ViaCyte and Gore Enter Clinical Phase Agreement Based on Novel Membrane Technology for PEC-Encap Product Candidate
Clinical evaluation of PEC-Encap has resumed using sentinels created with the novel membrane; preclinical and initial clinical data suggest the novel membrane can mitigate the foreign body host response
SAN DIEGO and NEWARK, Delaware, August 5, 2020 – ViaCyte, Inc., a clinical stage regenerative medicine company, and W. L. Gore & Associates, Inc. (“Gore”), a leading global materials science company with expertise in medical device development and drug delivery technologies, today announced the two companies have signed an agreement covering the next phase of their ongoing collaboration focused on the development of ViaCyte’s Encaptra® Cell Delivery System enabled by proprietary Gore advanced material technologies. The Encaptra System has the potential to negate the need for immunosuppression and is an important component of the PEC-Encap™ product candidate (also known as VC-01) that ViaCyte is developing as a potential transformative therapy for patients with type 1 diabetes. The PEC-Encap program has received funding and research support from the California Institute for Regenerative Medicine (CIRM) and JDRF.
“Tapping into Gore’s world-class materials science and medical device expertise, new membrane technology was developed that appears to allow successful engraftment and beta cell proliferation, while minimizing the host foreign body response,” said Paul Laikind, Ph.D., President and Chief Executive Officer of ViaCyte. “This agreement is an important next step on our path towards a commercial product as well as a template for future agreements for additional work ViaCyte and Gore may do together on cell delivery technology.”
“Our collaboration with ViaCyte has been very productive in enabling the clinical advancement of the PEC-Encap product candidate with proprietary Gore materials technology,” said Erin Hutchinson, Ph.D., Business Leader, Gore PharmBIO Cell Encapsulation Products. “We are delighted to further strengthen our collaboration on the path to the delivery of a potentially functional curative product for those currently suffering with type 1 diabetes and help pioneer the new field of cell replacement therapy.”
ViaCyte is the only company with stem cell-derived islet replacement candidates undergoing clinical testing and the only group to show that the implanted cells are capable of producing insulin in people with type 1 diabetes. The Company’s promising candidates have the potential to deliver a functional cure for people with type 1 diabetes and a significant advancement for people with insulin-requiring type 2 diabetes.
Summary of Agreement
Under the terms of the agreement, Gore will manufacture and supply a proprietary Gore membrane and the device component for use with ViaCyte’s PEC-Encap product candidate. The novel Gore membrane was the result of targeted material development and prototyping during the collaboration to improve the engraftment and function of PEC-Encap and has been evaluated in preclinical studies with excellent results. In addition, under this agreement, Gore will continue to collaborate with ViaCyte to optimize the device design and implant techniques in support of human clinical trials. Early human clinical trials of PEC-Encap with the new membrane are underway and preliminary histological results are encouraging. Should the membrane prove successful in the ongoing trial, Gore will assume the responsibility for manufacturing the Encaptra System incorporating the novel membrane technology for late stage clinical development and commercial use.
The biologically active component of the PEC-Encap product candidate is stem cell-derived pancreatic islet cell progenitors, called PEC-01™ cells. These cells are contained within the Encaptra System and implanted in a patient subcutaneously. ViaCyte has shown that once implanted and successfully engrafted, the PEC-01 cells mature into beta cells that secrete insulin in a regulated manner to control blood glucose levels. Other cells of the normal human islet are also produced. The Encaptra System serves to protect the PEC-01 cells from the host immune system thus eliminating the need for immune suppression drugs commonly used with other transplants.
A critical enabling component of the Encaptra System that contains and protects the cells is a specifically designed semi-permeable membrane that encapsulates the cells but allows for diffusion of oxygen and nutrients into the device and insulin and other hormones out of the device and into the circulation. This membrane enables the formation of a vascular network on the surface of the device after implantation. The Encaptra System membrane is composed of an expanded PTFE composite, similar to materials that are used in Gore’s implantable medical products. The goal of the collaboration with Gore is to engineer and deliver materials and device designs that facilitate the vascularization by modifying the host foreign body response to the Encaptra System and maximize the engraftment of the PEC-01 cells.
Gore and ViaCyte began a collaboration in 2017 to combine Gore’s material science and implantable medical device expertise and ViaCyte’s preclinical and clinical experience with human cell replacement therapies to develop leading cell encapsulation technologies. Since the collaboration started, ViaCyte and Gore have shown improved engraftment, reduction of foreign body response, and good function of the PEC-Encap product candidate in pre-clinical models that, based on ViaCyte’s clinical experience, have been selected to reflect the biological response in patients. Initial results from ViaCyte’s clinical studies using the Encaptra System with the novel Gore membrane appear to support the ability of the membrane to overcome the foreign body response.
W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Since 1958, Gore has solved complex technical challenges in demanding environments — from outer space to the world’s highest peaks to the inner workings of the human body. With more than 10,500 Associates and a strong, team-oriented culture, Gore generates annual revenues of $3.7 billion. www.gore.com
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 directed differentiation of pluripotent stem cells into PEC-01 pancreatic islet progenitor cells, which are then implanted in durable and retrievable cell delivery devices. Over a decade ago, ViaCyte scientists were the first to report on the production of pancreatic cells from a stem cell starting point and the first to demonstrate in an animal model of diabetes that, once implanted and matured, these cells secrete insulin and other pancreatic hormones in response to blood glucose levels and can be curative. More recently, ViaCyte demonstrated that when effectively engrafted, PEC-01 cells can mature into glucose-responsive insulin-producing cells in patients with type 1 diabetes. To accelerate and expand its efforts, ViaCyte has established collaborative partnerships with leading companies including CRISPR Therapeutics and W.L. Gore & Associates. ViaCyte is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF. ViaCyte is headquartered in San Diego, California.