Tune Therapeutics is a biotechnology company focused on developing therapies that modulate gene expression through epigenetic mechanisms.
By targeting the epigenome, which is the system that regulates gene activity without altering the DNA sequence, the company aims to address various diseases, including those associated with aging, by restoring proper gene function and cellular health.
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The Solution
Tune Therapeutics is advancing a pipeline of therapies centered on its proprietary TEMPO platform, which enables precise modulation of gene expression without altering the DNA sequence. This approach holds potential for treating a variety of diseases, including those associated with aging.
TUNE-401: Epigenetic Silencer for Chronic Hepatitis B
The lead candidate in Tune’s pipeline is TUNE-401, designed to treat chronic Hepatitis B virus (HBV) infection. TUNE-401 employs the TEMPO platform to epigenetically silence HBV DNA, targeting both covalently closed circular DNA (cccDNA) and integrated viral DNA within host cells. This silencing is achieved without cutting or editing the DNA, aiming for durable suppression of viral replication.
Preclinical studies have demonstrated near-complete repression of HBV RNA in human cells and in a humanized mouse model.
In November 2024, Tune received approval to initiate a Phase 1b clinical trial for TUNE-401 in New Zealand, followed by approval in Hong Kong. These trials will assess the safety and efficacy of TUNE-401 in individuals with chronic HBV infection.
Potential Applications in Anti-Aging Therapies
While TUNE-401 focuses on infectious disease, the underlying TEMPO platform has broader applications, including potential therapies for age-related conditions. By modulating gene expression patterns that change with age, TEMPO has the potential to address aspects such as cellular senescence, inflammation, and tissue degeneration. This approach may lead to therapies that not only extend lifespan but also improve healthspan, which is the period of life spent in good health.
Pipeline Expansion and Future Directions
Beyond TUNE-401, Tune Therapeutics is expanding its pipeline to include additional gene, cell, and regenerative therapy programs. The recent completion of over $175 million in Series B financing will support the development of these programs, advancing the company’s mission to apply epigenetic therapies to a wide range of diseases.
The Company
Tune Therapeutics was founded in 2021, and the company is headquartered in Durham, North Carolina, USA, with additional operations in Seattle, Washington, USA. The founding team includes Matt Kane, Akira Matsuno, and Charles Gersbach, whose research at Duke University laid the foundation for Tune’s proprietary TEMPO platform.
In terms of funding the company has successfully secured significant means to advance its research and development efforts:
- In December 2021, the company completed a Series A funding round, raising $40 million. This round included participation from investors such as New Enterprise Associates, Hatteras Venture Partners, Emerson Collective, and Mission BioCapital.
- In January 2025, Tune Therapeutics announced the completion of over $175 million in Series B financing. This round was led by New Enterprise Associates, Yosemite, Regeneron Ventures, and Hevolution Foundation. The substantial investment is intended to accelerate the development of the company’s existing pipeline, particularly Tune-401, its clinical-stage epigenetic silencing drug for chronic Hepatitis B (HBV).
Tune Therapeutics has established strategic partnerships to enhance its technological capabilities and therapeutic offerings. Notably, the company collaborates with Acuitas Therapeutics Inc., which provides lipid nanoparticle technology for Tune-401. This partnership supports the effective delivery of Tune’s epigenetic therapies.
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