Strengthens the Company’s intellectual property portfolio for lead in vivo program PBGENE-HBV with U.S. patent protection into 2042
Phase 1 ELIMINATE-B trial progressing through clinical investigation with dosing of Cohort 3 initiated in Third Quarter of 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 diseases with high unmet need, today announced that it will be issued U.S. Patent No. 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.”
