PEC-Direct: Clinical data from ViaCyte’s product candidate has shown that implanted cells, when effectively engrafted, are capable of producing circulating C-peptide, a biomarker for insulin, in patients with type 1 diabetes
PEC-Encap: ViaCyte’s cell therapy product candidate designed to treat all patients with insulin requiring diabetes is being studied in the clinic utilizing an encapsulated delivery technology developed in collaboration with W.L. Gore & Associates
PEC-QT: ViaCyte, in collaboration with CRISPR Therapeutics, is developing a product candidate for diabetes; based on an immune-evasive stem cell line, this approach has the potential to further broaden the availability of cell therapy for other diseases
The Company also announced board chair succession, naming Ian F. Smith as Executive Chairperson
SAN DIEGO, May 26, 2020 /PRNewswire/ — ViaCyte, Inc., a privately held regenerative medicine company, today announced the close of an approximately $27 million private financing, part of the Series D preferred stock financing entered into in late 2018. Investors included, Bain Capital Life Sciences, TPG Capital, RA Capital Management, Sanderling Ventures, and several individual supporters of the Company. Proceeds from the financing will be used to further advance the Company’s multi-product candidate approach to develop medicines that have the potential to transform the way insulin-requiring diabetes is managed, potentially providing a functional cure for patients with type 1 diabetes.
Coinciding with the financing, the Company also appointed Ian F. Smith as Executive Chairperson. Mr. Smith was appointed to the Company’s Board of Directors in July 2019 and succeeds Fred Middleton, who remains on the board.
Commenting on the financing, Paul Laikind, Ph.D., Chief Executive Officer and President of ViaCyte, said, “During these difficult times we are grateful for the continued support of our investors as well as our clinical trial participants, whose safety and health remains our focus and commitment. We are steadfast in our mission to deliver potentially life sustaining therapies for patients with insulin-requiring diabetes and to continue the significant progress we have made in the past year. ViaCyte is the first company to demonstrate production of C-peptide, a biomarker for insulin, in patients with type 1 diabetes receiving a stem cell-derived islet replacement. Moving forward, we are optimizing the effectiveness of both PEC-Direct and PEC-Encap, the latter of which incorporates novel device material technology created in collaboration with W.L. Gore & Associates. We are also making important progress on our PEC-QT program with our partner, CRISPR Therapeutics, and are now moving into pre-IND activities. This program is designed to eliminate the need for immuno-suppression and could have a transformative impact on a broader population of insulin-dependent patients.”
Dr. Laikind continued, “In conjunction with the closure of the financing, we are also pleased to announce the appointment of Ian F. Smith as our Executive Chairperson, succeeding Fred Middleton. Since joining the board last July, Ian and I have worked closely to accelerate ViaCyte’s growth and prepare for the future. We are extremely grateful to Fred for his many years of service as Chairperson of ViaCyte’s Board of Directors. Throughout his time leading the Board, Fred provided expert guidance as ViaCyte has consistently broken new ground in the field of regenerative medicine and cell replacement therapies.”
Mr. Middleton said, “I am proud to have chaired the Board as ViaCyte developed into a leading company in the regenerative medicine field. I am confident that Ian’s unique expertise and executive leadership, specifically with innovative growth-oriented companies, and specifically in corporate strategy and operations, as well as capital markets will help ViaCyte progress its important work and firmly establish itself as a leader in the cell therapy sector.”
About ViaCyte’s Pipeline
The PEC-Direct product candidate, currently being evaluated in the clinic, delivers ViaCyte’s PEC-01 cells (pancreatic islet progenitor cells) in a non-immunoprotective device and is being developed for type 1 diabetes patients who have hypoglycemia unawareness, extreme glycemic lability, and/or recurrent severe hypoglycemic episodes. The PEC-Encap (also known as VC-01) product candidate, also undergoing clinical evaluation, delivers the same pancreatic islet progenitor cells but in an immunoprotective device. PEC-Encap is being developed for all patients with type 1 diabetes. In collaboration with CRISPR Therapeutics, ViaCyte is developing immune-evasive stem cell lines from its proprietary CyT49 cell line. These immune-evasive stem cell lines, which are being used in the PEC-QT program, have the potential to further broaden the availability of cell therapy for all patients with insulin-requiring diabetes, type 1 and type 2. In addition, a pluripotent, immune evasive cell line has the potential to be used to produce any cell in the body, thus enabling many other potential indications.
ViaCyte is a privately held regenerative medicine company developing novel cell replacement therapies as potential long-term diabetes treatments to achieve glucose control targets and reduce the risk of hypoglycemia and diabetes-related complications. ViaCyte’s product candidates are based on directed differentiation of pluripotent stem cells into PEC-01 pancreatic islet progenitor cells, which are then implanted in durable and retrievable cell delivery devices. Over a decade ago, ViaCyte scientists were the first to report on the production of pancreatic cells from a stem cell starting point and the first to demonstrate in an animal model of diabetes that, once implanted and matured, these cells secrete insulin and other pancreatic hormones in response to blood glucose levels and can be curative. More recently, ViaCyte demonstrated that when effectively engrafted, PEC-01 cells can mature into glucose-responsive insulin producing cells in patients with type 1 diabetes. To accelerate and expand its efforts, ViaCyte has established collaborative partnerships with leading companies including CRISPR Therapeutics and W.L. Gore & Associates. ViaCyte is headquartered in San Diego, California. The Company also has a robust intellectual property portfolio, which includes hundreds of issued patents and pending applications worldwide. ViaCyte is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF. For more information on ViaCyte, please visit www.viacyte.com