Precision BioSciences Receives U.S. Patent Allowances Covering the PBGENE-HBV Program
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in vivo gene editingmedical
In vivo gene editing is a medical technique that changes a patient’s DNA directly inside their body, using tools that find and alter specific genes without removing cells for outside manipulation. For investors it matters because it promises one-time or long-lasting treatments for genetic diseases, creating high potential value but also carrying regulatory, safety and manufacturing risks similar to performing delicate repairs on wiring while the house is occupied.
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Meganucleases are proteins that act like highly specific molecular scissors, cutting DNA at long, unique sequences to enable precise changes to a gene. For investors, they matter because that precision can form the basis of therapeutic platforms or agricultural and industrial biotechnology products, influencing a company’s ability to develop treatments, secure patents, and manage regulatory and clinical risk — all key drivers of value and timelines.
hepatitis b virusmedical
A virus that infects the liver and can cause short-term illness, long-term liver damage, or lifelong infection; it spreads through blood and bodily fluids. For investors, hepatitis B matters because prevention and treatment create demand for vaccines, diagnostics, and medicines, and breakthroughs or regulatory decisions can change a healthcare company's sales prospects much like a new product can reshape a company's market position.
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Polypeptide linkers are short chains of protein building blocks that join two functional parts of an engineered protein, like connecting a targeting piece to a drug-carrying piece. Investors should care because these tiny connectors act like a hinge or rope that controls how the parts move, how stable the whole molecule is, and how it behaves in the body, which affects effectiveness, manufacturing ease, safety and regulatory risk.
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Composition of matter describes the specific chemical makeup and structure of a substance — essentially the “recipe” of which atoms or molecules are present and how they are arranged. For investors, it matters because that precise recipe is what patents, regulatory approvals, and product claims protect; control over a unique composition can create market exclusivity, influence manufacturing costs, and drive a company’s valuation or licensing potential.
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A nuclease is a biological molecule that cuts DNA or RNA, acting like microscopic scissors that trim, remove or join genetic material. Investors should care because nucleases are core tools in gene therapies, diagnostics and genetic engineering—areas that can drive product value, regulatory scrutiny, intellectual property stakes and manufacturing complexity; a company’s control of nuclease technology can materially affect its prospects and risks.
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A notice of allowance is an official communication from a patent office saying a patent application has passed review and the office intends to grant a patent once fees are paid. For investors, it signals that an invention or technology is likely to receive legal protection, which can strengthen a company’s market position, create barriers for competitors, and increase the potential value of products or licensing opportunities—similar to securing exclusive rights to a recipe before selling it widely.
DURHAM, N.C.--(BUSINESS WIRE)--
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 that it has received two Notices of Allowance from the U.S. Patent and Trademark Office (USPTO) for patent applications relating to the Company’s PBGENE-HBV program.
The first Notice of Allowance relates to U.S. Patent Application No. 19/347,136, titled “Engineered meganucleases having specificity for a recognition sequence in the Hepatitis B virus genome.” The ’136 application includes composition of matter claims that, when granted, will encompass the ARCUS nuclease utilized in PBGENE-HBV.
The second Notice of Allowance relates to U.S. Patent Application No. 19/273,982, titled “Polypeptide linkers for use in engineered meganucleases.” The ’982 application includes composition of matter claims that, when granted, will encompass any polypeptide—including the PBGENE-HBV ARCUS nuclease—that comprises a novel, shortened polypeptide linker developed by Precision. Future ARCUS nucleases incorporating this novel polypeptide linker will also be covered by the granted claims.
When issued, each patent arising from these applications is expected to have a standard expiration date in November 2044.
“The U.S. patents arising from these two applications represent another important step in strengthening our intellectual property estate supporting PBGENE-HBV,” said Jeff Smith, PhD, Co-Founder and Chief Research Officer of Precision BioSciences. “When issued, these patents will provide meaningful composition-of-matter protection for the PBGENE-HBV ARCUS nuclease through at least 2044 and provide additional overlapping coverage of this key program across multiple patent families.”
About PBGENE-HBV, A Hepatitis B Viral Elimination Program
PBGENE-HBV is Precision’s wholly owned in vivo gene editing program under investigation in a global first-in-human clinical trial, which is designed to be a potentially curative treatment for chronic Hepatitis B infection. In patients with chronic hepatitis B, cccDNA acts as a template to make new infectious viral particles. PBGENE-HBV is the only clinical stage program to date that targets the elimination of cccDNA, the sole source of viral replication, leading to sustained loss of HBV DNA and other downstream viral transcripts. PBGENE-HBV has been granted Fast Track designation by the FDA.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, expectations about operational initiatives, strategies, and further development of PBGENE-HBV; the design of PBGENE-HBV to be a potentially curative treatment for chronic Hepatitis B infection and to eliminate cccDNA while inactivating integrated HBV DNA; and planned ascending dose levels with multiple dose administrations per dose level in the ongoing ELIMINATE-B clinical trial. In some cases, you can identify forward-looking statements by terms such as “aim,” “anticipate,” “approach,” “belief”, “believe,” “contemplate,” “could,” “design,” “designed,” “estimate,” “expect,” “goal,” “intend,” “look,” “may,” “mission,” “plan,” “possible,” “potential,” “predict,” “project,” “pursue,” “should,” “strive,” “suggest,” “target,” “will,” “would,” or the negative thereof and similar words and expressions.
Forward-looking statements are based on management’s current expectations, beliefs, and assumptions and on information currently available to us. These statements are neither promises nor guarantees, and involve a number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various important factors, including, but not limited to, the progression and success of our programs and product candidates in which we expend our resources; our limited ability or inability to assess the safety and efficacy of our product candidates; our dependence on our ARCUS technology; the initiation, cost, timing, progress, achievement of milestones and results of research and development activities and preclinical and clinical studies, including clinical trial and investigational new drug applications; our ability to advance product candidates into, and successfully design, implement and complete, clinical trials; changes in interim “top-line” and initial data that we announce or publish; our current and future relationships with and reliance on third parties including suppliers and manufacturers; and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024 and our Quarterly Reports on Form 10-Q for the quarterly periods ended March 31, 2025, June 30, 2025, and September 30, 2025 as any such factors may be updated from time to time in our other filings with the U.S. Securities and Exchange Commission (SEC), which are accessible on the SEC’s website at www.sec.gov and the Investors page of our website under SEC Filings at investor.precisionbiosciences.com.
All forward-looking statements speak only as of the date of this press release and, except as required by applicable law, we have no obligation to update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
