ViaCyte and Janssen Enter Agreement for Developing New Diabetes Therapy

California based regenerative medicine company ViaCyte just announced that it has signed an agreement with Janssen Research & Development LLC (Janssen) for the research and development of a new cell replacement therapy product, VC-01, that ViaCyte is developing for Type 1 diabetes.

According to the rights agreement, ViaCyte receives $20 million from Janssen and Johnson & Johnson Development Corporation (JJDC), and in exchange, provides Janssen with the rights to evaluate transactions related to the VC-01 product, continuing through the initial evaluation of clinical efficacy of VC-01.

ViaCyte's novel VC-01 product is a stem cell-derived islet replacement therapy which consists of pancreatic progenitor cells (PEC-01) derived from a proprietary human embryonic stem cell line, and encapsulated in ViaCyte's proprietary Encaptra device. When these PEC-01 cells are implanted under the skin, they are expected to mature and differentiate into insulin-producing beta cells and other endocrine cells that regulate blood glucose. The VC-01 combination product is being developed as a potential long-term diabetes treatment without immune suppression, risk of hypoglycemia, or other such diabetes-related complications.

ViaCyte also announced last week that the U.S. FDA has accepted the company's Investigational New Drug Application (IND) for VC-01 to treat type 1 diabetes. The company plans to initiate the first Phase 1/2 clinical trials for the treatment of patients with type 1 diabetes. ViaCyte will be evaluating both safety and efficacy of VC-01 in this clinical study.

ViaCyte has also recently completed a private equity financing transaction for $5.4 million through the sale of its Series C-1 Preferred Stock. Along with the capital from Janssen, the company now has substantial resources for the further development of the VC-01 product candidate. ViaCyte plans to use the funds primarily for clinical development of VC-01.

"These important transactions provide us with additional resources we need to pursue the further development of the VC-01 product candidate as a potential new treatment option for patients with type 1 diabetes," said Paul Laikind, Ph.D., President and CEO of ViaCyte. "We are pleased to be extending our relationship with Janssen and JJDC in this area of mutual interest."

Although less common than type 2 diabetes, type 1 diabetes mellitus, also known as juvenile diabetes, can be a life-threatening chronic condition. In type 1 diabetes, the pancreas does not produce enough of the hormone insulin, which is required in order for glucose to enter the cells to produce energy. Type 1 diabetes affects several million Americans, and there is no cure for this condition at present. The current standard of care for type 1 diabetes involves multiple daily injections of insulin, and diet and lifestyle modifications.