Date: 2014-08-21
Type of information: Licensing agreement
Compound: VC-01™ combination product
Company: Janssen R&D, a J&J company (USA - NJ) - ViaCyte (USA - CA)
Therapeutic area: Metabolic diseases - Regenerative medicine
Type agreement:
Action mechanism: VC-01 combination product is a cell therapy based on the production of pancreatic progenitor cells derived from human pluripotent stem cells (PEC-01™ cells). These progenitor cells are implanted in a durable and retrievable encapsulation device (Encaptra®) . Once implanted and matured, these cells are designed to secrete insulin and other regulatory factors in response to blood glucose levels. The VC-01 combination product is being developed as a potential long-term diabetes treatment without immune suppression, and without risk of hypoglycemia or other diabetes-related complications
Disease: type 1 diabetes
Details: * On August 21, 2014, ViaCyte announced that it has entered into a Rights Agreement with Janssen Research & Development LLC (Janssen). The agreement provides Janssen with a future right to evaluate a transaction related to the VC-01™ combination product that ViaCyte is developing for type 1 diabetes. This right will continue through the initial evaluation of clinical efficacy of VC-01.
ViaCyte recently announced the allowance by the FDA of an Investigational New Drug application for the VC-01 product candidate, which will permit ViaCyte to begin clinical evaluation of the VC-01 product candidate for type 1 diabetes. ViaCyte plans to promptly initiate clinical development directly in patients with type 1 diabetes, seeking to evaluate both safety and efficacy in this first clinical study.California Institute for Regenerative Medicine and JDRF.
Financial terms: ViaCyte received $20 million from Janssen and Johnson & Johnson Development Corporation (JJDC). The payment included a rights fee and a note convertible into equity at a later date. JJDC has been a long-standing investor in ViaCyte. This new infusion of capital, together with the recently announced $5.4 million private equity financing transaction, provides substantial additional resources for the further development of the Company\'s stem cell derived islet replacement therapy for insulin-dependent diabetes. The Company plans to use the funds primarily to accelerate the clinical development of the VC-01 product candidate.
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