排名前五的靶点	数量

Cardiac myosin(心肌肌球蛋白复合体)	5
GPR40(游离脂肪酸受体-1)	5
PD-1(细胞程序性死亡-1)	4
MDM2(p53结合蛋白Mdm-2)	4
TRPV1(类香草素受体)	4

关联

449

项与 Amgen, Inc. 相关的药物

TARLATAMAB-DLLE

塔拉妥单抗

靶点

CD3 x DLL3

作用机制

CD3抑制剂 [+1]

在研机构

原研机构

在研适应症

非在研适应症

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2024-05-16

Tezepelumab

特泽鲁单抗

靶点

TSLP

作用机制

TSLP抑制剂

在研机构

原研机构

在研适应症

非在研适应症

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2021-12-17

Avacopan

阿伐可泮

靶点

C5AR1

作用机制

C5AR1拮抗剂

在研机构

Meditip Co. Ltd. [+8]

原研机构

ChemoCentryx, Inc. [+1]

在研适应症

血管炎 [+4]

非在研适应症

非典型溶血性尿毒症综合征 [+5]

最高研发阶段批准上市

首次获批国家/地区

日本

首次获批日期2021-09-27

1,924

项与 Amgen, Inc. 相关的临床试验

NCT06588153 / Not yet recruiting临床4期

A Phase 4 Single-arm Open-label Study for the Efficacy and Safety of Prolia® in Subjects With Glucocorticoid-induced Osteoporosis in Mainland China

The main objective of this study is to evaluate the efficacy of Prolia® in improving bone mass density (BMD) of lumbar spine at month 12.

开始日期2025-04-10

申办/合作机构

Amgen, Inc.

NCT06593522 / Not yet recruiting临床2期

A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of AMG 193 in Subjects With Methylthioadenosine Phosphorylase (MTAP)-Deleted Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC)

The main objective of the study is to characterize safety and efficacy of 2 dose levels of AMG 193 by investigator, and to evaluate AMG 193 monotherapy efficacy by Blinded Independent Central Review (BICR).

开始日期2024-12-18

申办/合作机构

Amgen, Inc.

NCT06649006 / Not yet recruiting临床1期

A Phase 1b Open-label Study to Investigate Safety, Tolerability and Pharmacokinetics of Intravenous Blinatumomab in Japanese Adult Subjects With Newly Diagnosed Philadelphia-negative B-precursor Acute Lymphoblastic Leukemia (B-ALL)

The main objective of the study is to evaluate safety and tolerability of blinatumomab in adult Japanese participants with newly diagnosed B-ALL.

开始日期2024-12-15

申办/合作机构

Amgen, Inc.

100 项与 Amgen, Inc. 相关的临床结果

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0 项与 Amgen, Inc. 相关的专利（医药）

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13,115

项与 Amgen, Inc. 相关的文献（医药）

2024-12-31·mAbs

Reduction of monoclonal antibody viscosity using interpretable machine learning

Article

作者: Tessier, Peter M ; Huang, Jie ; Winters, Dwight ; Wu, Lina ; Wang, Tiexin ; Maglalang, Erick ; Mock, Marissa ; Chen, Hsin-Ting ; Underhill, Patrick ; Makowski, Emily K ; Pelegri-O'Day, Emma

Early identification of antibody candidates with drug-like properties is essential for simplifying the development of safe and effective antibody therapeutics. For subcutaneous administration, it is important to identify candidates with low self-association to enable their formulation at high concentration while maintaining low viscosity, opalescence, and aggregation. Here, we report an interpretable machine learning model for predicting antibody (IgG1) variants with low viscosity using only the sequences of their variable (Fv) regions. Our model was trained on antibody viscosity data (>100 mg/mL mAb concentration) obtained at a common formulation pH (pH 5.2), and it identifies three key Fv features of antibodies linked to viscosity, namely their isoelectric points, hydrophobic patch sizes, and numbers of negatively charged patches. Of the three features, most predicted antibodies at risk for high viscosity, including antibodies with diverse antibody germlines in our study (79 mAbs) as well as clinical-stage IgG1s (94 mAbs), are those with low Fv isoelectric points (Fv pIs < 6.3). Our model identifies viscous antibodies with relatively high accuracy not only in our training and test sets, but also for previously reported data. Importantly, we show that the interpretable nature of the model enables the design of mutations that significantly reduce antibody viscosity, which we confirmed experimentally. We expect that this approach can be readily integrated into the drug development process to reduce the need for experimental viscosity screening and improve the identification of antibody candidates with drug-like properties.

2024-10-10·Journal of Clinical Oncology

Sustained Clinical Benefit and Intracranial Activity of Tarlatamab in Previously Treated Small Cell Lung Cancer: DeLLphi-300 Trial Update

Article

作者: Johnson, Melissa L. ; Bouchaab, Hasna ; Parkes, Amanda ; Chen, Xi ; Boyer, Michael ; Olmedo, Maria Eugenia ; Felip, Enriqueta ; Borghaei, Hossein ; Paz-Ares, Luis ; Hummel, Horst-Dieter ; Martinez, Pablo ; Dowlati, Afshin ; Yu, Youfei ; Izumi, Hiroki ; Steeghs, Neeltje ; Yoshida, Tatsuya ; Gadgeel, Shirish ; Jost, Philipp J. ; He, Kai ; Champiat, Stephane

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported . Tarlatamab, a bispecific T-cell engager immunotherapy targeting delta-like ligand 3, has shown durable anticancer activity and manageable safety in previously treated small cell lung cancer (SCLC) in DeLLphi-300 phase I and DeLLphi-301 phase II trials. Here, we report extended follow-up of DeLLphi-300 (median follow-up, 12.1 months [range, 0.2-34.3]) in fully enrolled cohorts treated with tarlatamab ≥10 mg dose administered once every two weeks, once every three weeks, or once on day 1 and once on day 8 of a 21-day cycle (N = 152). Overall, the objective response rate (ORR) was 25.0%; the median duration of response (mDOR) was 11.2 months (95% CI, 6.6 to 22.3), and the median overall survival (mOS) was 17.5 months (95% CI, 11.4 to not estimable [NE]). Among 17 patients receiving 10 mg tarlatamab once every two weeks, the ORR was 35.3%, the mDOR was 14.9 months (95% CI, 3.0 to NE), the mOS was 20.3 months (95% CI, 5.1 to NE), and 29.4% had sustained disease control with time on treatment ≥52 weeks. No new safety signals were identified. In modified Response Assessment in Neuro-Oncology Brain Metastases analyses, CNS tumor shrinkage of ≥30% was observed in 62.5% of patients (10 of 16) who had a baseline CNS lesion of ≥10 mm, including in a subset of patients with tumor shrinkage long after previous brain radiotherapy. In DeLLphi-300 extended follow-up, tarlatamab demonstrated unprecedented survival and potential findings of intracranial activity in previously treated SCLC.

2024-10-08·Blood Advances

A.R.R.O.W.2: once- vs twice-weekly carfilzomib, lenalidomide, and dexamethasone in relapsed/refractory multiple myeloma

Article

作者: Delimpasi, Sosana ; Beksac, Meral ; Upchurch, Terry ; Faber, Edward ; Leleu, Xavier ; Fang, Belle ; Talpur, Rakhshandra ; Dimopoulos, Meletios A. ; Coriu, Daniel ; Špička, Ivan

AbstractTwice-weekly carfilzomib (27 mg/m2) plus lenalidomide and dexamethasone (KRd27) is a standard of care in relapsed/refractory multiple myeloma (RRMM). Once-weekly carfilzomib regimens have shown clinical benefits with improved patient convenience. This open-label, phase 3, multicenter, randomized study aimed to demonstrate noninferiority of the overall response rate (ORR) for once-weekly carfilzomib (56 mg/m2) plus Rd (KRd56) vs twice-weekly KRd27 in RRMM. A total of 454 patients were randomized (1:1) to receive carfilzomib as once-weekly 30-minute infusions of 56 mg/m2 (KRd56; n = 228) or twice-weekly 10-minute infusions of 27 mg/m2 (KRd27; n = 226). Baseline characteristics were balanced between groups. ORR was 82.5% (95% confidence interval [CI], 76.9-87.2) in the once-weekly group vs 86.3% (95% CI, 81.1-90.5) in the twice-weekly group (risk ratio, 0.954 [95% CI, 0.882-1.032]) and did not meet the threshold for statistical significance of noninferiority (P = .0666). Complete response (CR) or better was obtained in 46.9% of patients in the once-weekly arm and 36.3% in the twice-weekly arm. The proportions of patients who achieved CR and were also assessed negative for minimal residual disease were 21.5% and 18.1%, respectively (odds ratio, 1.235 [95% CI, 0.775-1.970]). Progression-free survival was comparable between groups (hazard ratio, 0.945 [95% CI, 0.617-1.447]). The safety profile was similar for both groups. In conclusion, although statistical significance for noninferiority of ORR was not achieved, the efficacy and safety of once-weekly KRd56 were similar to those of twice-weekly KRd27, and once-weekly KRd56 may be an effective and convenient treatment option for patients with RRMM. This trial was registered at www.ClinicalTrials.gov as #NCT03859427.

6,503

项与 Amgen, Inc. 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

·PRNewswire

Carisma Therapeutics Announces Changes to its Board of Directors

Appointment of Sohanya Cheng Resignation of Michael Torok PHILADELPHIA, Oct. 30, 2024 /PRNewswire/ -- Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today announced the appointment of Sohanya Cheng, MBA to the Company's Board of Directors, effective October 31, 2024. Additionally, Michael Torok has informed the Board of his intention to step down as a member, effective October 31, 2024, due to other professional commitments. "It's a pleasure to welcome Sohanya to our Board," said Sanford Zweifach, Chair of the Carisma Board. "Her broad experience in oncology, alongside her skills in leadership, strategic planning, and commercialization, will be instrumental as we continue to advance our portfolio and strengthen our foundation. We are also thankful to Michael for his valuable service and wish him all the best in his next chapter." "I am excited to join Carisma's Board and collaborate with the management team as the Company advances its mission to deliver innovative immunotherapies to patients facing serious diseases," said Ms. Cheng. "I look forward to sharing my insights and supporting the Company's strategic goals as it solidifies its position as a leader in engineered macrophages within oncology and beyond." About Sohanya Cheng, MBA Ms. Cheng brings over 20 years of experience in biopharmaceutical commercialization and research, with a strong focus on oncology. She currently serves as the EVP, Chief Commercial Officer, and Head of Business Development at Karyopharm Therapeutics. Prior to this, she was Vice President, Head of Marketing and Corporate Affairs at Arrowhead Pharmaceuticals. Ms. Cheng also spent over a decade at Amgen in various leadership roles, including Executive Director, Head of Marketing & Sales for multiple myeloma and Head of Oncology National Sales, contributing to the commercialization of key oncology brands. She holds an MBA from the MIT Sloan School of Management and both a BSc and MA from the University of Cambridge, UK. About Carisma Carisma Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on utilizing our proprietary macrophage and monocyte cell engineering platform to develop transformative immunotherapies to treat cancer and other serious diseases. We have created a comprehensive, differentiated proprietary cell therapy platform focused on engineered macrophages and monocytes, cells that play a crucial role in both the innate and adaptive immune response. Carisma is headquartered in Philadelphia, PA. For more information, please visit . Investors: Shveta Dighe Head of Investor Relations [email protected] Media Contact: Julia Stern (763) 350-5223 [email protected] SOURCE Carisma Therapeutics Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

高管变更免疫疗法细胞疗法

100 项与 Amgen, Inc. 相关的药物交易

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