QIAGEN expands portfolio of immuno-oncology assets for future companion diagnostics and biomarkers
Nov 05 2019

QIAGEN expands portfolio of immuno-oncology assets for future companion diagnostics and biomarkers

  • Collaborates with Repertoire Genesis for access to T-cell /B-cell receptor repertoire assays for clinical next-generation sequencing
  • Acquires licensing rights for epigenomic (DNA methylation) immune checkpoint inhibitor biomarkers developed by researchers from the University of Bonn
  • Receives exclusive license to novel mRNA gene expression signatures from STRATIFYER Molecular Pathology GmbH which may guide treatment decisions for Immuno-oncology vs. targeted drugs in bladder cancer

Hilden, Germany, and Germantown, Maryland, November 5, 2019 – QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced a series of agreements that expand its immuno-oncology assets for future commercialization of novel companion diagnostics for precision medicine in immuno-oncology, in particular based on the powerful next-generation sequencing (NGS) technology.

The agreements include a new collaboration with the Japanese company Repertoire Genesis Inc., which will provide access to novel technologies for the development of T-cell / B-cell receptor repertoire assays for use on NGS systems. QIAGEN intends to highlight these new agreements and other elements of its oncology portfolio at the Association for Molecular Pathology (AMP) Annual Meeting, which is being held from November 7-9 in Baltimore, Maryland.

Additionally, QIAGEN has entered into a new licensing agreement with researchers at the University of Bonn in Germany for novel epigenomic biomarkers based on immune checkpoint gene methylation, including CTLA4, PD-L1 and PD1, with rights to co-develop predictive companion diagnostics. In a second licensing agreement, QIAGEN has gained exclusive access to biomarker intellectual property held by the German diagnostic company STRATIFYER Molecular Pathology GmbH that is intended to provide guidance for treatment decisions in bladder cancer.

This series of agreements comes after QIAGEN recently entered into an agreement with Illumina Inc. to accelerate the adoption of NGS in clinical decision-making. QIAGEN has non-exclusive rights to develop and globally commercialize companion diagnostics and other IVD kits to be used together with Illumina’s MiSeq™ Dx and NextSeq™ 550Dx Systems. The agreement also includes rights for expansion of the partnership on future Illumina diagnostic (Dx) systems. The partnership will initially focus on commercializing oncology IVD kits to support patient management and may expand in the future to include additional clinical diagnostic fields, such as cardiology, hereditary diseases, infectious diseases, as well as inflammatory and autoimmune diseases.

“We continue to expand our access to intellectual property and novel technologies that will help us to support our pharmaceutical and laboratory customers in the development of novel NGS-based solutions for precision medicine in immuno-oncology,” said Thierry Bernard, Senior Vice President, Head of the Molecular Diagnostics Business Area and Interim CEO of QIAGEN. “We look forward to working with our new partners and expanding the presence of their breakthroughs to customers around the world, and with the vision of improving outcomes for patients.”

Immuno-oncology collaboration with Repertoire Genesis

The worldwide, non-exclusive cross-marketing and promotion agreement with Repertoire Genesis covers joint market education efforts of the complementary capabilities of both companies. The goal is together to accelerate the development and availability of companion diagnostic tests on Illumina NGS platforms using the TCR technology developed by Repertoire Genesis in the field of immuno-oncology.

The TCR NGS technology includes the isolation of T-cells from peripheral blood as front-end processing, and uses a combination technology created by QIAGEN and Repertoire Genesis for TCR measurement, single primer set-based gene amplification, bioinformatics for interpretation of TCR repertoire analysis results, and the support of biomarker studies in Repertoire Genesis´ laboratory, located in Osaka, Japan.

”Providing a complete workflow for complex TCR analysis, combined with QIAGEN´s expertise in companion diagnostic development and commercialization and validated on Illumina´s NGS instruments, is a key step to leverage individual TCR diversity to clinical applications,” said Ryuji Suzuki, President & CEO of Repertoire Genesis Inc.

Immune checkpoint epigenomics

QIAGEN has received licensing rights relating to an epigenomic immune checkpoint gene methylation test developed at the University of Bonn.

Immuno-oncology drugs, e.g. immune checkpoint inhibitors targeting the programmed cell death 1 (PD-1) pathway or the cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) elicit powerful immune responses in various cancers. Researchers at the University of Bonn have studied epigenetic modification of immune checkpoint genes, including CTLA-4 and PD-1, and identified DNA methylation biomarkers to predict response to diverse immunotherapies.

QIAGEN intends to leverage this license to develop companion diagnostics for use in selecting patients likely to benefit from specific immuno-oncology therapies. Multiple pharmaceutical companies are developing immunotherapies that are designed to inhibit or activate a growing list of immune checkpoints, including the CTLA-4 pathway, to unleash an immune response to cancers.

mRNA gene expression signatures to guide treatment decisions

QIAGEN has gained exclusive access to biomarker intellectual property from STRATIFYER Molecular Pathology GmbH, a German company with more than 10 years of Research & Development experience in the field of molecular biology, that may provide guidance for treatment decisions in bladder cancer and potentially also in other urothelial cancers.

In retrospective clinical studies conducted by the interdisciplinary German Network of Pathologists and Urologists, BRIDGE (Bladder cancer Research Initiative for Drug targets Germany), the mRNA gene expression signatures were shown to potentially provide important guidance for the selection of therapies, including the selection of immuno-oncology therapies compared to other targeted therapies.

These developments build on QIAGEN’s I-O portfolio, which includes QIAseq panels for comprehensive profiling of TMB (tumor mutation burden) and MSI (micro-satellite instability), the Omicsoft ImmunoLand bioinformatics database for visualization of immuno-oncology datasets, and ongoing collaborations with various pharmaceutical companies to develop novel multimodal companion diagnostics for immuno-oncology therapies.

QIAGEN is a global pioneer in precision medicine and markets a portfolio of about 30 companion diagnostics, which detect genetic abnormalities to provide insights that guide clinical decision-making. QIAGEN continues to expand its pipeline of solutions for precision medicine in cancer and other diseases, partnering with more than 25 pharmaceutical and biotechnology companies to co-develop companion and complementary diagnostics. These solutions span various stages of the “patient care continuum” from screening, diagnostic, prognostic, predictive, therapeutic treatment and recurrence monitoring. QIAGEN’s pipeline draws on a full range of testing platforms: polymerase chain reaction (PCR) using QIAsymphony workflows, next-generation sequencing (NGS) solutions and near-patient testing with QIAstat-Dx.

About QIAGEN

QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of September 30, 2019, QIAGEN employed approximately 5,200 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.

Forward-Looking Statement

Certain statements contained in this press release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN's products, launches, regulatory submissions, collaborations, markets, strategy, taxes or operating results, including without limitation its expected net sales, net sales of particular products (including anticipated sales of its QuantiFERON latent TB Test, its portfolio of next generation sequencing solutions and QIAstat-Dx), adjusted net sales, adjusted diluted earnings per share results, product launches (including anticipated launches of digital PCR products, a new version of its QuantiFERON-TB test, QuantiFERON-TB Access, the QIAstat-Dx panel for respiratory conditions and a CE-IVD marked panel for meningitis), placements of QIAsymphony modular PCR instruments, improvements in operating and financial leverage, currency movements against the U.S. dollar, and plans for investment in its portfolio and share repurchase commitments, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics); variability of operating results and allocations between customer classes; the commercial development of markets for our products to customers in academia, pharma, applied testing and molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN's products (including fluctuations due to general economic conditions, the level and timing of customers' funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN's products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors' products; market acceptance of QIAGEN's new products and the integration of acquired technologies and businesses; and the other factors discussed under the heading “Risk Factors” contained in Item 3 of our most recent Annual Report on Form 20-F. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).

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