INDUSTRY WATCH
Tune Therapeutics in New Zealand
In November 2024 , Tune Therapeutics received clinical trial application ( CTA ) approval from the New Zealand Medicines and Medical Devices Safety Authority ( Medsafe ) to initiate a Phase 1b clinical trial for TUNE-401 .
With this approval , TUNE-401 expected to be the first epigenetic therapy to enter the clinic for the treatment of a common and infectious disease .
Tune-401 employs lipid nanoparticles ( LNPs ) to deliver RNA encoding the active , HBV-targeting construct directly to liver cells . Inside these cells , the construct is translated into an epi-silencing protein that targets both integrated HBV DNA and cccDNA episomes – free-floating loops of HBV DNA that generate new viral particles and sustain chronic infection for years on end .
Over 250 million people are currently living with chronic HBV infection , which is also the leading cause of hepatocellular carcinoma or liver cancer – accounting for around 56 % of cases worldwide . The first-in-human study will evaluate the safety , tolerability , pharmacokinetics ( PK ) and pharmacodynamics ( PD ) of TUNE-401 in adult participants with chronic HBV .
The initial clinical trial site will be in Auckland and led by Principal Investigator Dr . Ed Gane .
“ Tune-401 is designed to mimic and amplify a natural , innate immune response against HBV ,” said Jantz .
“ Despite the well-established role of epigenetics in virus control , Tune-401 is the first treatment to employ direct epigenetic silencing to inactivate a virus . We feel confident that this unique mechanism of action will deliver long-awaited benefits for HBV patients and create renewed interest and momentum in the broader field of genetic medicine .”
Clinicians assert that shutting down these cccDNA ‘ viral factories ’ is an essential prerequisite to achieving a functional cure for HBV .
Critically , Tune-401 is the first treatment to reach the clinic that aims to silence both integrated HBV and HBV cccDNA at the epigenetic level , without cutting or editing DNA . Its active , epi-silencing protein binds to DNA without cutting , adding methyl groups that repress or inactivate viral genes while leaving the human genome intact . The protein is also highly specific – targeting a DNA target sequence unique to HBV , and highly conserved among HBV genomes .
“ Hepatitis B remains a significant global health threat , with millions of people affected and in need of durable treatment solutions ,” said Dr . Ed Gane , Professor of Medicine , University of Auckland .
“ Epigenetic silencing has the potential to achieve a long sought-after goal in the community : the promise of sustained disease remission after a finite course of treatment .”
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 . 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 .
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 .
Armed with its innovative genetic tuning platform ( TEMPO ), Tune Therapeutics aims to bring gene , cell and regenerative therapies into a new era of human
Tune-401 is a first-in-class investigational product candidate for treating Hepatitis B ( HBV ) infection and 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 . p
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