Durham's Tune Therapeutics To Conduct First Epigenetic Therapy Trial

By Barry Teater, NCBiotech Writer

Durham and Seattle-based Tune Therapeutics is pioneering epigenetic therapy by initiating the first human clinical trial for a common infectious disease. The New Zealand Medicines and Medical Devices Safety Authority approved TUNE-401, an investigational epigenetic silencing therapy designed to treat chronic Hepatitis B (HBV), a condition affecting over 250 million people and the leading cause of liver cancer globally.

TUNE-401 aims to mimic a natural immune response, silencing both integrated HBV DNA and cccDNA episomes—“viral factories” that sustain infection. Using lipid nanoparticles to deliver RNA encoding an epi-silencing protein, the therapy represses viral genes without altering human DNA, offering a safer alternative to traditional gene-editing methods.

The Phase 1b trial, led by Dr. Ed Gane in Auckland, will enroll 36 patients over two years to assess safety, tolerability, and effectiveness. New Zealand was chosen for its advanced HBV outreach systems and Gane’s groundbreaking contributions to HBV treatment.

Tune’s proprietary TEMPO platform underpins its work, enabling precise epigenetic modifications to regulate gene expression without altering DNA. This breakthrough approach holds promise for addressing complex diseases beyond infectious conditions, like chronic and age-related illnesses.

Founded in 2021 by biotech leaders from Duke University and UC Berkeley, Tune has attracted investments from North Carolina-based venture firms Hatteras Venture Partners and Pappas Capital. The company employs 78 staff split between Durham and Seattle, advancing its mission to expand the potential of gene, cell, and regenerative medicine.