SAN DIEGO, Sept. 17, 2014 /PRNewswire/ — Denovo Biopharma, LLC, today announced that it has acquired enzastaurin, a late-stage oncology drug, from Eli Lilly and Company (NYSE: LLY). Denovo gains all rights to develop, manufacture and commercialize enzastaurin globally, including transfer of all intellectual property and other rights, data, and information.

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Lilly developed enzastaurin in a variety of indications, including in Phase 2 and Phase 3 clinical trials for diffuse large B-cell lymphoma (DLBCL). In studies conducted by Lilly, enzastaurin achieved promising clinical results in the DLBCL induction setting in Phase 2 trials, but did not meet the primary endpoint in the DLBCL maintenance setting in the Phase 3 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."

About Enzastaurin

Enzastaurin (DB102, formerly LY317615 HCl) is an investigational oral small molecule, serine/threonine kinase inhibitor of the PKC beta and AKT pathways [1] [2] 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.

About Denovo Biopharma

Denovo Biopharma is a privately-held biotechnology company that provides novel and proprietary biomarker approaches to personalized drug development, including re-evaluating medicines that have failed in general patient populations by personalizing them 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.

Contact:
Michael Haller, Chief Operating Officer
Denovo Biopharma, LLC
(858) 876-4012
mhaller@denovobiopharma.com

[1] Graff JR, et al. Cancer Res. 2005; 65:7462-7469
[2] Brautigam K, et al. Transl Oncol. 2009; 2; 164-173.