Anova Begins Phase 1/2a Study of DB107 for High-Grade Gliomas with First Patient Enrolled

LONDON, UK & CHICAGO, IL, USA I March 05, 2025 I Anova Enterprises, Inc., a pioneering technology-enabled clinical research organization, has initiated a significant clinical trial by enrolling its first two patients. This trial is focused on evaluating DB107 as a potential treatment for brain tumors, particularly high-grade gliomas (HGG).

The study, a Phase 1/2a clinical trial, is being conducted across multiple centers and adopts an open-label format. Its primary objective is to assess whether adding DB107 to the current standard-of-care treatments offers any clinical advantage to patients newly diagnosed with high-grade gliomas. This endeavor is backed by a grant from the California Institute for Regenerative Medicine (CIRM) aimed at furthering the development of DB107 for treating newly diagnosed cases of this aggressive cancer type.

Leading the study is Dr. Noriyuki Kasahara, Principal Investigator at the Brain Tumor Research Center at the University of California, San Francisco (UCSF). The trial is also taking place at the University of Southern California and the University of California, San Diego, and aims to enroll 70 participants over the coming months.

Dr. Nicholas Butowski, a Neuro-Oncologist and Lead Investigator at UCSF, expressed optimism about the trial, highlighting its potential to yield crucial insights into improving treatment outcomes and survival rates for newly diagnosed patients. High-grade gliomas are notoriously challenging to treat, and there have been few advancements in treatment options over the last two decades.

DB107, under development by Denovo Biopharma, represents an innovative approach in gene therapy targeting high-grade gliomas, including glioblastoma multiforme (GBM). The therapy comprises two key components: DB107-RRV and DB107-FC. DB107-RRV, or vocimagene amiretrorepvec, is a retroviral vector engineered to selectively infect and alter cancer cells. Meanwhile, DB107-FC is an extended-release formulation of 5-fluorocytosine. Once inside the tumor, 5-fluorocytosine is converted into a chemotherapeutic agent. This combination aims to destroy tumor cells and elicit a strong anti-cancer immune response while minimizing toxicity.

Chris Beardmore commented on the groundbreaking nature of this therapy, noting its potential to reduce the systemic toxicity often associated with conventional treatments. DB107's mechanism allows it to target cancer cells that are otherwise inaccessible by surgical or other interventions, potentially improving outcomes for patients with newly diagnosed brain tumors.

The trial is actively recruiting eligible participants who meet specific criteria at UCSF, USC, and UCSD. Those interested in taking part or seeking further information are encouraged to reach out to the study team.

DB107's development is part of Denovo Biopharma’s broader strategy utilizing their proprietary gene therapy platform. This approach employs a recombinant retroviral vector with cytosine deaminase and a prodrug of 5-FU (5-FC). The aim is to selectively target and destroy cancer cells while stimulating a lasting anti-cancer immune response with minimal side effects. DB107 has previously been tested in solid tumors such as recurrent high-grade GBM and colorectal cancer, including a Phase 3 trial involving 403 patients. The therapy has received Orphan Drug Designation for GBM from both the FDA and EMA, as well as Fast Track Designation from the FDA.

Anova Enterprises, Inc., through its proprietary technology platform AnovaOS™, is devoted to accelerating the clinical development process for emerging biopharmaceutical companies. Denovo Biopharma, on the other hand, is a clinical-stage biopharmaceutical firm leveraging a unique biomarker discovery platform to enhance the precision and efficacy of clinical trials. The company focuses on addressing significant unmet medical needs in oncology and central nervous system diseases.