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 , , , 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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