AgeX Therapeutics Licensee ImStem Biotechnology Announces FDA has Lifted the Hold & Cleared the Investigational New Drug Appl...
March 20 2020 - 9:00AM
Business Wire
AgeX Therapeutics, Inc. (“AgeX”; NYSE American: AGE), a
biotechnology company focused on developing therapeutics for human
aging and regeneration, announced today that ImStem Biotechnology,
Inc. (Farmington, CT), a biopharmaceutical company pioneering the
development of mesenchymal stem cells (hES-MSC) derived from human
embryonic stem cells has received notification from the U.S. Food
and Drug Administration (FDA) that it has lifted the hold and
cleared the Investigational New Drug (IND) application to evaluate
IMS001 for the treatment of multiple sclerosis (MS). IMS001 was
derived from the pluripotential cell line designated ESI-053
licensed from AgeX.
“Since pluripotent stem cells are capable of differentiating
into all human cell types potentially genetically modified in any
manner, they open the door to a wide array of new therapies,”
stated Dr. Michael D. West, PhD, founder and CEO of AgeX. “This
collaboration with ImStem is consistent with our aim to make our
clinical-grade pluripotent stem cell banks widely available for
diverse therapeutic applications.”
IMS001 is a formulation of cells derived from AgeX pluripotent
stem cells induced to differentiate into mesenchymal cells
(hES-MSC) and through a proprietary method using a trophoblast
intermediate stage (hence also known as T-MSC) for the treatment of
neurological, autoimmune, and rare orphan diseases. IMS001 is an
investigational, allogeneic cell product to be administered
intravenously to patients suffering from MS. ImStem believes this
is the first hES-MSC based allogeneic cell therapy accepted for
clinical trial by the FDA. ImStem plans to initiate a phase 1
clinical study in patients with relapsing-remitting, secondary, and
primary progressive forms of MS in 2020 in the US.
“The clinical-grade pluripotent stem cell lines from AgeX were
the first published GMP-compatible lines ever created,” said
Xiaofang Wang, MD, PhD, Founder and Chief Technology Officer of
ImStem. “As such, they have been widely distributed in the
scientific community and demonstrated to meet the needs of industry
for relatively rapid product development.”
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 is developing its core product pipeline for use in the clinic
to extend human healthspan and is seeking opportunities to
establish licensing and collaboration agreements around its broad
IP estate and proprietary technology platforms.
For more information, please visit www.agexinc.com or connect
with the company on Twitter, LinkedIn, Facebook, and YouTube.
About IMS001
IMS001 is an investigational, allogeneic, hES-MSC that has
undergone IND-enabling, preclinical biodistribution, engraftment,
tumorigenicity, toxicology, immunogenicity, and pharmacology
studies. IMS001 has demonstrated preclinical immunomodulatory
activities, which may lead to potential therapeutic benefits in a
wide array of neurological, autoimmune, and rare orphan diseases
with high unmet medical needs.
Previously published in-vitro data, in collaboration with
scientists at the University of Connecticut (UConn) Health, have
demonstrated potential advantages of hESC-MSCs in terms of their
immunomodulatory effects, as well as the potential to stabilize the
blood-brain-barrier (BBB). These mechanistic properties may lead to
therapeutic benefits in diseases such as MS, potentially reducing
relapses, disability progression, and inducing disease arrest.
About ImStem Biotechnology
ImStem Biotechnology, Inc. is aspiring to revolutionize how
serious diseases with significant unmet needs are treated with a
new generation of regenerative and cellular therapies. Pioneering
research by its current founder and Chief Technology Officer Dr.
Xiaofang Wang and Dr. Ren-He Xu, former director of UConn Stem Cell
Institute, led to the proprietary state-of-the-art pluripotent stem
cell technology, enabling off-the-shelf, allogeneic stem
cell-derived products to be manufactured in scale, differentiating
itself from the typical challenges imposed by autologous adult cell
therapy products. The company’s mission is to advance the science
and understanding of human pluripotent stem cell based regenerative
cellular therapies through novel and creative development pathways
and to fulfill unmet medical needs in serious diseases. And its
development strategy focuses on neurologic, autoimmune,
degenerative, and rare orphan diseases. ImStem Biotechnology, Inc.
is a privately held company headquartered in Farmington, CT. For
more information, visit http://www.imstem.com.
Forward-Looking Statements
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 Annual Report 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.
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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Media Contact for AgeX:
Bill Douglass Gotham Communications, LLC bill@gothamcomm.com
(646) 504-0890
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