Benzinga | Aug 9, 2021 05:15PM EDT

QIAGEN Reports Licensing, Master Companion Diagnostics Deal With OncXerna, No Terms Disclosed

* QIAGEN and OncXerna enter into a global master agreement to advance the development of the Xerna(tm) TME panel as a potential Next Generation Sequencing (NGS) companion diagnostic for OncXerna's Navicixizumab

* Agreements include a non-exclusive license for QIAGEN to the OncXerna Xerna(tm) TME panel

* The agreements broaden QIAGEN's NGS companion diagnostics capabilities in immuno- oncology clinical development programs

HILDEN, Germany & WALTHAM, Mass. & GERMANTOWN, Md.--(BUSINESS WIRE)-- QIAGEN (NYSE:QGEN, Frankfurt Prime Standard: QIA))) and OncXerna Therapeutics, Inc. ("OncXerna"), a precision medicine company using an innovative RNA-expression based biomarker platform to predict patient responses to its targeted oncology therapeutic candidates, today announced signing a master companion diagnostics (CDx) agreement to develop a NGS CDx for OncXerna's product candidate, Navicixizumab, and a non-exclusive license to the Xerna(tm) TME panel.

QIAGEN and OncXerna have agreed to collaborate to advance the Xerna(tm) TME panel towards IVD (in-vitro diagnostic) regulatory approval as a NGS companion diagnostic for Navicixizumab, which is being developed by OncXerna as a treatment for patients with ovarian cancer. The diagnostic will be used to determine if patients with ovarian cancer whose dominant tumor biology is driven by angiogenesis are more likely to benefit from treatment with Navicixizumab.

The Xerna(tm) TME panel uses proprietary RNA-based gene expression data and a machine learning-based algorithm to classify patients based on the dominant biology of their cancer so that patients can be matched with therapies that directly address these biologies. Pursuant to the non-exclusive license, which is for research use only ("RUO") and clinical development programs, OncXerna has granted QIAGEN the rights to integrate the Xerna(tm) TME panel into their NGS workflow solutions, which broadens QIAGEN's NGS CDx custom panel development capabilities.

"We are very pleased to complete these agreements with QIAGEN, which we see as providing important external validation for the Xerna(tm) TME panel and our broader RNA-based biomarker platform," stated Dr. Laura Benjamin, OncXerna Founder and CEO. "As an NGS industry-leader in precision medicine diagnostics with impressive global development, manufacturing and commercial capabilities, we believe QIAGEN is uniquely positioned to help advance the Xerna(tm) TME panel towards regulatory approval as an NGS companion diagnostic and, if approved, drive the panel's adoption. Moreover, integration of the Xerna(tm) TME Panel into their workflow solutions could enable QIAGEN to provide a new RNA-based offering to strengthen their overall immune oncology solutions for biopharma customers."

"We believe that the Xerna(tm) TME panel that we can now offer our customers will further enhance our strong portfolio in companion diagnostics. Through this agreement, we aim to foster additional NGS-based collaborations with pharmaceutical companies for the development of drug treatments for immune oncology and promote early clinical adoption of precision medicine diagnostics such as our therascreen portfolio and the Xerna(tm) TME panel," said Jonathan Arnold, Vice President, Head of Oncology and Precision Diagnostics at QIAGEN. "We are also thrilled to have the master CDx agreement in place and look forward to working with OncXerna to develop an NGS companion diagnostic for Navicixizumab based on our extensive track record with the development of companion diagnostics for a variety of cancers."

QIAGEN is a pioneer in Precision Medicine and the global leader in collaborations with pharmaceutical and biotechnology companies to co-develop companion diagnostics, which detect clinically relevant genetic abnormalities to provide insights that guide clinical decision-making in diseases such as cancer. QIAGEN has an unmatched depth and breadth of technologies from next-generation sequencing (NGS) to polymerase chain reaction (PCR) for companion diagnostic development. QIAGEN has ten PCR based companion diagnostic indications that are FDA approved, including therascreen EGFR for non-small cell lung cancer, therascreen KRAS for colorectal cancer, therascreen FGFR for urothelial cancer, therascreen PIK3CA for breast cancer based on tissue or plasma samples and the therascreen BRAF kit for colorectal cancer.

Currently, QIAGEN is working under master collaboration agreements with more than 25 companies to develop and commercialize companion diagnostic tests for their drug candidates -- a deep pipeline of potential future products to advance Precision Medicine for the benefit of patients.