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]

NCT05263180

/ Recruiting临床1期

A First-in-human, Phase I Trial of EMB-09, a Bispecific Antibody Targeting PD-L1 and OX-40 in Patients With Advanced or Metastatic Solid Tumors

This study is to evaluate the safety and tolerability of EMB-09 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). Pharmacokinetics (PK), immunogenicity, and the anti-multiple myeloma activity of EMB-09 will also be assessed.

开始日期2022-07-25

申办/合作机构

上海岸迈生物科技有限公司

NCT05176665

/ Recruiting临床1/2期

Phase Ib/II, Open-Label Study of EMB-01 in Patients With Advanced/Metastatic Gastrointestinal Cancers

This study is to evaluate the safety and antitumor activity of EMB-01 in advanced/metastatic gastrointestinal cancers, including gastric cancer, hepatocellular cancer, cholangiocarcinoma and colorectal cancer.

开始日期2021-10-21

申办/合作机构

上海岸迈生物科技有限公司

[+1]

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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）

2025-06-01·BRITISH JOURNAL OF CANCER

First-in-human phase I study of EMB-02, a bispecific antibody targeting PD-1 and LAG-3 in patients with advanced solid tumors

Article

作者: Aghmesheh, Morteza ; Chung, Ki ; Ganju, Vinod ; Zeng, Shuqi ; Day, Daphne ; Guo, Jun ; Si, Lu ; Zhu, Yonghong ; Zhang, Mingfei ; Jiang, Chengjun ; Lu, Qiaoyang ; Brewin, Kim ; Mao, Lili ; Hoyer, Robert ; Ren, Fang

Abstract:

Background:

EMB-02 is a symmetric bispecific antibody targeting programmed cell death protein-1 and lymphocyte-activation gene 3 simultaneously. Here, we present the first-in-human study results of EMB-02 in patients with advanced solid tumors.

Methods:

Patients were treated with intravenous infusions of EMB-02 at doses of 6–900 mg. The primary objective was to evaluate the safety and tolerability and to determine the maximum tolerated dose and/or recommended phase II dose(s). Secondary objectives included characterizing the pharmacokinetic (PK) profile, assessing preliminary antitumor activity and the immunogenicity.

Results:

A total of 47 patients were enrolled. All grade and grade 3/4 treatment-emergent and treatment related adverse events occurred in 97.9%, 48.9%, 68.1% and 12.8% patients, respectively. The objective response rate (ORR) was 6.4% and clinical benefit rate at 24 weeks (CBR-24) was 25.5% in overall population. The CBR-24 was 33.3% in checkpoint inhibitor (CPI)-naïve patients, and 15% in CPI-treated. No clear relationship was observed between the efficacy and PD-L1, LAG-3, or MHC II expression level. Doses 360 mg or higher resulted in sustained saturation of PD-1 receptors on circulating CD3 + T cells.

Conclusions:

EMB-02 demonstrated a favorable safety profile and early efficacy signals in multiple solid tumors, warranting further development. (NCT04618393).

2025-03-04·MOLECULAR CANCER THERAPEUTICS

A Novel Designed Anti–PD-L1/OX40 Bispecific Antibody Augments Both Peripheral and Tumor-Associated Immune Responses for Boosting Antitumor Immunity

Article

作者: Gaowa, Naren ; Wu, Xuan ; Wu, Chengbin ; Zhang, Yu ; Gong, Shiyong ; Lv, Zhou ; Li, Baocun ; Ganju, Vinod ; Dong, Liqin ; Wu, Danqing ; Wu, Jianfu ; Liu, Fan ; Shi, Beilei ; Zhang, Nianying ; Behzadigohar, Ramin ; Zhang, Rui

Abstract:

Bispecific antibodies (BsAb) combining simultaneous PD-L1 blockade and conditional costimulatory receptor activation have been developed to improve immune checkpoint therapy response. However, several PD-L1–based BsAbs have encountered clinical challenges, including insufficient activity or unexpected toxicity. In this study, we propose OX40 as a more suitable target partner for PD-L1–based BsAb design compared with ongoing clinical partners (CD27 and 4-1BB). We present a novel Fc-silenced tetravalent PD-L1/OX40 BsAb (EMB-09), which efficiently blocks PD-1/PD-L1 interactions and induces PD-L1–dependent OX40 activation, leading to enhanced T-cell activation. EMB-09 demonstrated improved antitumor activity compared with the anti–PD-L1 mAb. Significantly, EMB-09 activated effector memory T cells in the peripheral immune system and promoted the influx of stem-like CD8+ T cells into the tumor site, resulting in a more active phenotype of CD8+ tumor-infiltrating lymphocytes. In an ongoing first-in-human study in patients with advanced refractory solid tumors (NCT05263180), EMB-09 demonstrated a consistent pharmacodynamic response and early efficacy signals.

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.

1,935

项与上海岸迈生物科技有限公司相关的新闻（医药）

2025-07-14

·医药笔记

麦济生物递表港股IPO，上轮投后估值26.4亿元

▎Armstrong2025年7月14日，麦济生物港股IPO申请获得受理，招股书正式公开。麦济生物成立于2016年，聚焦开发自免疾病领域的大分子药物，首发管线IL-4R抗体处于三期临床阶段，后续管线还有TSLP抗体、MASP-2抗体、IL-33抗体、IL-1RA抗体等。2025年1月，麦济生物将IL-4R抗体大中华区和新加坡权益授权给康哲药业，获得数亿元的预付款和开发里程碑，以及一定比例的销售分成。麦济生物成立以来历经多轮融资，其中2025年6月最新一轮融资2.6亿元，投后估值26.4亿元人民币。麦济生物最新股权架构如下，康哲药业持股8.13%，湖南国创持股6.59%，天瑞丰年持股6.36%，上海张江持股6.13%，北京金汇金持股4.99%，桂林三金持股4.92%，石药仙瞳持股1.90%，黔力生物持股1.87%。总结近年来，国际市场上自免赛道热度持续高涨。国内方面，康诺亚的IL-4R已经有多个适应症获批上市，先声药业的IL-4R抗体已经申报上市。港股资本市场上，康诺亚为自免领域头部公司，三生国健、荃信生物等均为聚焦自免领域的大分子新药企业。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；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。

IPO引进/卖出临床3期抗体药物偶联物

2025-07-14

·医药笔记

9000万欧元预付款：勃林格殷格翰IL-36R抗体授权给LEO

▎Armstrong2025年7月14日，勃林格殷格翰与LEO Pharma达成合作协议，LEO Pharma将负责IL-36R抗体Spesolimab在全球范围内的商业化和进一步开发。根据协议，勃林格殷格翰将获得9000万美元预付款，以及未披露的里程碑金额和一定比例的销售分成。Spevigo于2022年获得FDA批准上市，用于治疗泛发性脓疱性银屑病（GPP）。总结国内方面，Spesolimab已经获批上市，华博生物的IL-36R抗体HB0034处于泛发性脓疱型银屑病（GPP）的2b期临床阶段。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；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。

引进/卖出抗体药物偶联物上市批准临床2期医药出海

2025-07-14

·医药笔记

辉瑞：KAT6抑制剂启动HR+/HER2-乳腺癌三期临床

▎Armstrong2025年7月14日，辉瑞在Clinicaltrials.gov网站上注册了KAT6抑制剂PF-07248144+氟维司群联合治疗HR+/HER2-乳腺癌的三期临床试验。该三期临床计划入组400例晚期HR+/HER2-乳腺癌患者，预计2027年初步完成。今年5月，辉瑞在ASCO会议上公布了PF-07248144治疗ER+/HER2-转移性乳腺癌的一期临床最新数据，推荐剂量扩展队列（RDE）共入组107例患者，所有患者均接受过CDK4/6抑制剂和ER抑制剂疗法治疗，35例患者接受5mg PF-07248144单药治疗，43例患者接受5mg PF-07248144+氟维司群联合治疗，29例患者接受1mg PF-07248144+氟维司群联合治疗。1mg、5mgPF-07248144+氟维司群治疗组ORR分别为24.1%、37.2%，CBR分别为37.9%、55.8%，mDOR分别为4.6个月、15.8个月，mPFS分别为3.6个月、10.7个月。安全性方面，最常见的3级及以上副作用为中性粒细胞贫血，3级发生率为20.7%、39.5%，4级发生率为0%、7%，该副作用可以逆转且可以通过剂量调整来控制，未发生肺炎副作用。辉瑞正在计划启动一项关键三期临床试验。去年6月，辉瑞PF-07248144一期临床数据发表在Nature Medicine期刊上，此次ASCO会议公布数据为该一期临床的更新数据。总结国内方面，英矽智能的KAT6在抑制剂ISM5043于2024年1月授权给美纳里尼，预付款为1200万美元，交易总金额超过5亿美元。齐鲁制药、康辰药业的KAT6抑制剂已经进入临床阶段。今年AACR会议上，齐鲁制药QLS1034、人福医药HW321005、复宏汉霖HLX97、英创医药KAT6抑制剂均汇报了临床前数据。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；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。

ASCO会议临床结果临床3期临床1期抗体药物偶联物

100 项与上海岸迈生物科技有限公司相关的药物交易

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管线布局中药物为当前组织机构及其子机构作为药物机构进行统计，早期临床1期并入临床1期，临床1/2期并入临床2期，临床2/3期并入临床3期

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药物(靶点)	适应症	全球最高研发状态

Bafisontamab ( EGFR x c-Met )	肝细胞癌更多	临床1/2期
EMB-09 ( OX40 x PDL1 )	晚期恶性实体瘤更多	临床1期
EMB-07 ( CD3 x ROR1 )	肺腺癌更多	临床1期
EM28 ( EGFR x c-Met )	肿瘤更多	临床前
EM1039	自身免疫性疾病更多	临床前