Precision BioSciences, Inc., an advanced gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits, including gene insertion, excision, and elimination, announced that the company has received pre-IND regulatory feedback from the U.S. Food and Drug Administration (FDA) and ex-U.S. agencies. Receipt of this regulatory feedback provides alignment and clarity on Precision’s final IND/CTA-enabling preclinical plans and clinical strategy for PBGENE-HBV prior to advancement into Phase 1 clinical studies.
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, resulting in degraded cccDNA and a reduction in HBsAg.
Read the full press release here.
Source : Precision BioSciences, Inc.
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