The patent allows ViaCyte to provide for alternative ways to produce pancreatic progenitor and endocrine cells that have potential for use in cell replacement therapies.
Pancreatic progenitor cell cultures are precursors to endocrine cells, and are designed to mature into cells found in the normal human islet that produce insulin and other regulatory hormones, after implantation in the patient.
“This patent further expands our intellectual property platform, which includes over 100 issued and 150 pending patents covering drug delivery devices and human pluripotent stem cells and their derivatives,” said Paul Laikind, President and CEO of San Diego-based ViaCyte. “The newly-issued patent is important because it covers yet additional methods of creating PEC-01 cells, which resemble the precursor cells that occur in natural human pancreatic development and are integral to our lead product candidate, VC-01. Our Phase 1/2 clinical trial of VC-01 for the treatment of type 1 diabetes is underway and we expect initial data from the first cohort of subjects in this study in early 2015.”
ViaCyte’s VC-01 is designed to deliver a therapeutic dose of PEC-01 cells via implantation just under a patient’s skin. In order to protect the implanted cells from immune rejection, the PEC-01 cells are encapsulated in a proprietary device with a selectively porous membrane called the Encaptra drug delivery system.
As the PEC-01 pancreatic progenitor cells represent a cell type that is present in a developing embryo, they are designed by nature to function in a hypoxic environment, promote vascularization, and differentiate into the critical endocrine cells that populate the pancreatic islets. Thus, ViaCyte believes that the use of PEC-01 has advantages over the implantation of more fully differentiated cells such as insulin-producing beta cells; however, the company continues to evaluate other approaches, as indicated by this patent.
The newly-issued patent forms part of ViaCyte’s broad intellectual property (IP) portfolio of 100 issued patents and more than 150 pending patent applications around its novel cell therapy and lead product candidate, VC-01. The current patent portfolio covers many of the intermediary cell types generated when pluripotent stem cells progress along the differentiation pathway to pancreatic endoderm cells, including mesendoderm and definitive endoderm. Methods of making the cells and implantable devices, as well as their use, are also protected.