ViaCyte and Gore Develop Collaboration to Develop Novel Membrane and Machine Applied sciences that Improve Supply of Cell Substitute Therapies for Diabetes

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SAN DIEGO and NEWARK, Del., March 2, 2021 / PRNewswire / – ViaCyte, Inc., a clinical-stage regenerative medicine company, and WL Gore & Associates, Inc. (“Gore”), a leading global materials science company with expertise in medical device and drug delivery technologies, announced today that Two Companies have signed an expanded joint development agreement to develop and use proprietary Gore materials and device features to further optimize ViaCyte’s product candidate portfolio for the treatment of diabetes. ViaCyte has shown that if transplanted successfully, cells 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 on our platform, including open and closed devices, and its proprietary capabilities, to pave our way for a commercial cell-based therapy product,” he said Ian Smith, Executive Chairman of ViaCyte. “Initial clinical studies suggest that Gore’s novel membrane technology can aid in the transplantation and proliferation of pancreatic beta cells while minimizing the host’s foreign body response. We look forward to sharing these results with clinical results for the first patient population later this year to confirm.”

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

The closed encapsulation system was jointly developed by ViaCyte and Gore to improve transplantation, survival, and overall function of the implanted cells by reducing the host host’s response and providing protection against 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 that is implanted subcutaneously. ViaCyte has shown that after implantation and successful transplant, cells mature into beta cells that secrete insulin, alpha cells that secrete glucagon, and other cells in the human pancreas that naturally control blood sugar levels . The closed encapsulation system is designed to protect the cells from the patient’s immune system, thereby eliminating the need for immune suppression drugs that are commonly used in other transplants. ViaCyte is the only company that has shown in clinical studies that implanted islet cells, other than stem cells, can produce insulin in T1D patients.

“Our collaboration with ViaCyte is a great example of how Gore’s leading expertise in materials science and medical devices can be applied to complex medical problems,” he said Lauren Zambotti, Technical Director, Gore PharmBIO Cell Encapsulation Products. “We are excited to use Gore’s skills to further develop materials and devices to optimize biological activity with ViaCyte’s cell therapy. Together we have the potential to change the lives of people with diabetes.”

ViaCyte and Gore have shown that the encapsulation system, which incorporates Gore’s novel membrane technologies, reduces foreign body reaction and improves transplantation, cell survival and function in both clinical trials and preclinical models. Data from the Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT04678557) of the first product candidate with the new Gore membrane (VC01-103) is expected in the second half of the year.

About Gore

WL Gore & Associates is a global materials science company dedicated to transforming industry and improving lives. Since 1958, Gore has solved complex technical challenges in demanding environments – from space to the highest peaks in the world to the inner workings of the human body. With more than 10,500 employees and a strong, team-oriented culture, Gore has annual sales 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 made from pluripotent stem cells and medical device systems for encapsulating and implanting cells. ViaCyte has the ability to use any technology individually or together to address critical human diseases and disorders that may be treated by replacing lost or defective 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 goals and reduce the risk of hypoglycemia and diabetes-related complications. To accelerate and expand the company’s efforts, ViaCyte has partnered with leading companies including CRISPR Therapeutics and WL Gore & Associates. ViaCyte is headquartered in San Diego, California. More information is available at www.viacyte.com. Connect with ViaCyte on Twitter, Facebook and LinkedIn.

SOURCE ViaCyte, Inc.

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