AgeX Therapeutics and Lineage Cell Therapeutics awarded US patent for ‘Method of Generating Induced Pluripotent Stem Cells’.

AgeX Therapeutics, Inc. and Lineage Cell Therapeutics, Inc. today announced that the United States Patent and Trademark Office (USPTO) has issued US Patent No. 10,501,723, entitled “Methods of Reprogramming Animal Somatic Cells” covering what is commonly designated “induced Pluripotent Stem” (iPS) cells. The issued claims include methods to manufacture pluripotent cells capable of becoming any cell in the body. The patent has an early priority date, having been filed before the first scientific publication of Shinya Yamanaka, for which he won the Nobel Prize for Physiology or Medicine in 2012.

“This patent broadly describes multiple techniques for reprogramming cells of the body back to the all-powerful stem cell state,” said Dr Michael D West, CEO of AgeX and first inventor on the patent. “Perhaps more significantly, it includes certain factors that address some of the difficulties currently encountered with iPS cells. It also reflects the foundational work our scientists have undertaken to apply reprogramming technology to age-reversal, specifically, induced Tissue Regeneration (iTR) which is currently a focus of AgeX product development.” This video describes the significance of the patent in AgeX’s product development:

Induced Pluripotent Stem Cells (iPS) are typically derived from adult skin or blood cells which have been “reprogrammed” or “induced” to retrace their developmental age and regain the potential to form all of the young cell and tissue types of the body. In 2010 inventors of the -723 patent issued today demonstrated that this reversal of developmental aging even extended to the telomere clock of cell aging.

This reprogramming technology provides an alternate source of starting material for the manufacture of potentially any type of human cell needed for therapeutic purposes. Because iPSCs can be derived directly from adult tissues, they can be used to generate pluripotent cells from patients with known genetic abnormalities for drug discovery or as an alternative source of cell types for regenerative therapies.

“The issuance of this patent highlights Lineage’s dominant position in the field of cell therapy,” stated Brian M Culley, CEO of Lineage. “Our efforts to develop new treatments rely on well-characterized and NIH-approved human cell lines. These lines are not genetically manipulated, which avoids the safety concerns associated with genetic aberrations arising from the creation of iPS cells.

We believe the Lineage cell lines provide the safest option for our current clinical-stage programs, particularly in immune-privileged anatomical sites such as the eye (OpRegen^® for the treatment of dry AMD) and spinal cord (OPC1, for the treatment of spinal cord injury).

However, the vast intellectual property estate which underlies our cell therapy platform has never been limited to these particular cell lines. As one example, this newly-issued patent provides us with proprietary methods for producing induced pluripotent stem cells, or, as it was practiced by us prior to Yamanaka, Analytical Reprogramming Technology (ART). In certain settings, an ART/iPS approach might offer important advantages, such as for an autologous treatment or when the selection of preferential attributes from a series of iPS lines is desirable.

Questions as to which stem cell technology is preferred ultimately will be answered by clinical safety and efficacy and likely will be indication-specific, so we believe it is in the best interest of our shareholders to generate patented technology which enables us to pursue programs in either or both formats which we believe will ensure the highest probability of success.”

US Patent No. 10,501,723, entitled “Methods of Reprogramming Animal Somatic Cells” was assigned to Advanced Cell Technology of Marlborough, Massachusetts (now Astellas Institute for Regenerative Medicine) and licensed to Lineage and sublicensed to AgeX Therapeutics for defined fields of use. Inventors of the patent include Michael D West, CEO of AgeX and previous CEO of Advanced Cell Technology, Karen B Chapman, PhD, and Roy Geoffrey Sargent, PhD.