Anova to Manage Study of DB107 Following Newly Awarded $11.8M CIRM Grant
May 01 2024 - 4:32AM
Business Wire
- 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 7TH 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 (DGM7TM), 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.
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 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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version on businesswire.com: https://www.businesswire.com/news/home/20240430585754/en/
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