SAN DIEGO, October 4, 2016 — ViaCyte, Inc., a privately-held regenerative medicine company with the first pluripotent stem cell-derived islet replacement therapy for the treatment of type 1 diabetes in clinical-stage development, today announced a presentation at the 2016 Cell and Gene Meeting on the Mesa. ViaCyte’s President and CEO, Paul Laikind, Ph.D., will provide a corporate update on Thursday, October 6 at 1:15 pm PDT. The conference will be held October 5-7 at the Estancia La Jolla Hotel & Spa in La Jolla, California.
ViaCyte is advancing two novel cell replacement therapies as potential long-term type 1 diabetes treatments. The Company’s potential breakthrough treatment for high-risk type 1 diabetes, called PEC-DirectTM, which recently received a $3.9 million grant from CIRM, is expected to begin clinical trials early next year. ViaCyte’s PEC-EncapTM (also known as VC-01TM) product candidate is the first pluripotent stem cell-derived islet cell replacement therapy for the treatment of type 1 diabetes in clinical-stage development.
Both the PEC-Direct and PEC-Encap product candidates deliver the same PEC-01 pancreatic progenitor cells as the active ingredient. The primary difference between the product candidates is the delivery vehicle. The PEC-Encap product candidate delivers the cells using the Encaptra® drug delivery system which is designed to protect the cells from the patient’s adaptive immune system. In contrast, the PEC-Direct product candidate delivers the PEC-01 cells in a device designed to allow direct vascularization of the cells.
With PEC-Direct, the direct vascularization is expected to allow for 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 organ transplants, will require chronic immune suppression. Thus it is being developed to treat patients with type 1 diabetes that are at high risk for acute complications such as severe hypoglycemic episodes, including patients with extreme glycemic lability and/or impaired awareness of hypoglycemia.
Patients with this type of high-risk type 1 diabetes can be eligible for a cadaver islet transplant procedure, which is often highly effective, but is limited by a severe lack of donor tissue. We believe the PEC-Direct product candidate could overcome the limitations of islet transplant by providing an unlimited supply of cells, manufactured under cGMP conditions, and a potentially safer, more optimal route of administration.
Dr. Laikind said, “The PEC-Direct product candidate further leverages the extensive work we have done with PEC-01 cells and benefits from information gained during the ongoing clinical evaluation of the PEC-Encap product candidate. We believe that PEC-Direct development will advance more quickly due to the nature of the product candidate and the likelihood for accelerated conditions, given the breakthrough nature of the approach, and the severe patient need.”
Clinical development of the PEC-Encap product candidate is continuing with sub-therapeutic dosing. The product candidate has thus far been safe and well-tolerated, the Encaptra Device appears to be protecting the delivered cells against rejection by the immune system as intended, and long-term cell viability has been demonstrated. Further preclinical and clinical work is underway to improve engraftment with a focus on making it more robust and consistent.
Dr. Laikind noted, “If approved, we expect that the PEC-Direct product candidate will be a first-generation treatment, indicated for high risk type 1 patients, while the PEC-Encap product candidate will follow as a second-generation therapy that expands the functional cure that we believe these product candidates can deliver to the larger population of all patients with type 1 diabetes.”
The presentation will be webcast live at: http://www.meetingonthemesa.com/webcast/.
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.