Denovo Biopharma is a clinical-stage biopharmaceutical company focused on the development of biomarker-driven precision medicines. Our technology platform can be broadly applied to biomarker discovery and biomarker-guided drug development in many therapeutic areas such as oncology, neurology, metabolic, cardiology, and immunology.
Our core technology is the industry's first platform and algorithm to perform de novo genomic biomarker discovery retrospectively using archived clinical samples. This technology is especially useful for late-stage drugs that have completed clinical trials with unsatisfactory efficacy. By identifying biomarkers correlated to patients' responsiveness to drug candidates retrospectively, our technology enables new clinical trials in a targeted patient population to achieve significant efficacy and/or less adverse effects.
A novel genetic biomarker discovered for treatment of diffuse large B-cell lymphoma (DLBCL); a biomarker-guided global pivotal Phase 3 clinical trial in patients with newly-diagnosed DLBCL initiated in 2018 with topline data expected in 2022; FDA and EMA orphan drug designations
A novel genetic biomarker discovered for treatment of treatment-resistant depression (TRD) - a breakthrough pharmacogenomic biomarker in neuropsychiatric diseases; a biomarker-guided global Phase 2b clinical trial to be initiated in 2022
A novel genetic biomarker discovered for treatment of newly-diagnosed glioblastoma (GBM); a biomarker-guided global pivotal Phase 3 clinical trial initiated in 2020 on track to complete enrollment by end of 2022; FDA Fast Track designation; FDA and EMA orphan drug designations
A novel genetic biomarker discovered for treatment of recurrent high-grade glioma; biomarker-guided clinical trial(s) being planned; FDA and EMA orphan drug designations