AgeX Therapeutics & Pluristyx Announce Manufacturing, Marketing, & Distribution Agreement to Expand Access to Clinical-Grade ...
16 June 2020 - 10:00PM
Business Wire
- Allows industry and academia access to cGMP-grade,
NIH-registered AgeX ESI human pluripotent stem cells for
development of cellular therapeutics
- AgeX ESI cell lines are among only a few pluripotent stem cell
lines from which derived cell therapy candidates have been granted
FDA IND clearance to begin human trials
- Pluristyx will manufacture, market, and distribute
Ready-to-Use™ and Ready-to-Differentiate™ ESI stem cell lines
vialed and frozen on behalf of AgeX
AgeX Therapeutics, Inc. (“AgeX”: NYSE American: AGE), a
biotechnology company developing therapeutics for human aging and
regeneration, and Pluristyx, Inc. (Seattle, WA), an advanced
therapy tools and services company serving customers in the rapidly
growing fields of regenerative medicine and cellular and gene
therapies, today announced they have entered into a Manufacturing,
Marketing, and Distribution Agreement through which Pluristyx will
undertake these activities on behalf of AgeX with respect to AgeX’s
research- and clinical-grade ESI brand human embryonic stem cells,
sometimes referred to as hESCs.
The agreement builds on Pluristyx’s strategy to manufacture,
market, and distribute high-quality standardized Ready-to-Use™ and
Ready-to-Differentiate™ pluripotent stem cells to industry and
academic scientists intent on developing therapeutic products to
treat human disease. AgeX’s ESI hESC lines are distinguished for
being the first clinical-grade hESC lines created under current
Good Manufacturing Practice (cGMP). The AgeX ESI hESC lines are
listed on the National Institutes of Health (NIH) Stem Cell
Registry and are among the best characterized and documented stem
cell lines available worldwide.
The agreement is a key step in AgeX’s licensing and
collaboration strategy to facilitate industry and academic access
to its hESC lines, its PureStem® cell derivation and manufacturing
platform, and its UniverCyte™ immunotolerance technology in order
to generate near- and long-term revenues.
“A recent FDA IND clearance for a biotech company to begin a
human trial for a cell therapy candidate derived from an AgeX ESI
hESC line has amplified interest from industry and academia to
utilize our cells in regenerative medicine. It is AgeX’s goal to
make its cell lines the gold standard when it comes to therapeutic
products derived from pluripotent stem cells. We are delighted to
be working with the Pluristyx team given their extensive cGMP
manufacturing experience with pluripotent stem cells,” said Dr.
Nafees Malik, Chief Operating Officer of AgeX.
“Pluristyx is excited to be working with AgeX and their ESI hESC
lines. As AgeX intends to make their cell lines the gold standard,
our aim is to disrupt and redefine stem cell therapy manufacturing
with our proprietary, high-density format, Ready-to-Use™ and
Ready-to-Differentiate™ hESC lines, which will dramatically reduce
both cost and time in translating revolutionary therapies from
bench to bedside,” said Dr. Benjamin Fryer, CEO of Pluristyx.
Academic and biopharma organizations will need to obtain
separate commercial licenses from AgeX in order to advance their
cellular product candidates generated from AgeX hESC lines into
human clinical trials and commercialization. AgeX retains all
rights to manufacture its own in-house cellular products as well as
to extend license rights to other third parties.
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 Pluristyx
Established in 2018, Pluristyx Inc. is a privately held,
early-stage company providing a complete cell manufacturing
solution. As an advanced therapy tools company, Pluristyx helps
companies and researchers solve manufacturing challenges in the
field of drug development, regenerative medicine, and cell and gene
therapy. Pluristyx is led by a team with decades of industry
experience each with specific expertise in key areas needed to
develop and manufacture pluripotent stem cells. Pluristyx provides
know how in every stage of the process from cell banking through
scale-up of clinical grade material as well as all aspects of
process development and manufacturing.
For more information, please visit www.pluristyx.com or connect
with the company on Twitter and LinkedIn.
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, with respect to AgeX’s Manufacturing,
Marketing and Distribution Agreement with Pluristyx there is no
assurance that (i) Pluristyx will generate significant sales of
AgeX ESI hESC lines, or (ii) AgeX will derive significant revenue
from sales of ESI hESC lines by Pluristyx. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20200616005377/en/
Media Contact for AgeX Andrea Park Chief Financial
Officer AgeX Therapeutics, Inc. apark@agexinc.com
Media Contact for Pluristyx Kaye Reiter, PhD, JD General
Counsel Pluristyx, Inc. info@pluristyx.com
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