Precision BioSciences Highlights Preclinical Data and Outlines Design of First-in-Human Clinical Trial for PBGENE-HBV for Treatment of Chronic Hepatitis B
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 sophisticated gene edits, today will present preclinical data supporting the advancement of PBGENE-HBV into clinical development. The Company will also outline the design of its first-in-human study, ELIMINATE-B, in patients with chronic hepatitis B. Company management will present these updates and host panel discussions on the unmet need in chronic hepatitis B and the approach to treatment with PBGENE-HBV during a virtual event being held today, November 15, 10:00 a.m. EST / 7:00 a.m. PST before commencement of the American Association for the Study of Liver Diseases (AASLD) Meeting.
Precision BioSciences Announces Receipt of FDA Fast Track Designation for ECUR-506, iECURE’s Program for the Treatment of Neonatal Onset Ornithine Transcarbamylase (OTC) Deficiency
Precision BioSciences, Inc. (Nasdaq: DTIL), 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, elimination, and excision, today announced that its partner iECURE has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for ECUR-506. ECUR-506 is iECURE’s in vivo gene insertion program designed to treat neonatal onset Ornithine Transcarbamylase (OTC) deficiency utilizing a PCSK9-specific ARCUS nuclease, licensed from Precision, that enables insertion of a functional copy of the OTC gene.
Precision BioSciences Presents Preclinical Data Highlighting PBGENE-PMM as a Potential Therapy for Primary Mitochondrial Myopathy
Precision BioSciences, Inc. (Nasdaq: DTIL), an advanced gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits, including gene elimination, insertion, and excision, today announced a poster presentation highlighting new data for the Company’s PBGENE-PMM program, evaluating an ARCUS nuclease as a potential treatment for m.3243-associated primary mitochondrial myopathy (PMM). These data are being presented at the Mitochondrial Medicine – Therapeutic Development Annual Conference, being held from March 18-20, 2024 in Hinxton, UK.
Precision BioSciences Receives Pre-IND Feedback from US FDA for PBGENE-HBV as it Advances Towards Clinical Readiness
Precision BioSciences, Inc. (Nasdaq: DTIL), 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, today 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.
Precision BioSciences Recaps 2022 Accomplishments and Outlines 2023 Corporate Priorities and Planned Portfolio Milestones
Precision BioSciences (Nasdaq: DTIL), a clinical stage gene editing company developing ARCUS®-based ex vivo allogeneic CAR T and in vivo gene editing therapies, today reported on its significant accomplishments in 2022 and announced its corporate priorities and anticipated clinical development and research milestones for 2023.
