This phase Ib/II trial studies the side effects and best dose of EMB-01 when given together with osimertinib in patients with EGFR-mutant non-small cell lung cancer that has spread to other places in the body (advanced or metastatic) and has progressed on standard treatment. EMB-01 and osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth in this type of cancer. EMB-01 in combination with osimertinib may work better in treating patients with EGFR-mutant advanced non-small cell lung cancer.

开始日期2023-06-01

申办/合作机构

上海岸迈生物科技有限公司

[+1]

CTR20230350 / Recruiting临床1期

一项EMB-07（一种双特异性抗体抗CD3和受体酪氨酸激酶样孤儿受体1[ROR1]）在局部晚期/转移性实体瘤或复发性/难治性淋巴瘤患者中的首次人体I期开放性研究

分别对于实体瘤以及淋巴瘤：评价EMB-07静脉注射（IV）给药的安全性和耐受性; 确定EMB-07的最大耐受剂量（MTD）和/或II期推荐剂量（RP2D）

开始日期2023-05-16

申办/合作机构

岸迈生物科技(苏州)有限公司

100 项与上海岸迈生物科技有限公司相关的临床结果

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0 项与上海岸迈生物科技有限公司相关的专利（医药）

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项与上海岸迈生物科技有限公司相关的文献（医药）

2024-04-05·Cancer Research

Abstract LB126: Generation of a novel ROR1 x CD3 bispecific T-cell engager for better tumor killing and minimal cytokine release

作者: Dong, Liqin ; Lensky, Stephan ; Wu, Xuan ; Wu, Chengbin ; Wu, Danqing ; Naren, Gaowa ; Gong, Shiyong

AbstractReceptor tyrosine kinase-like orphan receptor 1 (ROR1) expression is a highly specific tumor associated antigen expressed in multiple hematological malignancies and solid tumors. EMB-07 is a novel monovalent asymmetrical tandem Fab (MAT-Fab) antibody composed of two different Fab fragments targeting ROR1 and CD3ε respectively, and a “knob-in-hole” Fc fragment maintaining FcRn binding and Ig-like pharmacokinetics in vivo. To avoid light chain miss-pairing, the anti-ROR1 light chain was directly connected to the N-terminus of the anti-CD3 heavy chain. The ROR1 binding arm has a high affinity of 0.52 nM and recognizes a membrane distal epitope, which is different from a reference BiTE molecule currently in clinical trial. In comparison with this BiTE molecule, EMB-07 showed similar tumor killing efficacy to ROR1 expressing tumor cell lines while it induced much lower levels of cytokines both in vitro and in vivo. Moreover, comparing with a clinical stage ROR1-vc-MMAE ADC, EMB-07 demonstrated ~500-fold increased tumor lysis potency in vitro. In PD-1 resistant tumor xenograft mice models, EMB-07 showed potent tumor growth inhibition and synergistic activity in combination with PD-1 blockade. In a preclinical GLP toxicological study, EMB-07 was well tolerated in cynomolgus monkeys with no evidence of lethality, life-threatening toxicity, or obvious EMB-07-related macroscopic and histopathological adverse findings up to 50 mg/kg. By using a highly specific IHC clone, we validated membrane-associated ROR1 expression in multiple tumor types, including triple negative breast cancer, ovarian cancer, endometrial cancer, lung adenocarcinoma, and pancreatic cancer, while the observation of its expression in normal tissues is very limited. This study supports the clinical development of EMB-07 for treating multiple solid tumors with ROR1 expression. A FIH study of EMB-07 in locally advanced/metastatic solid tumors or relapse/refractory lymphoma is currently ongoing (NCT05607498).Citation Format: Danqing Wu, Shiyong Gong, Xuan Wu, Gaowa Naren, Liqin Dong, Stephan Lensky, Chengbin Wu. Generation of a novel ROR1 x CD3 bispecific T-cell engager for better tumor killing and minimal cytokine release [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(7_Suppl):Abstract nr LB126.

2023-07-24·Antibody Therapeutics

A NOVEL IMMUNOSTIMULATORY PD-L1/OX40 TETRAVALENT BISPECIFIC ANTIBODY FOR CANCER IMMUNOTHERAPY

作者: Zhang, Rui ; Wu, Jianfu ; Li, Baocun ; Wu, Xuan ; Naren, Gaowa ; Wu, Chengbin ; Liu, Fan ; Zhang, Nianying ; Lv, Zhou ; Zhang, Yu ; Wu, Danqing ; Gong, Shiyong

AbstractSingle agent immune checkpoint therapy has shown substantial and durable clinical activity in many tumor types; however, only a fraction of the patients could benefit from this approach. To improve beyond the anti-PD-1/PD-L1 treatment options, bispecific antibodies (BsAb) that combines PD-L1 blockade and conditional co-stimulatory receptor activation simultaneously in one molecule have been developed and demonstrated superior anti-tumor activity in pre-clinical models. However, many of these PD-L1 based BsAb faced challenge in clinical development due to insufficient activity or unexpected toxicity. Here, we demonstrated that OX40 might be a more suitable partner for PD-L1 based BsAb design than other agonistic targets (CD27 and 4-1BB, etc.) currently in clinical studies. A novel Fc silenced tetravalent PD-L1/OX40 (EMB-09) BsAb targeting optimal OX40 binding epitope has been developed based on EpimAb’s proprietary FIT-Ig® technology. Results showed that EMB-09 maintained the parental mAb binding characteristic and retained the functional properties of each parental mAb including OX40 agonistic as well as PD-L1/PD1 inhibitory pathways. In addition, EMB-09 induced OX40 activation only in the context of PD-L1 engagement. Concurrent PD-L1/PD-1 blockade and OX40 co-stimulation by EMB-09 led to synergistic activation of T cell in vitro and exerted superior anti-tumor activity in mouse tumor models compared to anti-PD-L1 mAb. The underlining mechanism was extensively analyzed, which indicated an increased CD8+ tumor-infiltrating T-cells (TIL) as well as enhanced CD8 TIL activation status upon EMB-09 treatment. Additionally, EMB-09 was well tolerated in cynomolgus monkeys at high dose levels with a favorable safety and PK profile in a GLP-TOX study. In conclusion, as a PD-L1/OX40 BsAb with a novel biology mechanism, EMB-09 demonstrated a markedly improved anti-tumor activity compared to anti-PD-L1 mAb. The first-in-human clinal study of EMB-09 has been initiated (NCT05263180).

2023-07-01·Antibody therapeutics

Efficient production of bispecific antibodies-optimization of transfection strategy leads to high-level stable cell line generation of a Fabs-in-tandem immunoglobin.

Article

作者: Wu, Chengbin ; Gong, Shiyong

Bispecific antibodies (bsAbs) are often composed of more than two component chains, such as Fabs-in-tandem immunoglobin (FIT-Ig) comprising three different component chains, which bring challenges for generating a high proportion of the correctly assembled bsAbs in a stable cell line. During the CHO-K1 stable cell line construction of a FIT-Ig, we investigated the FIT-Ig component chain ratio in transfection, where two sets of expression vectors were designed. Both designs utilized two vectors for co-transfection. Multiple transfections with plasmid ratio adjustment were applied, and the resultant minipools were evaluated for expression titer and quality of produced FIT-Ig. The results suggested that abundant outer Fab short chains (twofold chain genes versus other chains) can promote complete FIT-Ig assembly and therefore reduce the fragmental impurities of FIT-Ig. This adjustment of the component chain ratios at the beginning is beneficial to FIT-Ig stable cell line generation and brings favorable clones to process development.

1,516

项与上海岸迈生物科技有限公司相关的新闻（医药）

2024-10-31

·医药笔记

安进：第2款实体瘤CD3双抗，Xaluritamig将启动前列腺癌三期临床

▎Armstrong 2024年10月30日，安进发布三季度财报，介绍了研发管线的最新进展，肿瘤业务板块中重点提到STEAP1/CD3双抗Xaluritamig将在本季度启动紫杉醇后线的前列腺癌三期临床试验。 Xaluritamig采用Xencor的XmAb 2+1技术设计，目前处于一期临床阶段，意味着安进将直接推进到三期临床。 Xencor还有其他多款实体瘤CD3双抗在推进中，覆盖靶点包括ENPP3、Claudin6、B7H3等，均采用XmAb 2+1技术。今年AACR会议上，安进披露了Xaluritamig的一期临床数据，PSA和RECIST评估疗效数据如下，PSA50为49%，PSA90为28%。以RECIST评估，高剂量组ORR为41%，DCR为79%。总结作为最老牌的biotech，安进研发管线中还有多哥潜在爆款产品，除了前述两款实体瘤CD3双抗，还有自免领域的OX40抗体Rocatinlimab，代谢领域的GIPR抗体融合GLP-1分子MariTide等。 Armstrong技术全梳理系列 GPRC5D靶点全梳理； CD40靶点全梳理； CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向； Claudin 6靶点全梳理； Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇； CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理； Ambrx技术全梳理； Vir Biotech技术全梳理； Immune-Onc技术全梳理；亘喜生物技术全梳理；康哲药业技术全梳理；科济药业技术全梳理；恺佧生物技术全梳理；同宜医药技术全梳理；百奥赛图技术全梳理；腾盛博药技术全梳理；创胜集团技术全梳理；永泰生物技术全梳理；中国抗体技术全梳理；德琪医药技术全梳理；德琪医药技术全梳理2.0；和铂医药技术全梳理；荣昌生物技术全梳理；再鼎医药技术全梳理；药明生物技术全梳理；恒瑞医药技术全梳理；豪森药业技术全梳理；正大天晴技术全梳理；吉凯基因技术全梳理；基石药业技术全梳理；百济神州技术全梳理；百济神州技术全梳理第2版；信达生物技术全梳理；信达生物技术全梳理第2版；中山康方技术全梳理；复宏汉霖技术全梳理；先声药业技术全梳理；君实生物技术全梳理；嘉和生物技术全梳理；志道生物技术全梳理；道尔生物技术全梳理；尚健生物技术全梳理；康宁杰瑞技术全梳理；科望医药技术全梳理；科望医药技术全梳理2.0；岸迈生物技术全梳理；礼进生物技术全梳理；康桥资本技术全梳理；余国良的抗体药布局；荃信生物技术全梳理；安源医药技术全梳理；三生国健技术全梳理；仁会生物技术全梳理；乐普生物技术全梳理；同润生物技术全梳理；宜明昂科技术全梳理；派格生物技术全梳理；迈威生物技术全梳理； Momenta技术全梳理； NGM技术全梳理；普米斯生物技术全梳理；普米斯生物技术全梳理2.0；三叶草生物技术全梳理；贝达药业抗体药全梳理；泽璟制药抗体药全梳理；恒瑞医药抗体药全梳理；齐鲁制药抗体药全梳理；石药集团抗体药全梳理；豪森药业抗体药全梳理；华海药业抗体药全梳理；科伦药业抗体药全梳理；百奥泰技术全梳理；凡恩世技术全梳理。

AACR会议临床3期财报抗体药物偶联物

2024-10-31

·医药笔记

安进：CD3/CD19双抗启动狼疮肾炎二期临床

▎Armstrong 2024年10月30日，安进发布三季度三包，营收81.51亿美元，同比增长23%，扣除收购Horizon的影响，营收增长8%。肿瘤业务板块，CD3/CD19双抗Blincyto三季度销售额3.27亿美元，同比增长49%，小细胞肺癌的DLL3/CD3双抗Imdelltra首季度销售额3600万美元。 Blincyto正在探索皮下剂型，B-ALL的1/2期临床已经完成入组，预计2025年下半年推进到二期注册临床。安进正在积极开拓自免领域，CD3/CD19双抗和CD19单抗已经启动狼疮肾炎的二期临床试验。 2a期临床计划入组50例，其中CD3/CD19双抗采用皮下注射剂型。安全性终点观察52周，疗效终点观察12周和24周。总结 Blincyto为全球首个也是唯一一个获批上市的CD3/CD19双抗，这一波自免浪潮中第一个推进到二期临床。Cullinan刚刚启动1b期临床，计划入组24例狼疮患者。默沙东7亿美元引进了同润生物的CD3/CD19双抗，葛兰素史克8.5亿美元引进恩沐生物的CD3/CD19/CD20双抗。Xencor宣布CD3/CD20双抗、CD3/CD19双抗转战自免领域。Candid收购了嘉和生物的CD3/CD20双抗、岸迈生物的CD3/BCMA双抗。 Armstrong技术全梳理系列 GPRC5D靶点全梳理； CD40靶点全梳理； CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向； Claudin 6靶点全梳理； Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇； CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理； Ambrx技术全梳理； Vir Biotech技术全梳理； Immune-Onc技术全梳理；亘喜生物技术全梳理；康哲药业技术全梳理；科济药业技术全梳理；恺佧生物技术全梳理；同宜医药技术全梳理；百奥赛图技术全梳理；腾盛博药技术全梳理；创胜集团技术全梳理；永泰生物技术全梳理；中国抗体技术全梳理；德琪医药技术全梳理；德琪医药技术全梳理2.0；和铂医药技术全梳理；荣昌生物技术全梳理；再鼎医药技术全梳理；药明生物技术全梳理；恒瑞医药技术全梳理；豪森药业技术全梳理；正大天晴技术全梳理；吉凯基因技术全梳理；基石药业技术全梳理；百济神州技术全梳理；百济神州技术全梳理第2版；信达生物技术全梳理；信达生物技术全梳理第2版；中山康方技术全梳理；复宏汉霖技术全梳理；先声药业技术全梳理；君实生物技术全梳理；嘉和生物技术全梳理；志道生物技术全梳理；道尔生物技术全梳理；尚健生物技术全梳理；康宁杰瑞技术全梳理；科望医药技术全梳理；科望医药技术全梳理2.0；岸迈生物技术全梳理；礼进生物技术全梳理；康桥资本技术全梳理；余国良的抗体药布局；荃信生物技术全梳理；安源医药技术全梳理；三生国健技术全梳理；仁会生物技术全梳理；乐普生物技术全梳理；同润生物技术全梳理；宜明昂科技术全梳理；派格生物技术全梳理；迈威生物技术全梳理； Momenta技术全梳理； NGM技术全梳理；普米斯生物技术全梳理；普米斯生物技术全梳理2.0；三叶草生物技术全梳理；贝达药业抗体药全梳理；泽璟制药抗体药全梳理；恒瑞医药抗体药全梳理；齐鲁制药抗体药全梳理；石药集团抗体药全梳理；豪森药业抗体药全梳理；华海药业抗体药全梳理；科伦药业抗体药全梳理；百奥泰技术全梳理；凡恩世技术全梳理。

临床2期并购临床1期抗体药物偶联物

2024-10-30

·Armstrong生物药资讯

礼来：替尔泊肽前三季度大卖110亿美元

▎Armstrong 2024年10月30日，礼来发布三季度财报，前三季度营业收入315亿美元，同比增长27%，净利润61.8亿美元。前三季度，替尔泊肽降糖版Moujaro销售额80.10亿美元，去年同期为29.58亿美元，替尔泊肽减重版Zepbound销售额30.18亿美元。替尔泊肽合计销售额110亿美元，预计全年超过160亿美元。替尔泊肽去年11月份上市以来放量迅速，累计处方患者超过60万人。降糖版Mounjaro三季度与二季度销售额基本持平，美国处方份额约30%。总结诺和诺德司美格鲁肽今年上半年销售额为130亿美元，替尔泊肽正在快速抢占市场，与司美格鲁肽的差距快速缩小。横向对比，Keytruda今年上半年销售额142亿美元，未来新的药王争夺大概率会在司美格鲁肽、替尔泊肽中间产生。 Armstrong技术全梳理系列 GPRC5D靶点全梳理； CD40靶点全梳理； CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向； Claudin 6靶点全梳理； Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇； CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理； Ambrx技术全梳理； Vir Biotech技术全梳理； Immune-Onc技术全梳理；亘喜生物技术全梳理；康哲药业技术全梳理；科济药业技术全梳理；恺佧生物技术全梳理；同宜医药技术全梳理；百奥赛图技术全梳理；腾盛博药技术全梳理；创胜集团技术全梳理；永泰生物技术全梳理；中国抗体技术全梳理；德琪医药技术全梳理；德琪医药技术全梳理2.0；和铂医药技术全梳理；荣昌生物技术全梳理；再鼎医药技术全梳理；药明生物技术全梳理；恒瑞医药技术全梳理；豪森药业技术全梳理；正大天晴技术全梳理；吉凯基因技术全梳理；基石药业技术全梳理；百济神州技术全梳理；百济神州技术全梳理第2版；信达生物技术全梳理；信达生物技术全梳理第2版；中山康方技术全梳理；复宏汉霖技术全梳理；先声药业技术全梳理；君实生物技术全梳理；嘉和生物技术全梳理；志道生物技术全梳理；道尔生物技术全梳理；尚健生物技术全梳理；康宁杰瑞技术全梳理；科望医药技术全梳理；科望医药技术全梳理2.0；岸迈生物技术全梳理；礼进生物技术全梳理；康桥资本技术全梳理；余国良的抗体药布局；荃信生物技术全梳理；安源医药技术全梳理；三生国健技术全梳理；仁会生物技术全梳理；乐普生物技术全梳理；同润生物技术全梳理；宜明昂科技术全梳理；派格生物技术全梳理；迈威生物技术全梳理； Momenta技术全梳理； NGM技术全梳理；普米斯生物技术全梳理；普米斯生物技术全梳理2.0；三叶草生物技术全梳理；贝达药业抗体药全梳理；泽璟制药抗体药全梳理；恒瑞医药抗体药全梳理；齐鲁制药抗体药全梳理；石药集团抗体药全梳理；豪森药业抗体药全梳理；华海药业抗体药全梳理；科伦药业抗体药全梳理；百奥泰技术全梳理；凡恩世技术全梳理。

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药物(靶点)	适应症	全球最高研发状态

Cizutamig ( BCMA x CD3 )	浆细胞骨髓瘤难治更多	临床2期
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