Program will utilize AgeX’s proprietary PureStem® cell derivation and manufacturing technology platform
Goal of developing cellular therapies for Huntington’s disease and potentially Parkinson’s, Alzheimer’s and other neurological conditions
Builds on University’s research in neural stem cell transplantation for Huntington’s disease, including safety and efficacy animal data that may support an IND submission as early as 2021
AgeX Therapeutics, Inc. ("AgeX"; NYSE American: AGE), a biotechnology company focused on developing therapeutics for human aging and regeneration, announced a research collaboration with the University of California, Irvine (UCI) using AgeX’s PureStem® technology to derive neural stem cells, with the goal of developing cellular therapies to treat neurological disorders and diseases for which there are no cures. The collaboration’s initial R&D work, expected to take approximately one year, will be conducted in the UCI laboratory of Leslie Thompson, PhD, Chancellor’s Professor of Psychiatry & Human Behavior and Neurobiology & Behavior, a leading researcher in the field of Huntington’s disease and other neurological disorders, under a Sponsored Research Agreement handled by the Industry Sponsored Research team at UCI Beall Applied Innovation. The initial focus will be on Huntington’s disease, while other potential targets may include Parkinson’s, Alzheimer’s, and stroke.
The primary goal of the research will be to develop a robust method of deriving neural stem cells from pluripotent stem cells in sufficient quantity and with sufficient purity and identity for use in cell-based therapy. Professor Thompson’s laboratory has already accumulated safety and efficacy animal data that may support an IND submission to the FDA as early as 2021 for the commencement of clinical trials to treat Huntington’s disease.
"We look forward to utilizing AgeX’s cell derivation and manufacturing PureStem technology, with its many potential advantages, including industrial scalable manufacturing, lower cost of goods, and clonal cells with high purity and identity. Our goal is to have an improved neural stem cell production method ready within a year to move into clinical development," said Professor Thompson.
"We are absolutely delighted to start this exciting collaboration with Professor Thompson, who has worked tirelessly over her career to develop a neural stem cell product candidate for Huntington’s disease and who has already generated preclinical animal data that may support the initiation of clinical studies," said Dr. Nafees Malik, Chief Operating Officer of AgeX. "Moreover, we are very excited to be entering the field of neurology, which has huge clinical and commercial potential. Neural stem cells may be very useful in other neurological disorders that are common in aging demographics, such as Parkinson’s, Alzheimer’s and stroke."
"This is an example of the kind of collaboration we will be seeking under our newly-unveiled collaboration and licensing strategy, which is to run parallel to our in-house product development," said Dr. Greg Bailey, Chair of AgeX. "We will be collaborating with a world leader in their field on a research project which is close to the clinic."
The collaboration includes an opportunity for AgeX to organize a company to be jointly owned with Professor Thompson and other researchers to pursue clinical development and commercialization of cell therapies derived using licensed inventions arising from the research program, as well as certain patent pending technology for neural stem cell derivation, and certain technical data, including animal data, to support IND submissions.
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.
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 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). Further, in the case of AgeX’s new neural stem cell program there can be no assurance that: (i) any new cell derivation methods will be invented in the sponsored research program, (ii) any derivation methods that may be developed will be sufficient to derive neural stem cells in quantities and of purity suitable for clinical use and commercialization, (iii) that any new inventions or existing technology will be licensed on commercially favorable terms, (iv) that any neural stem cells derived for therapeutic use will be shown to be safe and effective in clinical trials, and (v) that any neural stem cells derived for therapeutic use will be successfully commercialized even if clinical trials are successful. Subsequent events and developments may cause these forward-looking statements to change. 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200203005261/en/