- Emerging Preclinical and Clinical Data Support Potential of
Mesenchymal Stem Cells (MSCs) to be Useful in COVID-19 and Acute
Respiratory Distress Syndrome (ARDS) from Other Causes
- ImStem’s MSC Product Candidate IMS001 is Derived from AgeX’s
Stem Cell Line ESI-053
- IMS001, which Recently Gained FDA IND Clearance to Begin Human
Study in Multiple Sclerosis, to be Considered for Development in
COVID-19 and ARDS More Generally
AgeX Therapeutics, Inc. (“AgeX”: NYSE American: AGE), a
biotechnology company developing innovative regenerative
therapeutics to treat human diseases to increase healthspan and
combat the effects of aging, and ImStem Biotechnology, Inc.
(“ImStem”), a biopharmaceutical company developing embryonic stem
cell (ESC) derived mesenchymal stem cells (MSCs), today announced
that ImStem has obtained from AgeX a non-exclusive, royalty-bearing
sublicense to use AgeX’s clinical-grade ESC line ESI-053 to derive
ImStem’s investigational MSC product candidate IMS001 for
development in COVID-19 as well as acute respiratory distress
syndrome (ARDS) from other causes.
ImStem will endeavor to file one or more investigational new
drug (IND) applications for IMS001 in COVID-19 and/or ARDS with the
U.S. Food and Drug Administration (FDA) or equivalent EU regulatory
agency within 18 months. Under the agreement, AgeX will be entitled
to receive revenues in the form of royalties on the sale of IMS001
if successfully developed by ImStem and approved for marketing by
the FDA or foreign regulatory authorities, as well as a share of
certain other revenues that ImStem may receive in connection with
the development or commercialization of IMS001, in COVID-19 and
ARDS.
This latest sublicensing arrangement between AgeX and ImStem is
a continuation of AgeX’s strategy to expand access to its ESI stem
cell lines for use in the generation of cellular therapies. An
ImStem publication in Stem Cell Reports (2014;3:115-130) showed in
a mouse model of multiple sclerosis that MSCs derived from ESCs
outperformed adult bone marrow MSCs. This ultimately led to
research and commercial sublicense agreements for the ESI-053 ESC
line by ImStem to develop IMS001 as an allogeneic, off-the-shelf
and industrially scalable MSC product candidate. Earlier this year,
the FDA cleared an IND application for IMS001 in multiple
sclerosis. IMS001 is believed to be the first MSC product derived
from an ESC line to be accepted for a human trial by the FDA.
Results from early clinical studies conducted in China by
unrelated groups using different MSC products suggest MSCs warrant
further exploration in COVID-19. First, a human study published in
Aging and Disease (2020;11:216-228) showed that an intravenous
infusion of adult-derived MSCs reduced COVID-19 symptoms and
improved functional outcomes in seven treated patients with
COVID-19 pneumonia. The MSCs appeared to be safe and well
tolerated. Second, a clinical study published in Stem Cell Research
& Therapy (2020;11:361) demonstrated that 12 severe COVID-19
patients who received an infusion of umbilical cord MSCs recovered
without requiring mechanical ventilation and were discharged home.
Even before being explored in COVID-19, MSCs were being
investigated as a therapeutic option in ARDS, and emerging data in
preclinical models is encouraging. However, the manufacturing
scalability of adult MSCs may limit their use. ARDS is a
respiratory condition characterized by inflammation and increased
endothelial and epithelial permeability to protein, leading to
fluid accumulation in the lungs, hemorrhage, cell injury, diffuse
alveolar damage, and blockage of oxygen from getting to vital
organs. ARDS affects around 200,000 patients in the U.S. every
year, accounts for 10% of intensive care admissions, and has a
mortality of approximately 40%, with 75,000 deaths in the U.S.
annually. No specific direct therapies exist for ARDS and only
supportive treatment is available.
“The COVID-19 pandemic continues to impact hundreds of millions
of people, with many countries now in the midst of a second wave.
Antivirals, antibodies and cell therapies may all ultimately play a
role in combating this disease, depending upon severity or stage.
We are glad to expand our relationship with ImStem, so it can now
utilize AgeX’s ESI-053 stem cell line to develop its cell therapy
candidate IMS001 for COVID-19 as well as acute respiratory distress
syndrome more broadly,” said Dr. Nafees Malik, Chief Operating
Officer of AgeX. “This latest sublicense is an example of AgeX’s
strategy to place our technologies in the hands of high-quality
industry and academic partners, with this deal marking the sixth
research and commercial arrangement AgeX has entered into this
year.”
The ESI stem cell lines are distinguished as the first
clinical-grade human pluripotent stem cell lines created under
current Good Manufacturing Practice as described in Cell Stem Cell
(2007;1:490-4). They are listed on the National Institutes of
Health (NIH) Stem Cell Registry and are among the best
characterized and documented stem cell lines in the world. ESI
cells are among only a few pluripotent stem cell lines from which a
derived cell therapy product candidate has been granted FDA IND
clearance for human studies.
“We welcome the opportunity to continue to collaborate with AgeX
and explore future development of our mesenchymal stem cell IMS001
product in COVID-19 and ARDS from other causes. Importantly, our
product may overcome the important issue of limited manufacturing
scalability associated with adult tissue derived MSCs,” commented
Xiaofang Wang, M.D., Chief Technology Officer of ImStem
Biotechnology.
About AgeX Therapeutics
AgeX Therapeutics, Inc. (NYSE American: AGE) is focused on
developing innovative regenerative therapeutics to treat human
diseases to increase healthspan and combat the effects of aging.
AgeX’s 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. HyStem® is AgeX’s delivery technology intended to stably
engraft PureStem® derived cell therapies in the body. 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 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, please visit www.imstem.com.
About ES Cell International
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. 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 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. In addition, with respect to AgeX’s sublicense agreement
with ImStem there is no assurance that (i) ImStem will be
successful in developing therapeutic products from the ESI-053 stem
cell line sublicensed from AgeX or that any therapeutic products
that may be developed will receive FDA or foreign regulatory
approval, (ii) any therapeutic products that may be developed will
be successfully commercialized, or (iii) AgeX will derive revenue
or other financial benefits from the sublicense agreement. 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/20201028005451/en/
Contact for AgeX Andrea Park Chief Financial Officer AgeX
Therapeutics, Inc. Tel: (510) 671-8620 apark@agexinc.com
Contact for ImStem Investor Relations Tel: (860) 281-7836
ir@imstem.com
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