Twenty-two New Patents Are Added To ViaCyte's Intellectual Property Portfolio

SAN DIEGO, Jan. 4, 2017 /PRNewswire/ -- ViaCyte, Inc., a privately-held regenerative medicine company, today announced the addition of twenty-two new patents in 2016.  In early 2016 the Company announced the consolidation of the assets of the Janssen BetaLogics group into ViaCyte.  Five of the new patents originated in the BetaLogics group, while the other seventeen are from ViaCyte research and development activity.  Collectively, these composition, method, and design patents cover the full spectrum of ViaCyte's activities, strengthen the already robust combined intellectual property position, and further ensure the success of the Company in its efforts to develop a functional cure for insulin-requiring diabetes.

"These new patents further bolster our leadership in the field and protect the Company's PEC-Direct™ and PEC-Encap™ cell therapy product candidates and its delivery technologies for the treatment of type 1 diabetes," said Paul Laikind, PhD, President and CEO of ViaCyte.  "The current combined portfolio of ViaCyte and BetaLogics comprises more than 450 patents worldwide (more than 80 in the U.S.) and more than 700 pending applications covering drug delivery devices, human pluripotent stem (hPS) cells, and their differentiation to multiple cell types that have potential application for the treatment of many diseases.  With more than 15 years of research and development in this field, we are a leading company delivering novel cell replacement therapies, with an initial focus on developing a functional cure for patients with type 1 diabetes."

The Company's potential breakthrough treatment for high-risk type 1 diabetes, called PEC-Direct™, is expected to begin clinical trials early this year and is likely to be the Company's first product to be approved.  ViaCyte's PEC-Encap™ (also known as VC-01) product candidate is the first pluripotent stem cell-derived islet cell replacement therapy for the treatment of type 1 diabetes in clinical-stage development.  PEC-Encap™ has the potential to provide an important therapy for all patients that depend on insulin to control their disease.  ViaCyte's scientists are hard at work improving the delivery technology to achieve this important goal.  The new U.S. patents that issued in 2016 are:

Seven U.S. patents directed to the following compositions: 

• hPS cell culture with human serum (U.S. 9,267,110)
• hPS cell culture with an hPS cell-selective inhibitor or cytotoxic agent (U.S. 9,365,830)
• Low density hPS single cell cultures with a neurotransmitter or a structural analog thereof (U.S. 9,458,426)
• Human definitive endoderm and PDX1-positive foregut endoderm cell cultures in a medium comprising a TGF-β superfamily member and a retinoid (U.S. 9,499,795)
• Definitive endoderm cell culture with BSA, GDF-8, a proprietary compound, and IGF-1 or insulin (U.S. 9,528,090)
• 3-D cell encapsulating devices (U.S. 9,526,880) 
• Cell encapsulation loading systems (U.S. 9,433,557) 

Six U.S. patents directed to the following methods:

• Expanding hPS cells with insulin, transferrin, selenium, fatty-acid free albumin, a TGF-β ligand, βFGF, IGF-1, and ascorbic acid (U.S. 9,434,920)
• Producing pancreatic cells in glucose, a TGF-β ligand, a WNT activator, a FGF ligand, a shh inhibitor, a PKC activator, a retinoid, and a BMP inhibitor (U.S. 9,388,386)
• Producing pancreatic endocrine precursor cells with GDF-8, a GSK3B inhibitor, and a CYP26A inhibitor (U.S. 9,458,430)
• Producing INS and MAFA-positive pancreatic endocrine lineage cells with the cyclin-dependent kinase inhibitor ethyl-(6-hydroxy-4-phenylbenzo[4,5]furo[2,3-b])pyridine-3-carboxylate (U.S. 9,234,178)
• Producing pancreatic endocrine cells with a cyclic aniline-pyridinotriazine and GDF-8, GDF-11, or GDF-15 (U.S. 9,388,387)
• Enriching pancreatic endoderm cells with a ligand that binds CD142, CD55, CD57, or CD98 (U.S. 9,506,034)

Nine U.S. design patents directed to the following devices:

• Six ENCAPTRA® drug delivery systems (EDDS; U.S. DESIGN D747,467; D747,468; D747,798; D750,769; D750,770; D755,986)
• Case for EDDS (U.S. DESIGN D760,399)
• Surgical deployment tool for implanting EDDS (U.S. DESIGN D761,424)
• Surgical sizing tool for implanting EDDS (U.S. DESIGN D761,423 S)

Dr. Laikind will present an update on ViaCyte's product development at the 9^th Annual Biotech Showcase™ Conference, on Monday, January 9, 2017, at 2:30 pm in Room 1 of the Hilton San Francisco Union Square.

About ViaCyte

ViaCyte is a privately-held regenerative medicine company developing novel cell replacement therapies as potential long-term diabetes treatments to reduce the risk of hypoglycemia and diabetes-related complications.  ViaCyte's product candidates are based on the derivation of pancreatic progenitor cells, which are then implanted in a durable and retrievable encapsulation device.  Once implanted and matured, these cells are designed to secrete insulin and other regulatory factors in response to blood glucose levels.  ViaCyte has two products in 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 that have severe hypoglycemic episodes, extreme glycemic lability, and/or impaired hypoglycemia awareness.  The PEC-Encap (formerly VC-01) product candidate delivers pancreatic progenitor cells in an immunoprotective device and is currently being evaluated in a Phase 1/2 trial in patients with type 1 diabetes who have minimal to no insulin-producing beta cell function.  ViaCyte is headquartered in San Diego, California with additional operations in Athens, Georgia.  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 here: www.twitter.com/viacyte and www.facebook.com/viacyte.

SOURCE ViaCyte, Inc.

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