SAN DIEGO & NEWARK, Del.—ViaCyte, Inc. and W. L. Gore & Associates, Inc. have announced the signing of an agreement covering the next phase of their ongoing collaboration, which is focused on the development of ViaCyte’s Encaptra Cell Delivery System. The system is enabled by proprietary Gore material technologies.
“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.”
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; it has been evaluated in preclinical studies with excellent results.
Gore will also 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 — PEC-01 cells. These cells are contained within the Encaptra system and subcutaneously implanted into a patient. Once implanted and successfully engrafted, the PEC-01 cells mature into beta cells which 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.
The Encaptra system has the potential to negate the need for immunosuppression, and is an important component of the PEC-Encap product candidate. ViaCyte is developing PEC-Encap 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 and JDRF.
“Our collaboration with ViaCyte has been very productive in enabling the clinical advancement of the PEC-Encap product candidate with proprietary Gore materials technology. 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,” noted Erin Hutchinson, Ph.D., business leader of Gore’s PharmBIO Cell Encapsulation Products.
Gore and ViaCyte began their collaboration in 2017. Since the partnership began, ViaCyte and Gore have shown improved engraftment, reduction of foreign body response and good function of the PEC-Encap product candidate in preclinical models. 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.
ViaCyte is reportedly 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 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.