Fab-mediated functions such as EGFR binding, growth inhibition, and ligand blockade. In addition, whole leukocyte ADCC was significantly increased when using this panel of IgA3.0 antibodies compared with their respective IgG counterparts, with no major differences between IgA3.0 antibodies. In vivo, IgA3.0 matuzumab outperformed the other antibodies, resulting in the strongest suppression of tumor outgrowth in a long intraperitoneal model. We showed that neutrophils are important for the suppression of tumor outgrowth. IgA3.0 matuzumab exhibited reduced receptor internalization compared with the other antibodies, possibly accounting for its superior in vivo Fc-mediated tumor cell killing efficacy. In conclusion, reformatting EGFR antibodies into an IgA3.0 format increased Fc-mediated killing while retaining Fab-mediated functions and could therefore be a good alternative for the currently available antibody therapies.

2024-06-01·Wiener klinische Wochenschrift

FOXP3 expression in esophageal squamous cell carcinoma

Article

作者: Wu, Shenghong ; Xiao, Zhijun ; He, Zhonghui ; Ye, Ming ; Zhang, Jinfeng ; Wang, Yu

OBJECTIVE:

Investigating the impact of FOXP3 (transcription factor forkhead box P3) expression on the biological behavior of esophageal squamous cell carcinoma (ESCC) and its influence on the sensitivity of ESCC cells towards cetuximab-targeted (an EGFR monoclonal antibody inhibitor) therapy.

METHODS:

A specifically designed recombinant FOXP3 shRNA plasmid was synthesized to target the human FOXP3 gene, and the plasmid was transfected into TE12 cells using a liposome method. Multiple assays were conducted to evaluate the effect of FOXP3 expression on ESCC cells and their response to cetuximab treatment. Proliferation activity and cetuximab sensitivity of ESCC cells were measured using the CCK‑8 assay. The invasion ability of cells was assessed using an in vitro invasion assay. Furthermore, the efficacy of cetuximab in treating ESCC was analyzed using a tumorigenesis assay in nude mice.

RESULTS:

Silencing the FOXP3 gene in the TE12 cell line (shFOXP3 group) resulted in a significant reduction in FOXP3 mRNA and protein expression (p = 0.013). The shFOXP3 group exhibited slowed cell growth (p = 0.035), decreased invasion rate (p = 0.031), and increased sensitivity to cetuximab treatment (p = 0.039) compared to the control group (shNC group). In the in vivo tumorigenesis assay, the shFOXP3 group demonstrated a significant reduction in tumor volume and lung metastasis rate following cetuximab treatment (p = 0.028 and 0.007, respectively).

CONCLUSION:

High FOXP3 expression promotes the proliferation and migration of ESCC cells, while negatively affecting their sensitivity to cetuximab-targeted therapy. Consequently, targeting FOXP3 shows potential therapeutic implications for enhancing the effectiveness of cetuximab treatment in ESCC patients.

2024-05-03·The oncologist

Efficacy and Safety of Panitumumab in Patients With RAF/RAS-Wild-Type Glioblastoma: Results From the Drug Rediscovery Protocol

Article

作者: Verheul, Henk M W ; Voest, Emile E ; de Leng, Wendy W J ; van der Noort, Vincent ; Geurts, Birgit S ; de Wit, Gijs F ; Hoeben, Ann ; Spiekman, Ilse A C ; Buter, Jan ; Kusters, Benno ; Jansen, Anne M L ; Gelderblom, Hans A J ; de Vos, Filip Y F L ; Beerepoot, Laurens V ; Roepman, Paul ; Zeverijn, Laurien J ; de Groot, Derk-Jan A ; de Groot, Jan Willem B

Abstract:

Background:

The prognosis of malignant primary high-grade brain tumors, predominantly glioblastomas, is poor despite intensive multimodality treatment options. In more than 50% of patients with glioblastomas, potentially targetable mutations are present, including rearrangements, altered splicing, and/or focal amplifications of epidermal growth factor receptor (EGFR) by signaling through the RAF/RAS pathway. We studied whether treatment with the clinically available anti-EGFR monoclonal antibody panitumumab provides clinical benefit for patients with RAF/RAS-wild-type (wt) glioblastomas in the Drug Rediscovery Protocol (DRUP).

Methods:

Patients with progression of treatment refractory RAF/RASwt glioblastoma were included for treatment with panitumumab in DRUP when measurable according to RANO criteria. The primary endpoints of this study are clinical benefit (CB: defined as confirmed objective response [OR] or stable disease [SD] ≥ 16 weeks) and safety. Patients were enrolled using a Simon-like 2-stage model, with 8 patients in stage 1 and up to 24 patients in stage 2 if at least 1 in 8 patients had CB in stage 1.

Results:

Between 03-2018 and 02-2022, 24 evaluable patients were treated. CB was observed in 5 patients (21%), including 2 patients with partial response (8.3%) and 3 patients with SD ≥ 16 weeks (12.5%). After median follow-up of 15 months, median progression-free survival and overall survival were 1.7 months (95% CI 1.6-2.1 months) and 4.5 months (95% CI 2.9-8.6 months), respectively. No unexpected toxicities were observed.

Conclusions:

Panitumumab treatment provides limited CB in patients with recurrent RAF/RASwt glioblastoma precluding further development of this therapeutic strategy.

项与马妥珠单抗相关的新闻（医药）

2024-06-26

·PRNewswire

Simcere Zaiming Announce Approval of Cetuximab Beta in China by the NMPA

NANJING, China, June 26, 2024 /PRNewswire/ -- On June 25, 2024, Simcere Zaiming, an innovative oncology company and a subsidiary of Simcere Pharmaceutical Group (2096.HK), announced that Enlituo® (generic name: cetuximab beta injection), a new generation anti-epidermal growth factor receptor (EGFR) antibody drug developed in collaboration with Mabpharm Limited (2181.HK), has recently received approval from the China National Medical Administration (NMPA) for marketing. Enlituo® is indicated for use in combination with the FOLFIRI regimen as a first-line treatment for RAS/BRAF wild-type metastatic colorectal cancer (mCRC). According to the 'Cancer Incidence and Mortality in China, 2022' by the National Cancer Center, colorectal cancer ranks as the second most common cancer in China. Annually, there are 1.571 million new cases and 240,000 deaths, imposing a substantial disease burden on the society. When colorectal cancer patients develop metastasis, the primary treatment options often include chemotherapy and targeted drugs. Previous clinical studies have demonstrated the effectiveness of EGFR-targeting antibody drugs in treating malignant tumors, particularly mCRC, in patients without RAS/BRAF mutations (wild-type). Enlituo® (cetuximab beta, originally known as CMAB009) is a recombinant EGFR monoclonal antibody developed independently in China. Classified as a 2.4 class modified biological new drug, cetuximab beta is prepared using a proprietary protein expression technique, effectively avoiding glycosylation modification that may lead to hypersensitivity. Enlituo® received approval based on robust evidence from a phase 2/3 study and a phase 3 confirmatory clinical trial. In an open-label, randomized, controlled, multicenter, prospective phase 3 study, 505 subjects with RAS/BRAF wild-type mCRC were treated and analyzed. Clinical data revealed that combining cetuximab beta with FOLFIRI significantly extended progression-free survival (PFS) compared to FOLFIRI alone (13.133 months vs. 9.567 months, P = 0.004). Additionally, the combination increased the objective response rate (ORR) (69.1% vs. 42.3%, P < 0.001) and overall survival (OS) (2.322 years vs. 1.900 years, P = 0.024). Dr. Renhong Tang, Chairman of Simcere Zaiming, emphasized Enlituo®'s unique clinical value in targeted therapy: "Its initial indication for colorectal cancer addresses a large patient population. The product synergizes well with Simcere Zaiming's existing offerings, and efforts are underway to accelerate its commercialization, benefiting more cancer patients." Dr. Hao Wang, Chief Executive Officer of Mabpharm, expressed excitement as Enlituo® bridged the gap in colorectal cancer treatment with domestically developed EGFR-targeted drugs. "This provides clinicians and patients with updated therapeutic options. By collaborating with Simcere Zaiming's Marketing Team, we are able to rapidly realize the clinical value of Enlituo®, benefiting hundreds of thousands of patients in China with an effective and affordable biological new drug. " Enlituo represents the first EGFR monoclonal antibody drug developed in China with independent intellectual property rights that are approved for the first-line treatment of mCRC. The successful launch of Enlituo® will provide high quality and affordable biological targeted remedy for Chinese cancer patients. In March 2023, the drug marketing application of Enlituo® was accepted by the NMPA. On August 18, 2023, the Group entered into a cooperation agreement with Mabpharm, pursuant to which the Group obtained the exclusive commercial rights in respect of Enlituo® in Chinese mainland. About Mabpharm Mabpharm (stock code: 2181) focuses on the development of monoclonal antibodies and has an experienced R&D team, multiple core technologies, leading domestic large-scale antibody preparation system and excellent quality control system. Mabpharm strives to bring high quality and affordable innovative biologics through its efficient R&D system and low-cost pharmaceutical production capability to the market, and develops various therapeutic products by fully utilizing its extensive R&D experience. About Simcere Zaiming Simcere Zaiming, an oncology-centric biopharmaceutical subsidiary of Simcere Pharmaceutical Group Limited (HKEX: 2096), was established in 2023. The company is devoted to crafting groundbreaking therapies aimed at fulfilling the unmet clinical needs of cancer patients globally. With a robust and innovative R&D pipeline featuring distinct clinical assets, Simcere Zaiming has successfully launched several products in China, including COSELA®, Endostar®, and Envafolimab. The company is determined to deliver potentially transformative treatment options to cancer patients worldwide through its internal R&D, manufacturing, and commercialization capabilities, complemented by strategic collaborations with leading partners in the field of innovative cancer therapeutics. SOURCE Simcere

上市批准临床3期引进/卖出临床结果CSCO会议

2024-04-30

·康方生物

2024 ASCO｜康方生物18项研究引领双抗治疗肿瘤新风潮

肺癌摘要号：8508 Ivonescimab combined with chemotherapy in patients with EGFR-mutant non-squamous non-small cell lung cancer who progressed on EGFR tyrosine-kinase inhibitor treatment (HARMONi-A): a randomized, double-blind, multi-center, phase 3 trial 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NSCLC患者的随机、双盲、多中心III期临床研究（AK112-301/HARMONi-A）展示形式：口头报告主要研究者：张力教授中山大学肿瘤防治中心汇报时间：2024年6月1日 3:45-6:45 AM 北京时间胃癌摘要号：4012 Efficacy and safety of Cadonilimab in combination with Pulocimab and Paclitaxel as Second-line Therapy in Patients with Advanced Gastric or Gastroesophageal Junction (G/GEJ) Cancer who Progressed on Immunochemotherapy: a Multicenter, Double-blind, Randomized Trial 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G/GEJ腺癌患者的疗效和安全性：一项多中心、随机、双盲试验展示形式：快速口头报告主要研究者：沈琳教授张小田教授北京肿瘤医院汇报时间：2024年6月3日 22:45-22:51 PM 北京时间摘要号：e16108 Neoadjuvant cadonilimab (PD-1/CTLA-4 bispecific antibody) plus FLOT chemotherapy in locally advanced gastric/gastroesophageal junction cancer (GC/GEJC): A prospective, multi-center, phase II study 卡度尼利单抗（PD-1/CTLA-4 双特异性抗体）联合 FLOT化疗新辅助治疗局部晚期胃/胃食管结合部癌 (GC/GEJC)：一项前瞻性、多中心、II 期研究展示形式：线上发表主要研究者：焦作义教授兰州大学第二医院食管癌摘要号：e16064 Efficacy, safety and DNA methylation analysis of cadonilimab combined with taxane and cisplatin as the first-line treatment in patients with advanced esophageal squamous cell carcinoma (ESCC): An open-label, multicenter phase II trial– Updated results from AK104-IIT-014 卡度尼利单抗联合紫杉醇和顺铂一线治疗晚期食管鳞癌（ESCC）的疗效、安全性和DNA甲基化分析：一项开放标签、多中心II期研究—AK104-IIT-014研究更新结果展示形式：线上发表主要研究者：黄镜教授瞿望教授中国医学科学院肿瘤医院肝细胞癌摘要号：e16267 Neoadjuvant Immune-Checkpoint Blockade Therapy Combining with TACE For Resectable Hepatocellular Carcinoma with High Recurrence Risk: A Phase II, Single-arm Clinical Trial (MORNING) 新辅助应用免疫检查点阻滞药物（卡度尼利单抗）联合TACE治疗具有高危复发因素的可切除肝细胞癌：一项Ⅱ期、单臂临床研究展示形式：线上发表主要研究者：匡铭教授中山大学附属第一医院胆道癌摘要号：4095 The safety and efficacy of ivonescimab in combination with chemotherapy as first-line treatment for advanced biliary tract cancer 依沃西单抗联合化疗作为晚期胆道癌一线治疗的安全性和有效性展示形式：壁报展示主要研究者：应杰儿教授浙江省肿瘤医院摘要号：e16152 Two stage, multi-center trial of cadonilimab and LM-302 for patients with CLDN18.2+ biliary tract cancer (BTC) that failed chemotherapy and PD-(L)1 antibody (ZSAB-Calm) 卡度尼利单抗联合LM-302治疗标准化疗和PD1/PD-L1单抗治疗进展的Claudin18.2阳性的晚期胆道恶性肿瘤患者两阶段、多中心临床研究展示形式：线上发表主要研究者：樊嘉院士施国明教授复旦大学附属中山医院摘要号：e6159 Cadonilimab in combined with gemcitabine and cisplatin in advanced biliary tract cancer (BicureX): A Phase II, Single-arm Clinical Trial 卡度尼卡度尼利单抗联合吉西他滨、顺铂在不可切除的局部晚期或转移性胆道恶性肿瘤一线治疗的疗效和安全性研究展示形式：线上发表主要研究者：王文涛教授四川大学华西医院胰腺癌摘要号：TPS4213 A phase II study of cadonilimab plus mFOLFIRINOX as induction therapy for locally advanced pancreatic adenocarcinoma (LAPC) 一项卡度尼利单抗联合mFOLFIRINOX转化治疗局部晚期胰腺导管腺癌（LAPC）的II期临床研究展示形式：壁报展示主要研究者：蒋奎荣教授涂敏教授江苏省人民医院妇科肿瘤摘要号：5538 Efficacy and safety of cadonilimab plus anti-EGFR monoclonal antibody as de-chemotherapy regimen in persistent, recurrent, or metastatic gynecologic cancer 卡度尼利单抗联合抗EGFR单克隆抗体作为去化疗方案治疗持续性、复发性或转移性妇科肿瘤的疗效和安全性展示形式：壁报展示主要研究者：张启应教授刘孜教授西安交通大学第一附属医院摘要号：5600 Cadonilimab plus lenvatinib in patients with advanced endometrial cancer: A multicenter, single-arm, phase II trial 卡度尼利单抗联合仑伐替尼治疗晚期内膜癌患者：一项多中心、单臂、II期研究展示形式：壁报展示主要研究者：蓝春燕教授中山大学肿瘤防治中心摘要号：e17510 Cadonilimab safety and efficacy in recurrent or metastatic cervical cancer: First real-world experience from a Chinese multicenter study 卡度尼利单抗在复发或转移性宫颈癌的安全性和疗效：中国第一项多中心真实世界研究展示形式：线上发表主要研究者：孙阳教授福建省肿瘤医院摘要号：e17519 Clinical efficacy and safety of cadonilimab immunotherapy in patients with advanced cervical cancer: A retrospective study 卡度尼利单抗治疗晚期宫颈癌患者的临床疗效和安全性：一项回顾性研究展示形式：线上发表主要研究者：韩修臣教授盛修贵教授中国医学科学院肿瘤医院深圳医院摘要号：e17522 Safety and clinical activity of cadonilimab, an anti PD-1/CTLA-4 bispecific antibody, for patients with persistent, recurrent, or metastatic cervical cancer (R/M CC): A retrospective, real-world study 抗PD-1/CTLA-4双特异性抗体卡度尼利单抗治疗持续性、复发性或转移性宫颈癌的疗效和安全性:一项回顾性、真实世界研究展示形式：线上发表主要研究者：施璠教授刘孜教授西安交通大学第一附属医院摘要号：e17552 An open, prospective, single arm, phase II study of cadonilimab (PD-1/CTLA-4 bispecific antibody) with neoadjuvant chemotherapy in patients with advanced ovarian cancer: Interim analysis from the AK104-IIT-003 study AK104（PD-1/CTLA-4双特异性抗体）联合化疗用于晚期卵巢癌新辅助治疗的一项开放、前瞻性、单臂II期临床研究：AK104-IIT-003研究期中分析展示形式：线上发表主要研究者：唐洁教授湖南省肿瘤医院头颈肿瘤摘要号：6044 An open-label, single-center phase II trial of cadonilimab (an anti-PD-1/CTLA-4 bispecific antibody) in combination with platinum-based dual-drug neoadjuvant chemotherapy for locally advanced, resectable head and neck squamous cell carcinoma 一项卡度尼利单抗（抗PD-1/CTLA-4双特异性抗体）联合含铂双药化疗新辅助治疗局部晚期可切除头颈鳞癌的开放标签、单中心、II期试验展示形式：壁报展示主要研究者：曹飞教授刘学奎教授中山大学肿瘤防治中心泌尿系统肿瘤摘要号：e16572 Disitamab vedotin (DV, RC48-ADC) combined with cadonilimab (anti-PD-1/CTLA-4 bispecific antibody) in patients with locally advanced or metastatic urothelial carcinoma (la/mUC): An open-label, single-arm, phase II study 维迪西妥单抗联合卡度尼利单抗用于局部晚期或转移性尿路上皮癌治疗的开放标签、单臂、II期临床研究展示形式：线上发表主要研究者：瓦斯里江教授邢念增教授山西省肿瘤医院/中国医学科学院肿瘤医院摘要号：e16591 Preliminary results from a phase II study to evaluate the efficacy and safety of perioperative disitamab vedotin (RC48-ADC) plus cadonilimab (AK104, PD-1/CTLA-4 bispecific antibody) for HER2-expressing muscle-invasive bladder cancer (MIBC) 维迪西妥单抗联合卡度尼利单抗用于HER2表达的肌层浸润性膀胱癌围手术II期研究初步结果展示形式：线上发表主要研究者：韩苏军教授邢念增教授中国医学科学院肿瘤医院关于依达方®（PD-1/VEGF双抗，依沃西）依达方®是康方生物独立自主研发的全球首创PD-1/VEGF双特异性抗体新药，基于本公司独特的Tetrabody技术设计，可阻断PD-1与PD-L1和PD-L2的结合，并同时阻断VEGF与VEGF受体的结合。PD-1抗体与VEGF阻断剂的联合疗法已在多种瘤种（非小细胞肺癌、肾细胞癌和肝细胞癌）中显示出强大的疗效。鉴于VEGF和PD-1在肿瘤微环境中的共表达，与联合疗法相比依达方®作为单一药物同时阻断这两个靶点，可能会更有效地阻断这两个通路，从而增强抗肿瘤活性。2022年12月，依达方®以总交易额高达50亿美金（5亿美金首付款），外加销售净额两位数提成的合作方案，授予美国Summit Therapeutics公司在美国、欧洲、加拿大和日本的开发独家许可权，创下中国单个创新药物对外权益许可最高交易金额纪录。此前，依达方®在肺癌领域的3项适应症已分别获得CDE授予的突破性治疗药物认定。2023年8月，依达方®首个新药上市许可申请（NDA）获得受理，并获优先审评资格。关于开坦尼®（PD-1/CTLA-4双抗，卡度尼利）开坦尼®是康方生物自主研发的全球首创PD-1/CTLA-4双特异性肿瘤免疫治疗药物，已于2022年6月29日获得国家药品监督管理局的批准，用于既往接受含铂化疗治疗失败的复发或转移性宫颈癌患者的治疗。开坦尼®已被《中国临床肿瘤学会（CSCO）宫颈癌诊疗指南（2023）》、《妇科肿瘤免疫检查点抑制剂临床应用指南（2023版）》、卫健委《新型抗肿瘤药物临床应用指导原则（2022年版）》、《肝细胞癌免疫联合治疗多学科中国专家共识(2023版)》、《中国食管癌放射治疗指南（2023版）》、《美国国家综合癌症网络（NCCN）临床实践指南2023.V1：中国版》《基于PD-L1蛋白表达水平的胃癌免疫治疗专家共识（2023年版）》等临床指南重磅推荐。开坦尼®是世界上第一个肿瘤免疫治疗双抗新药，也是中国的第一个双特异性抗体新药。开坦尼®主要用于治疗胃癌、肝癌、肺癌、宫颈癌、胰腺癌、食管鳞癌等多种恶性肿瘤。相关临床研究数据显示，卡度尼利与PD-1单抗联合CTLA-4单抗的联合疗法相比，毒性显著降低，具有明显的安全性和疗效优势。目前，卡度尼利加含铂化疗联合/不联合贝伐珠单抗一线治疗持续、复发或转移性宫颈癌的新药上市申请，以及卡度尼利联合化疗一线治疗晚期胃或胃食管结合部腺癌的新药上市许可申请，均已被CDE受理。关于普络西（VEGFR-2单抗，AK109）普络西单抗是康方生物自主研发的重组全人源化抗血管内皮生长因子受体-2（VEGFR-2）单克隆抗体新药。普络西单抗能够有效抑制VEGF/VEGFR-2结合所诱导的血管内皮细胞增殖，从而干扰肿瘤新生血管形成，抑制肿瘤的发生及发展。目前，普络西单抗联合康方生物自主研发的卡度尼利（PD-1/CTLA-4双抗）和化疗治疗PD-(L)1抑制剂治疗进展的晚期胃癌的Ⅲ期临床研究，以及其它联合疗法探索研究正在开展中。

ASCO会议临床结果临床2期临床1期

2024-04-08

·PRNewswire

Innovent to Present Preclinical Data of Multiple Novel Molecules at the 2024 AACR Annual Meeting

ROCKVILLE, Md. and SUZHOU, China, April 7, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that preclinical data on multiple novel bispecific antibodies as well as antibody-drug-conjugates (ADCs) from its oncology pipeline are presented at the American Association for Cancer Research (AACR) Annual Meeting 2024. Late-Breaking Research: Experimental and Molecular Therapeutics 1 Topic: IBI3001: a potentially first-in-class site-specific glycan-conjugated B7-H3/EGFR bispecific ADC for multiple solid tumors Abstract Number: LB055 Presentation Form: Poster Presentation Time : Sunday Apr 7, 2024 1:30 PM - 5:00 PM Location: Poster Section 53 Presenting Author: Dr. Kaijie He IBI3001 is a potentially first-in-class bispecific ADC against B7-H3 and EGFR that is site-specifically glycan-conjugated using the clinically validated SYNtecanE® platform. IBI3001 has multiple anti-tumor mechanisms of action: (1) enhanced EGFR signaling blockade; (2) EGFR- and B7-H3-aided payload internalization and cytotoxicity; and (3) potent bystander killing effects of ADC. The optimized B7-H3 arm not only enhances the EGFR signaling blockade but also reduces EGFR on-target toxicities. IBI3001 showed strong anti-tumor efficacy in vitro and in vivo across multiple solid tumors and is well tolerated with the therapeutic index at 40. Topic: IBI334, a novel ADCC-enhanced B7-H3/EGFR bispecific antibody, demonstrated potent pre-clinical efficacy in solid tumors Abstract Number: LB056 Presentation Form: Poster Presentation Time : Sunday Apr 7, 2024 1:30 PM - 5:00 PM Location: Poster Section 53 Presenting Author: Dr. Kaijie He IBI334 is an afucosylated bispecific antibody against B7-H3 and EGFR that is constructed using Innovent's proprietary Innobody platform. With the aid of B7-H3, IBI334 showed better tumor growth inhibition in vitro and in vivo than EGFR monoclonal antibody and c-met/EGFR bispecific antibody benchmarks. IBI334 has a favorable safety profile with the highest non-severely toxic dose (HNSTD) in cynomolgus monkeys at 120 mg/kg and a large therapeutic window of > 200 folds. As a promising bispecific antibody against multiple solid tumors, IBI334 is currently under clinical evaluation. Topic: Discovery and preclinical characterization of IBI343, a site-specific glycan-conjugated anti-Claudin18.2 ADC for treating solid tumors Abstract Number: LB057 Presentation Form: Poster Presentation Time : Sunday Apr 7, 2024 1:30 PM - 5:00 PM Location: Poster Section 53 Presenting Author: Dr. Kaijie He IBI343 is a potentially first-in-class anti-Claudin 18.2 ADC that is site-specifically glycan-conjugated to cytotoxin exatecan via Synaffix's GlycoConnect® technology. It demonstrated Claudin 18.2-specific in vitro cytotoxicity on a series of cancer cell lines at varying levels of target expression, and potent in vivo efficacy in multiple xenograft models. The glycan-based conjugation technology leads to enhanced stability of the ADC molecule. IBI343 displayed good safety profile in GLP toxicology study in rhesus monkey and was well tolerated up to 30 mg/kg. IBI343 has favorable pre-clinical efficacy and safety, and it is currently in preparation for Phase 3 clinical trial for Claudin-18.2-positive HER2-negative gastric cancer. Dr. Kaijie He, Vice President of Innovent, stated: "We are pleased that the pre-clinical studies of our novel anti-cancer drugs are accepted for Late-Breaking Research poster presentation at the 2024 AACR conference. This is the result of dedicated work from scientists at Innovent Academy with the aim to tackle cancers with innovative drugs that are more effective and safer. With careful design and optimization, our molecules can achieve favorable therapeutic windows of 40 to more than 200 times. We look forward to their performance in clinical settings and hope that these innovations can eventually benefit cancer patients." Poster Session: Immunology - Single Target and Bispecific Antibodies Topic: A novel TROP2-targeted immune stimulating antibody conjugate (ISAC) with potent anti-tumoral activity and acceptable safety Abstract Number: 2718 Presentation Form: Poster Presentation Time: Monday Apr 8, 2024 1:30 PM - 5:00 PM Location: Poster Section 6 Poster Board Number: 9 Presenting Author: Dr. Huizhong Xiong Immune stimulating antibody conjugates (ISACs) are a unique class of ADC in which antibodies recognizing tumor antigens are conjugated with immune agonists. ISACs target tumor tissue and specifically activate intra-tumoral myeloid cells, unleashing downstream immune response. Like the other immune agonists, balance between efficacy and safety remains a challenge for ISACs. Here we describe a potential first-in-class TROP2 ISAC with rationally selected antibody and TLR7/8 agonist linker-payload. The anti-TROP2 antibody elicited robust ADCP of TROP2+ tumor cells by macrophages. In-vitro, TROP2 ISAC mildly activated myeloid cells only in the presence of TROP2+ tumor cells. In-vivo, the molecule potently suppressed tumor growth in different TROP2+ xenograft tumors, and effectively enhanced killing of an ADC. In terms of safety, the ISAC was tolerated in both WT and hTROP2KI mice, and, importantly, in monkeys. Taken together, our data demonstrate a novel TROP2 ISAC with outstanding efficacy and manageable safety profile, which may benefit patients with TROP2+ tumors. Poster Session: Immunology - Immune Modulation Employing Agonist or Co-Stimulatory Approaches Topic: Tumor targeted-CD28 bispecific antibody with optimized potency, robust anti-tumoral activity and stringent CD3-dependence Abstract Number: 5295 Presentation Form: Poster Presentation Time: Tuesday Apr 9, 2024 1:30 PM - 5:00 PM Location: Poster Section 3 Poster Board Number: 4 Presenting Author: Dr. Huizhong Xiong We reported a rationally screened CD28 agonist antibody and its PSMAxCD28 bispecific format, IAR038. IAR038 has minimal activity in the absence of CD3, even under stringent conditions, different from benchmark antibody in clinical development. It demonstrated moderate activity in vitro in a CD3-dependent and PSMA-dependent manner. Notably, IAR038 elicited superior tumor killing in vivo and combined effectively with anti-PD1 antibody. In addition, it had an improved half-life compared with the Benchmark antibody. These features may translate to a wider therapeutic window and improved safety for CRPC patients. Dr. Huizhong Xiong, Senior Director of Immunology of Innovent, stated: "We keep pushing for deeper understanding and more rational design of agonistic and costimulatory molecules. Our work on tumor targeted TLR7/8 agonist and tumor targeted CD28 antibody demonstrates the capability of our biology-driven drug development to achieve better balance between efficacy and safety, made possible by our advanced technology platforms." About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to provide high-quality biologics that are affordable to all. The company discovers, develops, manufactures and commercializes innovative medicines that treat some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has 10 products in the market, 3 new drug applications under the NMPA review, 5 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare leaders, including Eli Lilly, Roche, Sanofi, Adimab, Incyte and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s). Forward-looking statement This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect. SOURCE Innovent Biologics

AACR会议临床结果临床1期抗体药物偶联物临床3期

100 项与马妥珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	马妥珠单抗	-	DB05101

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
食管癌	临床2期	德国	Merck KGaA	2005-08-31
食管癌	临床2期	西班牙	Merck KGaA	2005-08-31
食管癌	临床2期	瑞士	Merck KGaA	2005-08-31
食管癌	临床2期	英国	Merck KGaA	2005-08-31
转移性胃腺癌	临床2期	德国	Merck KGaA	2005-08-31
转移性胃腺癌	临床2期	西班牙	Merck KGaA	2005-08-31
转移性胃腺癌	临床2期	瑞士	Merck KGaA	2005-08-31
转移性胃腺癌	临床2期	英国	Merck KGaA	2005-08-31
非小细胞肺癌IIIB期	临床2期	美国	EMD Serono, Inc.	2005-05-31
非小细胞肺癌IIIB期	临床2期	奥地利	EMD Serono, Inc.	2005-05-31

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临床结果

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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


ASCO2019	N/A	转移性头颈部鳞状细胞癌	15	Cetuximab+Low-dose chemotherapy+Anti-PD1 therapy	廠簾鹹網鑰鹹觸襯築艱(製鹽網鹹鏇齋積鹹襯鏇) = Six patients (40%) died: 2 due to progression of disease, 1 due to tumour bleeding, 2 due to pneumonia, and 1 due to fungemia. 觸網願願壓鏇壓鹹襯壓 (簾鑰獵網鹽鏇鑰簾鏇衊 )	积极	2019-05-26
NCT00215644 (MATRIX EG, CTgov)	临床2期	食管癌 \| 转移性胃腺癌	72	Matuzumab+cisplatin+epirubicin+Capecitabine (Epirubicin, Cisplatin, Capecitabine (ECX)+Matuzumab)	壓積齋襯襯糧憲網願鏇(遞遞鏇鏇觸製壓構齋選) = 鏇醖觸網鬱築鬱願膚選醖襯壓艱顧糧願艱範衊 (遞網鏇憲遞願觸鹹網觸, 構醖壓衊衊糧餘糧繭糧 ~ 願憲簾鏇淵願繭蓋糧築) 更多	-	2018-11-02
				cisplatin+epirubicin+Capecitabine (ECX Only)	壓積齋襯襯糧憲網願鏇(遞遞鏇鏇觸製壓構齋選) = 範齋鑰選願製蓋顧願顧醖襯壓艱顧糧願艱範衊 (遞網鏇憲遞願觸鹹網觸, 淵憲製鏇選願衊選糧簾 ~ 壓範網鹹壓築鹽獵窪夢) 更多
NCT00111839 (CTgov)	临床2期	非小细胞肺癌IIIB期	150	pemetrexed (Pemetrexed Alone)	鹽鹹製鬱淵壓醖鹽簾遞(壓積鹹遞窪夢獵遞艱襯) = 願艱範簾窪顧製構憲襯觸廠蓋繭壓艱鏇衊淵蓋 (衊齋廠製廠鑰網窪壓顧, 繭鹹網糧選齋淵夢願遞 ~ 築範糧淵齋簾繭淵願淵) 更多	-	2018-04-06
				Matuzumab+pemetrexed (Pemetrexed Plus Matuzumab 800 mg Per Week)	鹽鹹製鬱淵壓醖鹽簾遞(壓積鹹遞窪夢獵遞艱襯) = 夢壓廠醖憲構鬱衊遞製觸廠蓋繭壓艱鏇衊淵蓋 (衊齋廠製廠鑰網窪壓顧, 淵夢選艱憲選範網醖壓 ~ 繭壓夢範範觸簾願積築) 更多
ASCO2014	N/A	转移性结直肠癌	195	anti-EGFR monoclonal antibody (CIMP-high)	餘遞選鏇齋製醖餘獵窪(積選齋廠憲衊簾壓網鹽) = 襯餘壓齋築獵遞廠遞夢鑰膚壓繭築壓醖積壓遞 (窪鹹繭蓋願網壓齋憲餘 )	-	2014-05-20
				anti-EGFR monoclonal antibody (CIMP-low)	餘遞選鏇齋製醖餘獵窪(積選齋廠憲衊簾壓網鹽) = 衊壓鬱艱鹹構衊鬱襯鬱鑰膚壓繭築壓醖積壓遞 (窪鹹繭蓋願網壓齋憲餘 )
ASCO2011	N/A	鼻咽癌	34	Nimotuzumab	餘選醖憲鬱鹹廠鹹淵選(鏇憲艱糧遞襯鑰鑰顧醖) = 醖膚鏇簾憲築網衊鑰鏇簾鹽膚膚範鬱範蓋糧鬱 (顧構夢窪願鹽艱膚鑰襯 ) 更多	-	2011-05-20
				Cetuximab	餘選醖憲鬱鹹廠鹹淵選(鏇憲艱糧遞襯鑰鑰顧醖) = 獵簾範艱鏇廠鑰鹹夢觸簾鹽膚膚範鬱範蓋糧鬱 (顧構夢窪願鹽艱膚鑰襯 ) 更多
FOxTROT (ASCO2011)	临床2期	局部晚期恶性肿瘤新辅助	150	Neoadjuvant chemotherapy	築淵製網糧構積積淵鏇(糧鹹蓋壓選糧顧遞鹹夢) = 顧鹽觸夢膚選糧製築醖淵夢製蓋構壓鑰簾範獵 (齋鑰鏇願淵醖衊膚餘醖 ) 更多	-	2011-05-20
NCT00111839 (Pubmed \| J Thorac Oncol)	临床2期	非小细胞肺癌二线	150	Pemetrexed alone	醖壓膚顧襯鹽鏇網鹹衊(糧夢窪範廠鑰衊壓鑰網) = 選獵鬱壓糧積願蓋願衊艱獵構齋鹽淵鑰鑰窪憲 (願遞範觸壓夢壓壓繭衊 ) 更多	-	2010-12-01
				Pemetrexed + Matuzumab 800 mg weekly	醖壓膚顧襯鹽鏇網鹹衊(糧夢窪範廠鑰衊壓鑰網) = 鑰願膚衊鏇構衊鑰壓鏇艱獵構齋鹽淵鑰鑰窪憲 (願遞範觸壓夢壓壓繭衊 ) 更多
NCT00215644 (Pubmed \| Ann Oncol)	临床2期	胃食管交界处癌一线	72	Matuzumab plus ECX	齋觸鏇夢鬱鏇壓築廠餘(膚窪衊壓醖鹹顧範糧衊) = 網選構蓋願餘觸獵鑰壓顧壓襯壓鬱醖艱築糧憲 (顧夢遞膚願淵餘遞獵鹽, 17 ~ 49) 更多	不佳	2010-11-01
				ECX alone	齋觸鏇夢鬱鏇壓築廠餘(膚窪衊壓醖鹹顧範糧衊) = 獵願鏇觸襯壓選獵構選顧壓襯壓鬱醖艱築糧憲 (顧夢遞膚願淵餘遞獵鹽, 41 ~ 74) 更多
ASCO2005	临床1期	HR阳性/HER2低表达实体瘤	26	Matuzumab 400mg	壓夢蓋製醖夢觸襯鏇觸(衊艱鹽構窪齋窪願選獵) = 窪遞構製憲觸鬱鑰夢憲鹽廠糧齋簾鬱鹽製築淵 (壓窪製鹽膚衊繭壓齋衊 )	-	2005-06-01
				Matuzumab 800mg	壓夢蓋製醖夢觸襯鏇觸(衊艱鹽構窪齋窪願選獵) = 鏇糧遞夢鹽顧繭獵夢鏇鹽廠糧齋簾鬱鹽製築淵 (壓窪製鹽膚衊繭壓齋衊 )
ASCO2004	临床1期	胃肠道肿瘤	24	EMD 72000 100 mg	鹽鑰願鹽鹽鏇築觸製簾(襯簾廠襯鹹積齋顧窪遞) = 製餘蓋壓齋壓艱製鏇夢積膚艱糧膚夢觸蓋憲鏇 (繭餘鹽餘網積餘憲憲鹹 )	-	2004-07-15
				EMD 72000 200 mg	鹽鑰願鹽鹽鏇築觸製簾(襯簾廠襯鹹積齋顧窪遞) = 醖壓齋範夢簾鬱壓顧齋積膚艱糧膚夢觸蓋憲鏇 (繭餘鹽餘網積餘憲憲鹹 )