DURHAM, N.C. - Precision BioSciences, Inc. (NASDAQ:DTIL), a gene editing company, has announced the initiation of a Phase 1 clinical trial for PBGENE-HBV, marking the first in vivo gene editing therapy for chronic hepatitis B to enter global clinical trials. The Clinical Trial Application (CTA) has been approved in Moldova, with additional applications pending in other regions.
PBGENE-HBV aims to cure chronic hepatitis B by targeting and eliminating cccDNA, the key source of replicating hepatitis B virus (HBV), and inactivating integrated HBV DNA in liver cells. This approach has the potential to provide a functional cure for the disease, which current treatments fail to achieve.
The ARCUS platform, which underpins PBGENE-HBV, is designed to deliver precise gene edits through a compact and simple structure. This novel therapy involves delivering an ARCUS nuclease-encoding mRNA to the liver via lipid nanoparticles, which then specifically cuts the hepatitis B viral genome in infected hepatocytes.
Michael Amoroso, Chief Executive Officer of Precision BioSciences, emphasized the company's commitment to advancing the clinical program rapidly by screening and dosing patients in Moldova. He also highlighted the pursuit of additional regulatory approvals to accelerate the trial's enrollment and generate clinical data.
Dr. Murray Abramson, Senior Vice President and Head of Clinical Development, noted Moldova's high prevalence of chronic hepatitis B and expressed confidence in the clinical team's ability to advance this novel treatment. The company plans to share further details on the safety data and Phase 1 trial plans at an investor event before the AASLD Annual Meeting in November.
According to the press release, chronic hepatitis B is a significant global health issue, with an estimated 300 million people living with the infection worldwide. Current treatments offer only a small chance of a functional cure and typically require lifelong administration.
Precision BioSciences will continue to submit additional CTA and IND filings as part of its global regulatory strategy for PBGENE-HBV. The company will provide updates as it receives further regulatory approvals to begin treating patients in additional markets.
This news is based on a press release statement from Precision BioSciences, Inc.
In other recent news, Precision BioSciences has made significant strides in gene editing technology. The company has submitted Clinical Trial Applications to initiate a Phase 1 study for PBGENE-HBV, a potential cure for chronic hepatitis B. This step is crucial as Precision BioSciences aims to tackle a global health issue affecting an estimated 300 million people, according to the World Health Organization.
The company has also reshuffled its clinical leadership team with Dr. Murray Abramson appointed as Senior Vice President, Head of Clinical Development, and John Fry named as Strategic Clinical Advisor. This move is part of their strategic efforts to advance gene editing therapies. Moreover, Precision BioSciences has received a $13 million convertible note payment from Imugene Limited, further bolstering its financial resources.
In addition to these developments, Precision BioSciences is set to share final clinical candidate safety data and details of the Phase 1 trial in November. The company also recently completed a private stock sale to its senior leadership team, raising $300,000 to fund ongoing research and development efforts. Lastly, Precision BioSciences' collaborator, iECURE, received FDA Fast Track designation for its gene therapy candidate ECUR-506, further advancing the company's gene editing therapies.
InvestingPro Insights
As Precision BioSciences (NASDAQ:DTIL) embarks on this groundbreaking Phase 1 clinical trial for PBGENE-HBV, investors may find additional context from InvestingPro's real-time data and tips particularly illuminating.
According to InvestingPro data, Precision BioSciences boasts a market capitalization of $61.85 million, reflecting its position as a smaller player in the biotech space. This relatively modest valuation could present an opportunity for investors if PBGENE-HBV proves successful in clinical trials.
Notably, the company's revenue growth has been impressive, with a 152.15% increase in quarterly revenue as of Q2 2024. This substantial growth aligns with the company's innovative approach to gene editing and its potential to address significant unmet medical needs like chronic hepatitis B.
However, it's important to note that Precision BioSciences is currently operating at a loss, with an adjusted operating income of -$7.29 million over the last twelve months. This is not uncommon for biotech companies in the clinical development stage, as they often prioritize research and development over immediate profitability.
InvestingPro Tips provide additional insights that may be relevant to potential investors. One tip indicates that the company "holds more cash than debt on its balance sheet," which could be crucial for funding ongoing clinical trials and research. Another tip suggests that the stock is "trading near its 52-week low," potentially presenting a buying opportunity for those confident in the company's long-term prospects.
These insights are just a sample of the valuable information available through InvestingPro. In fact, there are 8 additional tips listed for Precision BioSciences on the platform, offering a more comprehensive view of the company's financial health and market position.
As Precision BioSciences advances its innovative gene editing therapy, these financial metrics and expert insights can help investors make more informed decisions about the company's potential in the evolving biotech landscape.
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