Denovo plans on restarting DB102 trial, in China and US

Denovo plans on restarting DB102 trial, in China and US

February 16, 2017 Off By Dino Mustafić

Denovo Biopharma’s new clinical center in China opened last year will play a very important role in the biomarker driven DB102 trial, as the company has submitted the IND application to the China FDA.  

Denovo plans to kick off a biomarker driven phase 3 clinical trial for its lead drug DB102 as a first line therapy for diffuse large B-cell lymphoma (DLBCL) patients this year. China center in Beijing will work with San Diego based one on this project.

DB102 (Enzastaurin) is a PKCβ inhibitor originally developed by Eli Lilly and for which Denovo has acquired Worldwide rights. After showing promising clinical results in the DLBCL in a Phase 2 trial, it failed to meet the main goal in a Phase 3 study.

However, Denovo conducted an in-depth analysis and found that a subset of patients showed improved survival. Denovo has in turn produced a novel biomarker, DGM1 (Denovo Genomic Marker 1), for DB102.  The DGM1 positive patients exhibited significantly improved overall survival over DGM1 negative patients in DB102 treatment group in both phase 2 and 3 studies.  Based on this finding, Denovo said it plans to conduct a Randomized, Double-Blind, Placebo-Controlled, global Phase 3 Study in DGM1 positive DLBCL patients in the US and China.

Wen Luo, CEO of Denovo Biopharma, said: “If the DGM1 driven DB102 clinical trial is successful, as a first-line medication, it is expected to have a significant positive impact on patient outcomes and also to establish Enzastaurin as a significant new therapy for the treatment of DLBCL. “