Precision BioSciences to Present Gene Editing Therapy for Chronic Hepatitis B at Hep-DART 2025
Precision BioSciences, Inc. (NASDAQ:DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for high unmet need diseases, today announced that it will deliver an oral presentation at the Hep-DART 2025 meeting, to take place December 7–11, 2025, at the Hilton Hawaiian Village in Honolulu, Hawaii. The presentation will feature data from the Phase 1 ELIMINATE-B trial of PBGENE-HBV.
"We are pleased to share the latest clinical results from ELIMINATE-B with the international hepatology community at Hep-DART 2025," said Dr. Cassie Gorsuch, Chief Scientific Officer of Precision BioSciences. "Chronic hepatitis B continues to impose a significant global disease burden, and current therapies fall short of addressing the underlying cause of viral persistence. PBGENE-HBV is being developed to directly eliminate and inactivate the viral templates that drive ongoing infection with the potential to provide complete cures for patients."
Details of the presentation:
Presentation title: PBGENE-HBV, a first-in-class gene editing therapy for chronic hepatitis B, demonstrates safety and antiviral activity across three cohorts
Type of presentation: Oral presentation
Presenter: Man-Fung Yuen, MBBS, MD, PhD, DSc
Authors: Man-Fung Yuen, Alina Jucov, Edward Gane, Emily B. Harrison, Andrew Van Cott, Abhishek Chandiramani, Neil Leatherbury, John Fry, Jeff Smith, Cassandra L. Gorsuch, Stanley Frankel, Mark Sulkowski
Date and time: Tuesday, December 9th, 4:45pm HST
About PBGENE-HBV (Viral Elimination Program):
PBGENE-HBV is Precision's wholly owned in vivo gene editing program under investigation in a global first-in-human clinical trial, which is designed to potentially cure chronic hepatitis B infection. Currently, it is estimated that 300 million people worldwide are afflicted with chronic hepatitis B. PBGENE-HBV is the first and only potentially curative gene editing program to enter clinical investigation that is specifically designed to eliminate cccDNA and inactivate integrated HBV DNA. Lipid nanoparticle technology for PBGENE-HBV has been provided by Acuitas Therapeutics, Inc.
About the ELIMINATE-B Trial:
The Phase 1 ELIMINATE-B study is currently enrolling HBeAg-negative chronic hepatitis B patients at world-class sites in Hong Kong, New Zealand, United States and Moldova. The goal of the study is to define the optimal dose and number of dose administrations for safely eliminating cccDNA and inactivating integrated HBV DNA. With regulatory approval already granted, Precision expects to expand the study to clinical trial sites in the U.K. and continue accelerating recruitment and evaluation of a genetically diverse patient population in the Phase 1 study.
About Hepatitis B:
Hepatitis B is a leading cause of morbidity in the US and death globally, with no curative options currently available for patients. Despite the availability of approved antiviral therapies, an estimated 300 million people globally and 1-2 million people in the US are estimated to have chronic hepatitis B infection. An estimated 15% to 40% of patients with HBV infections may develop complications, such as cirrhosis, liver failure, or liver cancer (hepatocellular carcinoma), which account for the majority of HBV-related deaths.
Chronic hepatitis B infection is primarily driven by persistence of HBV cccDNA, which enables continued viral replication, and integration of HBV DNA into the human genome in liver cells. Current treatments for patients with chronic hepatitis B include agents that result in long-term viral suppression as indicated by reduction of circulating HBV DNA, but these therapies do not eradicate HBV cccDNA, rarely lead to functional cure, and require lifelong administration.