ViaCyte Substantially Expands Patent Portfolio in Stem Cell-Derived Cell Replacement Therapies for Type 1 Diabetes and Other Indications

SAN DIEGO, April 17, 2018 /PRNewswire/ -- ViaCyte, Inc., a privately-held regenerative medicine company, today announced the recent issuance of more than 200 patents, which provide protection to the company's core technologies around the world.  The newly issued patents further strengthen ViaCyte's already strong position in pluripotent cell-derived and implantable cell replacement therapies for insulin-requiring diabetes and other potential indications.  The newly issued composition of matter, method, and design patents include over 110 patents in Europe, 18 patents in the US, 14 patents in Japan, and 52 patents in other Asian/Pacific countries including China, Hong Kong, Singapore, South Korea, and Australia. 

With the newly issued patents, ViaCyte's patent portfolio now includes over 700 issued patents worldwide, and protection in the space extends for the next two decades or more.  Many of the newly issued patents protect intellectual property that originated at Janssen Biotech, Inc., in its BetaLogics division, including patents directed to later stage pancreatic endocrine cells.  ViaCyte's acquisition of the BetaLogics assets in 2016 bolstered the Company's intellectual property portfolio substantially by combining the patent estates and know-how of the two leaders in the field.  

"ViaCyte's intellectual property covers directed differentiation to various cell types from numerous pluripotent stem cell sources, including embryonic and induced pluripotent stem cells, by multiple methods, as well as delivery and encapsulation devices for cell replacement therapies," said Paul Laikind, Ph.D., President and CEO of ViaCyte.  "Highlighted by the newly issued patents, we believe that ViaCyte has all of the elements it needs to successfully deliver transformative cell therapies for insulin-requiring diabetes, including cell and device platform technologies, know-how, expertise, intellectual property, and clinical and manufacturing experience." 

Notable amongst the numerous new patents are:

• Pluripotent stem cell suspension culture methods
• Pluripotent stem cell media
• Small molecules to support pluripotent stem cell growth
• Compositions and methods for culturing differentiable cells
• Mesendoderm composition
• Definitive endoderm composition
• Foregut endoderm composition
• In vitro differentiation of pluripotent stem cells to pancreatic endoderm and endocrine cells
• Encapsulation of pancreatic cells derived from pluripotent cells
• Large-capacity cell encapsulation delivery device
• Directly vascularized delivery device

While cadaver islet transplants can be highly effective in treating type 1 diabetes, the procedure is limited because of a severe lack of donor material.  To deliver a functional cure for all patients with type 1 diabetes and an important new therapy for patients with type 2 diabetes who require insulin to maintain control, ViaCyte is developing products with numerous potential advantages including a virtually unlimited supply of cells manufactured under quality-controlled conditions, and a potentially safer and more optimal route of administration. 

ViaCyte's PEC-Direct™ product candidate is in clinical development for patients with type 1 diabetes with the highest risk of life-threatening acute complications.  The related PEC-Encap™ product candidate, also being studied in the clinic, and a product candidate called PEC-QT™ based on the use of a gene-edited immune-evasive cell line, have the potential to provide a functional cure for essentially all patients with insulin-requiring diabetes, both type 1 and type 2.  

Following implant, ViaCyte's PEC-01™ pancreatic progenitor cells are designed to mature into human islet tissue, including glucose-responsive insulin-secreting beta cells and other cells of the islet responsible for regulating blood glucose.  Data from ViaCyte's clinical experience thus far suggest that its product candidates are safe and well-tolerated, and in the case of PEC-Encap, appear to prevent immune rejection and immune sensitization.

For further information on ViaCyte's clinical trials, please visit https://www.clinicaltrials.gov. 

About ViaCyte

ViaCyte is a privately-held regenerative medicine company developing novel cell replacement therapies as potential long-term diabetes treatments to achieve glucose control targets and reduce the risk of hypoglycemia and diabetes-related complications.  ViaCyte's product candidates are based on the derivation of pancreatic progenitor cells from stem cells, which are then implanted in durable and retrievable cell delivery devices.  Once implanted and matured, these cells are designed to secrete insulin and other pancreatic hormones in response to blood glucose levels.  ViaCyte has two product candidates in clinical-stage development.  The PEC-Direct™ product candidate delivers the pancreatic progenitor cells in a non-immunoprotective device and is being developed for type 1 diabetes patients who have hypoglycemia unawareness, extreme glycemic lability, and/or recurrent severe hypoglycemic episodes.  The PEC-Encap™ (also known as VC-01) product candidate delivers the same pancreatic progenitor cells in an immunoprotective device and is being developed for all patients with diabetes, type 1 and type 2, who use insulin.  ViaCyte is also developing immune-evasive 'universal donor' stem cell lines, from its proprietary CyT49 cell line, which are expected to further broaden the availability of cell therapy for diabetes and other indications.  ViaCyte is headquartered in San Diego, California.  The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF.  For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.

SOURCE ViaCyte, Inc.

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