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FDA Clears Phase II Trial of Denovo Biopharma Gene Therapy in Glioma Patients

NEW YORK – Anova Enterprises on Tuesday said the US Food and Drug Administration has authorized a Phase II trial of Denovo Biopharma's gene therapy candidate DB107 in patients with high-grade glioma characterized by a newly discovered, undisclosed pharmacogenomic predictor.

San Diego-headquartered Denovo discovered the undisclosed biomarker through a retrospective analysis of a failed Phase III trial of the gene therapy Toca 511 plus the oral prodrug 5-fluorocytosine, called Toca FC, in recurrent high-grade glioma. In 2020, Denovo acquired Toca 511 and Toca FC from then-sponsor Tocagen and combined them into DB107. The gene therapy component delivers the enzyme cytosine deaminase to cancer cells, where it converts the 5-fluorocytosine prodrug into its active form.

While in the original Phase III trial Toca 511 plus Toca FC did not improve patients' overall survival compared to standard-of-care treatment, Denovo's analysis showed that a subset of patients with a biomarker, dubbed Denovo Genomic Marker 7 (DGM7), lived longer on the combination regimen versus those in the comparator arm.

Anova, an Arlington Heights, Illinois-headquartered organization that conducts clinical research in partnership with drugmakers, will manage the DB107 trial using its AnovaOS collaborative "learning system" technology. In the study, researchers aim to determine the efficacy of DB107 in about 70 newly diagnosed high-grade glioma patients with the DGM7 biomarker who will receive multiple doses of the treatment in addition to standard-of-care therapy. Researchers will compare patients' progression-free survival on treatment to historical controls.

"We regularly see patients responding to treatments in studies that fail in large, randomized patient populations," Anova President Martin Walsh said in a statement. "Identifying predictive biomarkers such as DGM7 and confirming results in smaller, targeted patient populations is the way toward better and more cost-effective treatments."

Denovo has several other studies underway in which it is hoping to rescue failed drugs, such as the depression drug liafensine and the oncology therapy enzastaurin, using a biomarker strategy.