ViaCyte, Inc. and Newark-based W. L. Gore & Associates, Inc. announced the two companies have signed an agreement covering the next phase of their collaboration focused on the development of ViaCytes Encaptra Cell Delivery System that uses Gore material technologies.
The technology is designed to produce insulin for patients with Type I diabetes, formerly known as juvenile diabetes.
The Encaptra System could be a transformative therapy for patients with type 1 diabetes, the companies noted.
Tapping into Gores 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, CEO 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, 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 Companys promising candidates have the potential to deliver a functional cure for people with type 1 diabetes and could be an advancement for people with insulin-requiring type 2 diabetes.
Under the terms of the agreement, Gore will manufacture and supply a proprietary membrane and the device component for use with ViaCytes PEC-Encap product candidate.
The novel Gore membrane has been evaluated in preclinical studies. 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.
ViaCyte has shown that once implanted and successfully engrafted PEC-01 cells mature into beta cells that secrete insulin in a regulated manner to control blood glucose levels. 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.
The Encaptra System membrane is composed of an expanded PTFE composite, similar to materials that are used in Gores implantable medical products..
Gore and ViaCyte began a collaboration in 2017.
ViaCyte is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF. ViaCyte is headquartered in San Diego.