FOR IMMEDIATE RELEASE
Denovo Biopharma Acquires Exclusive License of Novel Application of DB102 in the Treatment of Pulmonary Arterial Hypertension
DIEGO, June 4, 2018 --
Denovo Biopharma LLC, a pioneer in using precision medicine to develop innovative therapies, today announced it has entered into an exclusive global license agreement with the Stanford University School of Medicine that will enable Denovo to develop and commercialize its lead compound, enzastaurin (DB102), in treating pulmonary arterial hypertension (PAH) and emphysema.
The agreement is based on preclinical research conducted by Edda Spiekerkoetter, M.D. and her team at Stanford.
Researchers found that DB102 could prevent and reverse experimental pulmonary hypertension progression in preclinical models. It was discovered that DB102 modulates a therapeutically promising pathway through a previously unknown drug target which is distinct from DB102’s targets for malignancies. An international patent of this discovery has been filed under PCT.
“We are now able to expand DB102 development beyond oncology and into PAH which is a significant unmet medical need,” said Wen Luo, Ph.D., Chief Executive Officer and Chief Scientific Officer of Denovo Biopharma. “This new development allows DB102 to expand into unexpected new indications through traditional drug repurposing efforts which complements Denovo’s unique precision medicine approach of rescuing drugs through biomarker identification in their original indication. We will evaluate DB102’s activity in patients with PAH in the near future.”
About Pulmonary Arterial Hypertension
Pulmonary arterial hypertension (PAH), is a life-threatening disease associated with an increased pulmonary vascular resistance and progressive elevation of pulmonary pressure leading to right heart failure and, if untreated, death. PAH is characterized by an occlusive pulmonary vasculopathy with endothelial dysfunction, neointima formation, medial hypertrophy as well as adventitial fibrosis preventing blood flow to the capillaries. These pathological changes are thought to be caused by a combination of genetic and environmental factors that trigger the onset of PAH. There is no known cure for PAH.
DB102 (enzastaurin) is an orally available investigational 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 Denovo acquired worldwide rights. DB102 received orphan drug designation in DLBCL and GBM from the FDA and EMA. After acquiring the global rights to DB102 from Eli Lilly, Denovo identified a novel, potentially predictive, genetic biomarker, DGM1 (Denovo Genomic Marker 1) for DB102 response, and is currently conducting a global Phase 3 trial evaluating the efficacy of DB102 plus R-CHOP in patients with high risk diffuse large B-cell lymphoma (DLBCL).
About Denovo Biopharma
Denovo Biopharma is a clinical stage biopharmaceutical company that applies novel biomarker approaches to precision drug development to re-evaluate medicines that have failed in broad patient populations. The company applies its expertise to archived clinical samples to discover genomic biomarkers correlated with patients’ responses to drug candidates retrospectively. Denovo then designs and executes efficient clinical trials in targeted patient populations to optimize the probability of a successful trial. Denovo is enrolling patients in the U.S. and China with diffuse large B-cell lymphoma (DLBCL) in a Phase 3 clinical trial for its lead product candidate, DB102, which was in-licensed from Eli Lilly. The company has two additional late stage programs: DB103, for schizophrenia, and DB104, for depression. For additional information please visit www.denovobiopharma.com.
Michael F. Haller, Ph.D.
Chief Financial Officer
Denovo Biopharma LLC
10240 Science Center Drive, Suite 120
San Diego, CA 92121