Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage
gene editing company developing ARCUS®-based in vivo gene editing
and ex vivo allogeneic CAR T therapies, today announced that it has
received final meeting minutes from its recent Type B End of Phase
1 meeting with the U.S. Food and Drug Administration (FDA) for its
lead investigational allogeneic CAR T therapy azercabtagene
zapreleucel (azer-cel).
“The objective of our meeting with the FDA was to gain further
clarity on the potential registration path for azer‑cel including
study design, endpoints and the recommended phase 2 dose for the
CAR T relapsed patient setting – a patient population with dire
need for better therapeutic options,” said Alan List, MD, Chief
Medical Officer at Precision BioSciences. “We were able to
accomplish the meeting objective and are appreciative of the FDA’s
clear and thoughtful advice.”
The meeting with the FDA provided clarity and direction on
azer-cel development, including a potential pathway toward
registration. Based on the advice received from the FDA and
clinical data shared during the May 2023 CAR T update, Precision is
currently advancing discussions with multiple potential strategic
partners for its cell therapy assets, including hematologic and
non-hematologic applications.
“The ongoing collaborative discussions are intended to help us
meet two key objectives: securing the right partner to build on our
clinical-stage CAR T assets and allowing us to focus on core
capabilities of in vivo gene editing,” said Michael Amoroso, Chief
Executive Officer at Precision BioSciences. “We look forward to
providing additional updates on our cell therapy strategic
partnering initiatives as they develop.”
In Vivo R&D Day to be Held on September 12, 2023
Precision will host its in vivo gene editing R&D Day on
September 12, 2023. This presentation will be focused on providing
an update on ARCUS in vivo gene editing candidates and the broad
potential and versatility of the platform. Additionally, this
timing will allow strategic partnering discussions around the ex
vivo allogeneic cell therapies to mature and enable full investor
attention on our in vivo gene editing pipeline.
About Precision BioSciences, Inc.
Precision BioSciences, Inc. is a clinical stage biotechnology
company dedicated to improving life (DTIL) with its novel and
proprietary ARCUS® genome editing platform. ARCUS is a highly
precise and versatile genome editing platform that was designed
with therapeutic safety, delivery, and control in mind. Using
ARCUS, the Company’s pipeline consists of several in vivo gene
editing candidates designed to cure genetic and infectious diseases
where no adequate treatments exist and multiple ex vivo clinical
candidates. For more information about Precision BioSciences,
please visit www.precisionbiosciences.com.
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, expected efficacy,
and benefit of our product candidates, including our ability to
progress azer-cel and other product candidates towards potential
registration, the expected timing of updates regarding our
allogeneic CAR T and in vivo programs, expectations about our
operational initiatives and business strategy, expectations around
partnership opportunities, and the timing of our in vivo gene
editing R&D Day. In some cases, you can identify
forward-looking statements by terms such as “aim,” “anticipate,”
“approach,” “believe,” “contemplate,” “could,” “estimate,”
“expect,” “goal,” “intend,” “look,” “may,” “mission,” “plan,”
“possible,” “potential,” “predict,” “project,” “pursue,” “should,”
“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, but involve 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 and requirements under our current debt
instruments and effects of restrictions thereunder; risks
associated with raising additional capital; our operating expenses
and our ability to predict what those expenses will be; our limited
operating history; the 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; public
perception about genome editing technology and its applications;
competition in the genome editing, biopharmaceutical, and
biotechnology fields; our or our collaborators’ ability to
identify, develop and commercialize product candidates; pending and
potential product liability lawsuits and penalties against us or
our collaborators related to our technology and our product
candidates; the U.S. and foreign regulatory landscape applicable to
our and our collaborators’ development of product candidates; our
or our collaborators’ ability to advance product candidates into,
and successfully design, implement and complete, clinical or field
trials; potential manufacturing problems associated with the
development or commercialization of any of our product candidates;
our ability to obtain an adequate supply of T cells from qualified
donors; our ability to achieve our anticipated operating
efficiencies at our manufacturing facility; delays or difficulties
in our and our collaborators’ 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 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’ 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 the COVID-19 pandemic and variants
thereof, or any pandemic, epidemic, or outbreak of an infectious
disease; the success of our existing collaboration 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, 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, 2023, 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/20230727013670/en/
Investor and Media Contact: Mei Burris Director, Investor
Relations and Finance Mei.Burris@precisionbiosciences.com
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