By TAmiRNA GmbH
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TAmiRNA joins multinational TransBioLine biomarker research project
Vienna, Austria: Biotech innovators TAmiRNA have been recruited as members of the international IMI2 Translational Safety Biomarker Pipeline (TransBioLine) project.
TransBioLine will focus on development of biomarkers of injury for liver, kidney, pancreas, vasculature, central nervous system (CNS) and the development of non-invasive microRNA biomarkers using liquid biopsies.
Transnational biomarker database
The project aims to establish a transnational validated and qualified biomarker database to achieve a decisive advance in monitoring of drug safety in clinical trials along with diagnosis of toxicities in clinical practice.
TAmiRNA will play a key role in helping the project achieving one of its key objectives, to implement profiles of circulating microRNAs (miRNAs) as tissue- and mechanism- specific diagnostic tools, supported by suitable bioinformatics systems, to facilitate in-depth mechanistic understanding of drug side- effects and disease, and/or to strengthen risk assessment and safety monitoring.
Overcoming application challenges
TAmiRNA CEO Dr. Matthias Hackl, commented: “Circulating miRNAs have received recent attention as biomarkers with enormous potential for application in clinical diagnostics or drug development. However, we have seen little progress in this area in terms of translation from research into clinical or commercial applications. The reasons for this disappointing output of clinically-relevant miRNA biomarkers can be attributed to the general challenges that we face during biomarker discovery, validation, and qualification.”
“TransBioLine promises a decisive advance in biomarker discovery, development, validation, regulatory qualification and application,” said Dr. Hackl.
“This project therefore has significant implications for biotech and pharma companies participating in clinical studies, universities, clinical research groups, potential customers and partners,” he added.
Privately owned and headquartered in Vienna, TAmiRNA GmbH is a biotech company specialized in the identification and validation of non-coding RNAs as biomarkers for age-related diseases. The mission of TAmiRNA is to provide clinically useful biomarkers to improve and prolong patient stability, health and quality of life with increasing age.
TAmiRNA specializes in technologies for profiling levels of blood-circulating microRNAs and developing multi-parametric classification algorithms (“signatures”). TAmiRNA uses these technologies to develop minimal-invasive diagnostic tests for early diagnosis and prognosis of disease, or as companion diagnostic tests to support treatment decisions.
TAmiRNA’s pipeline includes developments in osteoporosis, cardiovascular disease, type-2 diabetes, and drug safety, which aim to provide ‘microRNA kit’ solutions that enable users to quantify the levels of specific microRNA combinations and platelet function in serum, plasma, urine or other biofluids. The company initially developed kits for bone disease (osteomiR™) and cardiovascular and metabolic diseases (thrombomiRs™).
TAmiRNA also offers contract research services for companies in need of targeted biomarker development. Customers include biopharma companies with drug development programs in human and veterinary medicine, medtech companies and clinical research groups.
More information available at: www.tamirna.com.
The Translational Safety Biomarker Pipeline (TransBioLine) aims for a decisive advance in biomarker discovery, development, validation, regulatory qualification and application to bring about a fundamental change in the way drug safety is monitored in clinical trials, and toxicities are diagnosed and managed in clinical practice.
The project aims to generate new exploratory and confirmatory data enabling regulatory qualification of new safety biomarkers for application in drug development. Detailed objectives include establishment of robust biomarker datasets across relevant patient populations, development of validated assays for new safety biomarkers and submission of key safety biomarkers for qualification as drug development tools by EMA, FDA, and PMDA.
The consortium will establish and maintain a European expert and knowledge network based on a “Safety Biomarker Factory” and “Safety Biomarker Warehouse”, to allow continuous feed-in and qualification of future biomarker candidates, as well as access to comprehensive safety biomarker data.
The project is coordinated by the University of Zurich with Pfizer as industry lead, and involves 27 partners. comprising pharmaceutical and biotech companies, small and medium-sized enterprises, and academic institutions from 10 European countries and the USA.
Further information from: https://transbioline.com/.