Durham's Tune Therapeutics raises $175M in venture capital

Tune Therapeutics, an epigenome-editing company with origins at Duke University, has raised over $175 million in financing to advance a potential treatment for chronic hepatitis B and other diseases.

The financing – among the largest ever for a North Carolina life science company – was led by New Enterprise Associates, Yosemite, Regeneron Ventures and Hevolution Foundation. 

“Thanks to the support of our investors, we anticipate the development of many more new epi-editing therapies in the years to come,” said Tune co-founder Charles Gersbach, Ph.D., whose research at Duke formed the basis for Tune’s TEMPO epi-editing platform.

The funding will accelerate Tune’s product development, anchored by Tune-401 – a clinical-stage epigenetic silencing drug for chronic hepatitis B (HBV), a viral infection of the liver that is a major global health threat.

An estimated 254 million people were living with chronic HBV in 2022, with 1.2 million new infections each year, according to the World Health Organization. That same year the disease caused more than 1.1 million deaths, mostly from cirrhosis and liver cancer.

Tune recently received regulatory approval to begin clinical trials of Tune 401 in New Zealand and Hong Kong – supported by world-renowned hepatologists and principal investigators Ed Gane, M.D., and Man-Fung Yuen, M.D., respectively. 

“We are incredibly proud to see Tune progress successfully into the clinic,” said Reed Jobs, founder and investor at Yosemite. “The Yosemite team has been an enthusiastic backer of Tune from the beginning, as we feel that few technologies have the biological power of epigenetic medicine to transform disease outcomes for the better. The range of potential applications and indications is vast and will only continue to expand.”

An epi-silencing protein

Tune-401 uses lipid nanoparticles to deliver RNA encoding an HBV-targeting “construct” directly to liver cells. Inside these cells, the construct is translated into an epi-silencing protein that targets both integrated HBV DNA and cccDNA episomes – free-floating loops of HBV DNA that generate new viral particles and sustain chronic infection for years on end. 

Clinicians assert that shutting down these cccDNA “viral factories” is essential to achieving a cure for HBV.

Tune-401 is the first treatment to reach the clinic that aims to silence both integrated HBV and HBV cccDNA at the epigenetic level, without cutting or editing DNA. Its active, epi-silencing protein binds specifically to the DNA target sequence unique to HBV.

“To date, modern medicine and pharmacology has done much to extend our lifespans, but far less for our active healthspans,” said William Greene, chief investment officer at Hevolution Foundation. “Chronic diseases of ageing are accelerating in incidence, prevalence, and severity, and current approaches are simply inadequate. It is our belief that epigenetic editing may prove to be the transformative modality we need to enable a new era of regenerative medicine.”

With its lead therapy now in the clinic and new financing in hand, Tune will begin developing other gene and cell therapy programs.

“We are well-positioned to advance our HBV clinical program, to invest in our platform, and to expand our pipeline," said Akira Matsuno, co-founder, president and chief financial officer of Tune. “We are grateful to all our investors for their deep confidence in our team and approach, backed by compelling data that continues to underscore the transformational potential of epi-editing as a therapeutic modality."

Mike Carnes, vice president of Emerging Company Development for the North Carolina Biotechnology Center, said North Carolina saw two other biotech companies receive more than $100 million in a funding round in the past 12 months. He said only two other states had more than three biotech companies achieve funding rounds exceeding $100 million in the same time period: California and Massachusetts.

Genetic tuning platform

Using its genetic tuning platform TEMPO, Tune aims to develop gene, cell and regenerative therapies for common, chronic and age-related diseases that are straining healthcare systems and limiting human healthspan.

Genetic tuning involves working with the epigenome, the chemical compounds that determine how, when and where a cell’s genes are expressed. Epigenomic changes drive the differences in cell types – such as nerve cells versus muscle cells –and the health status of cells.

“The structures and signals of the epigenome can keep a gene packed tight, inaccessible and silent or wide open, accessible and active within the cell,” the company explains on its website. “Our TEMPO genetic tuning platform works in concert with these master conductors of gene activity, allowing us to turn up the volume on genes required for healthy cells and tissues or turn down the volume on genes that cause or contribute to disease, ultimately rebalancing levels of gene expression – even in complex, multi-gene networks. Genetic tuning via the epigenome opens the door to a powerful new class of treatments for common and chronic diseases.”

Unlike genome editing, the tuning process does not generate double- or single-strand breaks in DNA and makes no permanent changes to the genome. This de-risks the precise targeting of entire gene networks, allowing Tune to simultaneously turn silenced genes on and dial over-expressed genes down, “in a practical, therapeutic context.”

Tune Therapeutics was launched in December 2021 by three co-founders: 

• Akira Matsuno, a biotech executive formerly with Juno Therapeutics and Lyell Immunopharma.
• Fyodor Urnov, professor of genetics, genomics, and development at UC Berkeley and scientific director for technology and translation at the Innovative Genomics Institute.
• Charles Gersbach, a renowned academic and genome engineer who is the John W. Strohbehn Distinguished Professor of Biomedical Engineering at Duke and director of the Duke Center for Advanced Genomic Technologies.

Tune’s TEMPO epi-editing platform was initially based on work done by Gersbach and his lab at Duke but continues to evolve with additional components developed internally or licensed from other sources, the company said.

Tune employs about 80 people. The staff is about evenly split between its Durham and Seattle sites, with a few working remotely elsewhere in the country. 

Investors in the company include two North Carolina venture capital firms: Hatteras Venture Partners and Pappas Capital, both of Durham.

Tune was profiled by NCBiotech in April 2024.