Precision BioSciences Announces Late-Breaking Poster Presentation at the European Association for Study of the Liver (EASL) Congress 2024
Precision BioSciences, Inc. announced a late-breaking poster presentation at the European Association for Study of the Liver Congress 2024, showcasing preclinical safety data for their clinical candidate PBGENE-HBV for the treatment of chronic hepatitis B. The data supports the progression of the gene editing program towards potential clinical trials and regulatory filings in 2024.
Presentation of late-breaking preclinical safety data at a prestigious congress demonstrates Precision BioSciences' commitment to advancing gene editing therapies for chronic hepatitis B.
The positive feedback received from both U.S. and international regulators indicates strong support for the PBGENE-HBV clinical candidate.
PBGENE-HBV is designed to safely eliminate cccDNA and inactivate integrated HBV DNA, potentially offering a curative gene editing program for HBV.
While the data supports the progression of the program, there is still a need for IND/CTA filing in 2024, which may pose regulatory challenges.
As the first potentially curative gene editing program for HBV, there may be heightened scrutiny and expectations regarding the clinical outcomes and efficacy of PBGENE-HBV.
Data to be presented will highlight latest preclinical safety data for PBGENE-HBV in preparation for regulatory filings in 2024
“We look forward to the opportunity to share the latest new preclinical safety data from our PBGENE-HBV clinical candidate at the EASL Congress,” said Jeff Smith, Co-Founder and Chief Research Officer at Precision BioSciences. “The late-breaking safety data to be presented at EASL, combined with our recent pre-IND feedback from both
Presentation Details:
Title: Preclinical safety data for PBGENE-HBV gene editing program supports advancement to clinical trials as a potentially curative treatment for chronic hepatitis B
Abstract Number: LB195
Presenter: Emily Harrison, Senior Scientist - Hepatitis Research Leader, Precision Biosciences
Date and Time: Wednesday, June 5, 2024, 8:30 AM – Saturday, June 8, 2024, 5:00 PM CEST
About Hepatitis B and PBGENE-HBV:
Hepatitis B is a leading cause of morbidity in the US and death globally, with no curative options currently available for patients. In 2019, despite the availability of approved antiviral therapies, an estimated 300 million people globally and more than 1 million people in the US were estimated to have chronic hepatitis B infection. An estimated
Chronic hepatitis B infection is primarily driven by persistence of HBV cccDNA and integration of HBV DNA into the human genome in liver cells, the primary source of HBsAg in late-stage disease. Current treatments for patients with HBV infection 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. PBGENE-HBV is a highly specific, novel therapeutic approach to treating patients with chronic HBV infection. It’s designed to directly eliminate cccDNA and inactivate integrated HBV DNA with high specificity, potentially leading to functional cures.
About Precision BioSciences, Inc.
Precision BioSciences, Inc. is an advanced 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 about Precision BioSciences, please visit www.precisionbiosciences.com.
The ARCUS® platform is being used to develop in vivo gene editing therapies for sophisticated gene edits, including gene insertion (inserting DNA into gene to cause expression/add function), elimination (removing a genome e.g. viral DNA or mutant mitochondrial DNA), and excision (removing a large portion of a defective gene by delivering two ARCUS nucleases in a single AAV).
View source version on businesswire.com: https://www.businesswire.com/news/home/20240501949627/en/
Investor and Media Contact:
Naresh Tanna
Vice President of Investor Relations
naresh.tanna@precisionbiosciences.com
Source: Precision BioSciences, Inc.
FAQ
What is Precision BioSciences announcing?
Precision BioSciences announced a late-breaking poster presentation at the EASL Congress 2024 for their clinical candidate PBGENE-HBV.
What is PBGENE-HBV designed to do?
PBGENE-HBV is designed to safely eliminate cccDNA and inactivate integrated HBV DNA for the treatment of chronic hepatitis B.
When will Precision BioSciences file for IND/CTA for PBGENE-HBV?
Precision BioSciences plans to file for an investigational new drug (IND) and/or clinical trial application (CTA) in 2024.
