Regulus Therapeutics Collaborates With Bio-Techne For Biomarker Development

Regulus Therapeutics与Bio-Techne合作开发生物标志物

2020-12-03 01:33:20 BioSpace

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 Bio-Techne Corporation and Regulus Therapeutics, Inc. announced a collaboration to support Regulus with biomarker analysis for the clinical development of RGLS4326, an Autosomal Dominant Polycystic Kidney Disease treatment. Regulus has utilized two Bio-Techne branded product lines, ProteinSimple and Exosome Diagnostics, to aid in their clinical trial patient testing.  RGLS4326 is a first in class anti-miR-17 therapy currently in Phase 1b clinical development in ADPKD patients. The Phase 1b trial is an adaptive design, open-label, multiple dose study in up to three cohorts of patients with ADPKD. This study will evaluate RGLS4326 for safety, pharmacokinetics, and pharmacodynamic effects on the levels of polycystin 1 (PC1) and polycystin 2 (PC2). Due to a mutation in the PKD genes, patients with ADPKD have been reported to have low levels of PC1 and PC2, the proteins encoded by the PKD1 and PKD2 genes, respectively. This study is designed to assess whether different dose levels of RGLS4326 can increase levels of PC1 and PC2 in ADPKD patients. Regulus has elected to collaborate with Bio-Techne for the development of high-performance biomarker assays to support the assessment of PC1 and PC2 levels using the fully automated Simple Western instrument as a read-out. The first cohort is expected to enroll up to nine patients who will receive RGLS4326 every two weeks over a six-week period.  The Company anticipates availability of results from the first cohort by the end of Q1 2021. Bio-Techne's product portfolio also includes protein analysis solutions, sold under the ProteinSimple brand name, offering researchers efficient and streamlined options for fully automated CE-Western blot, multiplexed ELISA workflow and tools to assess the identity, purity and heterogeneity profiles of therapeutic proteins.  ProteinSimple's instruments enable researchers to reveal new insights into proteins and their role in diseases while driving productivity within the research lab. Exosome Diagnostics is a world leader in developing liquid biopsy-based diagnostics. The company has clinical laboratories in Waltham, MA (US) and Munich (DE) to support its diagnostics and biopharma segments.  The company isolates and analyzes Exosomes to measure RNA, cell-free DNA, and proteins with their proprietary technology to explore and identify biomarkers.  "Our Exosome Diagnostics technology in combination with the Simple Western platform are powerful tools in biomarker discovery and assay development processes," commented Chuck Kummeth, President and Chief Executive Officer of Bio-Techne.  "Regulus adds to a large list of cutting-edge biopharmaceutical companies leveraging Bio-Techne's broad portfolio of life science tools to enable scientific discoveries and drug discovery efforts." "Regulus is pleased to enter this collaboration with Bio-Techne," said Jay Hagan, Chief Executive Officer of Regulus.  "We recently initiated the dosing of patients in our Phase 1b ADPKD study and our ability to determine PC1 and PC2 levels via urinary exosomes is intended to advance our understanding of the potential differentiation of RGLS4326 as a disease modifying treatment for ADPKD patients. We are excited to collaborate with Bio-Techne and employ their expert diagnostic capabilities towards generating this important clinical data."  About Bio-Techne Corporation (NASDAQ: TECH) Contact: David Clair, Senior Director, Investor Relations & Corporate Development david.clair@bio-techne.com 612-656-4416 multimedia:http://www.prnewswire.com/news-releases/regulus-therapeutics-collaborates-with-bio-techne-for-biomarker-development-301183166.html
Bio-Techne Corporation和Regulus Therapeutics,Inc.宣布合作支持Regulus进行生物标记分析,用于RGLS4326的临床开发,RGLS4326是一种常染色体显性多囊肾病治疗方法。 Regulus已经利用了两个生物技术品牌的产品线,ProteinSimple和Exosome Diagnostics,以帮助他们的临床试验患者测试。RGLS4326是目前在ADPKD患者中处于1B期临床开发的第一类抗miR-17疗法。1B期试验是一项适应性设计,开放标记,多剂量研究,多达三组ADPKD患者。本研究将评估RGLS4326的安全性,药代动力学,以及对多囊藻毒素1(PC1)和多囊藻毒素2(PC2)水平的药效作用。由于PKD基因的突变,ADPKD患者有低水平的PC1和PC2(分别由PKD1和PKD2基因编码的蛋白质)的报道。本研究旨在评估不同剂量水平的RGLS4326是否能提高ADPKD患者的PC1和PC2水平。Regulus公司选择与Bio-Techne公司合作开发高性能生物标记物分析法,以支持使用全自动简易西方仪器作为读出器评估PC1和PC2水平。第一组预计最多将有9名患者参加,他们将在6周的时间内每两周接受RGLS4326治疗。该公司预计第一组研究的结果将于2021年第一季度末公布。 Bio-Techne公司的产品组合还包括以ProteinSimple品牌销售的蛋白质分析解决方案,为研究人员提供高效和简化的选择,用于全自动CE-Western印迹,多路酶联免疫吸附工作流程和评估治疗性蛋白质的特性,纯度和异质性特征的工具。ProteinSimple的仪器使研究人员能够揭示蛋白质及其在疾病中的作用的新见解,同时提高研究实验室的生产力。 Exosome Diagnostics公司是开发基于液体活检诊断技术的世界领先企业。该公司在沃尔瑟姆,马萨诸塞州(美国)和慕尼黑(德国)设有临床实验室,以支持其诊断和生物制药部门。该公司通过分离和分析外泌体来测量RNA,无细胞DNA,以及利用他们的专有技术来探索和鉴定生物标志物的蛋白质。 Bio-Techne公司总裁兼首席执行官Chuck Kummeth评论说:“我们的Exosome诊断技术与Simple Western平台相结合,是生物标记物发现和化验开发过程中的强大工具。Regulus加入了一大堆利用Bio-Techne公司广泛的生命科学工具来实现科学发现和药物发现的尖端生物制药公司的行列。“ Regulus公司首席执行官杰伊·哈根说:“Regulus公司很高兴与Bio-Techne公司进行这项合作。“我们最近在我们的1B期ADPKD研究中启动了患者的剂量,我们通过尿外泌体测定PC1和PC2水平的能力旨在推进我们对RGLS4326作为ADPKD患者的疾病修饰治疗的潜在分化的理解。我们很高兴与Bio-Techne合作,并利用他们的专家诊断能力来生成这一重要的临床数据。” 关于Bio-Techne Corporation(纳斯达克代码:TECH) 联系人:David Clair,高级董事,投资者关系和公司发展部 电子邮件:David.clair@bio-techne.com 612-656-4416 多媒体:http://www.prnewswire.com/news-releases/regularus-therapeutics-collaborates-with-bio-techne-for-biomarker-development-301183166.html

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