ViaCyte Enters Clinical Trials for Type 1 Diabetes Treatment

February 4, 2016
Pharmaceutical Technology Editors

ViaCyte and Janssen Biotech have entered Phase I/Phase II clinical trials for VC-01, a candidate treatment for the treatment of type 1 diabetes.

ViaCyte a privately held regenerative medicine company, and Janssen Biotech, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, have entered into an agreement that provides ViaCyte with an exclusive license to all BetaLogics intellectual property in the field of metabolic disease, including diabetes.

ViaCyte’s clinical-stage VC-01 product candidate is composed of human pancreatic progenitor cells, called PEC-01 cells, contained in a semi-permeable encapsulation device, called the Encaptra drug delivery system.  The Encaptra system is designed to deliver the cells to the patient and protect them from attack by the patient’s immune system.  This cell replacement therapy for the treatment of type one diabetes is currently being evaluated in a Phase I/Phase II clinical trial called safety, tolerability, and efficacy of VC-01 combination product in Type 1 Diabetes (STEP ONE).

The VC-01 could potentially be a functional therapeutic for type 1 diabetes and could also be a possible treatment for the large number of insulin-requiring patients with type 2 diabetes as well. ViaCyte recently presented preliminary results from the STEP ONE clinical trial of the VC-01 product candidate.  The company is currently evaluating the candidate at a sub-therapeutic dose to establish safety and develop the procedures for successful implantation.  

As a result of the agreement, ViaCyte gains exclusive access to an additional 145 issued patents, 15 of which are in the United States, and an additional 565 pending patent applications, for a combined portfolio of the companies of 360 issued patents, including 75 in the United States, and 710 pending applications.  Financial terms of the deal were not disclosed. 
 

Source: ViaCyte