AgeX Therapeutics & ImStem Biotechnology Sign Non-Binding Letter of Intent Regarding Investigational MSC Candidate IMS001 for...
02 June 2020 - 10:00PM
Business Wire
- Emerging preclinical and clinical literature support MSCs may
be appropriate to develop for COVID-19 as well as non-COVID-19
ARDS
- ImStem’s investigational MSC candidate IMS001, for which FDA
recently removed a clinical hold on an IND to begin a human study
in multiple sclerosis, to be considered for further development in
COVID19 and ARDS from other causes
- IMS001 is derived from AgeX human embryonic stem cell line ESI
053
AgeX Therapeutics, Inc. (“AgeX”: NYSE American: AGE), a
biotechnology company developing therapeutics for human aging and
regeneration, and ImStem Biotechnology, Inc., a biopharmaceutical
company developing human embryonic stem cell-derived mesenchymal
stem cells (hES-MSC), today announced their signing of a
non-binding letter of intent for ImStem to obtain from AgeX a
non-exclusive license to use AgeX’s embryonic stem cell line ESI
053 to derive ImStem’s investigational MSC product IMS001 for
development in COVID-19 as well as acute respiratory distress
syndrome (ARDS) due to other causes. AgeX and ImStem are
co-operating to finalize financial terms and other provisions of a
license agreement.
ImStem has previously used AgeX ESI 053 to derive the ImStem
IMS001 product which is being investigated for multiple sclerosis
under an IND. Earlier this year, the U.S. Food and Drug
Administration (FDA) cleared IMS001 to begin a Phase 1 clinical
study in patients with multiple sclerosis, after a clinical hold on
its Investigational New Drug (IND) application was removed. This is
believed to be the first MSC product derived from human embryonic
stem cells to be accepted for a clinical trial by the FDA. AgeX and
ImStem already have a commercial license in place, which grants
ImStem rights to use AgeX’s ESI 053 to derive IMS001 as a product
candidate for development in autoimmune disease, including multiple
sclerosis.
To date, in patients with pneumonia and ARDS due to COVID-19,
preliminary literature suggests MSCs, such as ImStem’s hES-MSC
candidate IMS001, may warrant further development consideration. An
early clinical study conducted in China by an unrelated group with
a different MSC product, “Transplantation of ACE2- Mesenchymal Stem
Cells Improves the Outcome of Patients with COVID-19 Pneumonia,”
and published in Aging and Disease (2020, Vol. 11, No. 2, pp.
216-228) showed that an intravenous infusion of a different MSC
product appeared safe and improved functional outcomes in seven
treated patients with COVID-19 pneumonia. MSCs are well recognized
to be immunomodulatory in nature, possessing immunosuppressive and
anti-inflammatory properties.
Even before their application to COVID-19, MSCs were being
investigated as a potential therapeutic option in ARDS, and
emerging data in preclinical models has been encouraging. ARDS
remains an area of considerable unmet medical need, affecting
around 200,000 patients annually in the U.S., accounting for 10% of
all intensive care unit patients, and having a mortality of
approximately 40%. At the present time, no specific direct
therapies exist for ARDS and only supportive treatment is
available.
“We feel privileged to be part of a global effort to combat
COVID-19. This is a unique opportunity for AgeX to leverage its
resources to help with the public health challenge at hand. Decades
of pioneering work with human embryonic stem cells means this
technology is now at a point where it may play a role in the
development of a cell-based approach to combating COVID-19. We are
very excited by the prospect of expanding our relationship with
ImStem to include COVID-19 and ARDS,” said Dr. Nafees Malik, Chief
Operating Officer of AgeX.
“We welcome the opportunity to continue to collaborate with AgeX
and explore future development of our IMS001 product in COVID-19
and ARDS from other causes,” commented Richard Kim, M.D., Chief
Medical Officer of ImStem Biotechnology.
About AgeX Therapeutics
AgeX Therapeutics, Inc. (NYSE American: AGE) is focused on
developing and commercializing innovative therapeutics for human
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. 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 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 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 letter of intent with
ImStem there is no assurance that (i) AgeX and ImStem will
successfully conclude negotiations and enter into a license
agreement; (ii) ImStem will be successful in developing any
therapeutic products from a stem cell line licensed by AgeX or that
any therapeutic product that may be developed will receive FDA or
foreign regulatory approval, or (iii) AgeX will derive revenue or
other financial benefits from any license agreement that might be
signed with ImStem. 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/20200602005353/en/
Media Contact for AgeX Andrea Park Chief Financial
Officer AgeX Therapeutics, Inc. Tel: (510) 671-8620
apark@agexinc.com
Media Contact for ImStem Investor Relations Tel: (860)
281-7836 ir@imstem.com
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