Denovo Biopharma

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Denovo Biopharma LLC is a clinical-stage biopharmaceutical company that utilizes a novel biomarker approach to execute efficient, patient-targeted clinical trials for innovative therapies. The company has eight late-stage drug candidates in its pipeline, the majority of which are first-in-class drugs with global rights, addressing major unmet medical needs in oncology and central nervous system (CNS) diseases.

Denovo's key product offerings include DB104 (liafensine), a first-in-class triple reuptake inhibitor targeting transporters for dopamine, serotonin, and norepinephrine. In April 2024, the company announced positive results from the ENLIGHTEN Phase 2 billion clinical trial, which assessed the efficacy and safety of DB104 in patients with treatment-resistant depression (TRD). The trial met all major study endpoints, demonstrating highly significant improvements in depression symptoms compared to placebo, with over 40% improvement observed.

Another promising candidate is DB107, a late-stage gene therapy for high-grade glioma and glioblastoma, acquired from Tocagen in 2020. The company also has ongoing biomarker-guided Phase three trials for its lead asset DB102 (enzastaurin) in diffuse large B-cell lymphoma and glioblastoma. As of January 2022, over 1,700 subjects have been treated with DB104 across multiple clinical trials.

Denovo's approach involves identifying novel biomarkers that can predict a patient's response to its drug candidates, enabling precision medicine and optimizing trial success rates. For instance, the DGM4 biomarker was discovered to predict liafensine's efficacy in TRD patients, leading to the biomarker-guided ENLIGHTEN study.


Key customers and partnerships

In July 2022, Denovo entered into a Master Services Agreement with Nurosene Health Inc., a healthtech company focused on AI-based technology solutions for mental performance and wellness. Under this agreement, Nurosene's NetraMark division will aid in determining factors driving drug response and placebo response in Denovo's TRD clinical trials, leveraging its proprietary NetraAI technology.


HQ location:
10240 Science Center Dr #120 San Diego CA USA
Founded year:
2011
Employees:
11-50
IPO status:
Private
Total funding:
USD 183.6 mn
Last Funding:
USD 11.8 mn (Grant; Apr 2024)
Last valuation:
-
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