What Tune Therapeutics does

Tune Therapeutics is a clinical-stage biotechnology company developing a proprietary epigenetic programming platform called TEMPO for the treatment of disease. Founded in December 2021, the company uses a "genetic tuning" modality to modulate gene expression by adding or removing epigenetic marks — including DNA methylation, demethylation, and histone modification — without cutting or altering DNA sequences. The modular TEMPO architecture pairs a catalytically inactive DNA-binding domain (compatible with dCas9, ZFP, or TALE scaffolds) with interchangeable effector proteins, enabling graded, tunable, and reversible control of gene activity, durable changes from a single transient delivery, and simultaneous multiplex targeting of multiple genes. The platform's lead clinical candidate, TUNE-401, is a first-in-class LNP-RNA epigenetic silencer for chronic Hepatitis B that directly methylates both cccDNA and integrated HBV DNA; it is currently in Phase 1b/2a trials in New Zealand, Hong Kong, and Moldova, with positive proof-of-concept data presented at EASL 2026 showing 100% biomarker repression at higher dose levels and durability out to 17 months from a single dose. The pipeline also includes a preclinical PCSK9 epi-repressor for cardiovascular disease and a CAR T-cell engineering program for solid tumor immuno-oncology.

The company operates a platform-plus-pipeline business model with no current product revenue, pursuing a partnership-driven go-to-market motion that targets large pharmaceutical collaborators and out-licensing opportunities. It employs 51-100 staff across Durham, NC and Seattle, WA, and uses a network of leading academic KOLs and major hepatology/gene therapy conferences (EASL, AASLD, ASGCT, HepDART) for scientific disclosure. Future revenue is expected to derive from out-licensing deals, pharma co-development arrangements, and ultimately approved therapeutic sales. Tune has raised approximately $215M in venture capital across two rounds — a $40M Series A in December 2021 co-led by NEA and Emerson Collective, and a $175M+ Series B in January 2025 co-led by NEA, Yosemite, Regeneron Ventures, and Hevolution Foundation. The company's foundational IP was licensed from Duke University, based on the research of scientific co-founders Charles Gersbach (Duke) and Fyodor Urnov (UC Berkeley/IGI), who are pioneers in the genome and epigenome editing field. The leadership team includes CEO and Chairman John McHutchison (former Gilead CSO and Assembly Biosciences CEO), CSO Derek Jantz (former Precision BioSciences CSO and co-founder), and President/CFO/COO Akira Matsuno (former CFO of Lyell Immunopharma and VP at Juno Therapeutics).

Name

Tune Therapeutics

Legal name

Tune Therapeutics, Inc.

Website

https://tunetx.com

Company type

Private

Founded year

2021

Operating status

Operating

Headcount range

51–100 employees

Short description

Tune Therapeutics is a clinical-stage biotechnology company developing TEMPO, a proprietary epigenome editing platform that modulates gene expression without cutting DNA. Its lead candidate, TUNE-401, is an LNP-RNA epigenetic silencer in Phase 1b/2a trials for chronic Hepatitis B.

Ownership category

akta.pro rank

Product category

Epigenetic Editing Therapeutics / Gene Therapy

NAICS

Scientific Research and Development Services (5417), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)

akta.pro primary industry

CRISPR & Functional Genomics Screening Platforms (pooled/arrayed screens, perturb-seq) (HLAAAIAG)

akta.pro secondary industry

mRNA Therapeutics (vaccines, protein replacement, immuno-oncology) (HLAAADAA)

Keywords

• Epigenome editing therapeutics
• Gene therapy platform
• Hepatitis B treatment
• Epigenetic gene silencing
• Cell therapy engineering

Headquarters

HQ city

Durham

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Pre-revenue clinical-stage development: Tune Therapeutics is currently a clinical-stage biotechnology company with no commercial product revenue. The company is investing venture capital into the development of TUNE-401 (HBV) and other pipeline programs, with future revenue expected from potential pharma licensing deals, partnerships, and ultimately approved therapeutic sales. Partnering inquiries are directed via [email protected].

Pricing tiers

Go-to-market motion3 records

Distribution channels2 records

Marketing channels8 records

Core offering

Tune Therapeutics develops and sells investigational epigenetic editing therapeutics built on its proprietary TEMPO platform, which modulates gene expression up or down without cutting DNA. Its lead clinical-stage candidate TUNE-401 is an LNP-RNA-delivered epigenetic silencer for chronic Hepatitis B currently in Phase 1b/2a trials, with a preclinical PCSK9 epi-repressor program for cardiovascular disease and exploratory applications in CAR-T cell engineering and regenerative medicine.

Product overview

Tune Therapeutics operates a platform-plus-pipeline architecture centered on its proprietary TEMPO genetic tuning platform. TEMPO is the core engine: a modular system that combines a catalytically dead DNA-Binding Domain (e.g., dCas9, ZFP, or TALE) with interchangeable epigenetic effector domains to activate, silence, or fine-tune genes without cutting DNA. Built on top of TEMPO are multiple therapeutic programs, most notably the lead clinical-stage candidate TUNE-401 (an LNP-RNA epigenetic silencer for chronic Hepatitis B, currently in Phase 1b/2a development) and a preclinical PCSK9 epi-repressor program for cardiovascular disease demonstrated in non-human primates. The platform is also being applied to enhance cell therapies (including CAR T cells for solid tumors) and to enable regenerative medicine applications. Together, the TEMPO platform and its derivative programs position Tune to address common, chronic, and age-related diseases that are beyond the reach of conventional gene editing.

Differentiator

Problem solved

Functional benefit

Brands

• TEMPO: Tune's proprietary 'genetic tuning' epigenome editing platform — a modular system combining a DNA-binding domain with epigenetic effector domains to activate, silence, or fine-tune gene expression without cutting DNA.

Products and services

• TEMPO Platform Tune Therapeutics' proprietary genetic tuning platform. TEMPO is a modular system with two switchable elements: a DNA-Binding Domain (DBD) that binds to a tightly-targeted region of the genome without cutting DNA, and interchangeable effectors that alter local epigenetic marks or recruit proteins to alter the packaging and accessibility of a gene. It enables graded, tunable, and reversible control over gene activity for activating, silencing, and fine-tuning the output of specific genes to reverse cellular dysfunction and disease.
• TUNE-401 First-in-class investigational epigenetic silencing therapy for the treatment of chronic Hepatitis B (HBV) infection. TUNE-401 is an intravenously delivered LNP-RNA epigenetic silencing therapy translated in the liver into an HBV-targeting protein that potently and selectively methylates both cccDNA and integrated HBV DNA. It is the first epigenetic therapy to enter clinical trials for an infectious disease and the first treatment to aim to silence both integrated HBV and HBV cccDNA at the epigenetic level without cutting or editing DNA. Lipid nanoparticle technology is licensed from Acuitas Therapeutics Inc. Currently advancing into a larger Phase 2 study expected to initiate as early as late 2026.
• PCSK9 Epi-Repressor Program A TEMPO epi-repressor targeting the PCSK9 gene, encoded into RNA and delivered to cells via lipid nanoparticle (LNP). Preclinical proof-of-concept demonstrated stable repression of PCSK9 (ongoing past four months) and ~56% reduction in LDL-cholesterol levels in non-human primates following a single treatment, with methylation patterns practically unchanged between day 7 and day 85. Repression of up to 98% with effects maintained for over 6 months in rapidly dividing liver cells. Validated epigenetic DNA methylation as the core mode of action for cardiovascular disease applications.

Quantifiable outcome

• 100% biomarker repression at higher dose levels in Phase 1b/2a HBV trial
• +5 more outcomes

Segments5 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

Feature6 records

Partnerships

Four partnerships are on record, tiered core and flagship.

• University of Hong Kong / Queen Mary Hospital (Dr. Man-Fung Yuen)coreImplementation/ SI/ Consulting Partner · 7 January 2025Professor Man-Fung Yuen (Chair Professor of The University of Hong Kong and Chief of the Division of Gastroenterology and Hepatology at Queen Mary Hospital) leads the TUNE-401 clinical trial at the Hong Kong site following Certificate for Clinical Trial approval from the Hong Kong Department of Health.
• Acuitas Therapeutics Inc.coreTechnology or Integration · 14 November 2024Acuitas Therapeutics provides the lipid nanoparticle (LNP) technology used in TUNE-401 to deliver RNA encoding the HBV-targeting epi-silencing protein to liver cells. Acuitas LNP technology is foundational to Tune's clinical HBV program.
• University of Auckland / Auckland City Hospital (Dr. Ed Gane)coreImplementation/ SI/ Consulting Partner · 14 November 2024Dr. Ed Gane (Professor of Medicine, University of Auckland; Chief Hepatologist and Deputy Director of the New Zealand Liver Transplant Unit at Auckland City Hospital) serves as Lead Investigator for the TUNE-401 Phase 1b/2a clinical trial at the Auckland, New Zealand site. Dr. Gane also presented the EASL 2026 oral data readout.
• Duke UniversityflagshipOEM/ Whitelabel/ Licensing Partner · 2 December 2021Tune Therapeutics secured foundational intellectual property from Duke University at its founding, based on decades of epigenome editing research by co-founder Charles Gersbach (John W. Strohbehn Distinguished Professor of Biomedical Engineering at Duke and Director of the Duke Center for Advanced Genomic Technologies).

Scale indicators13 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Vir Biotechnology: Clinical-stage infectious disease company with multiple HBV programs (siRNA, neutralizing antibodies, capsid inhibitors) pursuing functional cure. Comparable as a major competing player in the chronic HBV curative space.
• Arrowhead Pharmaceuticals: Clinical-stage RNA interference (RNAi) therapeutics company with a deep HBV pipeline using LNP delivery to the liver. Direct overlap with Tune's TUNE-401 in both indication (HBV) and delivery modality (LNP to hepatocytes).
• Beam Therapeutics: Clinical-stage base editing company with strong liver-directed (LNP-delivered) programs including a PCSK9 cardiovascular program that directly overlaps Tune's preclinical PCSK9 epi-repressor. Comparable delivery modality and indication overlap.
• Intellia Therapeutics: Clinical-stage in vivo CRISPR/Cas9 gene editing company co-developing with Regeneron. Tunable in vivo gene modulation via LNP delivery is highly comparable to Tune's TEMPO; co-listed with Tune on Idea Pharma's Disruptive Pioneers 2026.
• Sangamo Therapeutics: Pioneer in zinc finger protein-based gene regulation, including epigenetic approaches, with clinical-stage programs across multiple indications. Directly relevant as a foundational technology comparator (ZFP scaffolds are part of TEMPO's DBD toolkit).
• CRISPR Therapeutics: Clinical-stage Cas9-based gene editing company with broad pipeline across hemoglobinopathies, oncology and regenerative medicine. Comparable as a large, well-capitalized genetic medicine platform; NEA partner Ali Behbahani has served on both boards.

Direct peers

• Chroma Medicine: Clinical-stage epigenetic editing company developing single-dose therapies that target chromatin regulators to silence or activate genes. Directly comparable to Tune as a fellow epigenome editing platform company pursuing similar indications and partnering-led business model.
• Omega Therapeutics: Clinical-stage epigenomic programming company using engineered omega-Insulated Genomic Domains to modulate gene expression. Comparable to Tune in modality (epigenomic control of single or multiple genes) and stage (clinical-stage with platform-plus-pipeline structure).
• Verve Therapeutics: Clinical-stage cardiovascular gene editing company with lead in vivo PCSK9 program for LDL-C lowering via LNP delivery. Most direct competitor to Tune's PCSK9 epi-repressor program on both modality and indication.

Emerging players

• Epicrispr Biotechnologies: Earlier-stage company applying CRISPR-based epigenetic editing to neurological and metabolic diseases. Comparable modality (gene regulation without DNA cleavage) with narrower indication focus than Tune.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/tunetx_news
• LinkedInlinkedin.com/company/tunetx

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles17 records

Funding overview

Funding rounds2 records

Investors8 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Tune Therapeutics