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Nordic Bioscience receives Letter of Support from the U.S. Food and Drug Administration (FDA) for further study of the PRO-C3 biomarker assay in tumor fibrosis studies

• Paves way for further testing of the PRO-C3 biomarker assay, which identifies patients with hard to treat ‘fibrotic’ tumors, in further clinical trials
• US FDA recognizes need for a blood test for cancer aggressiveness which would be ‘potentially more accessible’ for patients than today’s tumor biopsy approach
• Potential to enable more targeted therapy and bring treatments to market faster and at a lower cost

Herlev, Denmark, 15 June 2023 - Nordic Bioscience, a leading biomarker company, today announced that the Company’s PRO-C3 biomarker assay has received a Letter of Support (LoS) from the U.S. Food and Drug Administration (FDA)^[1]. This letter acknowledges and supports further study of the PRO-C3 biomarker assay as a prognostic biomarker in tumor fibrosis studies.

Nordic Bioscience has a successful track record of developing and marketing biomarkers for research in a broad range of chronic diseases with a fibrotic component. In recent years, the concept of tumor fibrosis, which encompasses the tumor microenvironment, cancer-associated fibroblasts, and the extracellular matrix, has gained significant attention. The FDA’s LoS demonstrates that Nordic Bioscience’s PRO-C3 biomarker is uniquely positioned to support research and clinical trials in this area. 

Morten A. Karsdal, Chief Executive Officer of Nordic Bioscience commented:“This is the world’s first blood-based tumor fibrosis biomarker for patients with aggressive solid tumors.  We strongly believe in the value and performance of our PRO-C3 biomarker and are proud to receive the LoS from the FDA.This recognition aligns with our belief in the biomarker's potential. Ultimately this is all about helping patients fight cancer by supporting drug developers in bringing treatments to market faster and at a lower cost.”

The PRO-C3 biomarker assay measures a specific peptide fragment released to the bloodstream during formation of type III collagen and associates with activity of associated fibroblasts and hence tumor fibrosis. Tumor fibrosis is prevalent in a subset of patients across different types of solid tumors and is linked to aggressive tumor progression and poor overall survival. Thus, there is a pressing medical need to identify this "fibrotic" group of cancer patients by developing and validating tools that assess the risk based on tumor fibrosis-related parameters. Such tools can serve as prognostic enrichment biomarkers in clinical cancer trials.

Jeffrey Siegel, M.D., Director Center for Drug Evaluation and Research, FDA^[2] added: “We encourage exploration of the PRO-C3 biomarker as a prognostic enrichment biomarker for patients with solid tumors who are more likely to experience adverse outcomes.”

PRO-C3 is measured on the Roche Diagnostics cobas® e automated platform, which enhances the robustness and accuracy of sample measurements. This platform also enables the development of future in-vitro diagnostic (IVD) use^[3].

Nordic Bioscience has a collaboration agreement with Roche Diagnostics to make the PRO-C3 assay broadly available on the cobas® e automated platform.

[1] https://www.fda.gov/drugs/biomarker-qualification-program/letter-support-los-initiative

[2] https://www.fda.gov/media/169332/download

[3] The current Elecsys® PRO-C3 prototype immunoassays from Roche Diagnostics, running on a fully automated cobas® e platform, is presently intended for research use only in exploratory studies. Not for use in diagnostic procedures.

Letter of Support for PRO-C3 in Tumor Fibrosis

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For more information please contact:

Optimum Strategic Communications
Hollie Vile, Stephen Adams
Tel: +44 (0) 20 3922 0890
Email: nordicbio@optimumcomms.com

Nordic Bioscience A/S
Dr. Nicholas Willumsen
Tel: +45 4452 5252
Email: nwi@nordicbio.com

About Nordic Bioscience

Nordic Bioscience is a Danish biomarker company headquartered in Herlev, Denmark. Nordic Bioscience is engaged in biomarker development using our unique neoepitope technology. We combine our expertise in biomarker development with preclinical and clinical research. This enables us to develop biomarkers that provide fast and objective decision-making for compound selection and development in clinical trials and provide value for patients in a diagnostic setting.

[1], [2] https://www.fda.gov/drugs/biomarker-qualification-program/letter-support-los-initiative

[3] The current Elecsys® PRO-C3 prototype immunoassays from Roche Diagnostics, running on a fully automated cobas® e platform, are presently intended for research use only in exploratory studies. Not for use in diagnostic procedures.