- Out licensed allogeneic CAR T azer-cel
receives IND clearance from U.S. FDA
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 that its partner TG Therapeutics has
received U.S. Food and Drug Administration (FDA) clearance for its
Investigational New Drug (IND) Application to investigate
Azercabtagene Zapreleucel (azer-cel) in human clinical trials for
the treatment of progressive forms of multiple sclerosis. Azer-cel
is an experimental allogeneic CAR T therapy discovered by Precision
BioSciences and licensed to TG Therapeutics for the treatment of
autoimmune diseases. TG Therapeutics anticipates commencing a phase
1 clinical trial in 2024.
“We would like to congratulate TG Therapeutics on receiving IND
clearance for azer-cel in patients with progressive multiple
sclerosis. We believe the expansion of allogeneic CAR T into
autoimmune diseases holds the potential to unlock new therapies for
patients living with chronic disease," said Michael Amoroso, Chief
Executive Officer of Precision BioSciences. “We look forward to TG
Therapeutics initiating a clinical trial for azer-cel in autoimmune
disease as we focus on the advancement of our own wholly owned in
vivo gene editing pipeline, including our planned IND and/or
Clinical Trial Application (CTA) submission for PBGENE-HBV for
hepatitis B this year.”
In January 2024, Precision BioSciences announced a licensing
deal with TG Therapeutics for the CAR T therapy azer-cel. In
exchange for global rights to azer-cel for automimmune diseases and
indications outside of cancer, Precision received upfront and
potential near-term economics valued at $17.5 million and up to
$288 million in other milestone payments based on achievement of
certain clinical, regulatory, and commercial milestones, in
addition to high-single-digit to low-double-digit royalties on net
sales.
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 (including azer-cel)
and gene editing approaches including editing efficiency and
differentiating aspects; the suitability of azer-cel for oncology
indications and non-oncology indications including multiple
sclerosis; the suitability of ARCUS nucleases for gene insertion,
large gene deletion, and other gene editing approaches; the
expected timing of regulatory processes; expectations around
partnership opportunities; expectations about achievement of key
milestones and receipt of any milestone, royalty, or other
payments; and anticipated timing of clinical trials. In some cases,
you can identify forward-looking statements by terms such as “aim,”
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“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, 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 U.S. 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/20240809990981/en/
Investor Contact: Naresh Tanna Vice President, Investor
Relations Naresh.Tanna@precisionbiosciences.com
Grafico Azioni Precision BioSciences (NASDAQ:DTIL)
Storico
Da Dic 2024 a Gen 2025
Grafico Azioni Precision BioSciences (NASDAQ:DTIL)
Storico
Da Gen 2024 a Gen 2025
