– Proprietary cell therapy derived from pluripotent stem cells intended to replace insulin-producing pancreatic beta cells lost in type 1 diabetes (T1D)

– Encapsulated delivery of cells utilizes proprietary Gore material science technology specifically designed to protect cells from the body’s immune response, in order to improve engraftment, cell survival, and cell function

– Actively recruiting an initial cohort of 10 T1D patients and potential to recruit a total of 70 T1D patients to evaluate safety and efficacy; data anticipated in 2H 2021

SAN DIEGO, CA, USA I February 3, 2021 IViaCyte, Inc., a clinical-stage regenerative medicine company, today announced that the first type 1 diabetes (T1D) patients have been implanted in a Phase 2 clinical study utilizing encapsulated delivery of cells. The encapsulation system was developed in collaboration with W. L. Gore & Associates, Inc. (“Gore”), a global materials science company, to improve engraftment, cell survival, and overall function by mitigating the foreign body host response and providing protection from immune rejection. The study is actively recruiting and implanting patients and initial safety and efficacy data are anticipated in the second half of 2021.

“ViaCyte’s Phase 2 clinical program will advance a leading encapsulated cell therapy candidate intended to replace the insulin-producing cells lost in type 1 diabetes. ViaCyte has demonstrated that when our cells engraft, they produce both insulin and glucagon in T1D patients, a first in the field of cell therapy for diabetes,” said Howard Foyt, M.D., Ph.D., Chief Medical Officer of ViaCyte. “We look forward to confirming our preclinical and initial clinical data demonstrating that the new encapsulation delivery has the potential to reduce the foreign body response and improve engraftment, cell survival, and function, and potentially leading to therapeutic outcomes.”

“We are excited that the new encapsulation system developed with proprietary Gore materials technology is advancing in clinical studies,” said Emily C. Oliver, Product Specialist, Gore PharmBIO Cell Encapsulation Products. “By working closely with ViaCyte, Gore was able to develop a membrane that appears to allow successful engraftment and beta cell proliferation, while minimizing the host foreign body response and without the need for long term immunosuppression.”

The Phase 2 clinical study will evaluate safety, engraftment, and efficacy of ViaCyte’s encapsulated cell therapy candidate (VC01-103) in T1D patients (ClinicalTrials.gov Identifier: NCT04678557). ViaCyte plans to enroll an initial cohort of 10 patients in this open-label study, with the potential to expand enrollment to up to 70 patients. The study is actively recruiting T1D patients with safety and efficacy data expected in the second half of 2021.

ViaCyte’s stem cell platform is used to differentiate pluripotent stem cells into pancreatic cells which are placed 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 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

ViaCyte and Gore have shown that the encapsulation system, incorporating Gore advanced proprietary material technologies, reduces the foreign body response and improves engraftment, cell survival, and function in both clinical studies and pre-clinical models.

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 funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF. ViaCyte is headquartered in San Diego, California. For more, please visit www.viacyte.com and connect with ViaCyte on Twitter, Facebook, and LinkedIn.