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Precision BioSciences, Inc. reports developments for a clinical-stage gene editing company using its proprietary ARCUS platform to develop in vivo therapies for diseases with high unmet need. Company news centers on PBGENE-HBV for chronic hepatitis B and PBGENE-DMD for Duchenne muscular dystrophy, including clinical-program updates, regulatory clearances and designations, scientific-meeting presentations, and data from the ELIMINATE-B and FUNCTION-DMD studies.
Recurring updates also include quarterly financial results, cash runway commentary, business priorities, and equity-compensation grants under Nasdaq inducement-award rules. Precision describes ARCUS applications across gene elimination, excision, and insertion, with program-specific disclosures tied to viral DNA, cccDNA, defective-gene removal, and AAV delivery.
Precision BioSciences (NASDAQ: DTIL) has received FDA clearance for its Investigational New Drug (IND) application for PBGENE-HBV, marking a significant milestone as the first-ever in vivo gene editing therapy cleared for clinical trials in treating chronic hepatitis B in the United States.
The company will expand its Phase 1 ELIMINATE-B study to the U.S., specifically at the Liver Center at Massachusetts General Hospital, adding to existing trial sites in Moldova, Hong Kong, and New Zealand. The trial's first cohort is currently receiving doses at 0.2 mg/kg, with plans to escalate to a higher dose level in Cohort 2.
PBGENE-HBV, developed using Precision's proprietary ARCUS® platform, aims to cure chronic hepatitis B by eliminating cccDNA and inactivating integrated HBV DNA in hepatocytes. The company plans to expand the study to the UK and will share detailed clinical data throughout 2025. The development addresses a significant medical need, as up to 2.4 million people in the U.S. live with chronic hepatitis B, with numbers remaining largely unchanged over the past 15 years despite existing treatments.
iECURE announced it will present initial data from its Phase 1/2 OTC-HOPE clinical trial for ECUR-506, an in vivo gene editing treatment for neonatal onset ornithine transcarbamylase (OTC) deficiency, at the 2025 ACMG Annual Clinical Genetics Meeting in Los Angeles.
The presentation will expand on previously reported data from January 2025, which showed that the first infant treated in the trial achieved a complete clinical response according to study protocol. Dr. Julien Baruteau from Great Ormond Street Hospital for Children, London, will present the findings on March 21, 2025.
Precision BioSciences (NASDAQ: DTIL) has announced an upcoming oral presentation of preclinical data from their PBGENE-DMD program at the 2025 Muscular Dystrophy Association Clinical & Scientific Conference. The presentation, scheduled for March 19, 2025, at 8:00 AM CT, will focus on the treatment of Duchenne muscular dystrophy (DMD) using their proprietary ARCUS® platform.
The presentation will detail how ARCUS-mediated excision of exons 45-55 leads to functional Del45-55 dystrophin and restoration of skeletal muscle function in DMD treatment. The company's ARCUS platform is being developed for various in vivo gene editing therapies, including gene elimination, insertion, and excision programs.
Precision BioSciences (NASDAQ: DTIL) announced initial results from the ELIMINATE-B Phase 1 trial of PBGENE-HBV, their novel gene editing therapy for chronic Hepatitis B. The first cohort of three patients received the lowest dose level (0.2 mg/kg) of PBGENE-HBV, which uses ARCUS-encoding mRNA in lipid nanoparticles.
Key findings include:
- The treatment was safe and well-tolerated with no Grade ≥2 treatment-related adverse events
- Two of three participants showed substantial reduction in Hepatitis B surface antigen (HBsAg)
- The trial is designed for three dose administrations per dose level
The study is currently enrolling HBeAg-negative chronic Hepatitis B patients in Moldova, Hong Kong, and New Zealand, with plans to expand to the U.S. and U.K. Precision plans to share detailed clinical data throughout 2025.
Precision BioSciences (NASDAQ: DTIL) announced key leadership changes to strengthen its in vivo gene editing programs. Cindy Atwell has been promoted to Chief Development and Business Officer, overseeing development functions including clinical, regulatory, and business development. She will supervise the PBGENE-HBV program and future in vivo initiatives.
Dr. Cassie Gorsuch has been elevated to Chief Scientific Officer, leading non-clinical development and gene therapy discovery. She will manage preclinical proof of concept and IND-enabling data for clinical studies advancement. The company's PBGENE-HBV program remains on schedule with Phase 1 clinical data expected in 2025.
Additionally, Dr. Sam Wadsworth has retired from his Director role on the company's Board.
Precision BioSciences (DTIL) announced positive clinical data from its partner iECURE's Phase 1/2 OTC-HOPE study. The first infant treated with ECUR-506, which uses Precision's ARCUS® nuclease technology, achieved a complete clinical response that was maintained from three to six months post-treatment.
The treatment was generally well-tolerated, with only asymptomatic transaminitis occurring at four weeks, which resolved within four weeks using immunosuppressive therapy. After twelve weeks, the patient no longer required ammonia scavenger medication and could increase protein intake to age-appropriate levels, with ammonia levels remaining normal.
iECURE expects to complete enrollment in 2025 and provide complete data in first half of 2026. The study is being conducted across the UK, US, Australia, and Spain. Separately, Precision's ELIMINATE-B trial for chronic hepatitis B is ongoing with Phase 1 data expected in 2025.
iECURE reported positive preliminary results from its Phase 1/2 OTC-HOPE clinical trial for ECUR-506, a gene editing therapy for ornithine transcarbamylase (OTC) deficiency. The first infant treated showed a complete clinical response at the lowest dose level, demonstrating successful removal of ammonia scavenging medicines and normalization of protein intake after three months, with results maintained through the six-month study period.
The treatment was generally well-tolerated, with only asymptomatic transaminitis occurring at four weeks, which resolved within four weeks through immunosuppressive therapy. The OTC-HOPE trial is currently enrolling patients across four regions (US, UK, Spain, and Australia), with complete data readout expected in 1H 2026. The therapy targets neonatal onset OTC deficiency, affecting over 1,000 births globally per year.
ECUR-506 utilizes two AAV vectors: an ARCUS® nuclease vector licensed from Precision BioSciences (DTIL) and a donor vector for OTC gene insertion.
Precision BioSciences (DTIL) has received Clinical Trial Application approval in Hong Kong for PBGENE-HBV, marking the first in vivo gene editing approach for chronic hepatitis B in Hong Kong and their second CTA approval in 2024. The ELIMINATE-B Phase 1 trial is actively recruiting patients in Moldova and expanding to Hong Kong.
PBGENE-HBV, utilizing the ARCUS® platform, is designed to cure chronic hepatitis B by eliminating cccDNA and inactivating integrated HBV DNA in hepatocytes. The therapy targets a viral site prevalent across all HBV genotypes, particularly relevant for Asia where over 400,000 individuals in Hong Kong live with chronic hepatitis B.
The company expects to report clinical data throughout 2025 and anticipates a U.S. investigational new drug (IND) application in 2025.
Precision BioSciences (Nasdaq: DTIL), a clinical stage gene editing company, has announced its participation in two upcoming investor conferences in November 2024. The company will take part in the JonesTrading Virtual Genetic Medicine Day on November 25 at 11:00 AM ET, participating in a panel discussion titled 'Next Generation of Gene Editing; Going Beyond "Cas"'. Additionally, Precision will present at AussieMit on November 29 at 2:50 PM AEDT, discussing 'Emerging Therapies'. The JonesTrading event webcast will be available on Precision's investor website, with replay access for approximately 30 days.
Precision BioSciences (DTIL) has presented preclinical data for PBGENE-HBV, its gene editing therapy for chronic hepatitis B, and outlined its Phase 1 ELIMINATE-B trial design. The preclinical data showed 99% viral DNA editing in non-human primates, effective hepatocyte distribution, and sustained declines in viral biomarkers. The ELIMINATE-B trial will evaluate up to 45 HBeAg-negative patients across five countries, with data expected throughout 2025. The company has received clearance to begin trials in Moldova, with additional regulatory applications pending. The therapy targets approximately 300 million people globally affected by chronic hepatitis B, addressing an unmet need in a multi-billion-dollar market where current treatments achieve functional cure in less than 3% of patients.