Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage
biotechnology developing allogeneic CAR T and in vivo gene
correction therapies with its ARCUS® genome editing platform, in
collaboration with Servier, an independent global pharmaceutical
company, today announced the companies have added two additional
hematological cancer targets beyond CD19 and two solid tumor
targets to its CAR T development and commercial license agreement.
“The addition of these new targets will build on the productive
multi-year collaboration between Precision and Servier that is
driving the development of PBCAR0191, our lead allogeneic CAR T
candidate targeting CD19,” said Matt Kane, CEO and Co-Founder of
Precision BioSciences. “We are pleased to expand our collaboration
with Servier and apply our proprietary single-step cell engineering
and unique allogeneic CAR T manufacturing and development
strategies to potentially extend the reach of 'off-the-shelf' CAR T
therapies beyond hematological cancers and into solid tumors.”
Under the terms of the existing development and commercial
license agreement between Servier and Precision, Servier has
selected two hematological and two solid tumor targets beyond those
already in Precision’s allogeneic CAR T pipeline. Precision intends
to leverage its proprietary ARCUS genome editing platform and CAR T
development and manufacturing expertise for early-stage research
and development activities, including Investigational New Drug
(IND) filing through the manufacturing of initial clinical trial
material for a Phase 2 study. Servier has the right to opt in for
late-stage development and commercialization, and Precision has the
right to participate in the development and commercialization of
any licensed products resulting from the collaboration through a
50/50 co-development and co-promotion option in the United States.
With the addition of these new targets, Precision expects to
receive milestone payments in 2020 and 2021. Precision is also
eligible for option fees, clinical, regulatory, and sales
milestones in addition to royalties on product sales.
“At Servier, we partner for a purpose – our patients. We are
pleased to add four additional targets beyond CD19 to our
collaboration with Precision BioSciences as part of our commitment
to oncology,” said Patrick Therasse, Deputy Head of global RD
oncology at Servier. “We look forward to utilizing their ARCUS
genome editing platform with these new targets to potentially
develop several innovative allogeneic CAR T therapies for patients
with a range of solid and hematological malignancies.”
About PBCAR0191PBCAR0191 is an investigational
allogeneic chimeric antigen receptor (CAR T) candidate targeting
CD19 in a Phase 1/2a multicenter, nonrandomized, open-label,
parallel assignment, dose-escalation, and dose-expansion study for
the treatment of patients with relapsed or refractory (R/R)
non-Hodgkin lymphoma (NHL) or R/R B-cell precursor acute
lymphoblastic leukemia (B-ALL). The NHL cohort includes patients
with mantle cell lymphoma (MCL), an aggressive subtype of NHL, for
which Precision has received both Orphan Drug and Fast Track
Designations from the U.S. Food and Drug Administration (FDA). More
information about the study is available at www.clinicaltrials.gov,
study identifier number NCT03666000.
About Precision’s Allogeneic CAR T Platform
Precision is advancing a pipeline of cell-phenotype optimized
allogeneic CAR T therapies, leveraging fully scaled, proprietary
manufacturing processes. The platform is designed to maximize the
number of patients who can potentially benefit from CAR T therapy.
Precision carefully selects high-quality T cells derived from
healthy donors as starting material, then utilizes its unique ARCUS
genome editing technology to modify the cells via a single-step
engineering process. By inserting the CAR gene at the T cell
receptor (TCR) locus, this process knocks in the CAR while knocking
out the TCR, creating a consistent product that can be reliably and
rapidly manufactured that is designed to prevent graft-versus-host
disease. Precision optimizes its CAR T therapy candidates for
immune cell expansion in the body by maintaining a high proportion
of naïve and central memory CAR T cells throughout the
manufacturing process and in the final product.
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 specific and
versatile genome editing platform that was designed with
therapeutic safety, delivery, and control in mind. Using ARCUS, the
Company’s pipeline consists of multiple “off-the-shelf” CAR T
immunotherapy clinical candidates and several in vivo gene
correction therapy candidates to potentially cure genetic and
infectious diseases where no known adequate treatments exist. More
information about Precision BioSciences is available at
www.precisionbiosciences.com.
About ServierServier is a Global pharmaceutical
company governed by a non-profit foundation, with its headquarters
in France (Suresnes). With a strong international presence in 149
countries and a total revenue of 4.6 billion euros in 2019, Servier
employs 22,000 people worldwide. Entirely independent, the Group
invests on average 25% of its total revenue (excluding generics)
every year in research and development and uses all its profits for
its development. Corporate growth is driven by Servier’s constant
search for innovation in five areas of excellence: cardiovascular,
immune-inflammatory, and neurodegenerative diseases, cancer and
diabetes, as well as by its activities in high-quality generic
drugs. Servier also offers eHealth solutions beyond drug
development. More information is available at www.servier.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 Company’s
expectations for milestone payments involving the additional
targets identified under its agreement with Servier, targets for
the Company’s clinical trial involving PBCAR0191 and results of the
Company’s CAR T therapies, including, without limitation, potential
treatment of hematological cancers and solid tumors. In some cases,
you can identify forward-looking statements by terms such as “aim,”
“anticipate,” “believe,” “could,” “expect,” “should,” “plan,”
“intend,” “estimate,” “target,” “mission,” “goal,” “may,” “will,”
“would,” “should,” “could,” “target,” “potential,” “project,”
“predict,” “contemplate,” “potential,” 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. Such statements are subject to 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 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; our dependence on our ARCUS technology; the
initiation, cost, timing, progress, achievement of milestones and
results of research and development activities, preclinical or
greenhouse studies and clinical or field trials; public perception
about genome editing technology and its applications; competition
in the genome editing, biopharmaceutical, biotechnology and
agricultural biotechnology fields; our or our collaborators’
ability to identify, develop and commercialize product candidates;
pending and potential 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 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; 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; the rate and degree of
market acceptance of any of our product candidates; 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; our ability to
effectively manage the growth of our operations; our ability to
attract, retain, and motivate key executives and personnel; market
and economic conditions; effects of system failures and security
breaches; effects of natural and manmade disasters, public health
emergencies and other natural catastrophic events effects of the
outbreak of COVID-19, or any pandemic, epidemic or outbreak of an
infectious disease; insurance expenses and exposure to uninsured
liabilities; effects of tax rules; risks related to ownership of
our common stock 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, 2020, 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 & Media page of our website 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 do not
plan to publicly update or revise any forward-looking statements
contained herein, whether as a result of any new information,
future events, changed circumstances or otherwise.
Precision BioSciences investor and media
contact:Maurissa MessierSenior Director, Corporate
Communicationsmaurissa.messier@precisionbiosciences.com
Servier Group press contacts:Sonia Marques:
presse@servier.com
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