ViaCyte Announces Initiation of Encapsulated Cell Therapy Study for Type 1 Diabetes

ViaCyte 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, 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.