Tune-401 Clinical Study: Information for Participants

Introducing a new clinical study of the first treatment of chronic Hepatitis B to incorporate epigenetic viral silencing technology

Introducing a new clinical study of the first treatment of chronic Hepatitis B to incorporate epigenetic viral silencing technology

How is CHB (chronic HepB) treated?

There are several existing treatments already available for CHB – including targeted antivirals (such as TDF/Viread®) and antibodies that can limit the activity of the virus and slow the progress of liver disease.

But none of these treatments stops the disease outright. Once you stop taking pills or injections, the virus reactivates, and disease and liver damage restart.

What is Tune-401, and how is it different?

What is Tune-401, and how is it different?

Tune-401 is an investigational treatment drug that aims to control HepB long-term, by silencing virus DNA – with no cutting or gene-editing required.

The Hepatitis B Virus hijacks the cell machinery inside liver cells to make copies of itself and continually re-infect the liver.

But HepB cannot copy itself if essential parts of its DNA are silenced, and its copying machinery is switched off.

The human body has a natural ‘silencing’ system to combat viruses like HepB that turns off the copying machinery by attaching these marks or tags to the DNA that effectively switch off viral genes.

Unfortunately, the HepB virus has evolved to avoid this system, so less than 5% of HepB patients achieve full control or functional cure in this way.¹

Viral Silencing mimics this natural system, binding to HepB DNA and attaching tags that aim to suppress or switch off HepB’s copying machinery, and keep it switched off long-term.

¹ Tseng TC, Liu CJ, Yang HC, et al. Hepatology. 2012;55:68–76

Tune-401 is an investigational treatment drug that aims to control HepB long-term, by silencing virus DNA – with no cutting or gene-editing required.

The Hepatitis B Virus hijacks the cell machinery inside liver cells to make copies of itself and continually re-infect the liver.

But HepB cannot copy itself if essential parts of its DNA are silenced, and its copying machinery is switched off.

The human body has a natural ‘silencing’ system to combat viruses like HepB that turns off the copying machinery by attaching these marks or tags to the DNA that effectively switch off viral genes.

Unfortunately, the HepB virus has evolved to avoid this system, so less than 5% of HepB patients achieve full control or functional cure in this way.¹

Viral Silencing mimics this natural system, binding to HepB DNA and attaching tags that aim to suppress or switch off HepB’s copying machinery, and keep it switched off long-term.

¹ Tseng TC, Liu CJ, Yang HC, et al. Hepatology. 2012;55:68–76

Tune-401 Viral Silencers are delivered to the liver in the form of coded RNA molecules wrapped in a fatty shell made of Lipid Nanoparticles (LNP). It is structured much like the COVID-19 vaccine, but is delivered via intravenous drip, rather than an injection.

Once inside the body, liver cells unpack the RNA and use it like a blueprint to build specially-designed proteins that bind to HepB virus DNA and silence it, throughout the liver. In contrast to some other gene therapy approaches, DNA is neither cut nor edited in the process.

In preclinical (animal) testing, a single dose of Tune-401 was shown to effectively silence viral DNA in every liver cell that received it. This data suggests that – if successful in humans – Epigenetic Silencing has the potential to become an effective, long-lasting, treatment approach for chronic HepB.

Tune-401 Viral Silencers are delivered to the liver in the form of coded RNA molecules wrapped in a fatty shell made of Lipid Nanoparticles (LNP). It is structured much like the COVID-19 vaccine, but is delivered via intravenous drip, rather than an injection.

Once inside the body, liver cells unpack the RNA and use it like a blueprint to build specially-designed proteins that bind to HepB virus DNA and silence it, throughout the liver. In contrast to some other gene therapy approaches, DNA is neither cut nor edited in the process.

In preclinical (animal) testing, a single dose of Tune-401 was shown to effectively silence viral DNA in every liver cell that received it. This data suggests that – if successful in humans – Epigenetic Silencing has the potential to become an effective, long-lasting, treatment approach for chronic HepB.

What are the risks and benefits?

Tune-401 is an investigational drug that has not yet been approved for the treatment of chronic HepB. Since no clinical data are currently available, its precise effects and side effects are not yet known.

Tune-401 has the theoretical potential to achieve lasting control of HepB infection following a single, one-time treatment. But for some patients it may not last, or may work less well.

Using Lipid Nanoparticles (LNPs) to deliver drugs like Tune-401 can create liver toxicity and immune/allergic reactions in some patients. Although typically mild and short-lived, symptoms may range from headache and nausea to acute allergic reactions.

For this reason, every individual in this small-group study will be carefully monitored throughout the trial, and treated for adverse reactions and effects.

How can I find out more?

How can I find out more?

For more information on participation – including study start date, duration, and eligibility criteria – please contact:

Stanley Yune - Study Coordinator
New Zealand Clinical Research

3 Ferncroft Street, Grafton, Auckland, New Zealand
+64 9 3733474 

rhythm.auckland@nzcr.co.nz

For more information on participation – including study start date, duration, and eligibility criteria – please contact:

Stanley Yune - Study Coordinator
New Zealand Clinical Research

3 Ferncroft Street, Grafton, Auckland, New Zealand
+64 9 3733474 

rhythm.auckland@nzcr.co.nz

Information provided by

Information provided by

A new clinical study for the first treatment for chronic Hepatitis B to incorporate Epigenetic Silencing technology.

This clinical study is being funded by Tune Therapeutics, Inc. The study has been approved by the Southern Health and Disability Ethics Committee, reference no. 2024 FULL 20736.

A new clinical study for the first treatment for chronic Hepatitis B to incorporate Epigenetic Silencing technology.

This clinical study is being funded by Tune Therapeutics, Inc. The study has been approved by the Southern Health and Disability Ethics Committee, reference no. 2024 FULL 20736.