- Murray Abramson, MD, MPH appointed as Senior
Vice President, Head of Clinical Development-
- John Fry appointed as Strategic Clinical
Advisor, Hepatitis -
- Alan List, MD, Chief Medical Officer to
Retire and Assume Role as Clinical Consultant as part of
Precision’s Scientific Advisory Board -
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, gene insertion, and gene
excision, today announced changes within the Company’s clinical
leadership team strengthening its infectious disease and hepatitis
capabilities as it prepares to initiate development of its first in
vivo gene editing candidate for hepatitis.
Murray Abramson, MD, MPH has been appointed Senior Vice
President, Head of Clinical Development and will oversee all
clinical, safety, and medical affairs activities including clinical
and operational strategy for our lead PBGENE-HBV program, as well
as for the Company’s PBGENE-PMM program as it approaches
Investigational New Drug (IND) and/or Clinical Trial Application
(CTA) filings. Dr. Abramson is an infectious diseases and drug
development expert who was most recently the Senior Vice President,
clinical innovation at Tempus A.I. following his nine years as Vice
President of Global Clinical Operations at Biogen. Dr. Abramson
also spent over twelve years at Merck in medical and medical
research operations roles. Prior to joining Merck, Dr. Abramson was
a full-time faculty member at Duke University School of Medicine
and Director, Infectious Diseases Clinical Research at Duke
Clinical Research Institute. Dr. Abramson received his Medical
Degree at Duke University Medical Center and his Masters of Public
Health degree in Epidemiology from the University of North Carolina
at Chapel Hill.
In addition, John Fry has been appointed as a Strategic Clinical
Advisor, specializing in hepatitis, and is supporting the clinical
development strategy for PBGENE-HBV leveraging his multi-decade
experience in early phase clinical research in the antiviral field,
including multiple first-in-human studies evaluating novel
therapies for chronic hepatitis B. Most recently, John was the
Executive Vice President of Aligos Therapeutics following senior
roles at Alios BioPharma, part of Janssen Pharmaceuticals,
including serving as the Head of Early Development for Infectious
Diseases. During his career, John also served in clinical research
roles at PDL BioPharma, Gilead, Abbott Laboratories and
Wellcome.
“I’m delighted to welcome Murray Abramson to the Precision team,
strengthening our core clinical capabilities and deepening our
expertise in virology,” said Michael Amoroso, Chief Executive
Officer of Precision Biosciences. “His extensive knowledge and
experience combined with our recently announced hepatitis
scientific advisory board, will play an essential role in setting
us up for global clinical success as we prepare to advance our
first wholly owned program, PBGENE-HBV, in hepatitis B through
clinic with anticipated Phase 1 data milestones in 2025.”
“We are also fortunate that John Fry is providing instrumental
advice and counsel to the PBGENE-HBV program built on many years of
successfully executing clinical trials, including early-stage
hepatitis B clinical trials,” added Mr. Amoroso. “As a near
clinical stage company with the mission of delivering lasting cures
in high impact diseases where no adequate treatments exist, we look
forward to leveraging Murray’s and John’s passion and experience
developing novel therapies for patients with infectious
diseases.”
In addition to these changes, Alan List, MD, Chief Medical
Officer communicated his intention to retire from Precision
effective September 13, 2024, following the one-year anniversary of
the divestment of azer-cel for oncology along with the Company’s
allogeneic CAR T infrastructure. Dr. List will assume a strategic
advisory role as a clinical consultant to the company and directly
support the CEO. In this capacity, Dr. List will provide ongoing
platform advice and support to Precision BioSciences, while also
providing continuity to ongoing clinical strategy and operations
through Precision’s scientific advisory board.
“I would like to thank Dr. List for his contributions to
Precision BioSciences. He was instrumental in leading the ex vivo
cell therapy hematology and oncology programs and building our
clinical capabilities to execute the PBGENE-HBV clinical study
which is planned for later this year,” added Mr. Amoroso. “Alan is
a world class hematologist oncologist and alongside his many
clinical accomplishments, his work at Precision BioSciences
resulted in multiple CAR T partnerships which may potentially
benefit patients with cancer and autoimmune disease as these
programs advance through clinical studies. Alan has been a trusted
thought partner, and I will miss his steady presence on the
leadership team. We look forward to continuing our work with Alan
as a strategic advisor as we continue to advance our programs
forward as an in vivo gene editing company.”
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 June 30, 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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version on businesswire.com: https://www.businesswire.com/news/home/20240912727351/en/
Investor Contact: Naresh Tanna Vice President, Investor
Relations Naresh.Tanna@precisionbiosciences.com
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