[May 01, 2024]

Anova to Manage Study of DB107 Following Newly Awarded $11.8M CIRM Grant

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 [email protected].

About Denovo's RRV Platform and DB107

DB107 is an innovative approach uilizing a proprietary gene therapy platform, recombinant retroviral vector (RRV) bearing cytosine deaminase, combined with a prodrug of 5-FU (5-FC), to selectively infect and kill cancer cells while stimulating a robust and durable anti-cancer immune response against a tumor with minimal toxicity. DB107 has been tested clinically in solid tumors including recurrent high-grade GBM and colorectal cancer, most recently in a randomized 403-patient Phase 3 trial. DB107 received Orphan Drug Designation in GBM from the FDA and EMA, and Fast Track Designation from the FDA.

About Anova

Anova Enterprises, Inc. (Anova) is technology enabled CRO committed to accelerating clinical development for start-up to mid-size biopharmaceutical companies utilizing the company's proprietary technology platform (AnovaOS™). For more information, please visit www.anovaevidence.com.

About Denovo Biopharma

Denovo Biopharma LLC (Denovo) is a clinical-stage 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. Denovo has eight late-stage drugs in its pipeline addressing major unmet medical needs in oncology and central nervous system diseases; most of the pipeline are first-in-class drugs with global rights. Denovo recently announced a major breakthrough in treatment-resistant depression (TRD) with its DGM4™ biomarker-guided DB104 drug (liafensine, a potential first-in-class triple reuptake inhibitor for TRD). The global Phase 2b clinical trial of DB104 in DGM4-positive patients with TRD demonstrated strikingly positive results, with highly significant improvements in symptoms of depression seen in DGM4-positive patients. Visit www.denovobiopharma.com for additional information.

About the California Institute for Regenerative Medicine (CIRM)

At CIRM, we never forget that we were created by the people of California to accelerate stem cell treatments to patients with unmet medical needs, and act with a sense of urgency to succeed in that mission. To meet this challenge, our team of highly trained and experienced professionals actively partners with both academia and industry in a hands-on, entrepreneurial environment to fast track the development of today's most promising stem cell technologies. With $5.5 billion in funding and more than 150 active stem cell programs in our portfolio, CIRM is one of the world's largest institutions dedicated to helping people by bringing the future of cellular medicine closer to reality. For more information, go to www.cirm.ca.gov.

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