A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Effects of Multiple Doses of Carbamazepine on the Single-Dose Pharmacokinetics of MK-5684 in Healthy Adult Male Participants

Researchers have designed a study medicine called opevesostat as a new way to treat prostate cancer.
The purpose of this study is to learn what happens to opevesostat in a person's body over time (a pharmacokinetic or PK study). Researchers will compare what happens to opevesostat in the body when it is given with and without another medicine called carbamazepine.

开始日期2025-01-02

申办/合作机构

Merck Sharp & Dohme Corp.

NCT06566989 / Completed临床1期

An Open-label Phase 1 Study to Evaluate Metabolism, Excretion, and Mass Balance of [¹⁴C]MK-5684 in Healthy Male Participants

This is a study of opevesostat in healthy adult male participants. The purpose of this study is to understand the absorption, distribution, metabolism, and elimination of opevesostat in humans, as well as its pharmacokinetics (PK), metabolic profile, and safety and tolerability.

开始日期2024-09-19

申办/合作机构

Merck Sharp & Dohme LLC

[+1]

CTIS2023-506288-33-00 / Recruiting

MK-5684-01A Substudy: A Phase 1/2 Umbrella Substudy of MK-5684-U01 Master Protocol to Evaluate the Safety and Efficacy of MK-5684-based Treatment Combinations or MK-5684 Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) - MK-5684-01A

开始日期2024-08-21

申办/合作机构

Merck Sharp & Dohme LLC

100 项与 Opevesostat 相关的临床结果

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100 项与 Opevesostat 相关的转化医学

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100 项与 Opevesostat 相关的专利（医药）

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项与 Opevesostat 相关的文献（医药）

2024-05-01·Current opinion in oncology

Targeting androgen biosynthesis in prostate cancer: implications on endocrine physiology

Review

作者: Malek, Rana ; Hussain, Arif ; Kango, Ghazal ; Mannuel, Heather

Purpose of review:

Targeting specific steroidogenic enzymes is effective in decreasing testosterone synthesis, resulting in significant antitumor effects in prostate cancer. Such treatments result in disruptions of complicated and intertwining pathways with systemic physiologic consequences via effects on the adrenal gland and renin–angiotensin–aldosterone axis. This review highlights some of these aspects that need to be taken into consideration when treating patients with androgen biosynthesis inhibitors.

Recent findings:

Targeting CYP17A1, a key enzyme involved in androgen biosynthesis, is a well established treatment in prostate cancer. More recently, efforts are underway to target a gatekeeper enzyme of steroidogenesis, CYP11A1. This enzyme mediates conversion of cholesterol to pregnenolone, the first step in steroid hormone biogenesis. Studies are beginning to demonstrate antitumor effects of ODM-208, a CYP11A1 inhibitor in prostate cancer. Although anticipated to have a therapeutic role in prostate cancer, there are potential downstream effects of CYP11A1 targeting arising from suppression of the entire adrenal cortex, including long-term adrenal insufficiency and possibly cardiovascular dysregulation.

Summary:

Agents targeting androgen biosynthesis can have systemic implications. Balancing management of prostate cancer with better understanding of the mechanisms associated with potential side effects will allow for patients to obtain improved antitumor benefit while mitigating against treatment-associated adverse effects.

2024-01-23·NEJM evidence

Targeted Inhibition of CYP11A1 in Castration-Resistant Prostate Cancer

Article

In the Original Article, "Targeted Inhibition of CYP11A1 in Castration-Resistant Prostate Cancer", originally published December 26, 2023 (DOI: https://doi-org.libproxy1.nus.edu.sg/10.1056/EVIDoa2300171), in the Abstract, under "Background", the sentence "ODM-208, a novel inhibitor of cytochrome P450 17A1 …" should have read "ODM-208, a novel inhibitor of cytochrome P450 11A1…" A corrected version of the article has been posted at evidence.nejm.org.

2024-01-01·NEJM evidence

Targeted Inhibition of CYP11A1 in Castration-Resistant Prostate Cancer

Article

作者: Ikonen, Tarja ; Fléchon, Aude ; Cook, Natalie ; Barthélémy, Philippe ; van der Voet, Johannes ; Roubaud, Guilhem ; Antonarakis, Emmanuel S. ; Pohjanjousi, Pasi ; Garratt, Chris ; Utriainen, Tapio ; Baldini, Capucine ; Peters, Niamh ; Ratta, Raffaele ; Parikh, Omi ; Tanner, Minna ; Bernard-Tessier, Alice ; Fizazi, Karim ; Gravis, Gwenaëlle ; Jones, Robert ; Joensuu, Heikki

BACKGROUND: Prostate cancer is regulated by steroid hormones, even in castration-resistant disease. ODM-208, a novel inhibitor of cytochrome P450 11A1 (which catalyzes the first step of steroid-hormone biosynthesis), was investigated in patients with heavily pretreated metastatic castration-resistant prostate cancer (mCRPC). METHODS: CYPIDES is a first-in-human phase 1 (3 + 3 design) and phase 2 study. We administered ODM-208 twice daily with glucocorticoid/mineralocorticoid replacement and ongoing androgen deprivation therapy to adults with previously treated mCRPC, regardless of androgen receptor gene (AR) ligand-binding domain mutations (phase 1) and with activating AR ligand-binding domain mutations (ARmut; phase 2). Safety, pharmacokinetics, steroid-hormone pharmacodynamics, and preliminary efficacy were the key outcomes. RESULTS: Ninety-two patients received one or more doses of ODM-208: 47 in phase 1 (20 [42.6%] with ARmut) and 45 in phase 2 (all ARmut). A dose of ODM-208 of 5 mg twice a day with dexamethasone 1 mg/fludrocortisone 0.1 mg provided a balance between decreased steroidogenesis and toxicity. Treatment-related adrenal insufficiency was the most common toxicity in phase 1 (n=17, 36.2%; necessitating ODM-208 discontinuation in one patient); this toxicity occurred in six patients (13.3%) at 5 mg twice a day in phase 2. Median circulating testosterone levels declined from 3.0 ng/dl (interquartile range, 1.3 to 6.2 ng/dl) at baseline to undetectable levels within the first week of ODM-208 5 mg twice a day treatment in 46 of 53 (87%) patients. A decrease in prostate-specific antigen levels of 50% or more occurred in 14 of 19 (73.7%) patients with ARmut and 2 of 23 (8.7%) patients with AR wild type in phase 1 and in 24 of 45 (53.3%) patients with ARmut in phase 2. CONCLUSIONS: ODM-208 potently inhibited steroid-hormone biosynthesis with the expected toxicity of adrenal insufficiency. Evidence of antitumor activity was observed in this heavily pretreated mCRPC population, especially in those with ARmut. (Funded by Orion Pharma; ClinicalTrials.gov number, NCT03436485.)

项与 Opevesostat 相关的新闻（医药）

2024-10-15

·E药经理人

K药全球上市十年，引领肿瘤免疫治疗！默沙东接下来是何打法？

多年来，默沙东凭借K药，引领了肿瘤免疫治疗，成为抗肿瘤领域最成功的药企之一，也在国内书写了一段峥嵘岁月。接下来，它将和更多新药研发人员、科学家以及临床专家一起，共同谱写肿瘤药物治疗的可期未来。一组老照片，瞬间将场上所有专家的思绪拉回到往昔，串联起他们各自与默沙东K药（帕博利珠单抗；Keytruda）背后的不同故事篇章。 K药注定是肿瘤免疫治疗史上，绕不过去的一大存在。可以说，它直接引领了肿瘤免疫治疗时代。凭借优异的临床数据，这款王牌药物不仅改写了不少瘤种治疗目前现状，且成为了新的标准治疗。自2014年上市以来，K药已在全球范围内获批40个适应证，这也是其年销售额能够高达数百亿美元的关键所在，并在2023年成功问鼎全球药王宝座。放眼国内，自2018年上市后，K药也已获批14个适应证，涵盖了黑色素瘤、肺癌、食管癌、结直肠癌、头颈部癌、胃癌、肝癌、乳腺癌、胆道癌以及MSI-H实体瘤等多个领域的治疗。而每一个历史时刻都值得被记录。 2024年，恰逢K药全球上市十周年，同时也是其在中国获批上市的第六个年头。在不久前于厦门举办的2024年COSO盛会期间，一场别开生面的《我和CSCO》专题活动——默沙东“默路相伴，希冀无限”专题，在场内温情上演。北京大学肿瘤医院郭军教授、北京大学肿瘤医院沈琳教授、江苏省人民医院殷咏梅教授与默沙东中国研发中心，肿瘤临床研究执行总监周余如数家珍，分别从各自视角，回忆了一段段动人往事。随着一页页故事接连翻开，每一个与K药相关的瞬间都熠熠生辉。值此时机，众人一起回顾了中国肿瘤药物治疗领域过去几十年的峥嵘发展，也一同展望了肿瘤药物治疗的可期未来。 01 忆往昔：我与K药的峥嵘岁月 “在家门口就可以买到并立刻用上比香港、欧美便宜几乎一半的著名‘K’药了！”这是2018年9月21日，北京大学肿瘤医院郭军教授的一条朋友圈配文。彼时，他正开出了K药在中国境内的首张处方。就在此两个月前的2018年7月，K药刚刚在中国获批上市，用于治疗一线治疗后疾病进展的局部晚期或转移性黑色素瘤。在当时，这是中国唯一一款针对这一患者群体的免疫治疗药物。在此之前，许多黑色素瘤患者不得不远赴海外购药，这不仅费用高昂，还伴随着走私药物的风险。K药在国内获批上市，则意味着这一僵局终被打破。时隔多年，当再次看到这张处方，郭军感触颇深，当年的记忆瞬间涌上心头。自2014年K药在全球上市以来，郭军教授一直密切关注着其在欧美市场的动态，深知这款药物为黑色素瘤的免疫治疗开启了新篇章，迫切盼望K药能尽快在中国落地。令人欣慰的是，2016年7月，K药终于在中国启动了针对黑色素瘤的首个临床研究。这项研究在短短一年内就成功招募了103例患者，而从2016年7月研究启动到2018年获批上市，也仅仅用了两年的时间，这在过去是前所未有的速度。类似的动人故事还有很多，这些瞬间同样活跃在北京大学肿瘤医院沈琳教授和江苏省人民医院殷咏梅教授的记忆中。时间拨至2019年9月，同样是在厦门的CSCO大会上，沈琳教授团队公布了国际多中心研究数据KEYNOTE-181研究的亚洲亚组分析结果。那时，晚期食管癌标准治疗方案主要是化疗，但化疗的有效率低，效果不尽如人意。而KEYNOTE-181作为全球第一个在食管癌治疗中头对头对比免疫治疗与标准化疗的大型Ⅲ期随机对照研究，成功打破了近50年食管癌治疗的僵局，证明了K药单药相比于化疗在复发局部晚期和转移性食管癌治疗中的优效性。在沈琳的回忆中，默沙东在消化道肿瘤领域的布局相当超前，不仅限于食管癌的二线治疗，还涵盖了胃癌的二线及一线治疗，且在国际上均属首批涉足此类研究的药企，其“敢于承认并重新尝试那些未成功实验”的魄力，格外让她印象深刻，毕竟背后意味着所承担的风险和挑战远超其他企业和产品。远不止如此。K药的出现，同样打破了三阴性乳腺癌患者“无药可医”的局面。这一关键时间节点发生在2022年11月，K药在中国获批早期三阴性乳腺癌适应证，这也是帕博利珠单抗在中国早期癌症领域获批的“首个”适应证。彼时，江苏省人民医院殷咏梅教授作为专家代表在新闻发布会上公布了这一喜讯。虽然距离当时已过去两年时间，但每每想起那一刻，殷咏梅仍感慨良多。这与三阴乳腺癌的药物研发历程漫长且艰难不无相关。与黑色素瘤、肾癌、消化道肿瘤相比，乳腺癌被视为“冷肿瘤”。过去，免疫治疗在乳腺癌，尤其是三阴乳腺癌晚期的临床研究中屡屡受挫，几乎未能在晚期阶段，特别是三阴乳腺癌的治疗中展现出应用前景。但K药的出现，为三阴乳腺癌患者带来了转机。无论是晚期的解救治疗还是新辅助治疗，都开启了免疫治疗的新篇章。翻开一张张照片，背后都是一段不可磨灭的记忆。可以看到，免疫药物在中国获批的短短几年间，肿瘤治疗格局已经发生了巨大的改变，K药在其中发挥着举足轻重的关键作用。 02 看今朝：创新治疗改变肿瘤诊疗格局毋庸置疑，随着免疫治疗等创新疗法的发展和广泛应用，如今肿瘤治疗格局焕然一新。在这场肿瘤治疗变革中，患者获益正日益最大化。如前所述，多年来，三阴乳腺癌患者一直处于治疗手段相对匮乏状态。然而，随着免疫治疗在临床实践中的深入应用，尤其是在三阴乳腺癌晚期乃至早期阶段的治疗中，过去两三年间，该治疗领域取得了显著的进展。殷咏梅指出，除了免疫治疗，ADC药物也为三阴乳腺癌患者提供了新的治疗选项。在晚期阶段，治疗方案不再局限于单一疗法，而是采用了多种组合方案，如化疗联合免疫、抗血管生成药物联合免疫、ADC药物联合免疫，以及PARP抑制剂联合免疫等。这些新型治疗手段不仅为患者提供了更多选择，也显著改善了预后。 “未来，希望通过更加精准的分型，能够实现对三阴乳腺癌患者的精准治疗，从而达到更好的疗效。”她期待，三阴乳腺癌治疗领域未来能有更多的突破和进展。然而，尽管医学界历来致力于创新突破，肿瘤领域仍存有不少待解难题。以消化肿瘤为例，在中国恶性肿瘤发病率前十的榜单中，消化道肿瘤独占五席。虽然近年来这一领域取得显著进展，特别是在胃和食管肿瘤的新药研发和综合治疗方面。但就治疗现状而言，沈琳认为，消化道肿瘤领域当前仍面临诸多亟待解决的挑战。首要难题在于公众对疾病成因的认知不足，这直接导致了发病率居高不下。消化道肿瘤与饮食、遗传、生活习惯、工作压力及情绪状态等多重因素密切相关，因此，提升公众对这些因素的全面认识显得尤为迫切。其次，我国在消化道肿瘤的早诊早治方面仍面临重重挑战。与日韩或欧美国家相比，我国在上消化道肿瘤和结直肠癌的早期诊断率上存在较大差距。显然，公众对早诊早治重要性的认识还需进一步深化。同时，国家在政策与医保方面也应给予更多支持与倾斜。再者，综合治疗在消化道肿瘤治疗中占据重要地位，而新药的发展则是其中关键一环。目前，消化道肿瘤在药物治疗方面与乳腺癌、非小细胞肺癌等其他实体瘤相比仍存在一定差距。这种差距既源于疾病的复杂性和治疗难度，也受制于新药研发过程中的诸多挑战。 “面对这些挑战，我们相信未来的研究将会取得快速发展。在这方面，默沙东等企业已经进行了诸多布局，而跨学科甚至跨界的合作也将成为推动这一领域发展的关键。”这些仍然需要药企、新药研发人员、科学家以及临床医生的共同努力，深入了解疾病的分子特征和免疫特征，以及患者疾病的演变规律，从而推动消化道肿瘤治疗领域的不断进步。归根结底，作为国内高发瘤种，肿瘤防治工作仍任重道远。 03 向未来：默沙东的中国肿瘤之道可以看到，“健康中国2030”战略规划以及《健康中国行动-癌症防治行动实施方案（2023-2030）》等一系列政策的出台，是我国肿瘤防治的重大机遇。在国家政策引导下，CSCO等学术组织的领导下，过去数年间，肿瘤临床诊疗探索得到了前所未有的发展。以K药背后的默沙东为例，作为在肿瘤领域的领先公司，在中国打造了全面的肿瘤产品线，不仅带来了不少重磅产品，也推动了临床治疗的规范化。据周余介绍，默沙东当前共有5款产品在华上市，累计获批22个适应证，覆盖13个癌症种类以及MSI-H/dMMR实体肿瘤，其中包含了多个发病死亡率高、总体生存率低、治疗难度大的恶性肿瘤。与此同时，在新产品获批后，下一个接踵而至的重要任务即推动临床治疗的规范化。为此，默沙东通过线上线下的会议、宣讲等多种方式，将最新的医疗进展传递给各位专家，加强医生的教育工作，进一步提升当前治疗的规范化水平，确保不同医院、不同地区的患者都能享受到高质量的医疗服务。此外，默沙东还积极与CSCO展开合作，并共同创立了CSCO默沙东肿瘤研发基金会，以激励年轻医生投身临床与转化医学研究，全面提升整个行业的科研与临床水平，最终造福广大患者。在国内，默沙东也建设了庞大的专业队伍。作为默沙东实验室在全球的关键战略组成部分，默沙东中国研发中心目前拥有逾1800位科研及药品开发科学家，并制定了“2025战略”，以为中国带来更多的创新药品管线，实现更快的药品研发与获批，建设更新的全周期研发技术与能力，以药物和疫苗改善中国公众健康，助力实现“健康中国2030”战略目标。但面向未来，肿瘤学科发展将往何方？药企又该如何顺应肿瘤发展潮流，促进肿瘤治疗迈向更高峰？这些问题同样需要厘清，方可明晰古今未来。作为先行者之一，默沙东接下来在中国的研发管线上有何新规划和方向？这也是业内尤其关注的重点。 “继续加深现有临床研究，未来能够将更多适应证带给中国患者”是其给出的答案，在广泛而多元的在研管线上不断创新，包括25种具有单药治疗或者与K药联合治疗潜力的新药。目前，默沙东在中国开展的临床研究项目已达80余项，涵盖黑色素瘤、消化道肿瘤、乳腺癌、妇科肿瘤、血液肿瘤及泌尿系统肿瘤等多个领域。第一类是以K药为代表的免疫治疗产品，在此基础上进一步开发了IO联合治疗方案。使得肿瘤免疫治疗领域得到进一步加强。同时，两年前默沙东与Moderna的合作也推动了肿瘤疫苗的研发。第二类是ADC靶向药物。目前默沙东有10款ADC药物处于不同药物开发阶段，其中有5款药物已经进入了III期的注册临床研究。第三类则是继续针对肿瘤的精准靶向治疗。如在中国，belzutifan片的上市申请已经于2024年2月被NMPA纳入优先审评，拟用于治疗von Hippel-Lindau（VHL）病相关肾细胞癌（RCC）等此外还有多款靶向治疗药物，如口服KRAS G12C抑制剂MK-1084、针对前列腺癌的CYP11A新药MK-5684，以及在血液领域针对LSD1的bomedemstat等。迅速将优秀产品线引入中国，不仅需要药企的努力，还离不开各界共同支持。 “鉴于默沙东丰富的产品布局，我非常期待未来能有更多机会将这些产品应用到消化系统肿瘤的治疗中。”沈琳强调，因消化系统肿瘤在国内所有实体瘤中占比较高，每年新发病人数接近200万，约占40%。她建设性提出，希望双方能有更多合作机会，从更早期就开始接触这些新产品，进行早期研究，寻找合适的患者，用最短的时间获得更多适应证，从而惠及更多患者。殷咏梅也表达了自己的期待，希望默沙东未来在三大领域的全方位布局能够通过临床研究改变临床实践，并期待未来的临床研究能够提升中国专家和学者的临床研究水平，甚至引领国际治疗领域的前沿。只有十年磨一剑，迎难而上，方能在未来5年乃至10年，书写下更多精彩纷呈、意义非凡的故事篇章。一审| 黄佳二审| 李芳晨三审| 李静芝精彩推荐 CM10 | 集采 | 国谈 | 医保动态 | 药审 | 人才 | 薪资 | 榜单 | CAR-T | PD-1 | mRNA | 单抗 | 商业化 | 国际化｜猎药人系列专题 | 出海启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 医药界·E药经理人 | 中国医药手册创新100强榜单 | 恒瑞 | 中国生物制药 | 百济 | 石药 | 信达 | 君实 | 复宏汉霖｜翰森 | 康方生物 | 上海医药 | 和黄医药 | 东阳光药 | 荣昌 | 亚盛医药 | 齐鲁制药 | 康宁杰瑞 | 贝达药业 | 微芯生物 | 复星医药｜再鼎医药｜亚虹医药跨国药企50强榜单 | 辉瑞 | 艾伯维 | 诺华 | 强生 | 罗氏 | BMS | 默克 | 赛诺菲 | AZ | GSK | 武田 | 吉利德科学 | 礼来 | 安进 | 诺和诺德 | 拜耳 | 莫德纳 | BI | 晖致 | 再生元

CSCO会议上市批准免疫疗法

2024-10-10

·PRNewswire

Metastatic Castration-Resistant Prostate Cancer Clinical Trial Pipeline Appears Robust With 90+ Key Pharma Companies Actively Working in the Therapeutics Segment | DelveInsight

Metastatic Castration-Resistant Prostate Cancer (mCRPC) refers to prostate cancer that has spread (metastasized) to other parts of the body and continues to progress despite treatments that lower testosterone levels (androgen deprivation therapy or ADT) major pharmaceutical companies are heavily investing in research and development of new treatments, including immunotherapy (e.g., sipuleucel-T) and targeted therapies, which are seen as the next frontier in treating mCRPC. The use of precision medicine to identify genetic profiles in patients has further expanded the potential for targeted treatment. LAS VEGAS , Oct. 10, 2024 /PRNewswire/ -- DelveInsight's ' Metastatic Castration-Resistant Prostate Cancer Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline mCRPC therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the mCRPC pipeline domain. Key Takeaways from the Metastatic Castration-Resistant Prostate Cancer Pipeline Report DelveInsight's mCRPC pipeline report depicts a robust space with 90+ active players working to develop 100+ pipeline therapies for mCRPC treatment. Key mCRPC companies such as Regeneron Pharmaceuticals, AstraZeneca, Hinova Pharmaceuticals, Zenith Epigenetic, Eli Lilly and Company, Astellas Pharma, Seagen, Pfizer, Progenics Pharmaceutical, Molecular Insight Pharmaceuticals, Bayer, Accutar Biotechnology Inc, Hinova Pharmaceuticals, Forma Therapeutics, Inc., HALDA THERAPEUTICS INC., Tavanta Therapeutics, Lantheus, Pfizer, AB Science, Syntrix Pharmaceuticals, Exelixis, Laekna Therapeutics Shanghai Co. Ltd., Cardiff Oncology, Ipsen, Norroy Bioscience, Astellas Pharma, Novartis, Johnson & Johnson, Tempest Therapeutics, and others are evaluating new mCRPC drugs to improve the treatment landscape. Promising mCRPC pipeline therapies such as REGN 4336, Capivasertib, Deutenzalutamide, ZEN003694, Abemaciclib, Enfortumab vedotin, Talazoparib, I-131-1095, Pelgifatamab corixetan, AC176, HP518, FT-7051, HLD-0915, TAVT-45, PNT2002, Mevrometostat, Masitinib, SX-682, XL092, LAE001, Onvansertib, Tazemetostat, 177Lu-NYM032, PRL-02, 225 Actinium PSMA 617, ARX51, TPST-1120, and others are under different phases of mCRPC clinical trials. In October 2024, Curium announced that it had entered into a strategic partnership with PDRadiopharma Inc, a wholly-owned subsidiary of PeptiDream, for the clinical development, regulatory filing, and commercialization in Japan of 177Lu-PSMA-I&T and 64Cu-PSMA-I&T. The two agents 177Lu-PSMA-I&T and 64Cu-PSMA-I&T target prostate-specific membrane antigen (PSMA) expressed on prostate cancer cells and are being investigated for prostate cancer treatment and diagnostics. In July 2024, the US FDA granted fast-track designation to the prostate-specific membrane antigen (PSMA)–targeted radiopharmaceutical 225Ac-FL-020 for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). In July 2024, Merck and Orion Corporation announced the mutual exercise of option providing Merck global exclusive rights to Opevesostat, an investigational CYP11A1 inhibitor, for the treatment of Metastatic Castration-Resistant Prostate Cancer. In July 2024, the US FDA granted fast-track designation to the antibody-drug conjugate (ADC) BNT324/DB-1311 to potentially treat patients with unresectable advanced or metastatic castration-resistant prostate cancer (mCRPC) whose disease had progressed on or after standard systemic regimens. In July 2024, FutureChem announced that the FC-705 has received orphan drug designation from the Ministry of Food and Drug Safety (MFDS) for the treatment of prostate cancer. In June 2024, CAR T-Cell Therapy demonstrated promising results for mCRPC according to Phase I trial results. In January 2024, Lava Therapeutics announced that it has signed a clinical trial collaboration and supply agreement with Merck to evaluate its prostate cancer therapy LAVA-1207 as a combination treatment with MSD's Keytruda (pembrolizumab). In July 2024, Blue Earth Therapeutics announced the signing of a clinical research collaboration with University College London (UCL). The collaboration is centered on a Phase I/II trial designed to evaluate the safety, tolerability, radiation dosimetry, and antitumor activity of the 225Ac-rhPSMA-10.1 in men with metastatic castrate-resistant prostate cancer who have previously responded to lutetium 177 (177Lu)-PSMA therapy. Request a sample and discover the recent advances in mCRPC treatment drugs @ Metastatic Castration-Resistant Prostate Cancer Pipeline Report The mCRPC pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage mCRPC drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the mCRPC clinical trial landscape. Metastatic Castration-Resistant Prostate Cancer Overview Metastatic castration-resistant prostate cancer (mCRPC) is an advanced stage of prostate cancer that continues to grow and spread despite hormone therapy aimed at lowering testosterone levels. The term "metastatic" refers to cancer spreading to other parts of the body, such as the bones, lymph nodes, or distant organs, while "castration-resistant" indicates that the cancer no longer responds to treatments that reduce testosterone, a key driver of prostate cancer growth. mCRPC is typically more aggressive and challenging to treat than earlier stages of prostate cancer. The causes of mCRPC stem from genetic and environmental factors. Genetic mutations in the androgen receptor pathway can make cancer cells less dependent on testosterone, allowing them to thrive even under hormone-suppressing treatments. Environmental factors like diet, lifestyle, and exposure to certain chemicals may also contribute to the development and progression of prostate cancer. Symptoms of mCRPC often include pain in bones, fatigue, difficulty urinating, weight loss, and general weakness. As the cancer spreads, it can impair the function of other organs, depending on the site of metastasis. Diagnosis of mCRPC usually involves a combination of tests, including prostate-specific antigen (PSA) blood tests, imaging studies like CT scans, MRIs, or bone scans, and sometimes biopsies to confirm the spread and resistance to treatment. Treatment options for mCRPC are more complex and may include newer hormonal therapies (e.g., abiraterone, enzalutamide), chemotherapy (docetaxel or cabazitaxel), immunotherapy (e.g., sipuleucel-T), or targeted therapies such as PARP inhibitors. Bone-targeting therapies, radiation, and palliative care can also be used to manage symptoms and improve the quality of life. Treatment is typically tailored to the individual based on the extent of the disease and the patient health. Find out more about mCRPC treatment drugs @ Drugs for Metastatic Castration-Resistant Prostate Cancer Treatment A snapshot of the mCRPC Pipeline Drugs mentioned in the report: Learn more about the emerging mCRPC pipeline therapies @ Metastatic Castration-Resistant Prostate Cancer Clinical Trials Metastatic Castration-Resistant Prostate Cancer Therapeutics Assessment The mCRPC pipeline report proffers an integral view of the mCRPC emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Metastatic Castration-Resistant Prostate Cancer Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous Therapeutics Assessment By Molecule Type: Small molecule, Cell therapy, Peptides, Polymer, Small molecule, Gene therapy Therapeutics Assessment By Mechanism of Action: Androgen receptor degradation enhancers, Antibody-dependent cell cytotoxicity, Proto-oncogene protein c-akt inhibitors, Androgen receptor antagonists, Bromodomain and extraterminal domain protein inhibitors, Cyclin-dependent kinase 4 inhibitors, Cyclin-dependent kinase 6 inhibitors, Ionizing radiation emitters, PPAR alpha antagonists. Key Metastatic Castration-Resistant Prostate Cancer Companies: Regeneron Pharmaceuticals, AstraZeneca, Hinova Pharmaceuticals, Zenith Epigenetic, Eli Lilly and Company, Astellas Pharma, Seagen, Pfizer, Progenics Pharmaceutical, Molecular Insight Pharmaceuticals, Bayer, Accutar Biotechnology Inc, Hinova Pharmaceuticals, Forma Therapeutics, Inc., HALDA THERAPEUTICS INC., Tavanta Therapeutics, Lantheus, Pfizer, AB Science, Syntrix Pharmaceuticals, Exelixis, Laekna Therapeutics Shanghai Co. Ltd., Cardiff Oncology, Ipsen, Norroy Bioscience, Astellas Pharma, Novartis, Johnson & Johnson, Tempest Therapeutics, and others. Key Metastatic Castration-Resistant Prostate Cancer Pipeline Therapies: REGN 4336, Capivasertib, Deutenzalutamide, ZEN003694, Abemaciclib, Enfortumab vedotin, Talazoparib, I-131-1095, Pelgifatamab corixetan, AC176, HP518, FT-7051, HLD-0915, TAVT-45, PNT2002, Mevrometostat, Masitinib, SX-682, XL092, LAE001, Onvansertib, Tazemetostat, 177Lu-NYM032, PRL-02, 225 Actinium PSMA 617, ARX51, TPST-1120, and others. Dive deep into rich insights for new drugs for mCRPC treatment, visit @ Metastatic Castration-Resistant Prostate Cancer Drugs Table of Contents For further information on the mCRPC Cancer pipeline therapeutics, reach out @ Metastatic Castration-Resistant Prostate Cancer Treatment Drugs Related Reports Metastatic Castration-Resistant Prostate Cancer Market Metastatic Castration-Resistant Prostate Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key mCRPC companies including AstraZeneca, Merck Sharp & Dohme, Hinova Pharmaceuticals, Pfizer, Astellas Pharma, Modra Pharmaceuticals, AB Science, Eli Lilly and Company, Zr Pharma & GmbH, Bristol-Myers Squibb, Ipsen, Exelixis, Takeda, Janssen Research & Development, Tesaro, Lantheus Holdings, Kintor Pharmaceutical, MacroGenics, Daiichi Sankyo, Madison Vaccines, Novartis, Point Biopharma, Xencor, Essa Pharma, Telix International, Bayer, Arvinas, among others. Metastatic Prostate Cancer Market Metastatic Prostate Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key metastatic prostate cancer companies including AstraZeneca, Arvinas, Madison Vaccines, Phosplatin Therapeutics, Hinova Pharmaceuticals, Bristol Myers Squibb, Merck, MacroGenics, Daiichi Sankyo, Seagen, Taiho Pharmaceutical, Modra Pharmaceuticals, Xencor, Point Biopharma, Lantheus Holdings, Zenith Epigenetics, Essa Pharma, Telix Pharmaceuticals, Kintor Pharmaceutical, AB Science, Eli Lilly and Company, Exelixis among others. Metastatic Castration-Sensitive Prostate Cancer Market Metastatic Castration-Sensitive Prostate Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key mCSPC companies including Myovant Sciences, Pfizer, Bayer, Orion, Novartis, AstraZeneca, Pfizer, Janssen, Merck, Eli Lilly, among others. Metastatic Castration-Sensitive Prostate Cancer Pipeline Metastatic Castration-Sensitive Prostate Cancer Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key mCSPC companies, including Myovant Sciences, Pfizer, Bayer, Orion, Novartis, AstraZeneca, Pfizer, Janssen, Merck, Eli Lilly, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

快速通道免疫疗法临床1期临床结果

2024-09-26

·Pharmaceutical Technology

Orion and Aitia partner for AI-driven oncology drug discovery

The collaboration is set to address translational questions and develop drug candidates for multiple cancer indications. Credit: metamorworks/Shutterstock. Finnish pharmaceutical company Orion has entered a partnership with Aitia to leverage artificial intelligence in drug discovery and simulation in the oncology field. Through their collaboration, the companies aim to develop new Gemini Digital Twins – innovative tools designed to enhance cancer treatment strategies. Orion and Aitia will leverage the Digital Twins technology of Aitia along with Orion’s extensive pre-clinical and clinical expertise to discover and validate new drug targets. Their collaboration is set to address translational questions and develop drug candidates for multiple cancer indications. Orion innovative medicines and research and development senior vice-president Outi Vaarala stated: “We are excited to collaborate with Aitia to harness the power of their Gemini Digital Twins and Causal AI technology in the discovery and development of new cancer treatments. See Also: Biologic API Manufacturing Companies (Protein and Peptide) in Contract Manufacturing for the Pharmaceutical Industry Bavarian Nordic gains US contract for additional mpox vaccine “By leveraging their cutting-edge technology, we aim to unlock deeper insights into the complex biology of cancer, ultimately accelerating the development of novel therapies that could significantly improve patient outcomes.” Orion has secured an exclusive option for the research, development and commercialisation of new drug candidates against the targets chosen by Aitia. Aitia is entitled to upfront payments and milestone payments on meeting development and regulatory goals. Milestone payments can exceed $10m per drug target. Aitia will earn tiered single-digit royalty payments on the sales of products developed through the partnership. Aitia CEO and co-founder Colin Hill stated: “Our collaboration with Orion is particularly exciting as it brings together our Gemini Digital Twins which leverage large quantities of multi-omic patient data and causal AI and simulation with Orion’s deep expertise in oncology drug discovery and development. “By creating highly accurate and predictive models of disease, we can uncover previously hidden mechanisms and pathways, accelerating the discovery of new, more effective medicines.” In July 2024, Orion and MSD announced that the agreement for the co-development and co-commercialisation of opevesostat (MK-5684/ODM-208) has changed to give MSD exclusive rights to the asset.

疫苗引进/卖出

100 项与 Opevesostat 相关的药物交易

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研发状态

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
转移性前列腺癌	临床3期	美国	Orion Corp.	2023-12-31
转移性前列腺癌	临床3期	美国	Merck Sharp & Dohme Corp.	2023-12-31
转移性前列腺癌	临床3期	中国	Orion Corp.	2023-12-31
转移性前列腺癌	临床3期	中国	Merck Sharp & Dohme Corp.	2023-12-31
转移性前列腺癌	临床3期	日本	Merck Sharp & Dohme Corp.	2023-12-31
转移性前列腺癌	临床3期	日本	Orion Corp.	2023-12-31
转移性前列腺癌	临床3期	阿根廷	Merck Sharp & Dohme Corp.	2023-12-31
转移性前列腺癌	临床3期	阿根廷	Orion Corp.	2023-12-31
转移性前列腺癌	临床3期	澳大利亚	Orion Corp.	2023-12-31
转移性前列腺癌	临床3期	澳大利亚	Merck Sharp & Dohme Corp.	2023-12-31

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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


NCT03436485 (CYPIDES, ESMO2024) 人工标引	临床2期	转移性去势抵抗性前列腺癌二线 AR-LBD mutations	134	Opevesostat 5mg BID (AR-LBD mutation-positive)	餘襯蓋獵築繭範願衊鬱(積鏇窪獵夢淵顧醖衊鏇) = 餘選築鏇餘鬱簾製選衊鬱範築願鑰積鑰築遞衊 (膚窪鑰壓獵簾繭築蓋襯 ) 更多	积极	2024-09-15
				Opevesostat 5mg BID (AR-LBD mutation-negative)	餘襯蓋獵築繭範願衊鬱(積鏇窪獵夢淵顧醖衊鏇) = 鏇廠蓋網鏇膚壓淵鑰簾鬱範築願鑰積鑰築遞衊 (膚窪鑰壓獵簾繭築蓋襯 ) 更多
NCT03436485 (CYPIDES, ASCO_GU2024) 人工标引	临床2期	转移性去势抵抗性前列腺癌 AR-LBD mutations	134	MK-5684 5mg BID (AR-LBD mutation-positive)	艱齋餘顧廠廠壓網鹽夢(壓願膚蓋遞觸窪憲積餘) = 鹹網衊製遞餘鑰構醖膚壓構顧齋糧願齋製築鑰 (製夢衊鹽餘積遞願艱構 ) 更多	积极	2024-01-25
				MK-5684 5mg BID (AR-LBD mutation-negative)	選壓鑰憲積襯獵繭範製(齋獵遞憲鏇鹹齋淵襯鏇) = 網網選鏇顧窪繭願夢衊壓構網鹽獵廠構蓋餘艱 (製簾淵鹽廠網願顧窪願 ) 更多
NCT03436485 (Pubmed) 人工标引	临床1/2期	转移性前列腺癌 Protein Expression Markers	102	ODM-208(phase Ⅰ) + dexamethasone 1 mg/fludrocortisone 0.1 mg	糧築艱醖繭選鏇淵顧膚(願構齋繭鏇夢鬱構範憲) = 壓鬱壓簾醖淵艱窪蓋繭製鬱鏇構衊壓襯簾窪簾 (艱醖積壓選選鹹齋襯製 ) 更多	积极	2024-01-01
				ODM-208(phase Ⅱ)+ dexamethasone 1 mg/fludrocortisone 0.1 mg	糧築艱醖繭選鏇淵顧膚(願構齋繭鏇夢鬱構範憲) = 醖獵獵鬱築簾齋獵選簾製鬱鏇構衊壓襯簾窪簾 (艱醖積壓選選鹹齋襯製 ) 更多
NCT03436485 (CYPIDES , Literature) 人工标引	临床1/2期	去势抵抗性前列腺癌 AR Mutation	92	ODM-208+glucocorticoid/mineralocorticoid replacement+androgen deprivation therapy (ARmut in phase 1)	繭積範艱積網簾顧製膚(鏇築簾鑰齋鹽觸築窪膚) = Treatment-related adrenal insufficiency was the most common toxicity in phase 1 (n=17, 36.2%; necessitating ODM-208 discontinuation in one patient); this toxicity occurred in six patients (13.3%) at 5 mg twice a day in phase 2. 鏇顧觸選簾衊鏇鹽簾遞 (夢衊憲願顧顧膚齋網製 )	积极	2023-12-26
				ODM-208+glucocorticoid/mineralocorticoid replacement+androgen deprivation therapy (AR wild type in phase 1)
NCT03436485 (CYPIDES, ESMO2022) 人工标引	临床2期	转移性去势抵抗性前列腺癌 AR LBD mutation	45	ODM-208+dexamethasone+fludrocortisone	繭憲鑰網積窪觸願範繭(鏇鏇廠築襯夢艱製艱鹽) = 壓醖窪夢範壓築顧鏇艱鹹觸齋鑰鏇廠襯獵積壓 (網窪鬱鏇蓋艱膚網餘製 ) 更多	积极	2022-09-11
NCT03436485 (CYPIDES, Corporate Publications) 人工标引	临床1/2期	转移性去势抵抗性前列腺癌 AR LBD mutation	44	ODM-208	願衊繭網廠膚願鑰壓醖(繭獵構繭觸鬱壓積醖築) = severe adrenal insufficiency 32% 顧簾鑰鑰選醖憲獵願鹽 (鏇憲醖顧窪範衊衊蓋壓 )	积极	2022-02-18