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DURHAM, N.C. - Precision BioSciences, Inc. (NASDAQ:DTIL), a $60 million market cap biotechnology company whose stock has gained over 33% year-to-date, announced Monday it will receive U.S. Patent No. 12,410,418 on September 9, covering its PBGENE-HBV gene editing therapy for chronic hepatitis B virus (HBV) infection. The patent, which extends protection until March 2042, follows similar patents granted earlier this year in Europe and Hong Kong.
The composition of matter patent specifically covers the ARCUS nuclease used in the company’s lead in vivo gene editing program. This nuclease targets a conserved sequence present in both HBV covalently closed circular DNA (cccDNA) and integrated HBV DNA.
"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," said Michael Amoroso, President and CEO of Precision BioSciences.
The company also reported progress in its Phase 1 ELIMINATE-B clinical trial, noting that dosing of patients in Cohort 3 began in the third quarter of 2025. The trial continues to administer repeat doses in Cohort 2 simultaneously.
PBGENE-HBV is described as the first gene editing program in clinical trials specifically designed to eliminate cccDNA and inactivate integrated HBV DNA. The therapy uses lipid nanoparticle technology provided by Acuitas Therapeutics Inc.
The ELIMINATE-B study is currently enrolling HBeAg-negative chronic hepatitis B patients at sites in Moldova, Hong Kong, and New Zealand, with U.S. sites expected to open soon. According to the press release, approximately 300 million people worldwide are affected by chronic hepatitis B.
Precision BioSciences stated it remains on track to provide additional data updates on the trial later in 2025.
This article is based on a press release statement from Precision BioSciences.
In other recent news, Precision BioSciences announced promising early results from its ELIMINATE-B clinical trial for the experimental gene editing therapy PBGENE-HBV, aimed at treating chronic hepatitis B. The therapy demonstrated substantial viral reductions and a favorable safety profile in the lowest dose cohort, with no serious adverse events reported. Additionally, the company received Orphan Drug Designation from the U.S. Food and Drug Administration for its PBGENE-DMD treatment, which targets Duchenne muscular dystrophy. This designation could offer financial incentives and potential market exclusivity for up to seven years if the treatment is approved. Precision BioSciences also updated executive contracts, specifying new severance terms for key officers, including the CEO and CFO. These recent developments highlight the company’s ongoing efforts in advancing its gene editing therapies.
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