SAN DIEGO, Nov. 12, 2020 /PRNewswire/ -- Denovo Biopharma, a pioneer in applying precision medicine to development of innovative therapies, today announced that its international Phase 3 registrational study for DB102 has fully enrolled. The ENGINE study is a randomized, double-blind, placebo-controlled, international multi-center Phase 3 pivotal clinical trial evaluating the efficacy of DB102 in combination with R-CHOP versus R-CHOP alone in newly-diagnosed high-risk (IPI >=3) DLBCL patients with the biomarker DGM1 (Denovo Genomic Marker 1).
Denovo utilized its deep expertise in the fields of genomics, big data analysis, and drug development to establish a platform technology that can use residual clinical samples to find biomarkers that can predict drug efficacy, creating a new model for developing innovative drugs at a lower cost and in a shorter timeframe through precision medicine. The novel biomarker DGM1 utilized in the ENGINE study was developed using this platform. This clinical trial aims to verify that high-risk DLBCL patients who are DGM1 positive can benefit significantly from DB102 treatment in combination with current standard of care, R-CHOP.
DLBCL is the most common type of non-Hodgkin lymphoma (NHL), accounting for about half of the total number of cases. While the current international standard of care, R-CHOP, is curative for the majority of low-risk patients with DLBCL, up to 40% of high-risk patients will fail first-line therapy. DB102 is the world's first oral small-molecule kinase inhibitor targeting PKC-β. A retrospective analysis found that it has significant curative effects in high-risk DLBCL patients who are DGM1 positive. Mr. Joe Zimmerman, Head of Global Clinical Operations at Denovo , said,"Through the joint efforts of our Chinese and American teams, we successfully completed the enrollment of all subjects. We hope that DB102 can bring new treatment options to patients with high-risk DLBCL, thereby reversing the dearth of new treatments for this group of patients over the past two decades."
DB102 (enzastaurin) is an orally available investigational first-in-class small molecule, serine/threonine kinase inhibitor of the PKC beta, PI3K, and AKT pathways that has been studied in more than 3,000 patients across a range of solid and hematological tumor types. DB102 was originally developed by Eli Lilly and for which Denovo has acquired worldwide rights. DB102 received orphan drug designation in DLBCL and glioblastoma multiforme (GBM) from the FDA and EMA. In July 2020 the US FDA granted DB102 Fast Track qualification for the first-line treatment of GBM with DB102.
About Denovo Biopharma LLC
Denovo Biopharma is a clinical-stage biopharmaceutical company that applies novel biomarker approaches to re-evaluate medicines that have failed in broad patient populations. The company seeks to discover genomic biomarkers correlated with patients' responses to drug candidates retrospectively. Denovo then designs and executes efficient clinical trials in targeted patient populations to optimize the probability of a successful trial. Denovo is enrolling patients in the U.S. and China with diffuse large B-cell lymphoma (DLBCL) in a Phase 3 clinical trial and will start a Phase 3 trial in Glioblastoma (GBM) for its lead product candidate, DB102 (enzastaurin), which was in-licensed from Eli Lilly. The company has five additional late-stage programs targeting major unmet needs: DB103 (pomaglumetad methionil) for schizophrenia, DB104 (liafensine) for depression, DB105 (formerly ORM-12741) for Alzheimer's Disease, DB106 (vosaroxin) for acute myeloid leukemia (AML) and DB107 (formerly Toca 511 and Toca FC) for recurrent high grade glioma. For additional information please visit www.denovobiopharma.com.
Michael F. Haller, Chief Business Officer
Denovo Biopharma LLC
SOURCE Denovo Biopharma LLC