Anova to Manage Study of DB107 Following Newly Awarded $11.8M CIRM Grant
Summary
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 betterOur partnership with Denovo Biopharma, UCSD, UCSF and USC is another example of Anovas 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.DB107 is an innovative approach utilizing 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. 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 todays 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 worlds largest institutions dedicated to helping people by bringing the future of cellular medicine closer to reality.