Denovo Biopharma, a San Diego-based, privately held biotechnology company, has acquired enzastaurin, a late-stage oncology drug, from Eli Lilly. Denovo gains all rights to develop, manufacture and commercialize enzastaurin globally, including transfer of all intellectual property and other rights, data and information.
Lilly developed enzastaurin in a variety of indications, including in phase II and phase III clinical trials for diffuse large B-cell lymphoma (DLBCL). In studies, enzastaurin achieved promising clinical results in the DLBCL induction setting in phase II trials, but did not meet the primary endpoint in the DLBCL maintenance setting in the phase III study.
A meaningful subset of patients showed significantly improved progression-free survival and Denovo Biopharma intends to conduct genetic analysis to identify biomarkers that are related to this outcome. By identifying genomic biomarkers that correlate with patients' responsiveness to treatment, Denovo plans to screen for appropriate patient subsets for enrollment in future clinical trials that the company plans to conduct.
"We appreciate Lilly's extensive efforts in the development of enzastaurin to date. As our first late-stage asset acquired from a premier pharmaceutical company, this high quality data package will enable Denovo to conduct our retrospective biomarker discovery," said Michael F. Haller, Ph.D., Denovo Biopharma's chief operating officer. "Our biomarker discovery efforts take only a few months, so when combined with Lilly's existing data package, we should be able to rapidly initiate a biomarker validation clinical trial for the original indication (DLBCL). We are actively seeking to acquire additional drugs in late-stage development where we can utilize our biomarker discovery platform to personalize and advance other potential treatments in similar fashion."
Enzastaurin (DB102, formerly LY317615 HCl) is an investigational oral 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. Diffuse large B-cell lymphoma occurs in approximately 25,000 patients annually in the U.S. Enzastaurin has received Orphan Drug designation from the FDA and EMA.