As the first company to advance a cell replacement therapy for type 1 diabetes into the clinic, ViaCyte is committed to developing a functional cure for all type 1 diabetes patients. As part of the product development work, ViaCyte entered into a collaborative research agreement with materials science company W.L. Gore & Associates (“Gore”) to improve the Company’s novel implantable cell therapy delivery devices.
The PEC-Encap product candidate is made of two separate components: 1) PEC-01 pancreatic progenitor cells, which are designed to differentiate into all of the cells of the pancreatic islet after implantation, and 2) the Encaptra Cell Delivery Device, a macro-encapsulation device that has been shown to protect the delivered cells from the host patient’s immune system. Positive preliminary clinical data from the STEP-ONE clinical trial with the PEC-Encap product candidate showed, once implanted, the Encaptra Device protects the PEC-01 cells from the immune system and the cells were capable of differentiating to beta cells when evidence of vascularization and engraftment was observed. However, vascularization and engraftment was found to be inadequate. ViaCyte believes that improvements to the macroencapsulation device could make the vascularization and engraftment more robust and consistent.
President and CEO, Paul Laikind, Ph.D., told Xconomy, “We needed to improve the ability to vascularize across the surface of that [device] membrane, and that’s where Gore comes in.” The goal is to combine Gore’s expertise in engineering biocompatible materials with ViaCyte’s experience in cell therapeutic approaches to make the PEC-Encap product candidate a more effective therapy for all patients with type 1 diabetes.
While these improvements in PEC-Encap are taking place, ViaCyte is continuing to move forward with their product candidate for the patients with the greatest need, called PEC-Direct. The PEC-Direct product candidate has the same PEC-01 cells, but the encapsulation device is engineered with larger pores to allow blood vessels to directly contact the cells, which it is expected to allow for robust vascularization and engraftment. The PEC-Direct product has the potential to complete clinical trials first and be a functional cure for type 1 diabetes patients with severe life-threatening hypoglycemia unawareness and related risks.