MINNEAPOLIS, Dec. 2, 2020 /PRNewswire/ -- Bio-Techne
Corporation (NASDAQ: TECH) and Regulus Therapeutics (NASDAQ: RGLS)
announced a collaboration to support Regulus with biomarker
analysis for the clinical development of RGLS4326, an Autosomal
Dominant Polycystic Kidney Disease (ADPKD) 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
View original content to download
multimedia:http://www.prnewswire.com/news-releases/regulus-therapeutics-collaborates-with-bio-techne-for-biomarker-development-301183166.html
SOURCE Bio-Techne Corporation