Acuitas Therapeutics, Inc.

DURHAM, N.C. & SEATTLE--( BUSINESS WIRE )--Leading epigenome editing company Tune Therapeutics (Tune) today announced the completion of over $175M in financing led by New Enterprise Associates, Yosemite, Regeneron Ventures and Hevolution Foundation. “It is deeply gratifying to have seen this platform and company evolve so far,” said Tune Co-Founder Dr. Charles Gersbach, whose research at Duke University formed the basis for Tune’s TEMPO epi-editing platform. “Tune has already achieved a global landmark in the field, in the clinical application of epi-editing to a common and chronic disease. Thanks to the support of our investors, we anticipate the development of many more new epi-editing therapies in the years to come.” The funding will accelerate the development of the company’s existing pipeline, currently anchored by Tune-401 – its clinical-stage epigenetic silencing drug for chronic Hepatitis B (HBV). It will also support the development of additional gene, cell, and regenerative therapy programs already underway at Tune, and to progress its broader mission of bringing the power and versatility of epigenetic therapies to bear on common and chronic diseases. “We are incredibly proud to see Tune progress successfully into the clinic,” said Reed Jobs, Founder and Investor at Yosemite. “The Yosemite team has been an enthusiastic backer of Tune from the beginning, as we feel that few technologies have the biological power of epigenetic medicine to transform disease outcomes for the better. The range of potential applications and indications is vast and will only continue to expand.” “To date, modern medicine and pharmacology has done much to extend our lifespans, but far less for our active healthspans,” explains William Greene, Chief Investment Officer at Hevolution Foundation. “Chronic diseases of ageing are accelerating in incidence, prevalence, and severity, and current approaches are simply inadequate. It is our belief that epigenetic editing may prove to be the transformative modality we need to enable a new era of regenerative medicine.” Since its founding in 2021, Tune has made impressive strides in the development and application of its novel and potentially transformative epigenome editing platform. At the 2023 ASGCT conference, Tune announced a global first in the field: the durable repression of a therapeutically relevant gene (PCSK9) in non-human primates using genetic tuning. This gene repression was accompanied by an enduring reduction of LDL cholesterol levels that is still ongoing almost 2 years after a single, transient delivery of the epi-silencing construct. Later that year, the company unveiled Tune-401, a first-in-class epigenetic silencer for chronic Hepatitis B, a condition that impacts over 250 million people, and is the leading cause of liver cancer worldwide. In November of 2024, Tune announced it was moving to the clinical stage, having received approval to begin clinical trials in New Zealand, and subsequently in Hong Kong – supported by world-renowned hepatologists and Principal Investigators Dr. Ed Gane and Dr. Man-Fung Yuen, respectively. With its lead program now in the clinic, Tune is leveraging this momentum to enhance its platform capabilities and develop its other gene and cell therapy programs. “With this renewed support, we are well-positioned to advance our HBV clinical program, to invest in our platform, and to expand our pipeline," said Akira Matsuno, Co-Founder, President and CFO of Tune Therapeutics. “We are grateful to all our investors for their deep confidence in our team and approach, backed by compelling data that continues to underscore the transformational potential of epi-editing as a therapeutic modality." 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 and chronic diseases. 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.

DURHAM, N.C. & SEATTLE--( BUSINESS WIRE )--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.

Preclinical data shows strong, durable, and precise repression of HBV DNA across in vitro and in vivo models, offering a possible pathway to a functional cure DURHAM, NC & SEATTLE, WA, USA I November 19, 2024 I Leading epigenome editing company Tune Therapeutics showcased new data yesterday at the American Association for the Study of Liver Diseases (AASLD) conference, in support of its drive to develop a lasting, functional cure for chronic Hepatitis B Virus (HBV). Tune unveiled its lead HBV program at the 2023 AASLD event with preclinical data showing strong and durable effect in targeted human hepatocytes. This year, Tune Therapeutics Principal Scientist Brian Cosgrove shared new in vitro and in vivo data, showcasing Tune’s clinically optimized liver-targeting LNP-RNA epi-silencing drug (Tune-401) – which enabled the near-complete repression of HBV RNA in human cells, and in a ‘true infection’ FRG mouse model. The challenge behind targeting chronic HBV infection, explained Cosgrove, is two-fold: HBV DNA integrates into the host genome, but it also exists as copies of extrachromosomal cccDNA (covalently closed circular DNA) in hepatocyte nuclei. This makes functional cure very rare with current standard-of-care treatments (less than 1-3% of patients achieve this), as no existing or pipeline therapy can effectively inactivate both integrated DNA (intDNA) and cccDNA. “Our groundbreaking approach addresses the dual challenges of HBV by targeting both integrated viral DNA and the source of viral latency – cccDNA – which current therapies do not target,” said Cosgrove. “The data we’ve gathered strengthens the case for epi-editing as a uniquely powerful treatment modality for HBV – and gives us confidence as we move into human clinical trials .” Tune-401 is a novel epigenetic silencing therapeutic that is designed to target both types of HBV DNA, in an effort to shut down viral transcription and suppress the production of new viral particles. As Cosgrove explained, the approach has achieved highly promising results in preclinical studies, including: “Tune-401 offers a unique opportunity to show the impact of epi-editing,” said Blythe Sather, Vice President, Head of Research. “Chronic Hepatitis B affects more than 250 million people worldwide – each one facing the daily reality of living with this devastating disease. I truly believe that our innovative epi-silencing approach, which targets all HBV viral reservoirs, could be the scientific advance we so sorely need – a new strategy that could meaningfully change the treatment paradigm for this disease.” 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 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. SOURCE: Tune Therapeutics