SAN DIEGO, April 3, 2018 /PRNewswire/ -- Denovo Biopharma LLC, a pioneer in using precision medicine to develop innovative therapies, today announced dosing of the first patient in its pivotal Phase 3 ENGINE trial. The ENGINE trial is a global, randomized, double-blind, registrational study evaluating the efficacy of DB102 in combination with R-CHOP versus R-CHOP alone in DLBCL patients with or without the biomarker DGM1. The study is to enroll 235 patients and the primary outcome measure is overall survival in patients with DGM1.
Denovo, applying its unique biomarker discovery platform to DB102 (enzastaurin) which had not demonstrated significant efficacy in prior clinical trials, identified a novel, potentially predictive, genetic biomarker, DGM1 (Denovo Genomic Marker 1), for DB102 response. DGM1-positive patients exhibited improved efficacy compared to DGM1 negative patients in the DB102 treatment group across multiple studies. Notably, DB102 demonstrated significantly improved overall survival when combined with R-CHOP in treating high risk (IPI >=3), DGM1 positive, DLBCL patients when compared to those treated by R-CHOP alone. The ENGINE trial is designed based on this encouraging discovery. The study is actively recruiting patients in the United States and China.
"The initiation of this innovative biomarker driven trial marks a significant milestone for Denovo Biopharma. Importantly, the addition of DB102 to R-CHOP may offer improved benefit over R-CHOP alone in patients with high-risk DLBCL identified by a biomarker," said Ronald Shazer, M.D., Chief Medical Officer of Denovo Biopharma. "Although treatment with R-CHOP is curative in the majority of patients with low-risk DLBCL, the same cannot be said for high-risk DLBCL and alternative treatments are urgently needed for these patients."
DB102 (enzastaurin) is an orally available investigational first-in-class 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. 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.
About Denovo Biopharma LLC
Denovo Biopharma is a clinical stage biopharmaceutical company that applies novel biomarker approaches to personalized drug development, including re-evaluating medicines that have failed in general patient populations. The company can utilize its patented platform and algorithm for de novo genomic biomarker discovery using archived clinical samples. By identifying biomarkers correlated with patients' responses to drug candidates retrospectively, Denovo Biopharma enables the design and execution of efficient follow-on clinical trials in targeted patient populations to optimize the probability of a successful clinical study. Denovo currently has three late stage drugs in its pipeline: DB102 for oncology, DB103 for schizophrenia, and DB104 for depression. For additional information please visit www.denovobiopharma.com.
Contact: Michael F. Haller, Chief Financial Officer Denovo Biopharma LLC (858) 799-2012 x710 [email protected]