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. “