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.
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.”
THIS ANNOUNCEMENT CONTAINS INSIDE
INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION 2014/596/EU
WHICH IS PART OF DOMESTIC UK LAW PURSUANT TO THE MARKET ABUSE
(AMENDMENT) (EU EXIT) REGULATIONS (SI 2019/310) ("UK MAR"). UPON
THE PUBLICATION OF THIS ANNOUNCEMENT, THIS INSIDE INFORMATION (AS
DEFINED IN UK MAR) IS NOW CONSIDERED TO BE IN THE PUBLIC
DOMAIN.
The person responsible for arranging for the release of this
announcement on behalf of Tiziana Life Sciences plc is Dr Kunwar
Shailubhai, Chief Executive Officer.
About Precision’s Allogeneic CAR T
PlatformPrecision 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 ForalumabForalumab (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 plcTiziana 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 StatementsThis 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 StatementsCertain
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.
Precision BioSciences Investor Contact:Alex
KellyChief Financial OfficerAlex.Kelly@precisionbiosciences.com
Precision BioSciences Media Contact:Maurissa
MessierSenior Director, Corporate
CommunicationsMaurissa.Messier@precisionbiosciences.com
Tiziana Life Sciences plc Contacts:United
Kingdom:Gabriele CerroneChairman and founder+44 (0)20 7495 2379
United States:Dave GentryChief Executive OfficerRedChip
Companies Inc.407-491-4498dave@redchip.com
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