NEW YORK – Qiagen and Denovo Biopharma said on Thursday that they are collaborating to develop a blood-based companion diagnostic test to identify patients expressing a genomic biomarker who are likely to respond to Denovo's investigational DB102 treatment for diffuse large B-cell lymphoma.
Under the agreement, Qiagen will develop an assay that can detect the biomarker, called Denovo Genomic Marker 1, in DLBCL patients. DGM1, discovered by Denovo, predicts responsiveness to DB102, also known as enzastaurin, a first-in-class small molecule inhibitor of PKC-beta, a protein that has been linked to DLBCL cases.
Qiagen will develop a real-time qualitative PCR companion diagnostic test for use on its Rotor-Gene Q MDx instrument and will apply for premarket approval with the US Food and Drug Administration. The companies said they aim to obtain the premarket approval alongside Denovo receiving approval for a new drug application for DB102. The drug and biomarker are currently being evaluated in a Phase III trial called ENGINE on newly diagnosed, high-risk DLBCL patients.
"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," Xiao-Xiong Lu, Denovo's chief technology officer, said in a statement.