Denovo Biopharma Announces Breakthrough Discovery of a Novel Genetic Biomarker for DB104 (Liafensine) for Depression

- Potential First Pharmagenomic Biomarker in Neurological Diseases

 

SAN DIEGO, March 12th, 2020 -- Denovo Biopharma LLC, a pioneer in applying precision medicine to develop innovative therapies, today announced it has successfully discovered a novel genetic biomarker associated with DB104 response to treat depression using its proprietary biomarker discovery platform.  DB104 was licensed from Albany Molecular Research, Inc. (NASDAQ: AMRI) following its return from Bristol-Myers Squibb, who had conducted two phase 2b clinical trials in treatment-resistant depression with this first-in-class triple reuptake inhibitor targeting transporters for dopamine, serotonin, and norepinephrine.

 

“Biomarkers are vital in oncology drug development, and we have successfully discovered novel biomarkers for oncology drugs using our unique biomarker platform.  However, precision medicine has not made its mark in psychiatric disorders and I am pleased to announce that we have identified DGM4TM, a novel genetic biomarker, after extensive efforts and innovation by our biomarker discovery team,” said Wen Luo, Ph.D., Denovo’s Chief Executive Officer and Chief Scientific Officer. “This finding has proven that our biomarker platform can deliver repeatable success and its capability to expand to therapeutic areas outside oncology.”

 

“Psychiatric disorders, such as treatment-resistant depression, are notoriously difficult to treat, and the little success in developing innovative drugs in this area has left physicians with few novel, effective treatment options,” said Steven Leventer, Ph.D., Denovo’s clinical lead for CNS disorders. “DGM4 TM has the potential to be an excellent companion diagnostic to guide  successful development of DB104, and to open an exciting new era for personalized drugs to treat CNS disorders.”

 

About Denovo Biopharma

Denovo Biopharma is a clinical stage biopharmaceutical company that applies novel biomarker approaches to re-evaluate medicines that have failed in broad patient populations. The company seeks 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 and will start a phase 2B study in Glioblastoma (GBM) for its lead product candidate, DB102, which was in-licensed from Eli Lilly. The company has four additional late stage programs targeting major unmet needs: DB103 for schizophrenia, DB104 for depression, DB105 for Alzheimer’s Disease, and DB106 for acute myeloid leukemia (AML). For additional information please visit www.denovobiopharma.com.

 

Contact:
Michael F. Haller, Chief Business Officer
Denovo Biopharma LLC
mhaller@denovobiopharma.com