202430 Apr

CIRM Awards $11.8 Million Grant for Clinical Trial in High-Grade Glioma Including Glioblastoma Using DB107, a Novel DGM7™ Genetic Biomarker-Guided Gene Therapy

Summary

CIRM has awarded the grant to Dr. Noriyuki Kasahara, MD, PhD, at the University of California San Francisco (UCSF) and a group of investigators at California universities to conduct a Phase 1/2 clinical trial studying DB107 in patients with newlydiagnosed HGG.The trial, titled "A Phase I/IIa Study to Evaluate the Efficacy of DB107RRV, Administered to Subjects at Time of Resection and Intravenously Thereafter, in Combination with DB107FC and Radiation Therapy or DB107FC, Temozolomide (TMZ) and Radiation Therapy in Patients with NewlyDiagnosed HighGrade Glioma," plans to enroll up to 70 patients. In addition to DB107RRV being administered both intratumorally and intravenously to provide more exposure, this study will also use the RRV in conjunction with radiation therapy and chemotherapy with temozolomide. The 5year survival rate of patients with GBM is less than 5%.About DB107 and the DGM7 BiomarkerDB107 is an investigational combination product consisting of the DB107RRV (vocimagene amiretrorepvec) gene therapy and DB107FC (extendedrelease 5fluorocytosine) oral prodrug. DB107RRV, an innovative proprietary retroviral replicating vector (RRV), is combined with DB107FC to selectively infect and kill cancer cells while stimulating a robust and durable anticancer immune response against a tumor with minimal toxicity. DB107 has received Fast Track Designation and Breakthrough Therapy Designation from the FDA, as well as Orphan Drug Designations from the FDA and EMA.About Denovo BiopharmaDenovo Biopharma LLC (Denovo) is a clinicalstage biopharmaceutical company that uses a novel biomarker discovery platform including whole genome sequencing (WGS) and artificial intelligence (AI) to find new genetic biomarkers predictive of drug efficacy, and then uses these biomarkers to execute efficient clinical trials in targeted patient populations to increase the probability of success.

Source: Prnewswire

Funding

$11.8M
Amount
Apr 30 2024
Date
-
Investor
Denovo Biopharma
Company

Classifications

Companies