Sernova to utilize AgeX’s UniverCyteTM gene
technology to generate transplantable, universal immune-protected
therapeutic cells for Sernova’s Cell PouchTM Platform
AgeX Therapeutics, Inc. (“AgeX”: NYSE American: AGE), a
biotechnology company developing therapeutics for human aging and
regeneration, and Sernova Corp. (TSX-V:SVA)(OTCQB:SEOVF)(FSE:PSH),
a clinical-stage regenerative medicine therapeutics company,
announced today a research collaboration where Sernova will utilize
AgeX’s UniverCyteTM gene technology to generate immune-protected
universal therapeutic cells for use in combination with Sernova’s
Cell PouchTM for the treatment of type I diabetes and hemophilia A.
The goal is to eliminate the need for immunosuppressive medications
following Cell Pouch cell transplantation.
The research collaboration will evaluate whether Sernova’s
pluripotent stem cell-derived pancreatic islet beta cells
engineered with AgeX’s UniverCyte technology can evade human immune
detection. The complementary combination of technologies could
enable the transplantation of therapeutic cells in patients with
type I diabetes in an off-the-shelf manner using Sernova’s Cell
Pouch, without human leukocyte antigen (HLA) tissue matching or
concurrent administration of immunosuppressive medications. With a
similar intent, pluripotent stem cell-derived or adult
donor-derived human Factor VIII-releasing cells modified with
AgeX’s UniverCyte will be evaluated in Sernova’s hemophilia A
program.
Under the terms of the agreement, Sernova has been granted a
time-limited, non-exclusive research license by AgeX. A commercial
license for Sernova to utilize UniverCyte to engineer cellular
products for therapeutic and commercial purposes may be negotiated
between the companies pending successful study outcomes.
The UniverCyte technology aims to mask therapeutic cells derived
from pluripotent stem cells or adult donors from human immune
detection to allow for off-the-shelf cellular products without the
need for immunosuppressant medications which may have potent side
effects, or HLA-matching between donor and patient. UniverCyte uses
a novel, modified form of HLA-G, a potent immunomodulatory
molecule, which in nature protects an unborn child from their
mother’s immune system. In almost all human cells, native HLA-G
expression is silenced after birth. AgeX’s modified HLA-G shows
evidence of being resistant to this silencing, thereby potentially
allowing for long-term, stable and high expression of the
immunomodulatory effect.
Sernova plans to utilize the universal therapeutic cells
generated through this research collaboration with its Cell Pouch
System, a proprietary, scalable, implantable macro-encapsulation
device, which, upon implantation, incorporates with tissue and
forms highly vascularized chambers. These chambers become a natural
environment in the body to house and favor long-term survival and
function of therapeutic cells. The Cell Pouch System has shown
initial safety and efficacy indicators in an ongoing Phase I/II
clinical study at the University of Chicago and in a preclinical
model of hemophilia A when assessed with human cells corrected to
produce Factor VIII.
“We are thrilled with our collaboration with Sernova, which is
at the forefront of cellular therapies for diabetes and hemophilia
and is already in the clinic for the former. The combination of
AgeX’s UniverCyte to cloak cells from a patient’s immune system and
Sernova’s Cell Pouch technologies to permit cells to function
long-term upon transplantation would be a landmark for regenerative
medicine. This deal marks another important step in AgeX’s
collaboration and licensing strategy to work with the very best
people, companies and institutions in the world of regenerative
medicine,” said Dr. Nafees Malik, Chief Operating Officer of
AgeX.
“We look forward to working with AgeX and its outstanding team
as we continue to identify and evaluate technologies complementary
to Sernova’s therapeutic platform and expand our immune protection
offerings. AgeX’s UniverCyte technology is a significant
advancement in the field of cell therapy and a perfect fit with
Sernova’s Cell Pouch technologies and therapeutic pipeline with its
potential benefit over current immunosuppressive strategies for
regenerative medicine therapeutics,” said Dr. Philip Toleikis,
President and CEO of Sernova Corp.
About AgeX Therapeutics
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 Sernova Corp.
Sernova Corp is developing regenerative medicine therapeutic
technologies using the Cell Pouch System, a medical device and
immune protected therapeutic cells (i.e., human donor cells,
corrected human cells and stem-cell-derived cells) to improve the
treatment and quality of life of people with chronic metabolic
diseases such as insulin-dependent diabetes, blood disorders
including hemophilia, and other diseases treated through
replacement of proteins or hormones missing or in short supply
within the body. For more information, please visit
www.sernova.com.
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. 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
subsidiaries, particularly those mentioned in the cautionary
statements found in more detail in the “Risk Factors” section of
AgeX’s most recent Annual Report on Form 10-K and Quarterly Report
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. In addition, there can be no assurance that Sernova’s
planned use of AgeX’s UniverCyteTM gene technology will
successfully generate immune-protected universal therapeutic cells
for use in combination with Sernova’s Cell PouchTM for the
treatment of type I diabetes and hemophilia A or any other disease,
and there can be no assurance that AgeX and Sernova will enter into
a commercial license for the use of UniverCyteTM in a therapeutic
or other product. 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 Sernova
This release may contain forward-looking statements.
Forward-looking statements are statements that are not historical
facts and are generally, but not always, identified by the words
“expects”, “plans”, “anticipates”, “believes”, “intends”,
“estimates”, “projects”, “potential” and similar expressions, or
that events or conditions “will”, “would”, “may”, “could” or
“should” occur. Although Sernova believes the expectations
expressed in such forward-looking statements are based on
reasonable assumptions, such statements including those related to
the potential of Univercyte combined with Sernova’s technologies
are not guarantees of future performance, and actual results may
differ materially from those in forward-looking statements.
Forward-looking statements are based on the beliefs, estimates, and
opinions of Sernova’s management on the date such statements were
made, which include our beliefs about the effect on company
operations of the COVID-19 virus and conduct and outcome of
discussions, clinical programs, and our clinical trials. Sernova
expressly disclaims any intention or obligation to update or revise
any forward-looking statements, whether as a result of new
information, future events or otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20200529005130/en/
Media Contact for AgeX: Andrea Park Chief Financial
Officer AgeX Therapeutics, Inc. Tel: (510) 671-8620
apark@agexinc.com Media Contact for Sernova: Dominic Gray
Sernova Corp Tel: (519) 858-5126 dominic.gray@sernova.com
www.sernova.com
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