AgeX Therapeutics, Inc. (“AgeX”; NYSE American: AGE), a biotechnology company focused on developing therapeutics for human aging and regeneration, announced today that ImStem Biotechnology, Inc. (Farmington, CT), a biopharmaceutical company pioneering the development of mesenchymal stem cells (hES-MSC) derived from human embryonic stem cells has received notification from the U.S. Food and Drug Administration (FDA) that it has lifted the hold and cleared the Investigational New Drug (IND) application to evaluate IMS001 for the treatment of multiple sclerosis (MS). IMS001 was derived from the pluripotential cell line designated ESI-053 licensed from AgeX.
“Since pluripotent stem cells are capable of differentiating into all human cell types potentially genetically modified in any manner, they open the door to a wide array of new therapies,” stated Dr. Michael D. West, PhD, founder and CEO of AgeX. “This collaboration with ImStem is consistent with our aim to make our clinical-grade pluripotent stem cell banks widely available for diverse therapeutic applications.”
IMS001 is a formulation of cells derived from AgeX pluripotent stem cells induced to differentiate into mesenchymal cells (hES-MSC) and through a proprietary method using a trophoblast intermediate stage (hence also known as T-MSC) for the treatment of neurological, autoimmune, and rare orphan diseases. IMS001 is an investigational, allogeneic cell product to be administered intravenously to patients suffering from MS. ImStem believes this is the first hES-MSC based allogeneic cell therapy accepted for clinical trial by the FDA. ImStem plans to initiate a phase 1 clinical study in patients with relapsing-remitting, secondary, and primary progressive forms of MS in 2020 in the US.
“The clinical-grade pluripotent stem cell lines from AgeX were the first published GMP-compatible lines ever created,” said Xiaofang Wang, MD, PhD, Founder and Chief Technology Officer of ImStem. “As such, they have been widely distributed in the scientific community and demonstrated to meet the needs of industry for relatively rapid product development.”
About AgeX Therapeutics
AgeX Therapeutics, Inc. (NYSE American: AGE) is focused on developing and commercializing innovative therapeutics for human aging. Its 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 is developing its core product pipeline for use in the clinic to extend human healthspan and is seeking opportunities to establish licensing and collaboration agreements around its broad IP estate and proprietary technology platforms.
IMS001 is an investigational, allogeneic, hES-MSC that has undergone IND-enabling, preclinical biodistribution, engraftment, tumorigenicity, toxicology, immunogenicity, and pharmacology studies. IMS001 has demonstrated preclinical immunomodulatory activities, which may lead to potential therapeutic benefits in a wide array of neurological, autoimmune, and rare orphan diseases with high unmet medical needs.
Previously published in-vitro data, in collaboration with scientists at the University of Connecticut (UConn) Health, have demonstrated potential advantages of hESC-MSCs in terms of their immunomodulatory effects, as well as the potential to stabilize the blood-brain-barrier (BBB). These mechanistic properties may lead to therapeutic benefits in diseases such as MS, potentially reducing relapses, disability progression, and inducing disease arrest.
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.