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Qiagen, OncXerna Therapeutics Ink Companion Dx Development, Technology-Licensing Deal

NEW YORK – Qiagen and OncXerna Therapeutics said on Monday that they have signed a master agreement to develop a next-generation sequencing companion diagnostic for navicixizumab, which OncXerna is developing as a treatment for patients with ovarian cancer.

The agreement also grants Qiagen a nonexclusive license to OncXerna's Xerna TME (tumor microenvironment) panel, which the partners will advance toward in vitro diagnostic regulatory approval as an NGS companion diagnostic for navicixizumab.

Xerna's TME panel uses proprietary RNA-based gene expression data and a machine-learning algorithm to classify patients based on the dominant biology of their cancer so patients can be matched with precision therapies.

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 partners said. Navicixizumab is an anti-DLL4/VEGF bispecific antibody that demonstrated antitumor activity in patients who were previously treated with bevacizumab (Genentech's Avastin) in a Phase Ib clinical trial. The US Food and Drug Administration granted Fast Track designation to navicixizumab for the treatment of high-grade ovarian, primary peritoneal, or fallopian tube cancer in patients who have received at least three prior therapies and/or prior treatment with bevacizumab.

In addition, the nonexclusive license enables Qiagen to integrate the Xerna panel into its NGS workflow products, thereby broadening its NGS-based companion diagnostic development capabilities.

OncXerna's founder and CEO, Laura Benjamin, said in a statement that the agreement provides "important external validation for the Xerna TME panel and our broader RNA-based biomarker platform."

"We believe that the Xerna TME panel that we can now offer our customers will further enhance our strong portfolio in companion diagnostics," Jonathan Arnold, vice president, head of oncology and precision diagnostics at Qiagen, said in a statement. "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 TME panel."