- AgeX Secures Independence to License out ESI Cell Lines as
Part of its Collaboration and Licensing Model
- Lineage Acquires Exclusivity for ESI Cell Lines in Spinal
Cord Injury and Certain Oncology Indications
AgeX Therapeutics, Inc. (“AgeX”: NYSE American: AGE), a company
focused on developing and commercializing innovative therapeutics
for human aging, and Lineage Cell Therapeutics, Inc. (“Lineage”:
NYSE American and TASE: LCTX), a clinical-stage biotechnology
company developing novel cell therapies for unmet medical needs,
and ES Cell International Pte Ltd. (ESI), a subsidiary of Lineage,
today announced the broadening of their collaborative relationship
with regard to ESI stem cell lines. ESI cell lines are current Good
Manufacturing Practice (cGMP)-compatible, registered with the
National Institutes of Health (NIH), and widely studied as a
potential source for the industrial-scale manufacture of any cell
type in the human body. Neither party made or received any cash
payments in connection with this arrangement.
“Both Lineage and AgeX are pioneering important aspects of
regenerative medicine. Working together, we have amended our
agreement regarding ESI cell lines derived under cGMP to be optimal
for the business needs of each company,” stated Brian M. Culley,
Lineage’s CEO. “In particular, Lineage has acquired exclusivity for
the use of ESI cell lines in spinal cord injury and certain
oncology indications. On the other hand, AgeX has gained greater
flexibility and independence to support its efforts toward
licensing certain technologies and cell lines to third parties.
With this step complete, we next intend to explore additional
opportunities to collaborate with AgeX on promising tissue
regenerating projects.”
The ESI cell lines are recognized for being the first
clinical-grade human pluripotent stem cell lines created under cGMP
as described in the publication Cell Stem Cell (2007;1:490-4). It
may become possible to generate potentially limitless quantities of
all the cell types of the human body from these master cell banks
with a wide array of potential therapeutic applications. These cell
lines are listed on the NIH Stem Cell Registry and are among the
best characterized and documented stem cell lines available
globally. Importantly, ESI cells are among only a few pluripotent
stem cell lines from which a derived cell therapy product candidate
has been granted FDA investigational new drug (IND) clearance to
commence human studies.
“Key to the creation of shareholder value is the placement of
these important assets in the hands of collaborators to advance the
development of a vast number of regenerative therapies,” said
Michael West, Ph.D., AgeX’s CEO. “Our collaborative relationship
with Lineage led to this streamlined process that may facilitate
the commercialization of these applications to the benefit of
shareholders of each company. Since the beginning of the year, AgeX
has entered into new research and commercial arrangements utilizing
an array of its technology platforms, such as UniverCyteTM for the
engineering of universally transplantable cells, PureStem® for the
manufacture and derivation of cells, and an ESI cell line as source
material for deriving cellular therapeutics.”
About AgeX Therapeutics, Inc
AgeX Therapeutics, Inc. (NYSE American: AGE) is focused on
developing and commercializing innovative therapeutics for human
aging. Its PureStem® and UniverCyte™ manufacturing and
immunotolerance technologies are designed to work together to
generate highly defined, universal, allogeneic, off-the-shelf
pluripotent stem cell-derived young cells of any type for
application in a variety of diseases with a high unmet medical
need. AgeX has two preclinical cell therapy programs: AGEX-VASC1
(vascular progenitor cells) for tissue ischemia and AGEX-BAT1
(brown fat cells) for Type II diabetes. AgeX’s revolutionary
longevity platform induced Tissue Regeneration (iTR™) aims to
unlock cellular immortality and regenerative capacity to reverse
age-related changes within tissues. AGEX-iTR1547 is an iTR-based
formulation in preclinical development. HyStem® is AgeX’s delivery
technology to stably engraft PureStem cell therapies in the body.
AgeX’s core product pipeline is intended to extend human
healthspan. AgeX is seeking opportunities to establish licensing
and collaboration arrangements around its broad IP estate and
proprietary technology platforms and therapy product candidates.
For more information, please visit www.agexinc.com or connect with
the company on Twitter, LinkedIn, Facebook, and YouTube.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology
company developing novel cell therapies for unmet medical needs.
Lineage’s programs are based on its robust proprietary cell-based
therapy platform and associated in-house development and
manufacturing capabilities. With this platform Lineage develops and
manufactures specialized, terminally differentiated human cells
from its pluripotent and progenitor cell starting materials. These
differentiated cells are developed to either replace or support
cells that are dysfunctional or absent due to degenerative disease
or traumatic injury or administered as a means of helping the body
mount an effective immune response to cancer. Lineage’s clinical
programs are in markets with billion dollar opportunities and
include three allogeneic (“off-the-shelf”) product candidates: (i)
OpRegen®, a retinal pigment epithelium transplant therapy in Phase
1/2a development for the treatment of dry age-related macular
degeneration, a leading cause of blindness in the developed world;
(ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a
development for the treatment of acute spinal cord injuries; and
(iii) VAC, an allogeneic dendritic cell therapy platform for
immuno-oncology and infectious disease, currently in clinical
development for the treatment of non-small cell lung cancer and in
preclinical development for additional cancers and as a vaccine
against infectious diseases, including SARS-CoV-2, the virus which
causes COVID-19. For more information, please visit
www.lineagecell.com or follow the Company on Twitter
@LineageCell.
About ESI
ES Cell International Pte Ltd (“ESI”). Established in 2000, ESI,
a wholly owned subsidiary of Lineage Cell Therapeutics, Inc.,
developed ESI hESC lines in compliance with the principles of
current Good Manufacturing Practices and has made them available to
various biopharmaceutical companies, universities and other
research institutions, including AgeX. These ESI cell lines are
extensively characterized and most of the lines have documented and
publicly available genomic sequences.
Forward-Looking Statements for AgeX
Certain statements contained in this release are
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995. Any statements that are
not historical fact including, but not limited to statements that
contain words such as “will,” “believes,” “plans,” “anticipates,”
“expects,” “estimates” should also be considered forward-looking
statements. Forward-looking statements involve risks and
uncertainties. Without limitation, such risks include those
associated with the use of human pluripotent stem cell lines in the
research, development, and use of therapies for the treatment of
human diseases, disorders, and injuries, and risks associated with
commercializing the pluripotent stem cell lines. Actual results may
differ materially from the results anticipated in these
forward-looking statements and as such should be evaluated together
with the many uncertainties that affect the business of AgeX
Therapeutics, Inc. and its respective subsidiaries, particularly
those mentioned in the cautionary statements found in more detail
in the “Risk Factors” section of its most recent Annual Reports on
Form 10-K and Quarterly Reports on Form 10-Q filed with the
Securities and Exchange Commissions (copies of which may be
obtained at www.sec.gov). Subsequent events and developments may
cause these forward-looking statements to change. Undue reliance
should not be placed on forward-looking statements, which speak
only as of the date on which they were made. AgeX specifically
disclaims any obligation or intention to update or revise these
forward-looking statements as a result of changed events or
circumstances that occur after the date of this release, except as
required by applicable law.
Forward-Looking Statements for Lineage
Lineage cautions you that all statements, other than statements
of historical facts, contained in this press release, are
forward-looking statements. Forward-looking statements, in some
cases, can be identified by terms such as “believe,” “may,” “will,”
“estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,”
“could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,”
“contemplate,” project,” “target,” “tend to,” or the negative
version of these words and similar expressions. Such statements
include, but are not limited to, statements relating to the
potential commercialization of ESI cell lines. Forward-looking
statements involve known and unknown risks, uncertainties and other
factors that may cause Lineage’s actual results, performance or
achievements to be materially different from future results,
performance or achievements expressed or implied by the
forward-looking statements in this press release, including risks
and uncertainties inherent in Lineage’s business and other risks in
Lineage’s filings with the Securities and Exchange Commission (the
SEC). Lineage’s forward-looking statements are based upon its
current expectations and involve assumptions that may never
materialize or may prove to be incorrect. All forward-looking
statements are expressly qualified in their entirety by these
cautionary statements. Further information regarding these and
other risks is included under the heading “Risk Factors” in
Lineage’s periodic reports with the SEC, including Lineage’s Annual
Report on Form 10-K filed with the SEC on March 12, 2020 and its
other reports, which are available from the SEC’s website. You are
cautioned not to place undue reliance on forward-looking
statements, which speak only as of the date on which they were
made. Lineage undertakes no obligation to update such statements to
reflect events that occur or circumstances that exist after the
date on which they were made, except as required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20200909005398/en/
AgeX Therapeutics Contact Andrea Park Chief Financial
Officer AgeX Therapeutics, Inc. apark@agexinc.com Lineage Cell
Therapeutics Contacts IR Ioana C. Hone
(ir@lineagecell.com) (442) 287-8963
Solebury Trout IR Gitanjali Jain Ogawa
(Gogawa@troutgroup.com) (646) 378-2949 Russo Partners – Media
Relations Nic Johnson or David Schull
Nic.johnson@russopartnersllc.com David.schull@russopartnersllc.com
(212) 845-4242
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