University Hospitals of Leicester

▎Armstrong 2025年3月10日，诺和诺德公布司美格鲁肽+Amylin类似物Cagrilintide联合治疗二型糖尿病合并肥胖患者三期临床REDEFINE 2的顶线数据。经过68周治疗，61.9%的患者达到的最高剂量，治疗组减重15.7%，安慰剂组减重3.1%，安慰剂校正后减重12.6%，两组减重幅度超过5%的患者比例分别为89.7%、30.3%。 消息发布后，诺和诺德股价盘前大跌6%，目前市值为3640亿美元。 去年年12月20日，诺和诺德公布了司美格鲁肽+Cagrilintide联合治疗肥胖三期临床REDEFINE 1的68周疗效和安全性数据，该三期临床入组3417例肥胖或合并一种及以上风险因素的超重患者。CagriSema、Cagrilintide、司美格鲁肽、安慰剂组治疗68周分别减重22.7%、11.8%、16.1%、2.3%。CagriSema、Cagrilintide、司美格鲁肽相比与安慰剂治疗68周减重幅度分别为20.4%、9.5%、13.8%。当时数据发布后，诺和诺德股价大跌18%。 不过在上个月的24日，诺和诺德公布了Amycretin治疗肥胖的1b/2a期临床最新数据，1.25mg、5mg、20mg剂量组治疗36周分别减重9.7%、16.2%、22.0%，安慰剂组减重2.0%左右，安慰剂校正后，20mg高剂量组治疗36周减重幅度达到20.0%。当天，诺和诺德股价大涨8%。 总结 诺和诺德将下一代的减重药物中心放在Amylin上，但司美格鲁肽+Amylin联合治疗数据不达预期，而GLP-1/Amylin双靶点激动剂则有望媲美三靶点GGG产品，随着这两款产品的顶线数据陆续发布，诺和诺德的股价也迎来股价的剧烈波动。 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。

Start-up US biotech company tackling rare diseases presents three case studies in France LILLE, France--(BUSINESS WIRE)-- RS Oncology is bringing exciting new science to patients who will have the best chance of benefiting from new therapies. PRX3 is a novel drug target with potential for treating patients with the asbestos related cancer, mesothelioma. It is a key defense against oxidative stress and is located in the mitochondria, the energy generating factories. Inhibiting PRX targets cancer, not normal cells. This press release features multimedia. View the full release here: MITOPE, a first-in-human Phase 1 clinical trial, is investigating a first-in-class PRX3 inhibitor, RSO-021 (clinicaltrials.gov using the identifier NCT05278975, sponsor RS Oncology, LLC [RSO], Boston, USA). Dose escalation is ongoing across four UK sites with a planned enrollment by Q2 2024. Phase 2 expansion will bring on board additional sites in Q4 of 2023. Early experience with RSO-021 in MITOPE was presented to a global audience of mesothelioma clinicians, scientists, and allied professionals at the 2023 International Mesothelioma Interest Group (iMig) conference hosted in Lille, France in June. The industrial symposium was entitled New Horizons for Cancer Therapy - Targeting Oxidative Stress Vulnerabilities. Brian Cunniff, Ph.D., Chief Science Officer for RSO, and Assistant Professor of Pathology and Laboratory Medicine at the University of Vermont Cancer Center, explained how tumor cells utilize increased levels of Reactive Oxygen Species (ROS) as a driver of pro-tumor signaling pathways. He also described the discovery of PRX3 as a target to leverage ROS dependency in cancer. RSO-021 irreversibly binds and inhibits PRX3, leading to tumor-specific cell death. Dr. Cunniff stated that “RSO-021 is an exciting new therapeutic option for patients suffering with mesothelioma. RSO-021 exploits a universal vulnerability of tumor cells through a novel mechanism of action, leaving tumor cells unable to clear toxic waste products. We are excited to see our laboratory findings translated to patients in collaboration with RS Oncology.” Dr. Sean Dulloo, a UK investigator based at the University Hospitals of Leicester and University of Leicester, shared early insights in the safety and activity in MITOPE. Three cases were presented demonstrating the impactful tumor responses and reduced MPE levels with disease stabilization and improved quality of life. Key opinion leader and IMIG 23 research medal winner, Professor Dean Fennell, also from Leicester, summarized the evolving mesothelioma treatment landscape and unmet needs. “PRX3 is a novel and interesting therapeutic drug target with potential for treating cancers, especially those with unmet need such as mesothelioma. We await the first clinical results with interest.” For more information about MITOPE clinical trial visit Mesothelioma UK. The study is supported by NIHR. About RS Oncology RSO is a clinical stage biotechnology company based in Cambridge, Massachusetts with a mission to eradicate mesothelioma and other diseases worldwide through novel science and an innovative business model. The lead program is currently focused on development of novel therapies that modulate mitochondrial pathways driving diseases of oxidative stress, including mesothelioma and other cancers.