- Anova is managing the 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 to explore safety and efficacy of DB107
- The first patient has enrolled following activation of UCSF, USC and UCSD in the study.
LONDON & CHICAGO--(BUSINESS WIRE)--#anova--Anova Enterprises, Inc. (Anova), a technology-enabled CRO dedicated to accelerating promising treatments, has announced enrollment of the first two patients in the highly anticipated study of DB107 for the treatment of brain tumors. 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 high-grade gliomas (HGG) when compared to historical performance.
The study is funded with a California Institute for Regenerative Medicine (CIRM) grant to advance the development of DB107 in patients with newly diagnosed high-grade glioma. Led by Noriyuki Kasahara, MD, PhD, Principal Investigator, Brain Tumor Research Center (BTRC) at University of California, San Francisco (UCSF), the study is also enrolling at the University of Southern California (USC) and the University of California at San Diego UCSD, and will enroll 70 participants over the coming months.
“Enrolling our first patients is an important milestone in our mission to advance treatment options for patients with high- grade glioma,” said Nicholas Butowski, MD, Neuro-Oncologist and Lead Investigator at UCSF. “We are optimistic this trial will provide valuable insights into how we can better treat patients and improve survival in newly diagnosed patients.”
High- grade gliomas remain one of the most challenging cancers to treat, with limited treatment options and a high degree of complexity. Treatment for the disease has not changed in 20 years. DB107 is an investigational gene therapy being developed by Denovo Biopharma for the treatment of HGG, including glioblastoma multiforme (GBM). It comprises two components: DB107-RRV (vocimagene amiretrorepvec), a retroviral replicating vector designed to selectively infect and change cancer cells, and DB107-FC, an extended-release oral formulation of 5-fluorocytosine (5-FC), which is converted into a chemotherapeutic agent within the tumor. This combination aims to eradicate tumor cells while stimulating a robust and durable anti-cancer immune response with minimal toxicity.
Chris Beardmore said, “This is revolutionary science where the treatment infects cancer cells and genetically changes them to make chemotherapy inside of the infected cells. This is known to reduce systemic toxicity commonly seen with systemic treatments. It also has a chance to infect cells that cannot be removed by surgery and other interventions to improve outcomes in newly diagnosed brain tumor patients.”
The clinical trial is currently recruiting eligible patients who meet the study criteria at UCSF, USC and UCSD. Individuals interested in participating or learning more about the trial can contact the study team at info.us@anovaevidence.com.
To find out more, contact info.us@anovaevidence.com.
About Denovo’s RRV Platform and DB107
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. 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 concierge research organization committed to accelerating clinical development for start-up 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)
The California Institute for Regenerative Medicine (CIRM) is a funding agency established by Californians to accelerate regenerative medicine research to deliver treatments for patients with unmet medical needs. Established in 2004 through the passage of Proposition 71, CIRM was initially funded with $3 billion from the state of California to support ongoing research, and in 2020, was funded again with another $5.5 billion through Proposition 14 to continue the Agency’s important work. CIRM has provided billions in funding to support stem cell, genetic research, and development programs in its portfolio. Through the Agency’s research, infrastructure, and education programs, CIRM aims to transform the field of regenerative medicine, stimulate economic growth, and improve the lives of diverse communities throughout the state. For more information go to cirm.ca.gov.
Contacts
Chris Beardmore, Co-Founder and CEO
chris@anovaevidence.com
Martin Walsh, Co-Founder and President
Anova Enterprises, Inc.
martin@anovaevidence.com
www.anovaevidence.com
Twitter feed at @anovaevidence
Follow Anova at www.linkedin.com/company/anovaevidence
Michael F. Haller, Chief Business Officer
Denovo Biopharma LLC
mhaller@denovobiopharma.com
Anova Enterprises, Inc.
One Arlington Executive Center
3400 West Stonegate Boulevard, Suite 101,
Arlington Heights, IL60005
(224) 218-2408
info.us@anovaevidence.com
