ViaCyte Awarded NIH SBIR Grant to Support In Vitro Development of Stem Cell-Derived Functional Human Pancreatic Beta Cells

SAN DIEGO, April 17, 2018 /PRNewswire/ -- ViaCyte, Inc., a privately held regenerative medicine company, today announced that it has been awarded a Small Business Innovative Research (SBIR) Phase II Award from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to support the further development of functional human beta cells in vitro. In addition to having the only islet cell replacement therapies in clinical-phase testing, ViaCyte continues to advance the field of differentiating pluripotent stem cells, including induced pluripotent stem cells, to optimize these therapies for type 1 diabetes and insulin-requiring type 2 diabetes. ViaCyte’s multipronged approach also includes engineering its well-characterized, regulatory-compliant CyT49 pluripotent stem cell line to be immune-evasive, which, if successful, would open up off-the-shelf therapeutic applications in a number of fields.

“With more than 15 years of research and development and a history of firsts, we are continuing to expand our leadership position as we have an unwavering commitment to bringing the first functional cure to type 1 diabetes patients,” said Paul Laikind, Ph.D., president and chief executive officer at ViaCyte. “At no other time in our company’s history have we been better positioned with our expert researchers and leadership team, progress in the clinic, strong patent portfolio, and ongoing grant awards to advance a cell therapy that could provide a functional cure for the millions who suffer from type 1 and insulin-requiring type 2 diabetes.”

The award is supporting a two-year project entitled, “Treatment of type 1 diabetes with human embryonic stem cell-derived pancreatic beta-like cells.” The principal investigator for the project is Kevin D’Amour, Ph.D., Vice President, Research and Chief Scientific Officer at ViaCyte, and the work will further expand research that was spearheaded by the Company’s Senior Director of Research, Alireza Rezania, Ph.D.

Dr. Rezania along with scientists from the University of British Columbia were the first to publish methods describing generation of glucose-responsive insulin-secreting human beta cells from both embryonic and induced pluripotent stem cells (Rezania et al., Nature Biotechnology, 2014, PMID: 25211370). Furthermore, ViaCyte has several patents, both issued and allowed, as well as pending applications, to protect the intellectual property around methods to manufacture functional human beta cells in vitro.

“We are tremendously grateful to the NIDDK for their support of our research characterizing pluripotent stem cell-derived human beta cells in vitro as well as our investigations into manufacturing methods for developing these cells into therapeutic products,” said Dr. D’Amour. “This SBIR funding will allow us to more completely explore and establish this more mature cell population as an additional option to our existing transformative cell therapies for type 1 and insulin-requiring type 2 diabetes.”

ViaCyte currently has two stem cell-derived product candidates in human clinical trials using pancreatic progenitor (PEC-01™) cells. 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 have been safe and well tolerated, and when suitably vascularized that the PEC-01 cells differentiate into endocrine islet tissue including insulin-expressing beta cells. In addition, clinical data indicate that the Encaptra cell delivery system will 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.

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