August 27, 2014 10:58 AM ET

Biotechnology

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

Phone:

858-455-3708

Fax:

858-455-3962

Key Executives for ViaCyte, Inc.

Chief Executive Officer and President
Age: 58
Vice President of Finance and Corporate Controller
Chief Medical Officer and Vice President of Clinical Development
Age: 60
Senior Vice President of Science & Technology
Chief Development Officer and Vice President of Device Research and Development
Compensation as of Fiscal Year 2014.

ViaCyte, Inc. Key Developments

ViaCyte, Inc. Grants Licensing Rights to Janssen for Type 1 Diabetes Candidate VC-01

ViaCyte, Inc. announced on August 21 that it had granted licensing rights to Janssen to evaluate a transaction related to the VC-01 combination product that the former is developing for type 1 diabetes. The firm received USD 20 million from Janssen and the agreement allows Janssen to continue the development of VC-01 through the initial evaluation of clinical efficacy. Although the USD 20 million investment in the product is comparatively small, it will contribute to the continued development of ViaCyte's stem-cell-derived islet replacement therapy for insulin-dependent diabetes.

ViaCyte, Inc. Announces FDA Acceptance of Investigational New Drug Application to Commence Clinical Trial of VC-01(TM) Candidate Cell Replacement Therapy for Type 1 Diabetes

ViaCyte, Inc. announced that the U.S. Food and Drug Administration has accepted the company's Investigational New Drug Application for its VC-01(TM) candidate cell replacement therapy to treat type 1 diabetes. The company plans to promptly initiate a Phase 1/2 clinical trial which it believes to be the first ever clinical evaluation of a stem cell-derived islet replacement therapy for the treatment of patients with type 1 diabetes. ViaCyte's VC-01 product candidate consists of pancreatic progenitor cells, called PEC-01(TM) cells, which are derived from a proprietary human embryonic stem cell line, encapsulated in ViaCyte's proprietary Encaptra(R) device. When implanted under the skin, the PEC-01 cells are specifically designed to mature and further differentiate into insulin-producing beta and other endocrine cells that regulate blood glucose in a manner similar or identical to the islets that normally comprise the endocrine pancreas. The Phase 1/2 clinical study will evaluate the VC-01 product candidate directly in patients with type 1 diabetes who have minimal to no insulin-producing beta cell function. In addition to evaluating the safety of the product candidate in these patients, the study is designed to demonstrate the effectiveness of the VC-01 product candidate in replacing the lost endocrine function that is central to the disease. In an open-label, dose-escalating format, ViaCyte expects to enroll approximately 40 patients in the study at multiple clinical sites. A primary goal of this first clinical trial will be to assess the safety and tolerance of the VC-01 product candidate in patients with type 1 diabetes. In addition, insulin production in the study subjects will be evaluated by measuring C-peptide, a biomarker for insulin produced by beta cells that is expected to provide a sensitive measure of efficacy in these patients. As proposed, the trial would also evaluate clinically-relevant secondary endpoints related to the need for administration of pharmaceutical insulin to control type 1 diabetes and the incidence of hypoglycemia, a common side effect associated with pharmaceutical insulin usage.

ViaCyte, Inc. Files Investigational New Drug Application and Device Master File with FDA for Novel Cell Replacement Therapy Product Candidate Designed to Treat Patients with Type 1 Diabetes

ViaCyte, Inc. announced that it has filed an Investigational New Drug application (IND) with the United States Food and Drug Administration (FDA) seeking to initiate a Phase 1/2 clinical trial in patients with type 1 diabetes. The trial would evaluate the safety and efficacy of ViaCyte's VC-01(TM) product candidate, a stem cell-derived, encapsulated cell replacement therapy. In a related development, ViaCyte submitted a Medical Device Master File (called MAF) to the FDA in support of the Encaptra(R) drug delivery system, the device component of the VC-01 product candidate. ViaCyte's VC-01 product candidate consists of pancreatic progenitor cells, called PEC-01(TM) cells, which are derived from a proprietary human embryonic stem cell line. These cells are then encapsulated by use of ViaCyte's Encaptra device. When implanted under the skin, the PEC-01 cells are designed to mature and further differentiate into insulin-producing beta and other endocrine cells that regulate blood glucose in a manner similar or identical to the normal islets that comprise the endocrine pancreas. Based on a pre-IND meeting with the FDA and subsequent consultations, ViaCyte is proposing to initiate clinical evaluation of the VC-01 product candidate directly in patients with type 1 diabetes who have minimal to no insulin-producing beta cell function. In addition to evaluating the safety of the product candidate in these patients, the study is designed to demonstrate the effectiveness of the VC-01 product candidate in replacing lost endocrine function that is central to the disease. In the proposed clinical trial, insulin production from the VC-01 implant would be assessed by measuring C-peptide, a biomarker for insulin produced by beta cells that is expected to provide a sensitive measure of efficacy in these patients. As proposed, the trial would also evaluate secondary end-points related to the need for administration of pharmaceutical insulin to control the disease and the incidence of hypoglycemia, a common side effect associated with pharmaceutical insulin usage. ViaCyte's proprietary Encaptra device is designed to contain the implanted cells, preventing biodistribution, as well as shielding them from the immune system. Although PEC-01 cells are human cells, they are not the patient's actual cells. As such, they are considered an allogeneic graft, which typically requires immunosuppression in order for the recipient to tolerate the implant. However, the Encaptra device is designed to prevent the patient's immune system from accessing the implanted cells, thereby facilitating successful engraftment and subsequent maturation to islets.

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