Allows industry and academia access to cGMP-grade, NIH-registered AgeX ESI human pluripotent stem cells for development of cellular therapeutics
AgeX ESI cell lines are among only a few pluripotent stem cell lines from which derived cell therapy candidates have been granted FDA IND clearance to begin human trials
Pluristyx will manufacture, market, and distribute Ready-to-Use™ and Ready-to-Differentiate™ ESI stem cell lines vialed and frozen on behalf of AgeX
AgeX Therapeutics, Inc. ("AgeX": NYSE American: AGE), a biotechnology company developing therapeutics for human aging and regeneration, and Pluristyx, Inc. (Seattle, WA), an advanced therapy tools and services company serving customers in the rapidly growing fields of regenerative medicine and cellular and gene therapies, today announced they have entered into a Manufacturing, Marketing, and Distribution Agreement through which Pluristyx will undertake these activities on behalf of AgeX with respect to AgeX’s research- and clinical-grade ESI brand human embryonic stem cells, sometimes referred to as hESCs.
The agreement builds on Pluristyx’s strategy to manufacture, market, and distribute high-quality standardized Ready-to-Use™ and Ready-to-Differentiate™ pluripotent stem cells to industry and academic scientists intent on developing therapeutic products to treat human disease. AgeX’s ESI hESC lines are distinguished for being the first clinical-grade hESC lines created under current Good Manufacturing Practice (cGMP). The AgeX ESI hESC lines are listed on the National Institutes of Health (NIH) Stem Cell Registry and are among the best characterized and documented stem cell lines available worldwide.
The agreement is a key step in AgeX’s licensing and collaboration strategy to facilitate industry and academic access to its hESC lines, its PureStem® cell derivation and manufacturing platform, and its UniverCyte™ immunotolerance technology in order to generate near- and long-term revenues.
"A recent FDA IND clearance for a biotech company to begin a human trial for a cell therapy candidate derived from an AgeX ESI hESC line has amplified interest from industry and academia to utilize our cells in regenerative medicine. It is AgeX’s goal to make its cell lines the gold standard when it comes to therapeutic products derived from pluripotent stem cells. We are delighted to be working with the Pluristyx team given their extensive cGMP manufacturing experience with pluripotent stem cells," said Dr. Nafees Malik, Chief Operating Officer of AgeX.
"Pluristyx is excited to be working with AgeX and their ESI hESC lines. As AgeX intends to make their cell lines the gold standard, our aim is to disrupt and redefine stem cell therapy manufacturing with our proprietary, high-density format, Ready-to-Use™ and Ready-to-Differentiate™ hESC lines, which will dramatically reduce both cost and time in translating revolutionary therapies from bench to bedside," said Dr. Benjamin Fryer, CEO of Pluristyx.
Academic and biopharma organizations will need to obtain separate commercial licenses from AgeX in order to advance their cellular product candidates generated from AgeX hESC lines into human clinical trials and commercialization. AgeX retains all rights to manufacture its own in-house cellular products as well as to extend license rights to other third parties.
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’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.
Established in 2018, Pluristyx Inc. is a privately held, early-stage company providing a complete cell manufacturing solution. As an advanced therapy tools company, Pluristyx helps companies and researchers solve manufacturing challenges in the field of drug development, regenerative medicine, and cell and gene therapy. Pluristyx is led by a team with decades of industry experience each with specific expertise in key areas needed to develop and manufacture pluripotent stem cells. Pluristyx provides know how in every stage of the process from cell banking through scale-up of clinical grade material as well as all aspects of process development and manufacturing.
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 Manufacturing, Marketing and Distribution Agreement with Pluristyx there is no assurance that (i) Pluristyx will generate significant sales of AgeX ESI hESC lines, or (ii) AgeX will derive significant revenue from sales of ESI hESC lines by Pluristyx. 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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Media Contact for AgeX
Chief Financial Officer
AgeX Therapeutics, Inc.
Media Contact for Pluristyx
Kaye Reiter, PhD, JD