ALAMEDA, Calif. & FARMINGTON, Conn.--(BUSINESS WIRE)--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.
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.