Denovo Biopharma, a US-China biopharma, acquired global rights to enzastaurin, a late-clinical-stage oncology drug from Eli Lilly (NYSE: LLY). In 2013, enzastaurin failed a Phase III clinical trial for diffuse large B-cell lymphoma (DLBCL), though it significantly improved progression-free survival in a subset of patients. Denovo believes it can use its proprietary biomarker expertise to identify that patient group and conduct a successful trial of enzastaurin. Denovo is headquartered in San Diego with a lab in Hangzhou.

Denovo gained all rights to enzastaurin, including manufacturing, global commercialization, IP and Lilly's data on the drug. Financial details of the deal were not disclosed.

According to Denovo, pharmas with drugs that fail late-stage clinical trials retain patients' plasma samples, which can be used to identify novel genetic biomarkers. Denovo scans the entire human genome of each sample and conducts a proprietary data analysis. Until recently, the cost of this analysis was prohibitive. But now the analysis can be completed in as little as 90 days, with, says Denovo, an attractive return on investment.

In its early years (Denovo is only three years old), Denovo was known as Denovo Biomarkers because of its primary emphasis. Now that it has begun using its personalized medicine technology to in-license previously failed drugs, it changed its name to Denovo Biopharma.

Lilly developed enzastaurin for several cancers, and completed Phase II and Phase III trials for diffuse large B-cell lymphoma (DLBCL). The results were positive in the Phase II trial, but the drug did not meet the primary maintenance endpoint in the Phase III study. Because some patients had a positive result, the drug is a viable candidate for Denovo's strategy. The company says it intends to develop biomarkers and run a smaller Phase III trial with an improved chance of success.

"We appreciate Lilly's extensive efforts in the development of enzastaurin to date," said Michael F. Haller, PhD, Denovo Biopharma's COO. "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. 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)."

Xiangming Fang, MD, PhD, is President of Denovo. She has 26 years of experience in biomedical research and product development, including 18 years in the biotech sector and 14 years in management. Dr. Fang obtained her Medical Degree from Zhejiang University Medical School and a PhD in Molecular Biology from the University of Alabama. She was Senior Vice President and Chief Scientific Officer at GenWay Biotech, was in charge of several programs at GenStar Therapeutics, and worked to help develop gene therapies for hemophilia at Baxter Healthcare and GeneMedicine.

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 US. Enzastaurin has received orphan drug designation from the FDA and EMA.

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Disclosure: none.