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October 13, 2015 5:30 PM ET


Company Overview of ViaCyte, Inc.

Company Overview

ViaCyte, Inc., a preclinical stage stem cell engineering company, develops and commercializes cell therapies to treat diabetes in the United States and internationally. The company develops human embryonic stem cells for Type 1 and Type 2 diabetic patients, as well as therapies based on pancreatic beta cell progenitors derived from human pluripotent stem cells. It develops insulin-producing cells from human embryonic stem cells to produce islet cells; and Encaptra, a vascularizing device that enables implanted pancreatic progenitor cells to survive and differentiate into functioning islet cells. The company was formerly known as Novocell, Inc. and changed its name to ViaCyte, Inc. in May 201...

3550 General Atomics Court

San Diego, CA 92121

United States

Founded in 1999





Key Executives for ViaCyte, Inc.

Chief Executive Officer and President
Age: 59
Vice President of Finance and Corporate Controller
Chief Medical Officer and Vice President of Clinical Development
Age: 61
Senior Vice President of Science & Technology
Chief Development Officer and Vice President of Device Research & Development
Compensation as of Fiscal Year 2015.

ViaCyte, Inc. Key Developments

ViaCyte, Inc. Presents at Alliance for Regenerative Medicine Stem Cell Meeting on the Mesa, Oct-07-2015 11:45 AM

ViaCyte, Inc. Presents at Alliance for Regenerative Medicine Stem Cell Meeting on the Mesa, Oct-07-2015 11:45 AM. Venue: Estancia La Jolla Hotel & Spa, 9700 North Torrey Pines Road, La Jolla, CA 92037, United States. Speakers: Paul K. Laikind, Chief Executive Officer and President.

ViaCyte Announces the Publication of a Report on Macroencapsulated Stem Cell-Derived Insulin-Producing Cells and the Issuance of Three Patents

ViaCyte, Inc. announced publication of a study demonstrating that insulin-producing cells created in vitro from human embryonic stem cells can mature and function after being encapsulated and implanted into an animal model. In addition, the Company announced the addition of three patents to its extensive portfolio covering its cell therapy platform. The article, entitled "Insulin-Producing Endocrine Cells Differentiated In Vitro From Human Embryonic Stem Cells Function in Macroencapsulation Devices In Vivo," is published in Stem Cells Translational Medicine. In the June 2015 issue of the same journal, ViaCyte scientists published a review article summarizing the advances in bioprocessing and scale-up that have enabled ViaCyte's VC-01 product candidate to be the first stem cell-based treatment for type 1 diabetes to enter clinical testing. The current article describes beta-like cells that have similar properties to the pluripotent stem cell-derived insulin-producing cells reported by other groups, except that ViaCyte produced populations with substantially higher endocrine cell content. The results demonstrated for the first time that nearly pure in vitro-produced endocrine cells can function in vivo. Populations comprised of up to 98% endocrine cells (and less than 2% pancreatic progenitor cells) exhibited robust glucose-responsive insulin production in a mouse model. The cells in the study were differentiated further down the beta cell lineage than the PEC-01™ pancreatic progenitor cells being tested in ViaCyte's VC-01 product candidate, which is currently in a Phase 1/2 clinical trial for treatment of type 1 diabetes. The animal study also demonstrated for the first time that when encapsulated in a device and implanted into mice, these more mature cells are capable of producing functional pancreatic beta cells. ViaCyte is also the first to show that these further differentiated cells can function in vivo following cryopreservation, a valuable process step when contemplating clinical and commercial application. In addition to demonstrating in vivo functionality, the time to functional maturation (i.e., glucose-responsive insulin production) following implantation of the more highly differentiated cells was compared to that of pancreatic progenitors. The results showed no appreciable differences between the two cell populations suggesting that engraftment and acquisition of a robust glucose response, not differentiation from progenitor cell to endocrine cell, are the rate-limiting steps following implantation. In addition to the research progress, ViaCyte continues to build its large patent portfolio with three more U.S. patents having issued since November 2014. These patents are directed to: Methods for making and enriching pancreatic endocrine type cells (U.S. Patent No. 9,045,736); Scale-up technology directed to pluripotent stem cell aggregates in suspension in a roller bottle (U.S. Patent No. 8,895,300); and Pancreatic endoderm cell cultures with an ERBB receptor tyrosine kinase activating agent (U.S. Patent No. 9,109,245). These patents bolster and further protect the Company's VC-01 product candidate and its cell therapy platform technology.

ViaCyte, Inc. Announces Second Clinical Trial Site at University of Alberta

ViaCyte, Inc. announced the opening of a second site in its Phase 1/2 trial called STEP ONE, or Safety, Tolerability, and Efficacy of VC-01™ Combination Product in Type One Diabetes. The new site, which is the first in Canada, will be at the University of Alberta Hospitals in Edmonton, Alberta. As a transplant surgeon, Shapiro is renowned for determining how to administer human islets, resulting in insulin independence for many diabetes patients, in some cases lasting years. However, these islets, derived from scarce organ donors, are in short supply. Moreover, the Edmonton Protocol requires recipients to take chronic immunosuppressive drugs in order to prevent destruction of the transplant by their immune system. Consequently, while generally effective, the implementation of islet transplant has been limited to type 1 diabetes patients who have the challenge in establishing glycemic control with pharmaceutical approaches, including patients with hypoglycemia unawareness. The VC-01 combination product candidate, comprised of human pancreatic progenitor cells in a macroencapsulation device, is intended to address both of the main limitations of islet transplantation. PEC-01™ cells address the supply issue, as they are manufactured from pluripotent stem cells, which can be expanded virtually indefinitely. And the VC-01 product candidate utilizes ViaCyte's proprietary Encaptra® drug delivery system which is designed to protect the PEC-01 cells from a patient's immune system, obviating the need for immunosuppressive drugs. The STEP ONE trial launched in late 2014 and has been steadily enrolling subjects with type 1 diabetes at until now, a single site, the University of California San Diego Health System, with the support of the UC San Diego Sanford Stem Cell Clinical Center. This first clinical trial of the VC-01 product candidate is designed to allow evaluation of the product candidate in two cohorts of patients. The first cohort is intended to evaluate the safety of the product candidate, as well as allow development and optimization of the surgical and post-surgical procedures required for the successful engraftment of the cells. Patients in this first cohort are receiving what is calculated to be a sub-therapeutic dose of cells. The number of patients to be studied in this first phase of the trial will be determined based upon preliminary results related to safety and cell engraftment as well as performance parameters.

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