ViaCyte and Gore Expand Collaboration to Develop Novel Membrane and Device Technologies that Enhance Delivery of Cell Replacement Therapies for Diabetes

• Agreement extends research and clinical development across ViaCyte's full product portfolio and Gore's full materials and device proprietary technologies
• Preclinical and clinical studies show that novel membranes and devices designed and developed by the collaboration both improve engraftment and reduce body's immune reaction
• ViaCyte's Phase 2 clinical study of closed device featuring Gore's novel membrane technologies is now enrolling patients with data expected in second half of 2021

SAN DIEGO and NEWARK, Del., March 2, 2021 /PRNewswire/ -- 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 and drug delivery technologies, today announced the two companies have signed an expanded joint development agreement covering the development and use of proprietary Gore materials and device capabilities to further optimize ViaCyte's portfolio of product candidates for the treatment of diabetes. ViaCyte has demonstrated that when the cells successfully engraft, they produce both insulin and glucagon in T1D patients, a first in the field of cell therapy for diabetes.

"This agreement expands our relationship with Gore across our platform, including both open and closed devices, and across their proprietary capabilities to establish our path for a commercial cell-based therapy product," said Ian Smith, Executive Chairman of ViaCyte. "Initial clinical studies suggest Gore's novel membrane technology can support engraftment and pancreatic beta cell proliferation, while minimizing the host foreign body response, and we look forward to confirming these findings with clinical results on the first group of patients later this year."

ViaCyte is currently evaluating open and closed devices to deliver cell replacement therapies for type 1 diabetes (T1D) in Phase 2 clinical trials. These devices contain the cell therapy while enabling oxygen and nutrients to flow into the device and insulin, glucagon, and other hormones to flow out.

The closed encapsulation system was jointly developed by ViaCyte and Gore to improve engraftment, survival, and overall function of the implanted cells by mitigating the foreign body host response and providing protection from immune rejection. ViaCyte's stem cell platform is used to differentiate pluripotent stem cells into pancreatic cells. The cells are then contained in an encapsulation system, which is implanted subcutaneously. ViaCyte has shown that once implanted and successfully engrafted, the cells mature into beta cells that secrete insulin, alpha cells that secrete glucagon, and other cells of the human pancreas that naturally control blood glucose (sugar) levels. The closed encapsulation system is designed to protect the cells from the patient's immune system, thus eliminating the need for immune suppression drugs commonly used with other transplants. ViaCyte is the only company to show in clinical trials that implanted islet cells, differentiated from stem cells, are capable of producing insulin in T1D patients.

"Our collaboration with ViaCyte is a great example of how Gore's leading materials science and medical device expertise can be applied to complex medical problems," said Lauren Zambotti, Technical Leader, Gore PharmBIO Cell Encapsulation Products. "We're excited to leverage Gore's capabilities to further advance materials and devices for optimization of the biologic activity with ViaCyte's cell therapy. Together, we have the potential to transform the lives of people suffering from diabetes."

ViaCyte and Gore have shown that the encapsulation system, incorporating Gore's novel membrane technologies, reduces the foreign body response and improves engraftment, cell survival, and function in both clinical studies and preclinical models. Data from the Phase 2 clinical study (ClinicalTrials.gov Identifier: NCT04678557) of the first product candidate with the new Gore membrane (VC01-103) is expected in the second half of this year.

About Gore

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

About ViaCyte

ViaCyte is a privately held regenerative medicine company developing novel cell replacement therapies based on two major technological advances: cell replacement therapies derived from pluripotent stem cells and medical device systems for cell encapsulation and implantation. ViaCyte has the opportunity to use each technology individually or together to address critical human diseases and disorders that can potentially be treated by replacing lost or malfunctioning cells or proteins. The company's first product candidates are being developed as potential long-term treatments for type 1 diabetes patients to achieve glucose control targets and reduce the risk of hypoglycemia and diabetes-related complications. To accelerate and expand the company's efforts, ViaCyte has established collaborative partnerships with leading companies, including CRISPR Therapeutics and W.L. Gore & Associates. ViaCyte is headquartered in San Diego, California. For more information, please visit www.viacyte.com and connect with ViaCyte on Twitter, Facebook, and LinkedIn.

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SOURCE ViaCyte, Inc.