AgeX Therapeutics Sublicenses Stem Cell Line ESI-053 to ImStem Biotechnology for Development of Cell Therapy Candidate IMS001 for COVID-19 and Acute Respiratory Distress Syndrome

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.