A Multicenter, Open-lable, Randomized Phase III Study of PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer

PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study will evaluate the efficacy and safety of PM8002 in combination with Paclitaxel as second-line treatment for SCLC

开始日期2024-10-25

申办/合作机构

普米斯生物技术（珠海）有限公司初创企业

NCT06584071 / Not yet recruiting临床1/2期

A Phase Ib/II Clinical Trial to Evaluate the Preliminary Efficacy, Safety and Pharmacokinetics of PM8002 Injection Combined With PM1009 Injection in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma

This study to evaluate the preliminary efficacy, safety and pharmacokinetics of PM8002 combined with PM1009 in Patients with first-line Hepatocellular Carcinoma.

开始日期2024-10-01

申办/合作机构

普米斯生物技术（珠海）有限公司初创企业

NCT06419621 / Recruiting临床3期

A Multicenter, Randomized, Double-blind Phase III Study of PM8002 or Placebo in Combination With Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic Triple-negative Breast Cancer(TNBC)

This multicenter, randomized, double-blind study will evaluate the safety and efficacy of PM8002 in combination with Nab-Paclitaxel compared with placebo combined with Nab-Paclitaxel as first-line treatment in inoperable locally advanced/metastatic triple-negative breast cancer(TNBC)

开始日期2024-06-11

申办/合作机构

普米斯生物技术（珠海）有限公司初创企业

100 项与普米斯生物技术（珠海）有限公司相关的临床结果

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0 项与普米斯生物技术（珠海）有限公司相关的专利（医药）

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项与普米斯生物技术（珠海）有限公司相关的文献（医药）

2024-06-01·Small

SSK1‐Loaded Neurotransmitter‐Derived Nanoparticles for Alzheimer's Disease Therapy via Clearance of Senescent Cells

Article

作者: Liu, Yan ; Gong, Baofeng ; Zhou, Honglei ; Ji, Wenbo ; Zhuang, Jianhua ; Zhang, Jian ; Yin, Tong ; Gao, Jie ; Liang, Wendanqi ; Zhang, Weicong ; Chu, Jianjian ; Luo, Yi ; Yin, You

AbstractAge is a significant contributor to the onset of AD. Senolysis has been recently demonstrated to ameliorate aging‐associated diseases that showing a great potential in AD therapy. However, due to the presence of BBB, the anti‐AD activity of senolytics are significantly diminished. SSK1 is a prodrug that can be activated by β‐gal, a lysosomal enzyme commonly upregulated in senescent cells, and thus selectively eliminates senescent cells. Furthermore, the level of β‐gal is significantly correlated with conventional AD genes from clinical sequencing data. SSK1‐loaded neurotransmitter ‐derived lipid nanoparticles are herein developed (SSK1‐NPs) that revealing good BBB penetration and bioavailability of in the body. At the brain lesion, SSK1‐NP treatment significantly reduces the expression of genes associated with senescence, induced senescent cells elimination, decreased amyloid‐beta accumulation, and eventually improve cognitive function of aged AD mice. SSK1‐NPs, a novel nanomedicine displaying potent anti‐AD activity and excellent safety profile, provides a promising strategy for AD therapy.

2023-10-01·Small

Simultaneous Delivery of Doxorubicin and EZH2‐Targeting siRNA by Vortex Magnetic Nanorods Synergistically Improved Anti‐Tumor Efficacy in Triple‐Negative Breast Cancer

Article

作者: Lu, Yunshu ; Luo, Yi ; Li, Ruonan ; Da, Xianhong ; Li, Xiang ; Jiang, Lan ; Ma, Yuwei ; Gu, Fenfen ; Liu, Yan

AbstractTriple‐negative breast cancer (TNBC), one of the most aggressive types of breast cancer, currently lacks a targeted therapy and has a high clinical recurrence rate. The present study reports an engineered magnetic nanodrug based on Fe3O4 vortex nanorods coated with a macrophage membrane loaded with doxorubicin (DOX) and Enhancer of zeste 2 polycomb repressive complex 2 subunit (EZH2) siRNA. This novel nanodrug displays excellent tissue penetration and preferential tumor accumulation. More importantly, it significantly increases tumor suppression compared to chemotherapy, suggesting the synergistic activity of the combination of doxorubicin and EZH2‐inhibition. Importantly, owing to tumor‐targeted delivery, nanomedicine shows an excellent safety profile after systemic delivery, unlike conventional chemotherapy. In summary, chemotherapy and gene therapy are combined into a novel magnetic nanodrug carrying doxorubicin and EZH2 siRNA, which shows promising clinical application potential in TNBC therapy.

2023-04-04·Cancer Research

Abstract 5675: Discovery and development of an asymmetric IgG-like bispecific antibody targeting EGFR and c-MET, engineered through H-H and H-L chain charge-based heterodimerization

作者: Zhao, Zhenting ; Yi, Luo ; Xu, Yingda ; Huang, Weifeng ; Wang, Chao ; Yan, Yao ; Dong, Tiantian ; Tsun, Andy ; Miao, Xiaoniu ; Peng, Shaogang ; Liu, Xiaolin ; Wang, Ping

AbstractBackground: Lung cancer remains the leading cause of cancer mortality and is the most commonly diagnosed cancer with an estimated 2.2 million cases per year. EGFR, a tyrosine kinase receptor, plays a central role in cellular proliferation, survival, differentiation, and migration. Gain-of-function somatic mutations of EGFR significantly drives disease progression. Small molecule tyrosine kinase inhibitors (TKIs), designed to inhibit EGFR signaling specific to these mutations (e.g., L858R and E19del etc.), have achieved excellent clinical outcomes. However, patients carrying TKI-insensitive mutations (e.g., E20ins) and/or those with disease progression after TKI treatment, by the upregulation of complementary signaling pathways (HGF/c-MET, etc.), remain an unmet medical need. Here, we report the discovery of a fully-human afucosylated anti-EGFR x cMET IgG-like bispecific antibody (PM1080).Methods: PM1080 was generated by introducing unique mutations to the CH1-CL domains of each binding arm to promote correct HC-LC pairing. KIH mutations were also introduced to each CH3 domain to support HC-HC heterodimerization and generate an IgG-like bispecific with one arm binding to EGFR and the other to cMET. PM1080 was expressed via a four-chain expression system in CHO cells carrying a fut8−/− knockout to generate afucosylated molecules with enhanced ADCC activity.Results: Through monovalent affinity measurements, PM1080 interacted with EGFR at single digit nanomolar affinity and at sub-nanomolar affinity to c-MET. PM1080 preferentially bound to EGFR/c-MET double-positive cells rather than EGFR single-positive cells. PM1080 blocked both EGF/EGFR and HGF/c-MET signals via physical blockade of the interaction between EGF/HGF to their corresponding receptors and induced EGFR/c-MET internalization and degradation from the cell surface. Through intricate engineering, PM1080 was expressed via a four-chain system and produced as an afucosylated antibody with significantly improved ADCC function. PM1080 induced potent anti-tumor efficacy against EGFR/c-MET-positive tumor cells as a single agent. Importantly, PM1080 induced anti-tumor activity regardless of EGFR mutations at the intracellular signaling domain, and thus may serve as a promising combinational agent to TKI therapies. As expected, synergistic anti-tumor activity was observed when PM1080 was combined with either 1st or 3rd generation TKIs in both in vitro and in vivo models.Conclusion: PM1080, a bispecific antibody targeting EGFR & c-MET was discovered for cancer treatment. PM1080 displayed potent anti-tumor efficacy either as a single agent or in combination with EGFR TKIs. Preclinical PK and toxicity studies have been conducted to support future first-in-human studies.Citation Format: Ping Wang, Weifeng Huang, Zhenting Zhao, Xiaoniu Miao, Shaogang Peng, Chao Wang, Yao Yan, Tiantian Dong, Andy Tsun, Yingda Xu, Xiaolin Liu, Luo Yi. Discovery and development of an asymmetric IgG-like bispecific antibody targeting EGFR and c-MET, engineered through H-H and H-L chain charge-based heterodimerization. [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 5675.

1,209

项与普米斯生物技术（珠海）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。

财报抗体药物偶联物

100 项与普米斯生物技术（珠海）有限公司相关的药物交易

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100 项与普米斯生物技术（珠海）有限公司相关的转化医学

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2024年12月31日管线快照

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

PM-8002 ( PDL1 x VEGF-A )	三阴性乳腺癌更多	临床3期
PM 1032 ( 4-1BB x CLDN18.2 )	晚期恶性实体瘤更多	临床2期
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PM-1003 ( 4-1BB x PDL1 )	晚期恶性实体瘤更多	临床2期
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