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BIO-TECHNE HIGHLIGHTS RECENTLY ANNOUNCED TOP-LINE BIOMARKER DATA FROM PARTNER, REGULUS THERAPEUTICS, USING THE COMPANY'S PROPRIETARY TECHNOLOGY

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Bio-Techne (NASDAQ: TECH) and Regulus Therapeutics Inc. announced positive top-line results from the second cohort of their Phase 1b MAD study of RGLS8429 for Autosomal Dominant Polycystic Kidney Disease (ADPKD). The collaboration, ongoing since 2020, utilizes Bio-Techne's Simple Western™ platforms and ExosomeDx CLIA laboratory for biomarker analysis. Regulus developed assays to measure polycystin 1 and 2 levels, key biomarkers in ADPKD, using Bio-Techne’s technology. This milestone highlights the clinical potential of RGLS8429 and advances the study, aiming to improve global healthcare with innovative therapeutics.

Positive
  • Positive top-line results from the Phase 1b MAD study of RGLS8429 for ADPKD.
  • Continued collaboration between Bio-Techne and Regulus Therapeutics.
  • Utilization of Bio-Techne's Simple Western™ platforms and ExosomeDx CLIA laboratory.
  • Development of high-performance biomarker assays for PC1 and PC2 by Regulus.
  • Ongoing clinical advancement in ADPKD treatment.
  • Potential for global healthcare improvement through innovative therapeutics.
Negative
  • The press release does not provide specific data or figures from the Phase 1b MAD study.
  • Potential risks associated with early-stage clinical trials not addressed.
  • Financial implications of continued collaboration not detailed.

Bio-Techne's collaboration with Regulus Therapeutics to measure biomarkers using their proprietary technology has shown promising results in a Phase 1b study for Autosomal Dominant Polycystic Kidney Disease (ADPKD). This is significant as the successful measurement of polycystin 1 (PC1) and polycystin 2 (PC2) levels can provide critical insights into the disease's mechanisms. ADPKD is characterized by the growth of numerous cysts in the kidneys, leading to kidney failure over time. Identifying and quantifying PC1 and PC2 in urine samples is pivotal since these proteins are typically low in ADPKD patients. The ability to use minimal sample volumes for sensitive and quantitative readouts makes the Simple Western platform particularly advantageous for clinical settings. This development may accelerate the timeline for bringing effective treatments to market, potentially improving patient outcomes significantly in the long term.

Rating: 1

From a financial perspective, Bio-Techne's ongoing collaboration with Regulus Therapeutics demonstrates the potential of their proprietary technology platform to generate revenue through partnerships and licensing. The successful Phase 1b results enhance Bio-Techne's credibility in the biotech sector, possibly attracting more partnerships and clients. Additionally, the use of Bio-Techne's Simple Western platform and ExosomeDx CLIA laboratory in generating these results could drive increased demand for these technologies. For Regulus, positive clinical data is important for securing further funding and strategic partnerships, which are essential for advancing to later-stage clinical trials. Investors should note that while early-stage clinical success is promising, it is essential to monitor the progression of these trials to later stages before making any long-term investment decisions.

Rating: 1

MINNEAPOLIS, May 22, 2024 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) and Regulus Therapeutics Inc., a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs, today announced continued technical and clinical collaboration following release of Regulus' positive topline results from the second cohort of patients in its Phase 1b MAD (multiple ascending dose) study of RGLS8429 for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD). The two companies began the collaboration in 2020 to support Regulus' biomarker analysis for the clinical development of anti-miR-17 therapies for ADPKD treatment.

To generate the recently reported topline clinical data for RGLS8429, Regulus utilized Bio-Techne's Simple WesternTM platforms and its ExosomeDx CLIA laboratory.  Simple Western enables full automation of western blotting for efficient and streamlined workflows to quantify expression and determine size and identity of therapeutic proteins. ExosomeDx, a Bio-Techne brand, is a world leader in developing liquid biopsy-based diagnostics with products and technologies for the isolation and analysis of exosomes to measure RNA, cell-free DNA, and proteins.

Regulus developed high-performance biomarker assays to measure polycystin 1 (PC1) and polycystin 2 (PC2) levels in urine samples using the fully automated Simple Western platform, which provides sensitive and quantitative protein expression readouts using a few microliters of a patient sample. Measuring PC1 and PC2 levels provides key mechanistic and pharmacodynamic information because patients with ADPKD have been reported to have low levels of these two proteins. The testing is being performed at Bio-Techne's ExosomeDx CLIA laboratory, to take advantage of their exosome expertise and clinical testing capabilities.

"Congratulations to the Regulus team for achieving this important milestone and advancing this study in patients living with ADPKD," said Will Geist, Bio-Techne's President, Protein Sciences Segment. "We look forward to continuing to work with Regulus on the next phase of the study and enabling other biotech companies to develop and advance cutting-edge therapeutics that improve global healthcare."

About Bio-Techne 

Bio-Techne Corporation (NASDAQ: TECH) is a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities. Bio-Techne products assist scientific investigations into biological processes and the nature and progress of specific diseases. They aid in drug discovery efforts and provide the means for accurate clinical tests and diagnoses. With thousands of products in its portfolio, Bio-Techne generated over $1.1 billion in net sales in fiscal 2023 and has approximately 3,100 employees worldwide. For more information on Bio-Techne and its brands, please visit http://www.bio-techne.com or follow the Company on social media at Facebook, LinkedIn, Twitter or YouTube.

About Bio-Techne Corporation (NASDAQ: TECH)
Contact: David Clair, Vice President, Investor Relations & Corporate Development
david.clair@bio-techne.com
612-656-4416

About Regulus

Regulus Therapeutics Inc. is a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs. Regulus has leveraged its oligonucleotide drug discovery and development expertise to develop a pipeline complemented by a rich intellectual property estate in the microRNA field. Regulus maintains its corporate headquarters in San Diego, CA.

Regulus Contact

Investor Relations Contact:
Cris Calsada
Chief Financial Officer
858-202-6376
ccalsada@regulusrx.com

Media Contact:
Sarah Sutton
Argot Partners
212-600-1902
regulus@argotpartners.com

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/bio-techne-highlights-recently-announced-top-line-biomarker-data-from-partner-regulus-therapeutics-using-the-companys-proprietary-technology-302152199.html

SOURCE Bio-Techne Corporation

FAQ

What are the recent top-line results for RGLS8429 in ADPKD treatment announced by Bio-Techne and Regulus?

Bio-Techne and Regulus announced positive top-line results from the second cohort of the Phase 1b MAD study of RGLS8429 for treating Autosomal Dominant Polycystic Kidney Disease (ADPKD).

How is Bio-Techne's technology utilized in the RGLS8429 study?

Regulus uses Bio-Techne's Simple Western™ platforms and ExosomeDx CLIA laboratory for biomarker analysis, specifically measuring polycystin 1 and 2 levels in urine samples.

What is the significance of measuring polycystin 1 and 2 levels in ADPKD patients?

Measuring polycystin 1 and 2 levels provides mechanistic and pharmacodynamic information, as ADPKD patients typically have low levels of these proteins.

When did Bio-Techne and Regulus begin their collaboration?

Bio-Techne and Regulus began their collaboration in 2020 to support biomarker analysis for the clinical development of anti-miR-17 therapies for ADPKD treatment.

What are the potential benefits of RGLS8429 for ADPKD patients?

The positive top-line results from the Phase 1b MAD study of RGLS8429 suggest its potential in advancing treatment for ADPKD, thereby improving patient outcomes.

Bio-Techne Corporation

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