SAN DIEGO, Feb. 16, 2017 /PRNewswire/ -- Denovo Biopharma LLC, a leading company in precision medicine announces the plan to initiate a biomarker driven global phase 3 clinical trial for its lead drug DB102 as a first line therapy for diffuse large B-cell lymphoma (DLBCL) patients this year.
DB102 (Enzastaurin) is a PKCβ inhibitor originally developed by Eli Lilly and for which Denovo has acquired Worldwide rights. DB102 showed promising clinical results in the DLBCL induction setting in a Phase 2 trial, but did not meet the primary endpoint in a Phase 3 study. Denovo subsequently conducted an in-depth analysis of the DB102 clinical data and identified that a subset of patients showed improved survival. Using our unique biomarker platform, Denovo has successfully discovered 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 encouraging finding, Denovo plans to conduct a Randomized, Double-Blind, Placebo-Controlled, global Phase 3 Study in DGM1 positive DLBCL patients in the US and China.
"The successful discovery of the DGM1 biomarker is a major breakthrough for Denovo Biopharma, and has validated again the advantage of the Denovo's biomarker discovery platform," said Dr. Wen Luo, CEO of Denovo Biopharma. "Denovo's unique precision medicine technology and business model allows us to unlock the hidden value in many of the drugs which have failed in late stage trials. 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. "
Denovo also opened a new clinical center in Beijing, China last year to complement the existing center in San Diego. Isabel Han, head of Denovo's clinical operations in Beijing, said "China will play a very important role in the biomarker driven DB102 trial, and we have successfully submitted the IND application to the China FDA. We are building an experienced clinical team to support all Denovo's global clinical trials."
DB102 (formerly Enzastaurin) is an orally available investigational small molecule, serine/threonine kinase inhibitor of the PKC beta and AKT pathways and has been studied in more than 3,000 patients across a range of solid and hematological tumor types. DLBCL occurs in approximately 25,000 patients annually in the U.S. Enzastaurin has received orphan drug designation from the FDA and EMA.
About Denovo Biopharma
Denovo Biopharma is a privately-held biotechnology company that provides novel and proprietary biomarker approaches to advance drug development, including re-evaluating medicines that have failed in general patient populations by stratifying the responders for the original indication. The company offers the first platform and algorithm for de novo genomic biomarker discovery using archived clinical samples. This technology may be especially useful for compounds with suboptimal late-stage trial results. By identifying biomarkers correlated with patients' responses to drug candidates retrospectively, Denovo enables the design and execution of follow-on clinical trials in targeted patient populations while optimizing efficacy, safety and tolerability. For additional information please visit www.denovobiopharma.com.
Robert Little, Chief Business Officer
Denovo Biopharma LLC
SOURCE Denovo Biopharma