New York and San Diego, May 22, 2017 — ViaCyte, Inc., a privately-held leading regenerative medicine company, and JDRF, the leading global organization funding type 1 diabetes research, jointly announced today JDRF grant funding to support the development of the PEC-Direct™ islet cell replacement therapy being developed for type 1 diabetes patients with severe life-threatening hypoglycemia unawareness and related risks. Under the agreement, JDRF will provide a new grant to support the preclinical studies designed to enable the clinical evaluation of the PEC-Direct product candidate, and re-allocate a portion of a previously awarded grant to milestones anticipated with the upcoming clinical development of the PEC-Direct product candidate.
“With JDRF’s support, ViaCyte has achieved the important goal of advancing innovative islet replacement therapies into clinical trials,” said Aaron Kowalski, Ph.D., JDRF Chief Mission Officer. “We are excited to support the preclinical and clinical development work with the PEC-Direct product candidate, given its potential to help the type 1 diabetes patients with the most urgent medical need, those at high risk of life-threatening acute complications. In addition, we believe that success with PEC-Direct is an important step on the path to a functional cure for all patients with type 1 diabetes, helping to fulfill our commitment of turning Type One into Type None.”
The PEC-Direct product candidate delivers ViaCyte’s pluripotent cell-derived PEC-01™ pancreatic progenitor cells in an implantable device designed to allow direct vascularization of the cells. Used with concomitant maintenance immune suppression therapy, the PEC-Direct product candidate has the potential of delivering a sustained functional cure to a subset of patients with type 1 diabetes. This novel islet replacement therapy is being developed for people with high-risk type 1 diabetes with hypoglycemia unawareness, severe hypoglycemic episodes, and/or extreme glycemic lability (also referred to as brittle diabetes). It is estimated that approximately 140,000 people in Canada and the U.S. have such high-risk type 1 diabetes.
“We are tremendously grateful to JDRF for their continued support,” said Paul Laikind, Ph.D., president and chief executive officer of ViaCyte. “High-risk type 1 diabetes has been successfully treated with cadaver islet transplants, but adoption of islet transplants has been limited, due in part to the insufficient supply of donor material. Because ViaCyte’s PEC-01 cells are manufactured from pluripotent cells with unlimited proliferative potential, they can be made in vast numbers and therefore may be capable of solving the cell supply issue. The PEC-Direct product candidate has the potential to be a life-saving therapy, and we are working to rapidly advance it in clinical trials.”
JDRF is the leading global organization funding type 1 diabetes (T1D) research. JDRF’s mission is to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. To accomplish this, JDRF has invested more than $2 billion in research funding since its inception. JDRF is an organization built on a grassroots model of people connecting in their local communities, collaborating regionally for efficiency and broader fundraising impact, and uniting on a national stage to pool resources, passion, and energy. JDRF collaborates with academic institutions, policymakers, and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Its staff and volunteers throughout the United States and its six international affiliates are dedicated to advocacy, community engagement and JDRF’s vision of a world without T1D. For more information, please visit jdrf.org or follow JDRF on Twitter: @JDRF.
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 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.