Denovo Biopharma has secured an $11.8m grant from the California Institute for Regenerative Medicine (CIRM) in the US to conduct a Phase I/IIa clinical trial of its gene therapy, DB107, to treat high-grade glioma (HGG).
DB107 will be analysed for indications, including glioblastoma (GBM), a deadly form of brain cancer.
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The trial will assess the efficacy of DB107–RRV when administered during tumour resection and intravenously thereafter. It will be combined with radiation therapy or with both temozolomide (TMZ) and radiation therapy.
It will enrol up to 70 subjects to demonstrate improvements in progression-free survival.
The trial will be managed by Anova Enterprises and carried out at UCSF, University of Southern California (USC), and University of California San Diego (UCSD).
DB107 is an investigational combination product comprising two components: DB107-RRV (vocimagene amiretrorepvec) as prodrug activator gene therapy and DB107-FC (extended-release 5-fluorocytosine [5-FC]) as an oral prodrug.
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By GlobalDataThe RRV component is administered intratumorally and intravenously to convert the orally taken 5-FC into the potent chemotherapeutic agent 5-fluorouracil (5-FU) at the tumour sites.
DB107 has been recognised by the Food and Drug Administration (FDA) with fast track and breakthrough therapy designations, along with orphan drug designations from both the FDA and European Medicines Agency (EMA).
A retrospective evaluation of a prior clinical trial in subjects with recurrent HGG indicated that DGM7-positive patients who received DB107 demonstrated improved overall survival.
Denovo Biopharma chief medical officer and chief development officer Dr Matthew Spear said: “We are thrilled to continue the clinical development of our biomarker–guided DB107 gene therapy in patients with HGG including GBM, a major unmet medical need with less than 5% of GBM patients surviving five years.
“Alongside our recent announcement of positive results in a Phase IIb clinical trial of our DGM4 biomarker–guided DB104 drug (liafensine) in treatment–resistant depression, the CIRM grant provides continued validation of Denovo’s approach to discovering new genetic biomarkers and developing biomarker–guided therapies.”
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