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Denovo Scores $11.8M Grant

BIOPHARMA: Funding for Fatal Brain Tumor Drug Development

LA JOLLA – Drugmaker Denovo Biopharma LLC was included in a $11.8 million grant from the California Institute for Regenerative Medicine (CIRM) to further develop its therapeutic that targets brain cancers. Denovo’s drug – DB107 – is a late-stage gene therapy for high-grade glioma (a specific type of brain tumor), along with glioblastoma (deadly brain cancer).

Dr. Michael Haller, PhD
Chief Business Officer & Head of U.S. Finance
Denovo Biopharma

“CIRM’s mission is to accelerate world-class science, and they award grants that further that mission, so it clearly signals confidence that our approach is cutting edge technology and has high scientific merit, since the CIRM grant process is highly selective,” Denovo Chief Business Officer and Head of U.S. Finance Dr. Michael Haller, PhD told the Business Journal.

The award was granted to Dr. Noriyuki Kasahara, MD, PhD, at the University of California San Francisco (UCSF), along with various other investigators at other UC schools, to launch a Phase 1/2 clinical trial of the drug in brain tumor patients.

Dr. Noriyuki Kasahara, MD, PhD
University of California San Francisco

“We are excited to conduct this novel trial which will be investigating several new approaches for the first time in patients with newly–diagnosed high–grade glioma,” Dr. Kasahara shared.

Denovo acquired the DB107 drug rights in 2020 from former San Diego biopharma firm Tocagen. The science behind it uses a gene therapy platform to selectively target and penetrate tumor cells, pumping the core of the cells full of a unique enzyme that transforms a harmless compound into a cancer-fighter.

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“It is like implanting hidden bombs into the cancer cells, then later on the patient will take oral pills which will trigger the bombs to explode and only kill the tumor cells and will keep the non-tumor cells unharmed,” explained Dr. Haller. “This is quite an elegant design which can avoid the non-specific killing of normal cells that many other cancer drugs do.”

Novel Biomarkers to Predict Drug Response

The company claims its tech allows its researchers to identify novel biomarkers that can predict a person’s response to one of its drugs. It carries this out by analyzing drugs that have already been tested in an unselected population before comparing the genetic profiles of patients who benefited from the drugs to those patients who did not see any benefits.

“It requires scanning the genome of these people and analyzing millions of data points via a complex computer algorithm or AI to find one or two DNA sequence changes (biomarkers) that can dictate a person’s response to the drug,” he added.

“We then conduct another clinical trial that focuses on the patients with the biomarker. This grant will permit DB107 to be tested in patients with brain cancer who have the biomarker that we discovered.”

With its headquarters in Torrey Pines, privately held Denovo says it has raised about $180 million since it first launched in 2012. Its shareholders are made up of more than 30 healthcare venture capital and private equity firms.

There are now eight drugs in the startup’s pipeline – four that target cancer and four that target mental health disorders like depression and Alzheimer’s Disease.

This April, the company shared positive initial results from its randomized, double-blind, placebo-controlled global Phase 2b trial of its drug called DB104, aimed at combating Treatment-Resistant Depression (TRD). The study reportedly revealed highly significant improvements over the 6-week treatment period, compared to patients who were given a placebo.

Dr. Matthew Spear, MD
Chief Medical Officer & Chief Development Officer
Denovo Biopharma

“I am truly excited about these positive results in TRD, which is one of the toughest central nervous system (CNS) diseases to treat,” shared Dr. Matthew Spear, MD, Chief Medical Officer and Chief Development Officer at Denovo. “The results are remarkable as we have seen a greater than 40% improvement in depression symptoms, which is a greater magnitude than some approved drugs in current use.”

Over the next five years, Denovo says it expects to further grow and industrialize its biomarker discovery initiative and drug development process by acquiring more drugs, discovering biomarkers for them, and conducting clinical trials for validation.

“We hope to bring DB104, DB107, and more innovative medicines to the market and benefit thousands or millions of patients around the world,” added Dr. Haller.

Denovo Biopharma LLC
FOUNDED: 2012
CEO: Dr. Wen Luo, PhD
HEADQUARTERS: Torrey Pines
EMPLOYEES: 25
BUSINESS: biopharma
CAPITAL RAISED: $180M
WEBSITE: denovobiopharma.com
CONTACT: info@denovobiopharma.com
NOTABLE: Denovo currently has eight drugs in its pipeline that target cancer and mental health disorders.

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