ViaCyte is developing PEC-Direct to address the urgent medical need of high-risk type 1 diabetes and provide a potentially life-saving therapy
SAN DIEGO, December 6, 2017 – ViaCyte today announced that CONNECT, a premier innovation company accelerator in San Diego that creates and scales great companies in the technology and life sciences sectors, is a winner of the 30th annual Most Innovative New Product Awards for the company’s PEC-Direct product candidate. The prestigious competition, which begins each year in the spring and culminates in the awards ceremony at the end of the year, is an annual signature event at CONNECT that recognizes and lauds stars of innovation and their latest groundbreaking products.
“The team at ViaCyte is thrilled to have our dedication, leadership, and innovation recognized by CONNECT’s prestigious Most Innovative New Product Award. This award acknowledges how ViaCyte has continually broken new ground in stem cell research, medical device engineering, and cell therapy scaling and manufacturing,” said Paul Laikind, PhD, President and Chief Executive Officer of ViaCyte. “With breakthrough technology, clinical stage product candidates, an extensive intellectual property estate, and a strong and dedicated team, ViaCyte has all the pieces to advance a transformative new life-saving approach that could help hundreds of thousands of people with high-risk type 1 diabetes around the world.”
The PEC-Direct product candidate is being developed for patients with high-risk type 1 diabetes, who often experience life-threatening acute complications, such as hypoglycemia unawareness and severe hypoglycemic episodes. PEC-Direct could also be important for patients that have undergone a kidney transplant as a result of diabetic complications. The PEC-Direct product candidate delivers stem cell-derived PEC-01 pancreatic progenitor cells in a device designed to allow direct vascularization of the cells, which is expected to allow for a robust engraftment and cellular performance similar to the anatomy of a normal islet. Given the open nature of the device, patients implanted with PEC-Direct, as with other transplants, would require immune suppression. After implantation, the cells are expected to mature into the full complement of islet cells, including insulin-producing beta cells, offering a potential functional cure for patients with high-risk type 1 diabetes. Besides being a potentially important advance for the patients with the greatest needs, PEC-Direct is also considered a stepping stone to cell therapy for all insulin requiring patients.
For more than a decade, ViaCyte has been developing innovative stem cell-derived cell replacement therapies with a focus on the treatment of insulin-requiring diabetes. The company was the first to describe directed differentiation of human pluripotent stem cells into pancreatic cells, and the first to demonstrate the differentiation of stem cell-derived pancreatic progenitor cells into glucose-responsive insulin-producing cells, both in vivo and in vitro. In addition, ViaCyte launched the first clinical trials for stem cell-derived islet replacement therapies for type 1 diabetes. PEC-Direct is currently being evaluated in a Phase 1/2 clinical trial at the UC San Diego School of Medicine’s Altman Clinical Trials Research Institute and other sites in the United States and Canada. It is estimated that about 140,000 people in United States and Canada have high-risk type 1 diabetes.
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 from stem cells, which are then implanted in a durable and retrievable cell delivery device. Once implanted and matured, these cells are designed to secrete insulin and other pancreatic hormones 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 who have severe hypoglycemic episodes, extreme glycemic lability, and/or impaired awareness of hypoglycemia. The PEC-Encap™ (also known as 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. The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF.
CONNECT is a premier innovation company accelerator in San Diego that creates and scales great companies in the technology and life sciences sectors. By creating an environment in which entrepreneurs and C-suite executives have access to the people, capital, and technology resources they need for success, CONNECT has assisted in the formation and development of more than 3,000 companies since 1985. Widely regarded as one of the world’s most successful organizations linking entrepreneurs and C-suite executives with the resources they need for the commercialization of innovative products and services; our program has been modeled in more than 50 regions around the world.