Denovo Biopharma LLC announced the formation of a neuroscience-focused Scientific Advisory Board to support the development of its precision medicine programs, particularly its Phase 3-ready lead asset DB104 (liafensine) for treatment-resistant depression (TRD). The advisory board will be chaired by Charles B. Nemeroff, M.D., Ph.D., Chair and Professor of the Department of Psychiatry and Behavioral Sciences at Dell Medical School at The University of Texas at Austin.
Dr. Nemeroff brings extensive leadership experience, having served as president of the American College of Psychiatrists and the American College of Neuropsychopharmacology, and as past-president of the Anxiety and Depression Association of America (ADAA).
"We are extremely honored to welcome such a distinguished group of scientific leaders to join our efforts at Denovo Biopharma as we work towards addressing a major unmet need in the psychiatry field with a novel precision medicine," said Wen Luo, Ph.D., Chief Executive Officer of Denovo Biopharma. "As we prepare our lead asset, DB104, to enter a biomarker-guided Phase 3 study in TRD, we believe their guidance will be instrumental in shaping both our clinical development strategy and our regulatory path forward."
Distinguished Advisory Board Members
The advisory board includes Stephen Brannan, M.D., a neuroscience drug development expert with over 15 years of industry experience. Dr. Brannan most recently served as Chief Medical Officer at Karuna Therapeutics, where he was instrumental in developing Cobenfy for schizophrenia treatment. Karuna was subsequently acquired by Bristol Myers Squibb for $14 billion.
Throughout his career at Forum Pharmaceuticals, Takeda, Novartis, Cyberonics, and Eli Lilly, Dr. Brannan contributed to the development of multiple important central nervous system treatments including Cymbalta, Exelon Patch, Trintellix, and Vagal Nerve Stimulation for TRD.
Sanjay Mathew, M.D., also joins the board as Professor of Psychiatry and Behavioral Sciences, Director of Mood and Anxiety Disorders Program, and Vice Chair for Research at Baylor College of Medicine. Dr. Mathew currently serves as ADAA's President-Elect and Chief Medical Officer, and is recognized as a leading expert in experimental therapeutics and pathophysiology of TRD, suicide, and PTSD.
Breakthrough Precision Medicine Approach
DB104 represents a first-in-class triple reuptake inhibitor that targets transporters for serotonin, norepinephrine, and dopamine. The compound was licensed from Albany Molecular Research, Inc. (now Curia) and was previously developed by Bristol-Myers Squibb, which conducted two large Phase 2b clinical trials in non-selected TRD patient populations.
Denovo's unique approach leverages artificial intelligence and whole genome sequencing through its Denovo Genomic Marker (DGM) biomarker platform. This technology enabled the discovery of a novel genetic biomarker at the ANK3 gene, which showed strong correlation with liafensine's efficacy in the Bristol-Myers Squibb studies.
First Genetic Biomarker Validation in Psychiatry
The company's ENLIGHTEN Phase 2b study results prospectively demonstrated the use of ANK3 as a predictive biomarker for liafensine's efficacy in TRD patients, marking a first for genetic biomarkers in psychiatry. This biomarker-guided approach represents a significant advancement in precision medicine for mental health treatment.
Denovo Biopharma is a clinical-stage biopharmaceutical company that specializes in using novel biomarker approaches to execute efficient clinical trials in targeted patient subpopulations. The company maintains a pipeline of seven late-stage drugs addressing major unmet medical needs in central nervous system diseases and oncology, with most being first-in-class drugs with global rights.
