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Precision BioSciences Announces New and Late-Breaking PBGENE-HBV Clinical Data from the ELIMINATE-B Study at European Association for the Study of the Liver Congress 2026
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May 27, 2026
see full press release pdf attached
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- New biopsy data demonstrate that PBGENE-HBV directly eliminated cccDNA through its primary mechanism leading to a 1-log (10-fold) reduction in cccDNA-derived transcripts -
- In the <1% of cccDNA remaining, PBGENE-HBV indels permanently inactivated viral replication by knocking out polymerase function -
- pgRNA established as the biomarker to directly reflect cccDNA elimination by PBGENE-HBV -
- New clinical data demonstrate that PGENE-HBV achieved pgRNA loss in 100% of patients with detectable pgRNA at baseline -
- PBGENE-HBV has a clear therapeutic window with a well-characterized and manageable safety profile across multiple dosing cohorts -
- Investor webcast with investigators and key opinion leaders today at 8:00 AM EDT -
DURHAM, N.C.--(BUSINESS WIRE)--May 27, 2026-- 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 high unmet need diseases, today announced the presentation of new and late-breaking clinical data from the ELIMINATE-B study evaluating PBGENE-HBV at the European Association for the Study of the Liver (EASL) Annual Congress 2026. The late-breaking data, titled 'First evidence of elimination and inactivation of cccDNA in liver biopsies collected from patients with chronic hepatitis B treated with PBGENE-HBV' was presented by Man Fung Yuen MD, Ph.D., Chair Professor of The University of Hong Kong and Li Shu Fan Medical Foundation Professor in Medicine, and the Chief of the Division of Gastroenterology and Hepatology, Queen Mary Hospital, Hong Kong.
These data represent the first ever clinical evidence for a therapeutic agent's elimination and inactivation of cccDNA in liver biopsies collected from treated patients with chronic hepatitis B. These data provide compelling evidence supporting PBGENE-HBV's primary mechanism, direct antiviral targeting and elimination of cccDNA (see Figure 1). To date, this has not been previously achievable with other commercial or development-stage modalities.
"....we now have the first data in patients supporting the ability of PBGENE-HBV to directly target and eliminate cccDNA driving viral destruction," said Michael Amoroso, President and Chief Executive Officer of Precision BioSciences. "We believe these data indicate that hepatitis B may be approaching a turning point where chronic care moves from lifelong suppression of an active virus toward a finite, biomarker-guided complete viral cure.
Liver Biopsies: Confirmation of cccDNA Elimination and Polymerase Inactivation
Liver biopsy analysis using long-read transcript sequencing, which enables distinct characterization of PBGENE-HBV's effect on cccDNA versus integrated hepatitis DNA, demonstrated a 1-log (10-fold) reduction in cccDNA transcripts through its primary mechanism, cccDNA elimination, after only two dose administrations at the 0.4 mg/kg dose (see Figure 2). These results represent the first evidence of cccDNA elimination by a direct targeting treatment modality.
Following the elimination edits, further editing of the remaining <1% of cccDNA occurred via the secondary mechanism of action, cccDNA indels. These indels permanently inactivate viral replication in the cccDNA by knocking out polymerase function. Both of these cccDNA editing outcomes result in viral destruction.
Additional biopsy evidence of cumulative PBGENE-HBV effect after repeat dose administrations was also observed, with editing reaching 80% of the remaining cccDNA after 3 administrations. These data suggest additional PBGENE-HBV administrations drive cumulative editing and a greater benefit of permanent viral eradication.
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