QIAGEN and Incyte Enter into Precision Medicine Collaboration

In this type of clonal blood cancer, the bone marrow functions abnormally, overproducing blood cells. Identifying genomic aberrations in clinically relevant biomarkers like calreticulin (CALR) is shown to be key, especially in MPNs. CALR is a protein involved in the regulation of cellular calcium levels and normal protein production. Somatic, or non-inherited, DNA mutations in the CALR gene (mutCALR) can result in abnormal protein function and lead to the development of MPNs. Now, a new precision medicine collaboration aims to co-develop companion diagnostics for patients with mutCALR-expressing MPNs.

QIAGEN (Venlo, Netherlands) and Incyte (Wilmington, DE, USA) have entered into a new global collaboration to co-develop a novel diagnostic panel to support Incyte’s extensive portfolio of investigational therapies for patients with MPNs. Incyte’s portfolio also includes its monoclonal antibody INCA033989, targeting mutant calreticulin (mutCALR), which is being developed in myelofibrosis (MF) and essential thrombocythemia (ET). Under the terms of the Master Collaboration Agreement with Incyte, QIAGEN will develop a multimodal panel using next-generation sequencing (NGS) technology for detecting clinically relevant gene alterations in hematological malignancies.

The panel will be validated using the NGS technology and the Illumina NextSeq 550Dx platform as part of QIAGEN’s partnership with Illumina to leverage its NGS diagnostic platforms for patient testing by laboratories worldwide. QIAGEN will support regulatory submission processes and market access activities across the United States, European Union, and Asia-Pacific regions. Incyte is at the forefront of developing novel therapies, including INCA033989 for patients with mutCALR ET or MF, that target only malignant cells, sparing normal cells. The use of companion diagnostics helps guide clinicians in making treatment decisions that can lead to better patient outcomes.

“Following our presentation of positive, late-breaking data from our first-in-class mutCALR-targeted antibody at EHA, we are excited to announce this partnership with QIAGEN, which will facilitate CALR testing for patients with MPNs on a global basis. The development of companion diagnostics for mutCALR, coupled with the potential for new medicines to selectively target disease-initiating cells, is a critical step toward changing the course of disease in patients with ET and MF,” said Pablo J. Cagnoni, M.D., President and Head of Research and Development, Incyte. “As a partner, QIAGEN has the proven expertise in companion diagnostics development and approvals needed to support our ongoing work and commitment to transforming the treatment of patients with CALR-mutant MPNs.”

“Together with Incyte we are building a multimodal companion diagnostic using a powerful technology like next-generation sequencing to facilitate highly accurate testing for several blood cancer genes at once,” said Jonathan Arnold, Vice President and Head of Partnering for Precision Diagnostics at QIAGEN. “This new partnership strengthens our role in offering companion diagnostics for the growing number of biomarkers being discovered in onco-hematology and maximizing the clinical utility of the diagnostic for payor and patient benefit, thus supporting the work of innovative, science-driven companies like Incyte to improve patient outcomes.”

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