The company’s leading therapeutic candidate, Tune-401, has now been approved for clinical trials in both Hong Kong and New Zealand

Leading epigenetic therapy company Tune Therapeutics announced today that it will begin a clinical trial in Hong Kong after receiving a Certificate for Clinical Trial from the Hong Kong Department of Health. This marks the second global approval to commence a Phase 1b clinical trial for Tune-401, an investigational epigenetic silencing therapy designed to treat chronic hepatitis B (CHB).

“We’re taking a fresh angle on the battle against chronic hepatitis B,” said Derek Jantz, Chief Scientific Officer at Tune Therapeutics. “Current standard-of-care treatments are rarely curative due to the virus mechanism of infection. But by employing epigenetic silencing to target both integrated viral DNA and cccDNA, we are replicating the natural processes observed in spontaneous functional cure and aiming to make that outcome the norm in HBV treatment.”

The Hong Kong trial will be led by Professor Man-Fung Yuen – world-renowned hepatologist and Chair Professor of The University of Hong Kong and the Chief of the Division of Gastroenterology and Hepatology at Queen Mary Hospital, Hong Kong. With a career spanning 30 years and over 600 published papers, Dr Yuen’s pioneering research has significantly advanced our understanding of chronic hepatitis B and liver cancer treatment in Asia and worldwide.

“Over 257 million people are still living with chronic hepatitis B, and worldwide the disease disproportionately impacts Asian and Pacific Islander populations,” explains Dr. Yuen. “While early screening and detection is still paramount, this novel epigenetic silencing approach offers new hope for clinicians, and could make a major impact in these patient groups in particular.”

According to the World Health Organization, the burden of Hepatitis infection is highest in the Western Pacific Region – including China, Japan, Cambodia, New Zealand, and Australia. With a parallel clinical trial occurring in Auckland, New Zealand, Tune is focusing on countries that would see the most immediate impact and benefit from a new HBV treatment paradigm.

Tune shared encouraging preclinical data in November 2024 demonstrating Tune-401’s ability to repress both cccDNA and integrated DNA in target cells and animal models.

About Tune Therapeutics

Armed with its powerful and innovative genetic tuning platform (TEMPO), Tune Therapeutics aims to bring gene, cell, and regenerative therapies into a new era of human medicine – expanding their range of application to common, chronic, and age-related diseases that are straining healthcare systems and limiting human healthspan on a global scale.

About Tune-401

Tune-401 is a first-in-class investigational product candidate for treating Hepatitis B (HBV) infection. Tune-401 utilizes the company’s versatile, modular TEMPO platform to epigenetically silence viral HBV intDNA and cccDNA necessary for sustained HBV infection. Lipid nanoparticle technology for Tune-401 has been provided by Acuitas Therapeutics Inc.

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