Qiagen and Denovo Biopharma to Develop Blood-Based CDx Test for Treatment of Diffuse Large B-Cell Lymphoma
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By LabMedica International staff writers Posted on 21 Dec 2021 |
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QIAGEN N.V. (Venlo, Netherlands) and Denovo Biopharma LLC (San Diego, CA, USA) have entered into a collaboration to develop a blood-based companion diagnostic (CDx) test to identify patients expressing Denovo Genomic Marker 1 (DGM1TM) who are likely to respond to Denovo’s investigational cancer drug DB102TM for treatment of diffuse large B-cell lymphoma (DLBCL), one of the most common lymphoid cancers.
Under the agreement, QIAGEN will develop a diagnostic assay that can detect the Denovo Genomic Marker 1 (DGM1TM) in DLBCL patients, a biomarker discovered by Denovo that predicts the responsiveness to DB102. Also known as enzastaurin, Denovo’s drug is a first-in-class investigational small molecule inhibitor of PKC-beta, a protein whose presence has been compellingly linked to DLBCL cases.
QIAGEN will develop a real-time qualitative PCR companion diagnostic for the QIAGEN Rotor-Gene Q MDx instrument and apply for premarket approval (PMA) with the US-based Food and Drug Administration (FDA). The goal is to get the PMA for the test contemporaneously with Denovo receiving new drug application (NDA) approval for its DB102. The drug and the DGM1 marker are currently in a phase III trial, called ENGINE, on newly diagnosed, high-risk DLBCL patients.
“We are proud to be at the cutting edge of precision medicine, a quantum leap from traditional one-drug-fits all medicine,” said Jonathan Arnold, Vice President, Head of Oncology and Precision Diagnostics at QIAGEN. “Our molecular testing expertise will help Denovo to develop the use of the DGM1 marker with the DB102 drug for patients with DLBCL.”
“As our ENGINE trial nears completion, we are pleased to be working with QIAGEN on commercial development of our DB102 program to enable patients and physicians to potentially benefit from DB102 treatment,” said Xiao-Xiong Lu, Denovo’s Chief Technology Officer. “As a pioneer in precision medicine QIAGEN brings extensive experience in companion diagnostics, including ten FDA-approved tests.”
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