Pharma Focus Asia

AgeX Therapeutics and Lineage Cell Therapeutics Announce Expansion of Agreement Related to ESI Clinical-grade Pluripotent Stem Cell Lines for Therapeutic Purposes

Thursday, September 10, 2020

AgeX Therapeutics, Inc., a company focused on developing and commercializing innovative therapeutics for human aging, and Lineage Cell Therapeutics, Inc., a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, and ES Cell International Pte Ltd. (ESI), a subsidiary of Lineage, announced the broadening of their collaborative relationship with regard to ESI stem cell lines. ESI cell lines are current Good Manufacturing Practice (cGMP)-compatible, registered with the National Institutes of Health (NIH), and widely studied as a potential source for the industrial-scale manufacture of any cell type in the human body. Neither party made or received any cash payments in connection with this arrangement.

“Both Lineage and AgeX are pioneering important aspects of regenerative medicine. Working together, we have amended our agreement regarding ESI cell lines derived under cGMP to be optimal for the business needs of each company,” stated Brian M. Culley, Lineage’s CEO. “In particular, Lineage has acquired exclusivity for the use of ESI cell lines in spinal cord injury and certain oncology indications. On the other hand, AgeX has gained greater flexibility and independence to support its efforts toward licensing certain technologies and cell lines to third parties. With this step complete, we next intend to explore additional opportunities to collaborate with AgeX on promising tissue regenerating projects.”

The ESI cell lines are recognized for being the first clinical-grade human pluripotent stem cell lines created under cGMP as described in the publication Cell Stem Cell (2007;1:490-4). It may become possible to generate potentially limitless quantities of all the cell types of the human body from these master cell banks with a wide array of potential therapeutic applications. These cell lines are listed on the NIH Stem Cell Registry and are among the best characterized and documented stem cell lines available globally. Importantly, ESI cells are among only a few pluripotent stem cell lines from which a derived cell therapy product candidate has been granted FDA investigational new drug (IND) clearance to commence human studies.

“Key to the creation of shareholder value is the placement of these important assets in the hands of collaborators to advance the development of a vast number of regenerative therapies,” said Michael West, Ph.D., AgeX’s CEO. “Our collaborative relationship with Lineage led to this streamlined process that may facilitate the commercialization of these applications to the benefit of shareholders of each company. Since the beginning of the year, AgeX has entered into new research and commercial arrangements utilizing an array of its technology platforms, such as UniverCyteTM for the engineering of universally transplantable cells, PureStem® for the manufacture and derivation of cells, and an ESI cell line as source material for deriving cellular therapeutics.”

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