12,410,418 by the U.S. Patent and Trademark Office on September 9, 2025, titled “Optimized engineered meganucleases having specificity for a recognition sequence in the Hepatitis B Virus genome.” The composition of matter claims in this U.S. patent will encompass the PBGENE-HBV ARCUS nuclease utilized in the Company’s lead in vivo gene editing program, which recognizes a highly conserved target sequence present in both HBV covalently closed circular DNA (cccDNA) and integrated HBV DNA. This U.S. patent will have an expiration date in March 2042. The Company was granted patents in Europe and Hong Kong earlier this year with similar composition of matter claims.
“As the ELIMINATE-B trial for PBGENE-HBV continues to advance, we are pleased that this newly issued U.S. patent, alongside our granted patents in Europe and Hong Kong, will significantly reinforce our intellectual property portfolio covering PBGENE-HBV, our lead product candidate aimed at transforming the treatment of chronic hepatitis B,” said Michael Amoroso, President and Chief Executive Officer at Precision BioSciences. “A key objective of the trial is the ability to safely escalate the dose. In Q3 2025, while continuing to safely administer repeat doses in Cohort 2, we initiated dosing patients in Cohort 3 in the Phase 1 ELIMINATE-B trial. This supports our therapeutic strategy of finding the right dose and schedule, defined as number of administrations and time interval between dosing, to drive complete cures for patients with chronic Hepatitis B. We remain on track to provide further data updates in 2025.”
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 Moldova, Hong Kong, and New Zealand, and imminently commencing in the U.S. 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.S. and U.K. and continue accelerating recruitment and evaluation of a genetically diverse patient population in the Phase 1 study.
About Precision BioSciences, Inc.
Precision BioSciences, Inc. is a clinical stage gene editing company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform that differs from other technologies in the way it cuts, its smaller size, and its simpler structure. Key capabilities and differentiating characteristics may enable ARCUS nucleases to drive more intended, defined therapeutic outcomes. Using ARCUS, the Company’s pipeline is comprised of in vivo gene editing candidates designed to deliver lasting cures for the broadest range of genetic and infectious diseases where no adequate treatments exist.
For more information please visit www.precisionbiosciences.com.
