An Uncontrolled, Open-label, Multicenter Safety Confirmation Study of 5 or More Cycles of Photoimmunotherapy with Cetuximab Sarotalocan Sodium (Genetical Recombination) in Patients with Unresectable, Locally Advanced or Locally Recurrent Head and Neck Cancer

开始日期2023-06-25

申办/合作机构-

NCT05265013 / Terminated临床2期

A Phase 2 Single-arm Study of ASP-1929 Photoimmunotherapy Combined With Pembrolizumab in Patients With Locoregional Recurrent Squamous Cell Carcinoma of the Head and Neck, With or Without Metastases, Not Amenable to Curative Local Treatment

开始日期2022-04-19

申办/合作机构

Rakuten Medical, Inc.

NCT05182866 / Recruiting临床2期

Phase 2, Open-label, Single-arm, Window of Opportunity Study of ASP-1929 Photoimmunotherapy With Fluorescence Imaging in Patients With Operable Primary or Recurrent Head and Neck or Cutaneous Squamous Cell Carcinoma

A Phase 2, Open-label, Single-arm, Window of opportunity Study of ASP-1929 Photoimmunotherapy with Fluorescence Imaging in Patients with Operable Primary or Recurrent Head and Neck or Cutaneous Squamous Cell Carcinoma

开始日期2022-01-21

申办/合作机构

Rakuten Medical, Inc.

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100 项与沙西妥昔单抗相关的临床结果

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100 项与沙西妥昔单抗相关的转化医学

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100 项与沙西妥昔单抗相关的专利（医药）

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项与沙西妥昔单抗相关的文献（医药）

2024-01-25·Investigative ophthalmology & visual science

Tumor Pigmentation Does Not Affect Light-Activated Belzupacap Sarotalocan Treatment but Influences Macrophage Polarization in a Murine Melanoma Model

Article

作者: Rich, Cadmus ; Hao, Yang ; Gu, Zili ; van Hall, Thorbald ; van Veelen, Peter A ; Mulder, Aat A ; Ma, Sen ; Huis In't Veld, Ruben V ; Jager, Martine J ; Gelmi, Maria Chiara ; Ossendorp, Ferry A ; Vu, T Khanh H

Purpose:

Pigmentation in uveal melanoma is associated with increased malignancy and is known as a barrier for photodynamic therapy. We investigated the role of pigmentation in tumor behavior and the response to light-activated Belzupacap sarotalocan (Bel-sar) treatment in a pigmented (wild type) and nonpigmented (tyrosinase knock-out [TYR knock-out]) cell line in vitro and in a murine model.

Methods:

The B16F10 (TYR knock-out) was developed using CRISPR/Cas9. After the treatment with light-activated Bel-sar, cytotoxicity and exposure of damage-associated molecular patterns (DAMPs) were measured by flow cytometry. Treated tumor cells were co-cultured with bone marrow-derived macrophages (BMDMs) and dendritic cells (DCs) to assess phagocytosis and activation. Both cell lines were injected subcutaneously in syngeneic C57BL/6 mice.

Results:

Knock-out of the tyrosinase gene in B16F10 led to loss of pigmentation and immature melanosomes. Pigmented tumors contained more M1 and fewer M2 macrophages compared with amelanotic tumors. Bel-sar treatment induced near complete cell death, accompanied with enhanced exposure of DAMPs in both cell lines, resulting in enhanced phagocytosis of BMDMs and maturation of DCs. Bel-sar treatment induced a shift to M1 macrophages and delayed tumor growth in both in vivo tumor models. Following treatment, especially the pigmented tumors and their draining lymph nodes contained IFN-gamma positive CD8+T cells.

Conclusions:

Pigmentation influenced the type of infiltrating macrophages in the tumor, with more M1 macrophages in pigmented tumors. Belzupacap sarotalocan treatment induced immunogenic cell death and tumor growth delay in pigmented as well as in nonpigmented models and stimulated M1 macrophage influx in both models.

2023-12-01·Cancer science

Near‐infrared photoimmunotherapy in the models of hepatocellular carcinomas using cetuximab‐IR700

Article

作者: Kato, Takuya ; Takao, Seiichiro ; Choyke, Peter L ; Fukushima, Hiroshi ; Kobayashi, Hisataka ; Escorcia, Freddy E ; Furusawa, Aki ; King, A Paden ; Okuyama, Shuhei ; Kano, Makoto

Abstract:

Epidermal growth factor receptor (EGFR) has emerged as an important therapeutic target in many cancers, and overexpression of EGFR is frequently observed in hepatocellular carcinomas (HCCs). Near‐infrared photoimmunotherapy (NIR‐PIT) is a new anticancer treatment that selectively damages the cell membrane of cancer cells after NIR light‐induced photochemical reaction of IR700, which is bound to a targeting antibody on the cell membrane. NIR‐PIT using cetuximab‐IR700 has already been approved in Japan, is under review by the US Food and Drug Administration (FDA) for advanced head and neck cancers, and its safety has been established. However, EGFR has not been investigated as a target in NIR‐PIT in HCCs. Here, we investigate the application of NIR‐PIT using cetuximab‐IR700 to HCCs using xenograft mouse models of EGFR‐expressing HCC cell lines, Hep3B, HuH‐7, and SNU‐449. In vitro NIR‐PIT using EGFR‐targeted cetuximab‐IR700 killed cells in a NIR light dose‐dependent manner. In vivo NIR‐PIT resulted in a delayed growth compared with untreated controls. In addition, in vivo NIR‐PIT in both models showed histological signs of cancer cell damage, such as cytoplasmic vacuolation and nuclear dysmorphism. A significant decrease in Ki‐67 positivity was also observed after NIR‐PIT, indicating decreased cancer cell proliferation. This study suggests that NIR‐PIT using cetuximab‐IR700 has potential for the treatment of EGFR‐expressing HCCs.

2023-08-01·Auris, nasus, larynx

Transnasal photoimmunotherapy with cetuximab sarotalocan sodium: Outcomes on the local recurrence of nasopharyngeal squamous cell carcinoma

作者: Yokoyama, Kazuki ; Omura, Go ; Honma, Yoshitaka ; Yoshimoto, Seiichi ; Eguchi, Kohtaro ; Itoyama, Mai ; Ohara, Akihiro ; Matsumoto, Yoshifumi ; Kato, Ken ; Watanabe, Takane ; Sakai, Toshihiko ; Shinozaki, Takeshi

Photoimmunotherapy for head and neck cancer (HNC-PIT) is a newly developed locoregional treatment targeting the epidermal growth factor. This treatment consists in administering cetuximab sarotalocan sodium that conjugates cetuximab with the dye IRdye700DX, which is activated by near-infrared ray illumination at 690 nm. HNC-PIT has been conditionally approved in Japan in September 2020 for the treatment of unresectable locally advanced or unresectable locoregionally recurrent HNC. However, its outcomes on the local recurrence of the nasopharyngeal squamous cell carcinoma (NPSCC) remain undetermined. In this report, we assessed the effects of HNC-PIT assisted by transnasal endoscopy on the local recurrence of NPSCC. A 77-year-old male presented with a local recurrence of NPSCC. The initial diagnosis revealed a squamous cell carcinoma, T2N2M0 stage III, positive for Epstein-Barr virus-encoded small RNA by in situ hybridization, which was treated with concurrent chemoradiotherapy (CRT). However, local recurrence was detected 14 months after CRT. We performed HNC-PIT under transnasal endoscopy. Seven months have passed since the HNC-PIT treatment, and the patient is alive without delayed adverse events and evidence of recurrence. Local recurrence of NPSCC, which is difficult to treat with minimally invasive surgery, is considered a potential candidate for HNC-PIT.

项与沙西妥昔单抗相关的新闻（医药）

2024-06-12

·药渡Daily

ASCO2024观察：IO+ADC，或将成为肿瘤免疫的发展主线

自2014年，首款PD-(L)1单抗获批上市以来，单抗药物成为肿瘤治疗的基石，但在使用单药免疫疗法治疗时，仅20%-30%的患者对PD-(L)1抑制剂具有持久生存优势的完全应答。因此，肿瘤免疫疗法（IO, Immuno-Oncology）与其他治疗方式进行联合以提高临床获益成为大势所趋，而其中，ADC凭借“精准靶向化疗”的优势，正显示出与IO联用的潜力。 IO+ADC也成为今年美国临床肿瘤学会（ASCO）年会的热点之一，吉利德、默沙东/科伦博泰、第一三共/阿斯利康、乐普生物等药企均公布了多项临床试验数据，其中Trop2 ADC+IO、EGFR ADC+IO联合治疗方案取得了积极疗效。全球临床III期的IO+ADC项目资料来源：兴业证券，作者整理 Trop2 ADC+IO 人滋养层细胞表面抗原2（TROP2）是一种在多种不同肿瘤中广泛表达的糖蛋白，涉及多个细胞内信号通路，包括介导癌细胞增殖、迁移和侵袭的MAPK/PI3K/AKT通路，在乳腺癌、胃癌和卵巢癌中，TROP2的过度表达与肿瘤生长加速和不良预后相关，因此TROP2已成为肿瘤药物研发的重要靶点。目前，吉利德的戈沙妥珠单抗（SG，Sacituzumab Govitecan）已获批上市，用于治疗经治的HR+/HER2-转移性乳腺癌患者。此外，全球约有20多款在研靶向TROP2的ADC药物，阿斯利康/第一三共的Dato-Dxd，科伦博泰/默沙东的SKB264已处于上市申请阶段。 TROP2联合PD-(L)1在多个肿瘤适应症中表现出疗效提升。阿斯利康/第一三共、吉利德、科伦博泰/默沙东已开启多项TROP2 ADC联合PD-(L)1治疗非小细胞肺癌、乳腺癌临床研究并在今年的ASCO会议上公布了相关的临床研究进展。第一三共公布了Ib期研究在晚期或转移性非小细胞肺癌患者中评价Dato-DXd联合帕博利珠单抗（K药）±含铂化疗的亚组分析结果：全人群患者的ORR达52%，DCR达到88%，中位PFS达11.1个月。作为非小细胞肺癌的一线疗法，无论患者的PD-L1表达水平，Dato-Dxd+K药、Dato-Dxd+K药+含铂化疗的治疗方案都显示出了持久的抗肿瘤活性。 Dato-DXd+K药±铂类化疗一线治疗非小细胞肺癌疗效资料来源：参考资料【4】吉利德正在开展一项评估SG+K药±铂类化疗一线治疗转移性非小细胞肺癌疗效的II期临床研究，吉利德在本次ASCO会议上公布了队列A（既往未接受过系统性治疗的转移性非小细胞肺癌患者，驱动基因阴性且PD-L1表达水平≥50%）相关疗效数据：SG联合K药，在PD-L1高表达的患者中，ORR达67%，中位PFS为13.1个月。 SG+K药联合方案治疗转移性非小细胞肺癌疗效资料来源：参考资料【5】此外，吉利德在此次大会上还公布了一项评估SG联合K药治疗HR+/HER2-乳腺癌疗效的II期临床研究。数据显示，相比K药单药，接受SG联合K药治疗的患者的PFS和OS均呈现出延长趋势。在PD-L1阳性、HR+/HER2-的转移性乳腺癌患者亚组中，中位无进展生存期延长了4.4个月，中位生存期延长了6个月。科伦博泰在2024年的ASCO大会上公布了SKB264联合KL-A167（PD-L1单抗）治疗晚期非小细胞肺癌的2期临床研究初步结果。此项研究纳入了未经治疗的晚期驱动基因阴性的非小细胞肺癌患者。研究包括队列1A（接受SKB264 5mg/kg Q3W+KL-A167 1200mg Q3W治疗）和队列1B（接受SKB264 5mg/kg+ KL-A167 900mg Q2W治疗），队列1A的ORR达48.6%，队列1B的ORR达77.6%。此外，科伦博泰还将针对SKB264 Q2W开展进一步研究。一项评估SKB264 Q2W联合K药对比K药单药一线治疗PD-L1 TPS≥50%的转移性非小细胞肺癌的有效性和安全性的3期研究正在进行中。队列1B治疗效果情况资料来源：参考资料【6】此外，今年4月，科伦博泰/默沙东已启动SKB264联合K药治疗不可切除的、局部晚期或转移性HR+/HER-乳腺癌临床III期研究。 EGFR ADC+IO EGFR（epidermal growth factor receptor, 表皮生长因子受体）的异常激活或过度表达与多种肿瘤的发生和疾病进存在密切关联。目前，全球唯一获批的EGFR ADC药物是Rakuten Medical公司研发的Cetuximab saratolacan，用于治疗头颈癌。研发进展紧随其后的是乐普生物的MRG003以及百利天恒的EGFR×HER3双靶ADC BL-B01D1，目前均处于III期临床中，前者用于治疗鼻咽癌和头颈鳞癌，后者用于治疗鼻咽癌、非小细胞肺癌等。除此之外，默克，阿斯利康，石药，复宏汉霖均有在研EGFR ADC药物，大多处于临床I期阶段。 2024年ASCO年会上，乐普生物公布了EGFR ADC MRG003联合PD-1单抗普特利单抗治疗PD-1+化疗经治的鼻咽癌以及未经全身性治疗的头颈癌的临床I/II期数据，数据显示，相比MRG003单药使用，联合用药将进一步提升疗效，具体来看：截至2024年1月30日，共纳入33名患者，其中包括23名鼻咽癌患者（I期：9名；II期：14名）以及7名头颈癌患者（I期：1名；II期：6名）。在9名疗效可评估的、接受PD-1加铂类化疗的一线治疗后EGFR阳性的鼻咽癌患者中，2名患者达到完全缓解，5名患者达到PR及2名患者达到SD，ORR及DCR分别为77.8%和100%。此前，MGR003单药治疗鼻咽癌的II期临床数据显示，2.3mg/kg剂量组中，在29例疗效可评估的患者中，ORR为55.2%，DCR为86.2%，mDoR为6.8个月，mPFS未成熟。在5例疗效可评估的、未接受过系统治疗的头颈癌患者中，3名患者达到PR以及1名患者达到SD，ORR及DCR分别为60%和80%。MGR003单药治疗头颈癌的II期临床数据显示，针对PD-(L)1抗体耐药患者，2.3mg/kg剂量组中，主要研究终点ORR为43%，次要研究终点DCR为86%，mPFS为4.2个月，mOS为11.3个月。 IO+ADC正在开启肿瘤免疫的新时代。后期，预计将有更多的IO+ADC治疗方案临床数据将披露，疗效确定性也将进一步加强，IO+ADC有望成为未来5-10年肿瘤免疫的发展主线，多个肿瘤适应症的一线方案或将从IO演变为IO+ADC。此外，值得注意的是，中国药企在次轮IO+ADC浪潮中占据重要地位。四大PD-(L)1巨头：BMS的O药（Nivolumab）、默沙东的K药（Pembrolizumab）、罗氏的T药（Atezolizumab）以及阿斯利康的I药（Durvalumab），能够与这四大单抗药物联用的ADC药物势必将拥有广阔的市场前景。国内企业在自主研发外，通过与PD-(L)1巨头企业授权合作研发ADC药物以获得与明星单抗产品联用的先机。例如，科伦博泰与默沙东合作，百利天恒与BMS达成合作，康诺亚与阿斯利康达成合作。参考资料《ADC引领治疗变革，IO+ADC潜力巨大》，兴业证券，2024年2月乐普生物官网： https://tc.lepubiopharma.com/upload/listedco/listconews/sehk/2024/0524/2024052400069_c.pdf 乐普生物官网：乐普生物MRG003头颈癌、鼻咽癌临床获积极数据https://www.lepubiopharma.com/new/202.html Datopotamab deruxtecan (Dato-DXd) plus pembrolizumab (pembro) with or without platinum chemotherapy (Pt-CT) as first-line (1L) therapy for advanced non-small cell lung cancer (aNSCLC): Subgroup analysis from TROPION-Lung02. https://meetings.asco.org/abstracts-presentations/232875 Sacituzumab govitecan (SG) + pembrolizumab (pembro) in first-line (1L) metastatic non-small cell lung cancer (mNSCLC) with PD-L1 ≥ 50%: Cohort A of EVOKE-02 https://ascopubs-org.libproxy1.nus.edu.sg/doi/10.1200/JCO.2024.42.16_suppl.8592 Sacituzumab tirumotecan (SKB264/MK-2870) in combination with KL-A167 (anti-PD-L1) as first-line treatment for patients with advanced NSCLC from the phase II OptiTROP-Lung01 study. https://ascopubs-org.libproxy1.nus.edu.sg/doi/10.1200/JCO.2024.42.16_suppl.8502

ASCO会议抗体药物偶联物临床3期临床结果免疫疗法

2024-05-29

·BiG生物创新社

荣昌生物「维迪西妥单抗」，首款中国原创HER2 ADC

作者｜大道至简前言上期文章中，我们提到“在已上市的ADC中，从2000年到2020年二十年间，始终未见中国原创ADC的身影……”。2021年，荣昌生物打破了这一局面，首个中国自主研发的ADC“维迪西妥单抗”获得NMPA批准上市。今天，我们就来了解一下它。 01 首款中国原创HER2 ADC-爱地希®（维迪西妥单抗，来源：参考资料1）2021年6月，维迪西妥单抗（Disitamab Vedotin，爱地希®，RC48）通过国家药品监督管理局（NMPA）优先审评审批程序，附条件批准用于至少接受过2种系统化疗的HER2过表达局部晚期或转移性胃癌，包括胃食管结合部腺癌患者的治疗。当年12月，又获批用于尿路上皮癌治疗。维迪西妥单抗为荣昌生物自主研发的首款国产ADC，是首个获得FDA、NMPA突破性疗法双重认定的ADC。剂型为注射剂，规格60mg/支，辅料包含盐酸组氨酸、甘露醇、蔗糖、聚山梨酯80、氢氧化钠。推荐剂量，如下：（1）胃癌：2.5mg/kg，每两周一次，静脉滴注，直至疾病进展或出现不可耐受的毒性。（2）尿路上皮癌：2.0mg/kg，每两周一次，静脉滴注，直至疾病进展或出现不可耐受的毒性。（结构示意图，来源：参考资料1）维迪西妥单抗由单抗Disitamab与细胞毒素MMAE，通过可切割连接子偶联而成。Disitamab为一种重组的人源化HER2的IgG1单克隆抗体。所采用的连接子为MC-Val-Cit-PAB，是一种能被蛋白酶裂解的二肽可切割连接子。细胞毒素为单甲基澳瑞他汀E（Monomethyl Auristatin E, MMAE）一种微管抑制剂。这种毒素在全球已获批ADC中出现频率较高，上市的15款ADC中，有5款都采用了MMAE。它是一种海兔毒素（Dolastatin 10）的类似物，具有极强的细胞毒性。维迪西妥单抗的作用机制为单抗Disitamab将药物选择性地输送至HER2阳性的肿瘤细胞，肿瘤细胞内吞后，连接子在溶酶体蛋白酶存在下被剪切，细胞毒素MMAE被释放到细胞质中，与微管蛋白结合并抑制其聚合，从而触发细胞凋亡，肿瘤细胞程序性死亡。 02 临床研究2021年6月，维迪西妥单抗首次批准基于一项开放性、多中心、单臂临床II期研究，这项研究在至少接受过2个系统化疗的HER2 过表达局部晚期或转移性胃癌，包括胃食管结合部腺癌患者，共纳入127例受试者。研究主要终点为独立疗效评价委员会（IRC）根据 RECIST 1.1 标准评估的客观缓解率（ORR），次要研究终点为研究者评价的 ORR、无进展生存期（PFS）、总生存期（OS）、缓解持续时间（DOR）、肿瘤进展时间（TTP）、疾病控制率（DCR）等。研究结果显示，IRC评价的客观缓解率（ORR）为24.4%，中位缓解持续时间（DOR）为4.7个月，疾病控制率（DCR）为41.7%，研究者评价的客观缓解率（ORR）为23.6%。总体人群中位无进展生存期（PFS）为4.1个月，中位总生存期（OS）为7.9个月。（临床结果，来源：参考资料2）安全性常见的实验室检查类不良反应包括：白细胞计数降低、中性粒细胞计数降低、转氨酶升高；常见的临床症状、体征类不良反应包括脱发、乏力、感觉减退等。市场表现维迪西妥单抗2021年6月在中国首次上市，当年年底销售额达到8400万元人民币。2021年12月，被纳入国家医保目录，定价由最初的13500元/支调整为3800元/支。根据公司财报估算，2023年维迪西妥单抗销售超过6亿人民币。2021年8月，荣昌生物将维迪西妥单抗以26亿美元的价格授权给美国ADC巨头Seagen，创下中国当年单药海外授权记录。接下来，我们就从这个最热门的ADC赛道中，选出即将上市的HER2 ADC，对比一下看看它们的异同。 03 同类竞品SYD985（Trastuzumab duocarmazine）原研：Byondis（荷兰）靶点：HER2抗体：人源化IgG1单抗毒素/有效载荷：DUBA前药（DNA）连接子：Val-Cit（二肽）适应症：乳腺癌、子宫内膜癌、胃癌等研究状态：申请上市SYD985由荷兰Byondis公司原研，利用ByonZine®技术开发。ByonZine®技术是一种连接子-药物合成技术，用于构建可切割连接子-药物(LD，Linker-Drug)。Byondis公司利用该技术对Duocarmazine-Linker进行优化，得到vc-seco-DUBA及其衍生物（val-cit-seco-Duocarmycin-hydroxyBenzamide-Azaindole），再采用ByonShieLD®技术将vc-seco-DUBA与曲妥珠单抗偶联，得到了SYD985。所采用的细胞毒素Duocarmycin属于DNA烷化剂，具有高效的抗肿瘤毒性。整个过程就是，SYD985经曲妥珠单抗靶向HER2肿瘤细胞，内化后可切割连接子被蛋白酶水解，无活性的前体毒素seco-DUBA被激活成活性DUBA，诱导细胞DNA损伤，导致肿瘤死亡。因此SYD985的血浆稳定性更好，毒素只在靶细胞内稳定释放，相比上一代ADC，它解决了治疗窗口窄的问题。在一些临床研究中，SYD985显示出比罗氏Kadcyla更高的活性。2023年6月，鉴于SYD985在临床III期试验TULIP®的积极结果，FDA接受了SYD985的BLA，用于HER2阳性不可切除的局部晚期或转移性乳腺癌（MBC）治疗。目前，SYD985在欧盟和英国的上市申请也在持续推进。写在最后众所周知，HER2是ADC研究最充分、竞争最激烈的靶点之一。有统计显示，全球在研ADC中，HER2靶点占38.4%，其次是TROP2、Claudin18.2。目前，全球已有3款HER2 ADC上市，除了今天分享的爱地希®，剩余两款分别是，“商业化最成功的ADC”—罗氏Kadcyla和“最佳ADC”—第一三共Enhertu。可以预见，后来者们除非能拿出和Enhertu同样亮眼的成绩。否则，想要在HER2 ADC这个赛道分一杯羹绝非易事。上市ADC系列往期文章第一期：上市抗体偶联药物（ADCs）系列第一期：全球首款ADC Mylotarg第二期：全球首款批准用于一线治疗的ADC——Adcetris第三期：迄今商业化最成功ADC：Kadcyla第四期：Besponsa：辉瑞的第二款ADC，这次“命运”会好点吗？第五期：阿斯利康Lumoxiti，20年来首款批准用于毛细胞白血病的新药第六期：罗氏第二款ADC，能续写Kadcyla的成功吗？第七期：Best in Class，“头对头”优效，这款ADC一度颠覆治疗指南第八期：ADC扎堆HER2，Nectin-4靶点能杀出重围么？第九期：全球首款Trop2 ADC：三年，从加速批准到跻身重磅—Trodelvy®第十期：全球首款靶向BCMA ADC：从加速批准到美国退市，现在进展如何？第十一期：全球首款光免疫疗法ADC—Akalux® BiG 十周年预告 6月26-29日，苏州，将召开BiG十周年庆典，此次会议将首次分为国内和国际篇章，以原创科学和临床需求为出发点，讨论创新技术平台和创新疗法（PROTACT/分子胶、双抗/ADC、siRNA/ASO、CGT、AI制药）的重大进展和发展前景，十年一药曙光现，大浪淘沙始见金！▼架构&完整议程（点击图片，跳转链接）论坛2: 抗体&ADC：从创新靶点到临床进展冠名支持：东曜药业策划：田丰、刘军B2皇冠宴会厅C上半场：抗体&ADC，新靶点与新技术14:00-14:30 肺癌领域：双抗&ADC最新临床开发进展周彩存：同济大学附属东方医院肿瘤科主任14:30-15:00 全球ADC新一代技术亮点梳理田丰：Luxvitae Therapeutics 联合创始人/CEO15:00-15:30 肿瘤全新免疫检查点CD3L1：从源头发现到新药研发许杰：柏全生物创始人15:30-15:50 善用糖定点偶联技术构建创新ADC分子段清：东曜药业药物研发及技术开发负责人15:50-16:10 Break下半场：CD3双抗与双抗ADC16:10-16:40 CD3双抗：全球进展&创新设计思路康小强：维立志博董事长/CEO16:40-17:00 高通量仿临床研究平台，如何加速双抗/ADC开发陈大为：创模生物联合创始人、CSO17:00-17:40 Panel：如何开发一款双抗ADC？靶点选择vs.CMC开发vs.临床&市场潜力刘军：东曜药业CEO兼执行董事（主持）李竞：橙帆医药联合创始人/CEO周辉：信达生物集团高级副总裁更多讨论嘉宾邀请中报名参会会议门票：审核制(免费)；含主论坛+分论坛，不含餐；优先biotech/Pharma、临床、院校科学家。咨询BiG商务合作：Lisa 18662346610（同微信）参会/会员：Kathy 17621909690（同微信）媒体合作：静渝 18335445068（同微信）秘书长：李圆 18521514899（同微信）共建Biomedical创新生态圈！如何加入BiG会员？

抗体药物偶联物优先审批突破性疗法上市批准临床2期

2024-05-29

·BioSpace

Rakuten Medical to Host R&D Day Highlighting Recent Interim Data from Phase 1b/2 Clinical Trial of ASP-1929 Photoimmunotherapy in Combination with anti-PD-1 in r/m HNSCC

Dr. Gillenwater will review the updated safety and efficacy findings which will be presented at ASCO 2024 Rakuten Medical's management team will provide recent clinical and business updates The event will be held virtually on Thursday, June 20, 2024, at 1:00 pm ET / 10:00 am PT SAN DIEGO, May 29, 2024 /PRNewswire/ -- Rakuten Medical, Inc., a global biotechnology company developing and commercializing precision, cell-targeting photoimmunotherapy based on its proprietary Alluminox™ platform, today announced that it will host a virtual R&D Day on Thursday, June 20, 2024 at 1:00 pm ET / 10:00 am PT. The event will feature a key opinion leader, Dr. Ann M. Gillenwater, Professor, Department of Head and Neck Surgery, Division of Surgery, The University of Texas MD Anderson Cancer Center, who will discuss the updated safety and efficacy findings from an interim evaluation of Rakuten Medical's open-label Phase 1b/2 study (ASP-1929-181/ClinicalTrials.gov Identifier: NCT04305795) of photoimmunotherapy using ASP-1929 in combination with anti-PD-1 therapy in first line recurrent and/or metastatic head and neck squamous cell carcinoma, which will be presented in a poster at ASCO 2024. Rakuten Medical's executive management team will provide other key clinical and business updates including, but not limited to, development programs including a new study and Japan commercial updates. A live question and answer session will follow the formal presentation. Please note that practicing healthcare professionals and patients are not permitted to attend. R&D Day event site: R&D Day event site: About Rakuten Medical, Inc. Rakuten Medical, Inc. is a global biotechnology company developing and commercializing precision, cell targeting therapies based on its proprietary Alluminox™ platform, which, in pre-clinical studies, has been shown to induce rapid and selective cell killing and tumor necrosis. Alluminox therapies have not yet been approved outside of Japan. Rakuten Medical is committed to its mission to conquer cancer by delivering our innovative treatments as quickly as possible to as many patients as possible all over the world. The company has offices in 6 countries, including the United States, where it is headquartered, Japan, the Netherlands, Taiwan, Switzerland and India. For more information, visit . About Alluminox™ platform The Alluminox™ platform is an investigational technology platform based on a cancer therapy called photoimmunotherapy, which was developed by Dr. Hisataka Kobayashi and team from the National Cancer Institute in the United States. Rakuten Medical is developing the Alluminox platform as a technology consisting of a drug, device, and other related components. The drug component of the platform consists of a targeting moiety conjugated with one or more dyes leading to selective cell surface binding. The device component consists of a light source that locally illuminates the targeted cells with light to transiently activate the drug. Pre-clinical data have shown that this activation elicits rapid and selective necrosis of targeted cells through a biophysical process that compromises the membrane integrity of the targeted cells. Therapies developed on the Alluminox platform may also result in local and systemic innate and adaptive immune activation due to immunogenic cell death of the targeted cancer cells and/or the removal of targeted immunosuppressive cells within the tumor microenvironment. Outside of Japan, Alluminox therapies have not yet been approved by any regulatory authority. Forward Looking Statements This press release contains forward looking statements that correspond to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements include various risks, uncertainties, and assumptions that may cause Rakuten Medical's business plans and results to differ from the anticipated results and expectations expressed in these statements. These "forward looking statements" contain information about the status and development of our products, including the Alluminox™ platform, as well as other regulatory and marketing authorization efforts, the potential benefits, efficacy, and safety of therapies created using the Alluminox platform, and the status of regulatory filings. The approval and commercial success of the product may not be achieved. Forward looking statements relate to the potential benefits, efficacy, and safety of our therapies, and the status of regulatory filings. Such statements may include words such as "expect," "believe," "hope," "estimate," "looks as though," "anticipate," "intend," "may," "suggest," "plan," "strategy," "will," and "do", and are based on our current beliefs. In addition, this press release uses terms such as "important," "notable," and "abnormal" to express opinions about clinical trial data. Ongoing clinical trial studies include various risks and uncertainties, in particular, problems that arise during the manufacturing stage of our therapies, the occurrence of adverse safety events, situations in failure to demonstrate therapeutic benefits, and other various risks and uncertainties, both reasonable and unreasonable. For this reason, actual results, including regulatory approvals and uncertainties in the commercialization process of our therapies, may differ from published information. Except to the extent required by applicable law, we undertake no obligation to publicly update this or any other forward-looking statement, whether because of new information, future developments or events, changes in assumptions, changes in the factors affecting forward-looking statements. If one or more forward-looking statement(s) is updated, no inference should be drawn that additional updates will be made to those or other forward-looking statements. Contact Us

免疫疗法临床研究

100 项与沙西妥昔单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
头颈部肿瘤	日本	Rakuten Medical, Inc.	2020-09-25

未上市

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
复发性头颈癌	临床3期	美国	Rakuten Medical, Inc.	2019-05-09
复发性头颈癌	临床3期	日本	Rakuten Medical, Inc.	2019-05-09
复发性头颈癌	临床3期	印度	Rakuten Medical, Inc.	2019-05-09
复发性头颈癌	临床3期	中国台湾	Rakuten Medical, Inc.	2019-05-09
复发性头颈癌	临床3期	乌克兰	Rakuten Medical, Inc.	2019-05-09
复发性头颈部鳞状细胞癌	临床3期	美国	Rakuten Medical, Inc.	2019-05-09
复发性头颈部鳞状细胞癌	临床3期	日本	Rakuten Medical, Inc.	2019-05-09
复发性头颈部鳞状细胞癌	临床3期	印度	Rakuten Medical, Inc.	2019-05-09
复发性头颈部鳞状细胞癌	临床3期	中国台湾	Rakuten Medical, Inc.	2019-05-09
复发性头颈部鳞状细胞癌	临床3期	乌克兰	Rakuten Medical, Inc.	2019-05-09

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临床结果

适应症

分期

评价

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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


NCT04305795 (ASP-1929-181, ASCO2024) 人工标引	临床1/2期	晚期头颈部鳞状细胞癌 EGFR Positive	19	ASP-1929 PIT+pembrolizumab	鹹顧選鹹獵齋艱鬱糧衊(鑰餘襯衊繭蓋衊構選顧) = 鏇築鑰遞觸襯構選醖築醖衊鬱糧淵製鹹壓蓋憲 (夢窪選膚醖餘膚顧醖鬱, 13.3-59.0) 更多	积极	2024-05-25
NCT04305795 (ASP-1929-181, AHNS2023)	临床1/2期	晚期头颈部鳞状细胞癌 EGFR-expressing	26	ASP-1929 photoimmunotherapy	鏇淵憲鬱鹽艱夢顧醖簾(廠憲築壓鏇築願淵襯淵) = 繭糧衊衊廠鑰齋選鏇製衊繭憲構齋糧繭蓋遞廠 (糧遞艱簾觸餘窪網蓋鏇, 10.3 ~ 56.0) 更多	积极	2023-07-10
NCT02422979 (Pubmed \| Head Neck)	临床1/2期	复发性头颈部鳞状细胞癌	40	RM-1929	範遞襯網齋醖膚鏇獵觸(齋淵窪艱衊艱構遞蓋醖) = 襯築築範壓觸鏇遞蓋鏇構艱襯網築窪壓鏇顧膚 (觸餘繭窪繭構繭顧衊範, 12.28% ~ 45.89%) 更多	-	2021-10-09
NCT02422979 (RM-1929-101, PMDA) 人工标引	临床1期	头颈部鳞状细胞癌	9	Akalux 160mg/m2 + Radiotherapy	餘鏇憲窪製願範醖遞憲(窪遞窪鏇淵醖夢糧艱襯) = 選鬱鑰築鹽繭築襯繭願簾醖選艱積獵壓顧積壓 (醖鏇憲鹹廠壓蓋蓋獵窪 ) 更多	积极	2020-09-25
NCT02422979 (RM-1929-101, PMDA) 人工标引	临床1期	头颈部鳞状细胞癌	9	Akalux 320mg/m2 + Radiotherapy	餘鏇憲窪製願範醖遞憲(窪遞窪鏇淵醖夢糧艱襯) = 壓蓋廠觸鹽鏇窪選衊衊簾醖選艱積獵壓顧積壓 (醖鏇憲鹹廠壓蓋蓋獵窪 ) 更多	积极	2020-09-25
RM-1929-102 (PMDA) 人工标引	临床1期	头颈部鳞状细胞癌	3	Akalux 640mg/m2 + Radiotherapy	餘網獵壓膚遞觸膚範製(鏇鑰獵夢鬱壓觸醖膚鑰) = 廠衊醖鹹壓鏇憲觸齋觸鏇選淵鹽膚糧鬱網鹽壓 (糧觸淵願簾糧願廠夢鬱 ) 更多	积极	2020-09-25
NCT02422979 (RM-1929-101, PMDA) 人工标引	临床2期	头颈部鳞状细胞癌	30	Akalux 640mg/m2 + Radiotherapy	願獵鑰膚遞鏇糧鑰範夢(遞積鑰鏇顧醖餘簾選遞) = 壓淵製簾築鏇廠簾壓構淵製鏇醖選蓋蓋鏇構鏇 (鑰獵鏇衊鬱觸獵願醖選 ) 更多	积极	2020-09-25
Biospace 人工标引	临床2期	复发性头颈部鳞状细胞癌	30	Cetuximab Sarotalocan Sodium	鹹糧壓繭簾遞艱觸鬱蓋(選遞構壓網網選鬱願鹽) = 襯憲憲鬱構齋蓋齋顧蓋選積夢衊齋鹽鏇壓廠艱 (選範廠鹽築簾壓網觸築, 2.1 ~ 5.5) 更多	积极	2019-06-01