• Anova to manage delivery of Phase 1/2a study of DB107 at UCSF, USC, UCSD and with Denovo Biopharma
• DB107 is a proprietary gene therapy platform for the treatment of patients with newly diagnosed high grade glioma
• Anova helped secure $11.8m CIRM funding, and will manage the Phase 1/2a study to explore safety and efficacy of DB107
• DB107 study is the 7^TH brain cancer program Anova is advancing this year

Anova Enterprises, Inc. (Anova), a technology enabled CRO dedicated to accelerating promising treatments, has collaborated with University of California at San Francisco (UCSF), University of California at San Diego (UCSD), the University of Southern California (USC) and Denovo Biopharma to manage a newly awarded $11.8M California Institute for Regenerative Medicine (CIRM) grant to support the development of DB107 in patients with newly diagnosed high-grade glioma.

In December of 2021, Denovo Biopharma announced discovery of a novel genetic biomarker, Denovo Genomic Marker 7 (DGM7^TM), by leveraging Tocagen’s randomized 403-patient Phase 3 study in recurrent high-grade glioma (HGG) that had didn’t achieve its primary endpoint, but that had subsets of patients who received clear benefit.  DGM7 has been shown to be associated with increased overall survival with treatment of recurrent HGG, via retrospective analysis.

Anova was approached to assist with the development of the product and was instrumental organizing leading neuro-scientists, developing the study plans, securing FDA approval, preparing the CIRM application, and securing the ultimate CIRM award.

The Phase 1/2a clinical trial is a multicenter, open-label study designed to confirm whether treatment DB107, when added to standard-of-care (SOC), provides clinical benefit to patients with newly diagnosed HGG when compared to historical performance.

“I am excited to see DB107 heading back into the clinic” said Noriyuki Kasahara, MD, PhD, Principal Investigator, Brain Tumor Research Center (BTRC) at University of California, San Francisco (UCSF).  “Outcomes in patients newly diagnosed with HGG are essentially unchanged for 40 years and confirming DB107 works in patients with the DGM7 biomarker may change outcomes in those patients for the better”

“Our partnership with Denovo Biopharma, UCSD, UCSF and USC is another example of Anova’s ability to efficiently navigate the complexities of bringing newly discovered, or even orphaned, drugs through development for early to mid-stage bio pharmaceutical companies ultimately improving access to promising new treatments for patients in need” said Chris Beardmore, CEO at Anova.

To find out more contact info.us@anovaevidence.com.

The CIRM announcement for the CLIN2-15311 award can be found here.