Precision BioSciences to Showcase PBGENE-HBV Preclinical Safety Data and Phase 1 Trial Plans
Alpha InspirationMonday, Oct 28, 2024 7:10 am ET
1min readPrecision BioSciences, Inc. (DTIL) is set to host a virtual investor event on November 15, 2024, to highlight the preclinical safety data and Phase 1 clinical trial plans for its lead candidate, PBGENE-HBV. The event aims to provide investors with an in-depth understanding of the company's progress in developing a potentially curative therapy for chronic hepatitis B.
PBGENE-HBV is Precision BioSciences' wholly owned in vivo gene editing program designed to eliminate cccDNA, the key source of replicating hepatitis B virus, and inactivate integrated HBV DNA in hepatocytes. The program has shown promising results in preclinical studies, demonstrating high specificity and no detectable off-target editing in the human genome at relevant doses.
The non-human primate studies have further supported the advancement of PBGENE-HBV to clinical trials. The multi-dosing approach in non-human primates was well-tolerated, with only minor and transient elevations in liver transaminases that normalized within two weeks. Additionally, there were no adverse changes in blood parameters, indicating the safety and potential translatability of the therapy to human clinical trials.
Precision BioSciences has submitted multiple global clinical trial applications and is on track to submit additional CTA and IND filings as part of its global Phase 1 regulatory strategy for PBGENE-HBV. The company has received its first CTA approval in Moldova and is working diligently to screen and dose patients at its first clinical site. The company plans to provide updates as it receives additional regulatory approvals to begin treating patients in other markets.
The primary endpoints of the Phase 1 trial will focus on safety and tolerability, while secondary outcomes will include antiviral effects and potential functional cure rates. Precision BioSciences plans to enroll and randomize patients for the trial, with the goal of generating important clinical safety and efficacy data to bring a potentially curative treatment to the nearly 300 million patients living with chronic hepatitis B globally.
The virtual investor event on November 15, 2024, will provide investors with a comprehensive overview of the PBGENE-HBV program, including the final preclinical safety package and plans for the Phase 1 trial. The event is expected to generate excitement and confidence in the company's ability to rapidly enroll patients and generate robust clinical data in patients with chronic hepatitis B.
PBGENE-HBV is Precision BioSciences' wholly owned in vivo gene editing program designed to eliminate cccDNA, the key source of replicating hepatitis B virus, and inactivate integrated HBV DNA in hepatocytes. The program has shown promising results in preclinical studies, demonstrating high specificity and no detectable off-target editing in the human genome at relevant doses.
The non-human primate studies have further supported the advancement of PBGENE-HBV to clinical trials. The multi-dosing approach in non-human primates was well-tolerated, with only minor and transient elevations in liver transaminases that normalized within two weeks. Additionally, there were no adverse changes in blood parameters, indicating the safety and potential translatability of the therapy to human clinical trials.
Precision BioSciences has submitted multiple global clinical trial applications and is on track to submit additional CTA and IND filings as part of its global Phase 1 regulatory strategy for PBGENE-HBV. The company has received its first CTA approval in Moldova and is working diligently to screen and dose patients at its first clinical site. The company plans to provide updates as it receives additional regulatory approvals to begin treating patients in other markets.
The primary endpoints of the Phase 1 trial will focus on safety and tolerability, while secondary outcomes will include antiviral effects and potential functional cure rates. Precision BioSciences plans to enroll and randomize patients for the trial, with the goal of generating important clinical safety and efficacy data to bring a potentially curative treatment to the nearly 300 million patients living with chronic hepatitis B globally.
The virtual investor event on November 15, 2024, will provide investors with a comprehensive overview of the PBGENE-HBV program, including the final preclinical safety package and plans for the Phase 1 trial. The event is expected to generate excitement and confidence in the company's ability to rapidly enroll patients and generate robust clinical data in patients with chronic hepatitis B.
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