Precision BioSciences, Inc. (Nasdaq: DTIL), an advanced gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits, including gene elimination, insertion, and excision, today announced the appointment of Mark Sulkowski, M.D. and Jordan Feld, M.D., M.P.H. to its Hepatitis Scientific Advisory Board (SAB). Dr. Sulkowski and Dr. Feld will join Raymond Schinazi, Ph.D., DSc, inaugural member of Precision’s Hepatitis SAB, to provide counsel and deepen the Company’s scientific and clinical expertise ahead of Precision’s anticipated Investigational New Drug (IND) and/or Clinical Trial Application (CTA) submission of PBGENE-HBV for the treatment of chronic hepatitis B in the second half of 2024.
“We are thrilled and privileged to welcome Dr. Sulkowski and Dr. Feld as members of our SAB as we rapidly advance the development of PBGENE-HBV towards the clinic,” said Michael Amoroso, President and Chief Executive Officer of Precision BioSciences. “Together, they bring immense expertise as investigators in hepatitis clinical trials, which will be invaluable as we expect to submit the IND and/or CTA applications for PBGENE-HBV later this year, bringing our first wholly owned ARCUS nuclease into clinical trials. We look forward to leveraging the SAB’s input to guide the development of PBGENE-HBV and the broader potential of our ARCUS platform.”
“Dr. Sulkowski and Dr. Feld are welcome additions to the SAB as Precision nears key inflection points,” said Dr. Raymond Schinazi, a pioneer of treatments for hepatitis and member of Precision’s Hepatitis Scientific Advisory Board. “Mark’s and Jordan’s contributions to the existing hepatitis B body of knowledge establishes them as leaders in the field, and we are delighted to have advisors of their caliber coming aboard.”
Precision BioSciences Hepatitis Scientific Advisory Board includes:
Mark Sulkowski, M.D. is a Professor of Medicine at the Johns Hopkins University School of Medicine and the Director of the Division of Infectious Diseases at Johns Hopkins Bayview Medical Center. He also serves as the Medical Director of the Viral Hepatitis Center in the Divisions of Infectious Diseases and Gastroenterology /Hepatology in the Department of Medicine and is the Senior Associate Dean for Clinical Trials. Dr. Sulkowski has been the principal investigator for more than 120 clinical trials related to the management of viral hepatitis B and C and has published over 300 peer reviewed articles with works in Annals of Internal Medicine, New England Journal of Medicine, JAMA, Clinical Infectious Diseases, Journal of Hepatology, and Hepatology.
Jordan Feld, M.D., M.P.H. is the Site Lead for Clinical Research at Toronto General Hospital. He is also Professor of Medicine and the R. Phelan Chair in Translational Liver Research at the University of Toronto, where he serves as Research Director in Gastroenterology with the Francis Family Liver Clinic at Toronto Western Hospital. Dr. Feld is a Hepatitis B Special Interest Group Executive of AASLD, a member of the AASLD Viral Hepatitis Elimination Task Force, the ASCO Provisional Clinical Opinion on Hepatitis B Reactivation Working Group, and the Hepatitis Steering Committee of the AIDS Clinical Trials Group Network Coordinating Center/Hepatitis Transformative Science Group. Dr. Feld is deeply involved in clinical and laboratory-focused translational research and has published extensively on prevention of viral hepatitis transmission, long-term nucleotide analogue therapy in chronic hepatitis B, and hepatitis B vaccination.
Raymond Schinazi, Ph.D., DSc is the Frances Winship Walters Professor of Pediatrics and Director of the Laboratory of Biochemical Pharmacology at Emory University and Co-Director of the HIV Cure Scientific Working Group for the NIH-sponsored Emory University Center for AIDS Research. Dr. Schinazi has authored over 550 peer-reviewed papers, seven books and holds over 100 issued US patents, which have resulted in 22 New Drug Applications. A world leader in nucleoside chemistry, Dr. Schinazi is best known for his pioneering work on HIV, HBV, and HCV drugs d4T (stavudine), 3TC (lamivudine), FTC (emtricitabine), LdT (telbivudine), and sofosbuvir (Sovaldi), which are all approved by the US FDA and the EMEA. More than 94% of HIV-infected individuals in the US on combination therapy take at least one of the drugs he invented.
About Hepatitis B and PBGENE-HBV:
Hepatitis B is a leading cause of morbidity in the US and death globally, with no curative options currently available for patients. In 2019, despite the availability of approved antiviral therapies, an estimated 300 million people globally and more than 1 million people in the US were estimated to have chronic hepatitis B infection. An estimated 15% to 40% of patients with HBV infections may develop complications, such as cirrhosis, liver failure, or liver cancer (hepatocellular carcinoma), which account for the majority of HBV-related deaths.
Chronic hepatitis B infection is primarily driven by persistence of HBV cccDNA and integration of HBV DNA into the human genome in liver cells, the primary source of HBsAg in late-stage disease. Current treatments for patients with HBV infection include agents that result in long-term viral suppression as indicated by reduction of circulating HBV DNA, but these therapies do not eradicate HBV cccDNA, rarely lead to functional cure, and require lifelong administration. PBGENE-HBV is a highly specific, novel therapeutic approach to treating patients with chronic HBV infection. It’s designed to directly eliminate cccDNA and inactivate integrated HBV DNA with high specificity, potentially leading to functional cures.
About Precision BioSciences, Inc.
Precision BioSciences, Inc. is an advanced gene editing company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform that differs from other technologies in the way it cuts, its smaller size, and its simpler structure. Key capabilities and differentiating characteristics may enable ARCUS nucleases to drive more intended, defined therapeutic outcomes. Using ARCUS, the Company’s pipeline is comprised of in vivo gene editing candidates designed to deliver lasting cures for the broadest range of genetic and infectious diseases where no adequate treatments exist. For more information about Precision BioSciences, please visit www.precisionbiosciences.com.
The ARCUS® platform is being used to develop in vivo gene editing therapies for sophisticated gene edits, including gene insertion (inserting DNA into gene to cause expression/add function), elimination (removing a genome e.g. viral DNA or mutant mitochondrial DNA), and excision (removing a large portion of a defective gene by delivering two ARCUS nucleases in a single AAV).
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, statements regarding the clinical development and expected safety, efficacy and benefit of our product candidates and gene editing approaches including editing efficiency; the design of PBGENE-HBV to directly eliminate cccDNA and inactivate integrated HBV DNA with high specificity, potentially leading to functional cures; the suitability of ARCUS nucleases for gene elimination, insertion and excision and differentiation from other gene editing approaches due to its small size, simplicity and distinctive cut; the expected timing of regulatory processes (including filings such as IND’s and CTA’s and studies for PBGENE-HBV); expectations about operational initiatives, strategies, and further development of our programs; expectations about achievement of key milestones; and anticipated timing of clinical data. In some cases, you can identify forward-looking statements by terms such as “aim,” “anticipate,” “approach,” “believe,” “contemplate,” “could,” “designed,” “estimate,” “expect,” “goal,” “intend,” “look,” “may,” “mission,” “plan,” “possible,” “potential,” “predict,” “project,” “pursue,” “should,” “strive,” “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, our ability to become profitable; our ability to procure sufficient funding to advance our programs; risks associated with our capital requirements, anticipated cash runway, requirements under our current debt instruments and effects of restrictions thereunder, including our ability to raise additional capital due to market conditions and/or our market capitalization; our operating expenses and our ability to predict what those expenses will be; our limited operating history; 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; the risk that other genome-editing technologies may provide significant advantages over our ARCUS technology; 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; public perception about genome editing technology and its applications; competition in the genome editing, biopharmaceutical, and biotechnology fields; our or our collaborators’ or other licensees’ ability to identify, develop and commercialize product candidates; pending and potential product liability lawsuits and penalties against us or our collaborators or other licensees related to our technology and our product candidates; the US and foreign regulatory landscape applicable to our and our collaborators’ or other licensees’ development of product candidates; our or our collaborators’ or other licensees’ ability to advance product candidates into, and successfully design, implement and complete, clinical trials; potential manufacturing problems associated with the development or commercialization of any of our product candidates; delays or difficulties in our and our collaborators’ and other licensees’ ability to enroll patients; changes in interim “top-line” and initial data that we announce or publish; if our product candidates do not work as intended or cause undesirable side effects; risks associated with applicable healthcare, data protection, privacy and security regulations and our compliance therewith; our or our licensees’ ability to obtain orphan drug designation or fast track designation for our product candidates or to realize the expected benefits of these designations; our or our collaborators’ or other licensees’ ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate; the rate and degree of market acceptance of any of our product candidates; our ability to effectively manage the growth of our operations; our ability to attract, retain, and motivate executives and personnel; effects of system failures and security breaches; insurance expenses and exposure to uninsured liabilities; effects of tax rules; effects of any pandemic, epidemic, or outbreak of an infectious disease; the success of our existing collaboration and other license agreements, and our ability to enter into new collaboration arrangements; our current and future relationships with and reliance on third parties including suppliers and manufacturers; our ability to obtain and maintain intellectual property protection for our technology and any of our product candidates; potential litigation relating to infringement or misappropriation of intellectual property rights; effects of natural and manmade disasters, public health emergencies and other natural catastrophic events; effects of sustained inflation, supply chain disruptions and major central bank policy actions; market and economic conditions; risks related to ownership of our common stock, including fluctuations in our stock price; our ability to meet the requirements of and maintain listing of our common stock on Nasdaq or other public stock exchanges; and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2024, as any such factors may be updated from time to time in our other filings with the 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.
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Contacts
Investor and Media Contact:
Naresh Tanna
Vice President of Investor Relations
naresh.tanna@precisionbiosciences.com
