{"id":13552,"date":"2026-05-30T17:00:00","date_gmt":"2026-05-30T15:00:00","guid":{"rendered":"http:\/\/stocks-future.com\/?guid=996b94c9a1c161ced6c485b7a7198834"},"modified":"2026-05-30T17:00:00","modified_gmt":"2026-05-30T15:00:00","slug":"tune-therapeutics-presents-positive-phase-1b-2a-proof-of-concept-data-on-tune-401-a-first-in-class-epigenetic-silencer-for-patients-with-hepatitis-b-at-easl-2026","status":"publish","type":"post","link":"https:\/\/stocks-future.com\/?p=13552","title":{"rendered":"Tune Therapeutics Presents Positive Phase 1b\/2a Proof of Concept Data on TUNE-401: a First-in-Class Epigenetic Silencer for Patients with Hepatitis B at EASL 2026"},"content":{"rendered":"

\nInitial clinical data shows deep and durable antiviral activity, including direct silencing of cccDNA, offering a possible pathway to a finite cure for HBV patients<\/i><\/p>

DURHAM, N.C. & SEATTLE--(BUSINESS WIRE)--Tune Therapeutics, a leading epigenome editing company, presented new data today at the European Association for the Study of Liver (EASL) Congress in Barcelona, Spain, demonstrating the first clinical evidence of epigenetic silencing in hepatitis B virus (HBV).<\/p><\/a><\/a>

\nThe oral presentation was delivered by Dr. Ed Gane, Professor of Medicine at the University of Auckland and world-renowned authority on HBV. The phase 1b\/2a clinical trial evaluated the safety and tolerability of TUNE-401 in patients with Chronic Hepatitis B (CHB).<\/p>

\nCHB affects more than 240 million<\/a> people globally, and current therapies rarely achieve a functional cure (\u22481 per annum)<\/a>. The key barrier to cure remains the persistence of intranuclear covalently closed circular DNA (cccDNA) within liver cells that serves as the stable viral reservoir. Both current and investigational therapies have indirect mechanisms of action that do not directly silence cccDNA; therefore, when these regimens are discontinued, the virus almost universally comes back.<\/p>

\n\u201cThe development of a finite HBV cure has long been stalled by a central challenge: how to safely and specifically target and permanently silence cccDNA,\u201d said Dr. Gane<\/a>. \u201cThe TUNE-401 study provides the first clinical evidence that direct epigenetic silencing of HBV cccDNA can achieve this goal, with the potential to meaningfully improve long-term health outcomes for all patients living with chronic hepatitis B.\u201d<\/p>

\nUsing Tune\u2019s proprietary \u2018genetic tuning\u2019 platform, TEMPO, TUNE-401 is an intravenously delivered LNP-RNA epigenetic silencing therapy that is translated in the liver into an HBV-targeting protein, which potently and selectively methylates both cccDNA and integrated HBV DNA.<\/p>

\nThe ongoing study includes a single-ascending-dose cohort, which consisted of four dose-escalation levels of TUNE-401 IV infusion (SAD1=0.2 mg\/kg, SAD2=0.45 mg\/kg, SAD3=0.65 mg\/kg, SAD4=0.85 mg\/kg). The multiple-dose cohort consisted of up to three IV infusions (MD3 = 0.65 mg\/kg), administered at least four weeks apart.<\/p>

\nWhen evaluating the safety and tolerability of TUNE-401 in patients with chronic hepatitis B, researchers across the three study sites in New Zealand, Hong Kong, and Moldova observed:<\/p>

\nAnti-viral activity<\/i><\/b><\/p>