Denovo Acquires Lilly's Oncology Drug Enzastaurin

Denovo Biopharma announced its acquisition of Eli Lilly’s late-stage oncology candidate enzastaurin. The company has bought worldwide rights to develop, produce, and market enzastaurin, along with the intellectual property rights and other data.

Enzastaurin is an investigational oral serine/threonine kinase inhibitor of the PKC beta and AKT pathways that has been studied in multiple solid and hematological tumor types, including diffuse large B-cell lymphoma (DLBCL). The drug has received orphan designation from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Though the drug demonstrated promising clinical results in a Phase 2 trial for DLCBL, enzastaurin failed to meet the primary endpoint of a subsequent Phase 3 study. Lilly reported that the study did not show a statistically significant increase in disease-free survival in patients at high risk of relapse following rituximab-based chemotherapy compared to placebo. The company then decided to end the clinical development of the drug. “We are disappointed in the results that we're announcing today,” commented Richard Gaynor at the time. Gaynor is the VP of product development and medical affairs for Lilly Oncology.

Denovo noted however, that a group of patients showed significantly improved progression-free survival. The company said it plans to run genetic analysis of the group to determine biomarkers which could explain the patients’ responsiveness to the treatment. The company added that it intends to screen for appropriate patient subsets for future clinical trials of enzastaurin.

Dr. Michael F. Haller, Denovo Biopharma's COO, said that the acquisition from Lilly will help Denovo facilitate its retrospective biomarker discovery for the drug. “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.”

No financial terms of the transaction were disclosed by either company.