Precision Gains Access to Tiziana’s Anti-CD3
Antibody, Foralumab, to Evaluate as a Lymphodepletion Agent with
its Allogeneic CAR T Portfolio
Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage
biotechnology company developing allogeneic CAR T and in vivo gene
correction therapies with its ARCUS® genome editing platform, and
Tiziana Life Sciences plc (Nasdaq: TLSA / LSE: TILS), a clinical
stage biotechnology company focused on innovative therapeutics for
oncology, inflammation, and infectious diseases, today announced an
exclusive license agreement to explore Tiziana’s foralumab, a fully
human anti-CD3 monoclonal antibody (mAb), as an agent to induce
tolerance of allogeneic CAR T cells to potentially improve the
clinical outcome of CAR T cell therapy.
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The Cluster of Differentiation (CD) 3 is a receptor on effector
T cells and an anti-CD3 antibody, such as foralumab, has the
potential to eliminate or tolerize patient effector T cells.
Precision’s manufacturing process, which uses ARCUS to knock out
the TRAC gene and implements a CD3-depletion step, produces
allogeneic CAR T candidates that are >99.9% CD3-negative. Thus,
an anti-CD3 antibody, such as foralumab, might be used to enable
the CAR T cells to expand, proliferate, and persist to maximize
long term clinical benefits.
Under the terms of the agreement, Precision gains an exclusive
license to use foralumab as a lymphodepletion agent in conjunction
with its allogeneic CAR T therapeutics for the treatment of
cancers. Precision will be responsible for the development,
commercialization, and costs for use of foralumab, and Tiziana will
receive upfront payment, certain milestone payments, and royalties
for foralumab.
“We are building out an allogeneic CAR T platform with editing
strategies and novel conditioning regimens, such as a
lymphodepleting agent like foralumab, for a broad range of
hematologic malignancies and solid tumors,” said Alan List, M.D.,
Chief Medical Officer at Precision BioSciences. “By combining
Precision’s know-how in constructing novel CAR T products with
novel conditioning regimens, we will explore this approach to
potentially improve durability of clinical responses to our
therapeutic platform.”
“We’re pleased to offer Precision the exclusive opportunity to
explore foralumab, our fully human anti-CD3 monoclonal antibody,
for use as a potential lymphodepletion strategy with their
allogeneic CAR T programs,” said Kunwar Shailubhai, Chief Executive
Officer and Chief Scientific Officer of Tiziana Life Sciences.
“While CAR T therapies have been clinically successful, relapse
rates remain high, which continues to limit broad utility. We are
impressed with Precision’s novel approaches to CAR T development,
offering the potential for a meaningful off-the-shelf solution.
Further, given Precision’s approach to manufacturing that produces
CAR T cells virtually CD3-negative, we believe use of foralumab as
a lymphodepletion or tolerizing agent has the potential, either
alone or in combination with other co-stimulatory molecules, to
improve the long-term success of CAR T in cancer treatment.”
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 Company's allogeneic CAR T 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 uses its 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, which is designed to create a
consistent product that can be reliably and rapidly manufactured
and 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 Foralumab
Foralumab (TZLS-401, formerly NI-0401), the only entirely human
anti-CD3 mAb, shows reduced release of cytokines as compared to
other anti-CD3 mAbs after IV administration in patients with
Crohn's disease with decreases in the classic side effects of
cytokine release syndrome and improves the overall safety profile
of Foralumab. In a humanized mouse model (NOD/SCID IL2γc-/-), it
was shown that while targeting the T cell receptor, orally
administered Foralumab modulates immune responses of the T cells,
enhances regulatory T-cells (Tregs) and thus provides therapeutic
benefit in treating inflammatory and autoimmune diseases without
the occurrence of potential adverse events usually associated with
parenteral mAb therapy (Ogura M. et al., 2017 Clin Immunol 183,
240-246). Based on animal studies, the nasal and oral
administration of Foralumab offers the potential for the
immunotherapy of autoimmune and inflammatory diseases in a safe
manner by the induction of Tregs.
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 cure genetic and infectious
diseases where no adequate treatments exist. For more information
about Precision BioSciences please visit
www.precisionbiosciences.com.
About Tiziana Life Sciences plc
Tiziana Life Sciences plc is a dual listed (Nasdaq: TLSA &
UK LSE: TILS) biotechnology company that focuses on the discovery
and development of novel molecules to treat human diseases in
oncology, inflammation and infectious diseases. In addition to
Milciclib, the Company will be shortly initiating Phase 2 studies
with orally administered Foralumab for Crohn's Disease and nasally
administered Foralumab for progressive multiple sclerosis.
Foralumab is the only fully human anti-CD3 monoclonal antibody
("mAb") in clinical development in the world. This Phase 2 compound
has potential application in a wide range of autoimmune and
inflammatory diseases, such as Crohn's Disease, multiple sclerosis,
type-1 diabetes ("T1D"), inflammatory bowel disease ("IBD"),
psoriasis and rheumatoid arthritis, where modulation of a T-cell
response is desirable. The Company is accelerating development of
anti-Interleukin 6 receptor ("IL6R") mAb, a fully human monoclonal
antibody for treatment of IL6-induced inflammation, especially for
treatment of COVID-19 patients.
Precision 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 agreement with Tiziana for the
exploration, use, development or commercialization of foralumab as
a lymphodepletion agent in conjunction with the Company’s
allogeneic CAR T therapeutics for the treatment of cancers and any
future milestone or royalty payments thereunder. In some cases, you
can identify forward-looking statements by terms such as
“anticipate,” “believe,” “could,” “expect,” “should,” “plan,”
“intend,” “estimate,” “target,” “mission,” “may,” “will,” “would,”
“should,” “could,” “target,” “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; 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 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 achieve our
anticipated operating efficiencies at our manufacturing facility;
delays or difficulties in our and our collaborators’ ability to
enroll patients; if our product candidates do not work as intended
or cause undesirable side effects; risks associated with applicable
healthcare, data 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 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 scientific and management personnel; market and
economic conditions; 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, 2021, as any such
factors may be updated from time to time in our other filings with
the SEC, and 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.
Tiziana Forward-Looking Statements
Certain statements made in this announcement are forward-looking
statements. These forward-looking statements are not historical
facts but rather are based on the Company's current expectations,
estimates, and projections about its industry; its beliefs; and
assumptions. Words such as 'anticipates,' 'expects,' 'intends,'
'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions
are intended to identify forward-looking statements. These
statements are not guarantees of future performance and are subject
to known and unknown risks, uncertainties, and other factors, some
of which are beyond the Company's control, are difficult to
predict, and could cause actual results to differ materially from
those expressed or forecasted in the forward-looking statements.
The Company cautions security holders and prospective security
holders not to place undue reliance on these forward-looking
statements, which reflect the view of the Company only as of the
date of this announcement. The forward-looking statements made in
this announcement relate only to events as of the date on which the
statements are made. The Company will not undertake any obligation
to release publicly any revisions or updates to these
forward-looking statements to reflect events, circumstances, or
unanticipated events occurring after the date of this announcement
except as required by law or by any appropriate regulatory
authority.
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Precision BioSciences Investor Contact: Alex Kelly Chief
Financial Officer Alex.Kelly@precisionbiosciences.com Precision
BioSciences Media Contact: Maurissa Messier Senior Director,
Corporate Communications
Maurissa.Messier@precisionbiosciences.com
Tiziana Life Sciences plc Contacts: United Kingdom:
Gabriele Cerrone Chairman and founder +44 (0)20 7495 2379
United States: Dave Gentry Chief Executive Officer RedChip
Companies Inc. 407-491-4498 dave@redchip.com
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