To learn about the effectiveness of adding talazoparib to the standard of care treatment combination of androgen ablation therapy (hormone therapy, also known as ADT) and enzalutamide in patients with prostate cancer that has spread into the lymph nodes.

开始日期2025-09-30

申办/合作机构

The University of Texas MD Anderson Cancer Center

NCT06894511

/ Not yet recruiting临床2期

A Phase II, Open-label, Multi-Center, Randomized Study Comparing the Combination of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) and Androgen Receptor Pathway Inhibitor (ARPI) vs. Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in First-line Treatment of Patients With Prostate-Specific Membrane Antigen (PSMA)-Positive Progressive Metastatic Castration Resistant Prostate Cancer (mCRPC)

The purpose of this study is to assess whether the combination of AAA617 (administered for 6 cycles at a dose of 7.4 GBq (200 mCi) +/- 10%) and ARPI improves radiographic progression-free survival (rPFS) or time to death compared to AAA617 alone in PSMA-positive mCRPC patients who were previously treated and progressed on ARPI in the biochemical recurrence (BCR)-non metastatic hormone sensitive prostate cancer (mHSPC), mHSPC, or non-metastatic Castration Resistant Prostate Cancer (nmCRPC) setting and have not previously received a taxane-containing regimen in the castrate resistant prostate cancer (CRPC) setting.

开始日期2025-08-29

申办/合作机构

Novartis Pharmaceuticals Canada, Inc.

NCT06922318

/ Not yet recruiting临床2期IIT

A Phase II Study of Sequential Bipolar Androgen Therapy and ZEN-3694 in Sequence With Enzalutamide + ZEN-3694 in Asymptomatic Patients With Metastatic CRPC: The COSMYC Trial (COmbined Suppression of MYC)

This research is being done to determine if receiving the combination of testosterone and ZEN-3694 followed by the combination of enzalutamide plus ZEN-3694 will decrease the size of tumors in patients with prostate cancer that has become resistant to castration and other therapies. The investigators also want to determine if dosing first with the combination of testosterone and ZEN-3694 may cause enzalutamide and ZEN-3694 to work more effectively.

开始日期2025-06-30

申办/合作机构

The Sidney Kimmel Comprehensive Cancer Center

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100 项与恩扎卢胺相关的临床结果

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100 项与恩扎卢胺相关的转化医学

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100 项与恩扎卢胺相关的专利（医药）

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4,543

项与恩扎卢胺相关的文献（医药）

2025-12-31·CANCER BIOLOGY & THERAPY

Assessing the potential for in vivo modulation of FTH1 gene expression with small peptides to restore and enhance androgen receptor pathway inhibition in prostate cancer

Article

作者: Nicol, McKayla ; Kumar, Sateesh ; Currie, Crawford ; Framroze, Bomi ; Bjerknes, Christian

Increased levels of intratumoral free iron drive more aggressive behavior with the development of treatment resistance and spread in a range of cancers including prostate cancer (PCa). This phenotype is associated with an increase in TFRC expression and a decrease in FTH1, a profile supporting increased iron acquisition. In this study we investigated the anti-oncogenic effects of two small peptides (FT-002 and FT-005) that upregulate FTH1 expression and downregulate TFRC expression when combined with standard androgen receptor pathway inhibitors (ARPIs) in xenograft models of PCa in male athymic nude mice. The PC3 cell line was used to establish xenografts representing highly aggressive, androgen-resistant PCa and the LNCaP cell line as a model of androgen-sensitive PCa. Both peptides enhanced the anti-tumor efficacy of ARPI therapy. Efficacy was more marked with the combination of the second-generation APRI enzalutamide than the first-generation agent bicalutamide, a result consistent with known resistance mechanisms to different ARPI therapy. Further, the FT-peptide/enzalutamide combination drove tumor regression whereas enzalutamide monotherapy only slowed growth, even in the hormone-sensitive xenograft. The FT-002a-enzalutamide combination was more effective than FT-005 in reducing tumor mass and volume and modulating FTH1 and TFRC expression. The reversal by the peptides of this oncogenic expression pattern points to a reduction in the tumor free iron via increased iron storage in ferritin and a reduction in iron influx via the transferrin receptor. Peptide-mediated modulation of tumor iron metabolism may therefore offer a novel means to enhance ARPI efficacy and delay resistance in advanced prostate cancer.

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness of enzalutamide with androgen-deprivation therapy (ADT) versus ADT alone for the treatment of high-risk biochemically recurrent non-metastatic castration-sensitive prostate cancer in Canada

Article

作者: Johnston, Karissa ; Aprikian, Armen ; McLean, Thomas ; Li, Yuxin ; Chilelli, Andrew ; Saad, Fred ; Wywial, Ewa

AIM:

The EMBARK (NCT02319837) trial demonstrated that enzalutamide with androgen-deprivation therapy (ADT; enzalutamide combination) or without ADT (enzalutamide monotherapy) significantly improved metastasis-free survival compared with ADT alone in high-risk biochemically recurrent (BCR) non-metastatic castration-sensitive prostate cancer (nmCSPC; also known as non-metastatic hormone-sensitive prostate cancer [nmHSPC]). No new safety signals were observed during the trial. The findings of EMBARK led to Health Canada's approval of enzalutamide for this patient population. The aim of this analysis was to assess the cost-effectiveness of enzalutamide combination versus ADT alone in patients with high-risk BCR nmCSPC from the Canadian payer's perspective.

MATERIAL AND METHODS:

A semi-Markov model was created to represent the treatment and disease progression of patients with high-risk BCR nmCSPC over a 30-year horizon. Costs and outcomes were discounted at 1.5% annually. Treatment effects for high-risk BCR nmCSPC were informed by data from the EMBARK trial. Life-years (LYs), quality-adjusted life-years (QALYs), lifetime costs and incremental cost-effectiveness ratio (ICER) were estimated for enzalutamide combination and ADT alone. A one-way sensitivity analysis (OWSA) and scenario analyses were conducted to assess the robustness of results.

RESULTS:

In the base-case deterministic analysis over the modeled time horizon, enzalutamide combination accumulated 11.85 LYs and 8.96 QALYs versus 8.75 LYs and 6.24 QALYs for ADT alone. The total cost for enzalutamide combination was Canadian dollars (CAD) 166,199, compared with CAD 95,146 for ADT alone. When combining cost and clinical outcome data, enzalutamide combination was associated with an ICER of CAD 26,129 per QALY gained. The OWSA and scenario analysis results were consistent with the base-case results.

CONCLUSION:

The study findings suggest that enzalutamide combination was associated with an ICER of CAD 26,129 per QALY gained, which is within the standard Canadian thresholds for willingness-to-pay (i.e.

2025-09-01·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Impurity profiling and stability analysis of enzalutamide: Identification, genotoxicity assessment, and development of UHPLC methods for critical impurities

Article

作者: Keskin, Elif ; Özkan, Sibel A ; Kaygu, Pelin ; Bellur Atici, Esen ; Soyer Can, Okşan ; Miser, Melike Ceren ; Ağtaş, Çağan ; Oktar Uzun, Burcu ; Bostancıoğlu, Gamze

This study aims to comprehensively evaluate and control the impurity profile of enzalutamide, an androgen receptor signaling inhibitor used to treat metastatic castration-resistant prostate cancer. Using liquid chromatography-mass spectrometry (LC-MS), twenty impurities were identified based on their mass-to-charge ratios (m/z) during synthetic method development and stress testing studies. Classification of these compounds according to ICH M7 guidelines revealed two potentially genotoxic impurities: Enzal-2 (4-isothiocyanato-2-(trifluoromethyl)benzonitrile), classified as a Class 3 impurity due to its isothiocyanate group, and Enzal-2A (4-amino-2-(trifluoromethyl)benzonitrile), classified as a Class 2 impurity due to a positive Ames test result. Based on the threshold of toxicological concern (TTC) of 1.5 µg/day and the maximum daily dose of enzalutamide of 160 mg, a control limit of 9.4 ppm was established for Enzal-2 and Enzal-2A to mitigate safety risks. Both Enzal-2 and Enzal-2A were identified as process-related impurities, with Enzal-2A also recognized as a hydrolysis degradation product. Specific ultra-high-performance liquid chromatography (UHPLC) methods were developed and validated for the precise, accurate, and robust quantification of enzalutamide, Enzal-2, Enzal-2A, and related impurities. These methods were applied to enzalutamide samples subjected to various stress conditions, including elevated temperature, daylight, UV radiation, and exposure to oxidative, neutral, alkaline, and acidic environments, as well as under accelerated and long-term stability testing. The findings underscore the importance of comprehensive impurity profiling and validated analytical methods to ensure the safe and effective manufacture, quality control, and use of enzalutamide.

1,107

项与恩扎卢胺相关的新闻（医药）

2025-05-27

·CPHI制药在线

新一波专利悬崖面前，制药巨头安危分析

关注并星标CPHI制药在线制药领域是一个花无百日红的场所，不仅是因为“江山代有才人出”，也因为“风流总被雨打风吹去”。一款曾经“一览众山小”的重磅药物，在专利到期之后面对的通常会是“故国不堪回首月明中”的落寞。药品专利，这个起初旨在维护制药公司利益的保护伞，在逐渐走向专利悬崖的后期，却成为这些公司如芒在背的威胁。专利悬崖对大型制药公司，尤其是对那些依赖几款超级重磅炸弹药物的制药公司构成非常严重的威胁。当这些药物的专利到期后，仿制药制造商迅速进入市场，推出价格远低于原研药的替代品。这将直接导致原研药销售额的骤降，并削弱了这些开发商的盈利能力。由于超级重磅炸弹药物通常占公司总收入的相当大部分，一旦失去专利保护，公司可能难以在短期内通过新药研发或收购来弥补收入缺口。因此专利悬崖不仅威胁到公司的财务稳定，还可能影响其研发投入和市场竞争力。放眼大时代，2026-2030 年，生物制药行业将进入动荡时期，众多超重磅药物将在这一时期失去美国市场独占权。几乎所有大型制药公司都将或多或少受到头顶的这把专利到期达摩克利斯之剑的影响，但受威胁程度疾徐不一。诺和诺德、赛诺菲、吉利德、礼来和拜耳可能是2030年前“受灾”程度最小的五家制药巨头（表1，图1-2）。根据 Evaluate Pharma 的数据和Scrip的分析，预计从2026年至2030年，这五家制药商因专利到期遭受的损失将不超过各自2025年美国市场预测收入的15% 。在诺和等五家制药公司“事大如天醉亦休”地置身其外的同时，感受“日长似岁”般煎熬的制药巨头将面临渡劫。这些公司可能会因 2026 年至 2030 年美国专利到期药物而损失50% 以上的收入，其中葛兰素史克、百时美施贵宝和默沙东将面临最大危局。葛兰素史克的 Tivicay（多替拉韦）和 Dovato（拉米夫定）、百时美施贵宝的 Eliquis（阿哌沙班）和 Opdivo（纳武利尤单抗）以及默沙东的药王 Keytruda（帕博利珠单抗）等超级重磅药物可能将在这个时间段面临仿制药或生物类似药的竞争。表1. 全球大型制药公司2026-2030年受专利悬崖影响数据（数据来源：Evaluate Pharma）图1. 2025年预计美国市场收入中遭受2026-2030年间市场独占权丧失威胁的比例。（数据来源：Evaluate Pharma)图2. 大型制药公司2025年预计收入中面临2026-2030年间市场独占权丧失威胁的绝对数额。（数据来源：Evaluate Pharma）A.安全榜1.诺和诺德（2% 风险）诺和诺德的支柱性产品无疑是其Semaglutide产品组合，尤其是Ozempic和Wegovy。虽然诺和诺德将在GLP-1市场遭遇礼来和众多后来者的严峻挑战，以及Medicare价格谈判的潜在影响，但从专利悬崖的角度来看，诺和面临的压力要比默沙东小得多。Semaglutide在美国市场的核心专利保护预计将延续到2031年，这将赋予诺和诺德宝贵的开发新产品的黄金时间，在享受semaglutide巨大红利的同时，将利润投入到新一代产品的开发中，例如GLP-1/胰淀素类似物联合疗法CagriSema。2.赛诺菲（9% 风险）赛诺菲CEO Paul Hudson在今年1月召开的摩根大通医疗保健大会的演讲中就曾信誓旦旦地表态，“就独占权丧失而言，赛诺菲是业内最低的”。赛诺菲的当家花魁Dupixent (dupilumab) 仍处在生命周期的黄金时代，被批准用于从牛皮癣到哮喘等多种炎症疾病，最近还获得了慢性阻塞性肺病 (COPD)的批准，进一步夯实了这款超重磅药物的盈利能力。Dupixent 的专利保护期将持续到 2030 年代初。其活性成分专利将于 2031 年到期，其他专利有效时间则更长。Evaluate Pharma 的数据显示，赛诺菲预计的2025 年美国收入中只有 9% 会因 2026 年至 2030 年期间的市场独占丧失而损失，但这些损失多数来自“帐中副将”，例如乙型血友病药物Alprolix（重组凝血因子IX-Fc融合蛋白）和慢性移植物抗宿主病药物Rezurock（belumosudil），预计它们将分别在 2028 年和 2029 年失去独占权。3.吉利德（9%风险）吉利德追求的目标之一是在其核心 HIV 业务之外成功实现更多多元化，这个志向是建立在其HIV 业务一直在实现增长的基础之上的。吉利德最畅销的联合疗法的专利目前还一眼望不到底，2033 年底之前可保无虞。Biktarvy 在 2024 年的销售额为 134 亿美元，占吉利德总收入的将近48%。吉利德表示，在Biktarvy收入曲线进入下行阶段之前，他们将有能力推出新一代长效HIV药物。吉利德2025 年美国收入中只有9%将遭受到2026-2030年市场独占权丧失的影响，包括2027 年到期的CD19 靶向CAR-T疗法，而考虑到 CAR-T 疗法制造的复杂性，Tecartus未必在市场独占期到来之后立即面临生物类似药的竞争。4.拜耳（风险 13%）处在多事之秋的拜耳，其重磅产品血液稀释剂 Xarelto（rivaroxaban）市场独占期在2024年4月已经到来，令拜耳更加感受到压力重重。但遭受亏损的拜耳有望在2027年实现业务增长。拜耳CEO Bill Anderson 认为，用于治疗与 2 型糖尿病相关的慢性肾病的盐皮质激素受体拮抗剂 Kerendia（finerenone）和前列腺癌药物 Nubeqa（darolutamide）等新药将有助于推动拜耳回春。此外，BridgeBio 的 acoramidis 在欧洲将由拜耳负责商业化（欧洲商品名Beyonttra），针对转甲状腺素蛋白淀粉样心肌病 (ATTR-CM)。拜耳的elinzanetant针对更年期相关的中度至重度血管舒缩症状的申请正在等待FDA的监管审批。5.礼来（风险 15%）礼来的旗舰产品Mounjaro和Zepbound相对于其直接竞争对手，诺和诺德的Ozempic和Wegovy更加年轻。其活性成分tirzepatide的专利至少要到2036年才到期，这位礼来长期盈利提供了关键保障。礼来公司在 2026-2030 年期间也将面临一些畅销药物的专利损失，包括预计在 2027 年失去市场独占的糖尿病重磅药物 Trulicity（dulaglutide），其2024 年为礼来创造了 52.5 亿美元的收入；以及在 2030 年失去专利保护的牛皮癣药物 Taltz（ixekizumab），其2024 年销售额达到36 亿美元。B.风险榜1.默沙东（78%）Keytruda，默沙东的这款支柱产品免疫检查点抑制剂肿瘤学产品2024年销售额高达295亿美元，而默沙东全年销售额为642亿美元。也就是说，Keytruda以一己之力贡献了默沙东全部销售额的46%，这是一个非常卓越的成就，但同样也包藏祸机，因为Keytruda在美国的关键专利将在2028年到期，Keytruda专利悬崖危机成为默沙东目前的头号挑战。随着 Keytruda、Sitagliptin/Metformin和 Letermovir 的专利即将到期，默沙东未来五年将面临严峻挑战。另一个主要收入来源 HPV 疫苗 Gardasil 9 因中国市场饱和而表现不佳，导致默沙东于 2024 年 2 月暂停发货以清理库存，在 2025 年可能会恢复增长。为了保持增长，默沙东抗体药物偶联物 (ADC) 方面投入了大量资金，包括与科伦生物科技和第一三共的合作。2.GSK（62%）葛兰素史克的dolutegravir一直是其HIV 药物组合的主要产品，是葛兰素史克四个最畅销的 HIV 品牌 Tivicay（13.5亿英镑）、Triumeq（13.3亿英镑）、Juluca（6.85亿英镑）和 Dovato （22.4亿英镑）中的成分。但其关键专利可能将于2027年到期。3.BMS (55%)百时美施贵宝的Eliquis (Apixaban) 和 Opdivo 正面临专利悬崖危机，2024 年这两款药物的营收为 234 亿美元，占公司总营收的近一半。Eliquis面临即将到来的仿制药竞争，Eliquis是BMS与辉瑞共同商业化的产品，是一种用于预防成人血栓的小分子药物，2012年获得FDA批准，2023年实现全球122亿美元的销售额。其专利已于2022年到期，但得益于补充保护证书（Supplementary Protection Certificate）的荫护，其保护期已延长到2026年。实际上，Eliquis仿制药已经获得了FDA的临时批准，但BMS与仿制药商已经达成和解，仿制药不会在2027年之前上市。作为回应，BMS 实施了积极的成本削减措施，包括 2024 年 4 月的 15 亿美元成本削减计划和 2025 年 2 月的额外 20 亿美元削减计划，包含削减产品线和裁员。BMS 还将重点转向神经科学，以 140 亿美元收购了 Karuna Therapeutics，并投资了精神分裂症药物 Cobenfy。C.2025-2031年间失去市场独占权的重要药物2025年• Entresto (sacubitril/valsartan，诺华，2015年获批，2024年全球销售额：78.2亿美元，下同)• Farxiga (Dapagliflozin，诺华，2014年获批，2型糖尿病，38.4亿美元)• Prolia (denosumab，安进，2010年获批，骨质疏松症，43.7亿美元)• Xgeva (denosumab，安进，2010年获批，肿瘤，22.3亿美元) 2026年• Eliquis (apixaban，BMS/辉瑞，2012年获批，血栓，122亿美元)• Revlimid (lenalidomide，BMS，2005年获批，骨髓增生异常综合征、多发性骨髓瘤、淋巴瘤、滤泡性淋巴瘤等，57.7亿美元) 2027年• Trulicity (dulaglutide，礼来，2014年获批，2型糖尿病，52.5亿美元)• Ocrevus (ocrelizumab ，罗氏，2017年获批，多发性硬化症，67亿美元)• Ibrance (Palbociclib，辉瑞，2015年获批，乳腺癌，43.7亿美元)• Xtandi (enzalutamide，安斯泰来/辉瑞，2012年获批，前列腺癌，63亿美元)• Imbruvica (ibrutinib，艾伯维/强生，2013年获批，慢性淋巴细胞白血病等，49亿美元)• Dolutegravir药物组合 (GSK，2013年获批，HIV，56亿英镑) 2028年• Keytruda (pembrolizumab，默沙东，2014年获批，肿瘤，295亿美元)• Opdivo (nivolumab，BMS，2014年获批，肿瘤，93亿美元)• Gardasil 9 (human papillomavirus 9-valent vaccine ，2014年获批，默沙东，86亿美元) 2029年• Darzalex (daratumumab，强生/Genmab，2015年获批，多发性骨髓瘤，117亿美元)• Cosentyx (secukinumab，诺华，2015年获批，斑块性银屑病等，61.4亿美元)• Enbrel (etanercept，安进，1998年获批，类风湿性关节炎等，33.2亿美元) 2031年• Dupixent (dupilumab，赛诺菲/再生元，2017年获批，特应性皮炎、哮喘、慢性阻塞性肺病等，131亿欧元)Ref. 1、Merck Announces Fourth-Quarter and Full-Year 2024 Financial Results. Merck Press Release. 04. 02. 2025. 2、Merrill, J. et al. Five Companies Heading Toward 2030 With Wind At Their Back. Scrip. 26. 02. 2025. 3、2024 Financial report of various pharmaceuticals. 4、Pharma patent cliff. LinkedIn: Joanna-sadowska-phdEND【企业推荐】智药研习社直播预告来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

专利到期并购生物类似药

2025-05-27

·岸迈生物

岸迈生物与TCG Labs Soleil投资组合公司Juri Biosciences签署KLK2 T细胞接合分子的全球许可协议

岸迈生物与TCG Labs Soleil投资组合公司Juri Biosciences签署在转移性前列腺癌KLK2-定向 T细胞接合分子的全球许可协议上海/旧金山 2025年5月27日岸迈生物，一家专长于为高度未满足临床需求的疾病发现和开发多特异性抗体的临床阶段生物医药公司，以及TCG Labs Soleil，一家整合专用资本与自有生物技术研发中心的风险投资公司，今天宣布，Juri Biosciences，Inc.，一家TCG Labs Soleil的投资组合公司，已与岸迈生物签订全球许可协议。该协议授予Juri Biosciences用于治疗转移性前列腺癌的靶向激肽释放肽相关肽酶2（KLK2）和CD3开发的T细胞接合分子的全球独家权利。根据协议条款，岸迈生物有权收取高达2.1亿美元的资金，包括首付款，和开发、注册和商业化相关的里程碑付款，以及特许权使用费。进一步的财务细节没有披露。Juri Biosciences是TCG Labs Soleil组建的数家投资组合公司之一。Charles Sawyers博士i是斯隆-凯特琳癌症中心人类肿瘤和发病机制项目的创始负责人，他将担任战略科学顾问，与TCG Labs Soleil团队密切合作，支持该项目并帮助指导KLK2靶向治疗的开发。Sawyers博士是转移性前列腺癌和转化肿瘤学领域的顶级专家，他共同发现了恩杂鲁胺，这个当下在晚期前列腺癌中被最广泛使用的疗法之一。“与岸迈生物的这项协议清楚地表明了我们的风险投资-生物技术模式正在发挥作用。我们获得了一项令人兴奋的外部创新，并正在部署我们的专用资本、科学领导力和运营基础设施，以迅速将其推向临床，”TCG Labs执行合伙人兼TCG Labs Soleil首席执行官Jin-Long Chen博士表示：“前列腺癌症仍然是男性与癌症相关死亡的主要原因，而KLK2是一种前列腺高度特异的抗原，有可能实现更精确的靶向治疗。我们期待着通过我们的投资组合公司Juri Biosciences推进这一计划。”岸迈生物创始人和CEO 吴辰冰博士评论道：“我们很高兴为我们的KLK2项目找到了在经验丰富的TCG Labs Soleil团队支持下的合作伙伴Juri Biosciences。通过在实体瘤领域的合作，岸迈进一步验证了我们的TCE平台在超越免疫学和血液学之外的广阔潜力。”关于TCG Labs SoleilTCG Labs Soleil正在与The Column Group合作开创一种风险投资-生物技术模式。我们的使命是为面临严重疾病的患者有效地将科学见解转化为治疗方案。我们的方法将专门的风险基金（TCG Labs）与由顶级科学家（Soleil）领导的一个常驻的研发中心相结合。这创造了一个强大的生态系统，形成并监督独立的投资组合公司，每家公司都致力于单一资产项目，指导他们从构思到临床概念验证，并为战略合作伙伴关系和变革性医疗进步做好准备。有关更多详细信息，请访问TCGLSoleil.com并在领英上关注该公司。关于岸迈生物岸迈生物是一家临床阶段生物医药企业，公司专长于多特异性抗体的开发。利用我们广泛的内部研究和技术能力，包括拥有自主知识产权的双特异性抗体技术平台FIT-Ig® (Fabs-In-Tandem Immunoglobulin) 和MAT-Fab (Monovalent Asymmetric Tandem Fab)，岸迈生物正在推出并在全球推进一系列独特的管线项目，其中包括以造福癌症患者为目标的革新性临床前和临床阶段项目。若需获取更多信息，请访问：www.epimab.comTCG Labs Soleil联系方式公司联系人Lucinda Y. Quan首席运营官电子邮件：lquan@tcglsoleil.com媒体联系人Priyanka ShahElephant Head Communications电话：908-447-6134电子邮件：pshah@elephantheadcommunicationsllc.com岸迈生物联系方式投资人联系人顾新一博士，首席财务官电话：+86-21-61951011电子邮件：IR@epimab.comBD联系人唐晔盛博士，高级BD总监电话：+86-21-61951014电子邮件：partnering@epimab.comi注：Sawyers博士与The Column Group有相关的财务利益Juri Biosciences, a TCG Labs Soleil Portfolio Company, and EpimAb Biotherapeutics Enter into a Worldwide Licensing Agreement for KLK2-Directed T-Cell Engager in Metastatic Prostate Cancer San Francisco and Shanghai May 27, 2025TCG Labs Soleil, a venture firm integrating dedicated capital with an in-house biotech R&D hub, and EpimAb Biotherapeutics, Inc. ("EpimAb") today announced that Juri Biosciences, Inc. ("Juri"), a portfolio company of TCG Labs Soleil, has entered into a worldwide licensing agreement with EpimAb, a clinical-stage biopharmaceutical company specializing in the discovery and development of multi-specific antibodies for diseases with high unmet need. The agreement grants Juri exclusive global rights to a development-ready T-cell engager targeting kallikrein-related peptidase 2 (KLK2) and CD3 for the treatment of metastatic prostate cancer.Under the terms of the agreement, EpimAb is eligible to receive up to $210 million, including an upfront payment and milestone payments tied to development, regulatory, and commercial events, plus tiered royalties. Further financial details were not disclosed.Juri is one of several portfolio companies formed by TCG Labs Soleil. Dr. Charles Sawyersi, the inaugural Director of the Human Oncology and Pathogenesis Program at Memorial Sloan Kettering Cancer Center, will serve as a strategic scientific advisor, working closely with the TCG Labs Soleil team to support the program and help guide the advancement of KLK2-directed therapies. A leading expert in metastatic prostate cancer and translational oncology, Dr. Sawyers co-discovered enzalutamide, one of the most widely used therapies for advanced prostate cancer today. "This agreement with EpimAb is a clear demonstration of our venture-biotech model at work. We've acquired an exciting external innovation and are deploying our dedicated capital, scientific leadership and operational infrastructure to move it rapidly into the clinic," said Jin-Long Chen, Ph.D., Managing Partner of TCG Labs and Chief Executive Officer of TCG Labs Soleil. "Prostate cancer remains a leading cause of cancer-related death in men, and KLK2 is a highly prostate-specific antigen with the potential to enable more precise, targeted therapy. We look forward to advancing this program through our portfolio company, Juri Biosciences." Chengbin Wu, Ph.D., Founder and Chief Executive Officer of EpimAb Biotherapeutics, commented, "We are pleased to have identified a partner for our KLK2 program in Juri Biosciences, backed by the experienced team of TCG Labs Soleil. By partnering in the solid tumor space, EpimAb further validated the broad potential of our TCE platform beyond immunology and hematology."About TCG Labs SoleilTCG Labs Soleil is pioneering a venture-biotech model in collaboration with The Column Group. Our mission is to efficiently translate scientific insights into therapeutic solutions for patients facing serious diseases. Our approach integrates a dedicated venture fund (TCG Labs) with an evergreen R&D hub led by top-tier scientists (Soleil). This creates a powerful ecosystem forming and overseeing independent portfolio companies, each dedicated to single-asset programs, guiding them from ideation to clinical proof of concept and positioning them for strategic partnerships and transformative medical advancements. For more details, visit TCGLSoleil.com and follow the company on LinkedIn. About EpimAb Biotherapeutics IncEpimAb Biotherapeutics is a clinical-stage biopharmaceutical company specializing in the development of multi-specific antibodies. Utilizing a broad range of in-house research and technology capabilities, including the proprietary FIT-Ig® (Fabs-In-Tandem Immunoglobulin) and MAT-Fab (Monovalent Asymmetric Tandem Fab) bispecific platform, EpimAb is generating and globally advancing a unique pipeline of transformative preclinical and clinical assets that aim to benefit cancer patients. For further information, please visit: www.epimab.com.TCG Labs Soleil ContactsCompany ContactLucinda Y. QuanChief Operating OfficerE-mail: lquan@tcglsoleil.comMedia ContactPriyanka ShahElephant Head Communications Phone: 908-447-6134E-mail: pshah@elephantheadcommunicationsllc.comEpimAb Biotherapeutics ContactsInvestor ContactDr. David Gu, CFODirect: +86-21-61951011IR@epimab.comBD ContactDr. Jason Tang, Senior BD DirectorDirect: +86-21-61951014partnering@epimab.comiDr. Sawyers has financial interests related to The Column Group.

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2025-05-27

·GlobeNewswire-Health Care

Juri Biosciences, a TCG Labs Soleil Portfolio Company, and EpimAb Biotherapeutics Enter into a Worldwide Licensing Agreement for KLK2-Directed T-Cell Engager in Metastatic Prostate Cancer

SAN FRANCISCO and SHANGHAI, May 27, 2025 (GLOBE NEWSWIRE) -- TCG Labs Soleil, a venture firm integrating dedicated capital with an in-house biotech R&D hub, and EpimAb Biotherapeutics, Inc. (“EpimAb”) today announced that Juri Biosciences, Inc. (“Juri”), a portfolio company of TCG Labs Soleil, has entered into a worldwide licensing agreement with EpimAb, a clinical-stage biopharmaceutical company specializing in the discovery and development of multi-specific antibodies for diseases with high unmet need. The agreement grants Juri exclusive global rights to a development-ready T-cell engager targeting kallikrein-related peptidase 2 (KLK2) and CD3 for the treatment of metastatic prostate cancer. Under the terms of the agreement, EpimAb is eligible to receive up to $210 million, including an upfront payment and milestone payments tied to development, regulatory, and commercial events, plus tiered royalties. Further financial details were not disclosed. Juri is one of several portfolio companies formed by TCG Labs Soleil. Dr. Charles Sawyersi, the inaugural Director of the Human Oncology and Pathogenesis Program at Memorial Sloan Kettering Cancer Center, will serve as a strategic scientific advisor, working closely with the TCG Labs Soleil team to support the program and help guide the advancement of KLK2-directed therapies. A leading expert in metastatic prostate cancer and translational oncology, Dr. Sawyers co-discovered enzalutamide, one of the most widely used therapies for advanced prostate cancer today. “This agreement with EpimAb is a clear demonstration of our venture-biotech model at work. We’ve acquired an exciting external innovation and are deploying our dedicated capital, scientific leadership and operational infrastructure to move it rapidly into the clinic,” said Jin-Long Chen, Ph.D., Managing Partner of TCG Labs and Chief Executive Officer of TCG Labs Soleil. “Prostate cancer remains a leading cause of cancer-related death in men, and KLK2 is a highly prostate-specific antigen with the potential to enable more precise, targeted therapy. We look forward to advancing this program through our portfolio company, Juri Biosciences.” Chengbin Wu, Ph.D., Founder and Chief Executive Officer of EpimAb Biotherapeutics, commented, “We are pleased to have identified a partner for our KLK2 program in Juri Biosciences, backed by the experienced team of TCG Labs Soleil. By partnering in the solid tumor space, EpimAb further validated the broad potential of our TCE platform beyond immunology and hematology.” About TCG Labs Soleil TCG Labs Soleil is pioneering a venture-biotech model in collaboration with The Column Group. Our mission is to efficiently translate scientific insights into therapeutic solutions for patients facing serious diseases. Our approach integrates a dedicated venture fund (TCG Labs) with an evergreen R&D hub led by top-tier scientists (Soleil). This creates a powerful ecosystem forming and overseeing independent portfolio companies, each dedicated to single-asset programs, guiding them from ideation to clinical proof of concept and positioning them for strategic partnerships and transformative medical advancements. For more details, visit TCGLSoleil.com and follow the company on LinkedIn. About EpimAb Biotherapeutics, Inc. EpimAb Biotherapeutics is a clinical-stage biopharmaceutical company specializing in the development of multi-specific antibodies. Utilizing a broad range of in-house research and technology capabilities, including the proprietary FIT-Ig® (Fabs-In-Tandem Immunoglobulin) and MAT-Fab (Monovalent Asymmetric Tandem Fab) bispecific platform, EpimAb is generating and globally advancing a unique pipeline of transformative preclinical and clinical assets that aim to benefit cancer patients. For further information, please visit: www.epimab.com. TCG Labs Soleil Contacts Company ContactLucinda Y. QuanChief Operating OfficerE-mail: lquan@tcglsoleil.com Media ContactPriyanka ShahElephant Head Communications Phone: 908-447-6134E-mail: pshah@elephantheadcommunicationsllc.com EpimAb Biotherapeutics Contacts Investor ContactDr. David Gu, CFODirect: +86-21-61951011IR@epimab.com BD ContactDr. Jason Tang, Senior BD DirectorDirect: +86-21-61951014partnering@epimab.com_______________ i Dr. Sawyers has financial interests related to The Column Group.

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100 项与恩扎卢胺相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10218	恩扎卢胺	L02BB04	DB08899

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
前列腺癌	韩国	Astellas Pharma Korea, Inc.	2024-12-03
去势敏感前列腺癌	美国	Astellas Pharma US, Inc.	2023-11-16
HRR 基因突变去势抵抗性前列腺癌	美国	Pfizer Inc.	2023-06-20
转移性前列腺癌	日本	Astellas Pharma, Inc.	2020-05-29
去势抵抗性前列腺癌	欧盟	Astellas Pharma Europe Ltd.	2013-06-21
去势抵抗性前列腺癌	冰岛	Astellas Pharma Europe Ltd.	2013-06-21
去势抵抗性前列腺癌	列支敦士登	Astellas Pharma Europe Ltd.	2013-06-21
去势抵抗性前列腺癌	挪威	Astellas Pharma Europe Ltd.	2013-06-21
激素依赖性前列腺癌	欧盟	Astellas Pharma Europe Ltd.	2013-06-21
激素依赖性前列腺癌	冰岛	Astellas Pharma Europe Ltd.	2013-06-21
激素依赖性前列腺癌	列支敦士登	Astellas Pharma Europe Ltd.	2013-06-21
激素依赖性前列腺癌	挪威	Astellas Pharma Europe Ltd.	2013-06-21
转移性去势抵抗性前列腺癌	美国	Astellas Pharma US, Inc.	2012-08-31

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
阿尔茨海默症	临床3期	中国	安斯泰来制药（中国）有限公司	2019-09-02
阿尔茨海默症	临床3期	中国	Astellas Pharma Global Development, Inc.	2019-09-02
晚期三阴性乳腺癌	临床3期	美国	Astellas Pharma, Inc.	2016-09-01
晚期三阴性乳腺癌	临床3期	美国	Pfizer Inc.	2016-09-01
晚期三阴性乳腺癌	临床3期	美国	MediVation, Inc.	2016-09-01
前列腺腺癌	临床3期	美国	Astellas Pharma US, Inc.	2014-01-22
前列腺腺癌	临床3期	美国	MediVation, Inc.	2014-01-22
前列腺腺癌	临床3期	加拿大	MediVation, Inc.	2014-01-22
前列腺腺癌	临床3期	加拿大	Astellas Pharma US, Inc.	2014-01-22
前列腺腺癌	临床3期	波多黎各	MediVation, Inc.	2014-01-22

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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


NCT03300505 (UMCC 2017.055, CTgov)	临床1期	转移性去势抵抗性前列腺癌	9	enzalutamide+ARRx (Level 1)	製顧艱鹽齋顧製鹽壓襯(窪憲鏇鹹醖繭蓋遞襯築) = 觸窪繭網簾衊憲憲獵淵選鬱願獵鏇醖壓壓鹹衊 (積簾蓋窪蓋廠廠餘製觸, 觸築襯廠鏇鏇獵繭窪願 ~ 積觸鬱構艱鏇積糧鹽夢) 更多	-	2025-05-13
				enzalutamide+ARRx (Level 2)	鹽淵餘蓋憲鑰衊夢夢積 = 糧構糧衊壓願餘構選夢夢窪艱窪選願夢淵鹽憲 (顧襯鹽顧糧齋餘願構鬱, 築齋餘襯衊獵淵願鑰餘 ~ 蓋憲膚範網蓋獵鏇醖窪) 更多
NCT02677896 (ARCHES, Pubmed \| JAMA Netw Open)	临床3期	转移性前列腺癌 prostate-specific antigen	1,150	Enzalutamide plus ADT	廠鬱蓋鏇窪顧鹽繭窪鏇(膚廠顧衊艱蓋齋鑰構願): HR = 0.24 (95% CI, 0.17 ~ 0.34) 更多	积极	2025-05-07
				Placebo plus ADT
AACR2025	N/A	前列腺癌	-	enzalutamide (Parental LNCaP cells)	襯獵淵遞壓鏇鑰齋範願(鹹淵夢醖夢築艱襯網選) = 鬱觸淵網淵蓋壓醖製齋繭簾遞醖鏇構淵獵遞繭 (壓製憲餘構鹹襯鹹鹽蓋 )	-	2025-04-28
				ENZA-resistant LNCaP cells	襯獵淵遞壓鏇鑰齋範願(鹹淵夢醖夢築艱襯網選) = 鬱選鑰鬱窪襯選齋構網繭簾遞醖鏇構淵獵遞繭 (壓製憲餘構鹹襯鹹鹽蓋 )
AACR2025	N/A	androgen receptor \| prostate specific androgen (PSA)	-	enzalutamide (C4-2B Enz-R cell line)	鹽鑰簾鏇鏇壓膚鹽範壓(遞夢觸願衊願蓋艱願蓋) = 獵觸鏇範襯壓鹽蓋獵網繭鏇遞鏇蓋憲壓獵襯膚 (選願築壓蓋願鏇壓壓壓 ) 更多	-	2025-04-28
NCT02319837 (EMBARK, Pubmed \| Prostate Cancer Prostatic Dis)	临床3期	前列腺癌 prostatic-specific antigen doubling time ≤9 months	-	Enzalutamide + Leuprolide	-	积极	2025-03-26
				Enzalutamide Monotherapy
NCT03460977 (ASCO_GU2025) 人工标引	临床1期	转移性去势抵抗性前列腺癌 H3K27Me3	-	Mevrometostat from 150 to 1250 mg BID + Enzalutamide 160 mg QD	獵膚餘築窪積淵範糧衊(齋糧鹹廠蓋選網簾選選) = 襯憲衊襯鹹鹽構繭壓網繭繭夢獵繭構鏇餘蓋簾 (積構餘願齋壓遞觸襯醖, –86 ~ –23) 更多	积极	2025-02-13
NCT06013475 (DEAR-EXT, ASCO_GU2025) 人工标引	未知	去势抵抗性前列腺癌	1,205	DarolutamideDarolutamide (DARO) (Black pts)	-	积极	2025-02-13
				DarolutamideDarolutamide (DARO) (White pts)
STAMPEDE phase 3 trial (ASCO_GU2025)	临床3期	非转移性前列腺癌 HSD3B1	594	ADT	壓鹹積製蓋壓夢積壓餘(鹹醖壓餘糧選繭艱積繭): HR = 1.32, P-Value = 0.025	积极	2025-02-13
				ADT+ENZ+AAP
ASCO_GU2025	N/A	转移性去势抵抗性前列腺癌	256	177Lu-PSMA-617 with ARPI	鑰憲網範獵壓窪製壓築(廠構鏇範憲鏇蓋壓糧襯) = 網獵淵膚網願繭顧糧遞範鬱鬱夢襯餘繭蓋衊築 (蓋鹽糧壓餘鹹範醖糧夢, NE ~ NE)	-	2025-02-13
				177Lu-PSMA-617 alone	鑰憲網範獵壓窪製壓築(廠構鏇範憲鏇蓋壓糧襯) = 醖製餘鹹醖膚襯鏇夢蓋範鬱鬱夢襯餘繭蓋衊築 (蓋鹽糧壓餘鹹範醖糧夢, 11.6 ~ 19.1)
ASCO_GU2025	N/A	chronic kidney disease	-	Enzalutamide	齋廠夢簾夢鹹齋繭壓構(遞襯網糧選鏇製選窪獵) = 積憲範淵壓網獵蓋蓋衊構醖廠淵簾構襯簾窪糧 (範鏇鑰壓餘齋構製築膚 ) 更多	积极	2025-02-13
				Abiraterone	齋廠夢簾夢鹹齋繭壓構(遞襯網糧選鏇製選窪獵) = 襯鹹艱蓋鏇膚淵繭膚蓋構醖廠淵簾構襯簾窪糧 (範鏇鑰壓餘齋構製築膚 ) 更多