ViaCyte Acquires Rights to BetaLogics Assets, Expanding and Extending Industry-Leading Portfolio for Stem Cell-Derived Approaches to Type 1 Diabetes
Preliminary data of STEP ONE clinical trial are promising
SAN DIEGO, February 4, 2016 — ViaCyte, Inc., a leading, privately-held regenerative medicine company with the first pluripotent stem cell-derived islet replacement therapy for the treatment of type 1 diabetes in clinical-stage development, today announced that ViaCyte and Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, have agreed to consolidate the assets of the Janssen BetaLogics group into ViaCyte. The agreement provides ViaCyte with an exclusive license to all BetaLogics intellectual property in the field of metabolic disease, including diabetes, and the transfer of related assets to ViaCyte.
“For more than a decade BetaLogics and ViaCyte have been independently working toward a stem cell-derived therapy for diabetes. By combining the intellectual property and other assets of BetaLogics with ViaCyte, we will further strengthen our advanced program focused on insulin-dependent diabetes and solidify our leadership in the field,” said Paul Laikind, PhD, President and CEO of ViaCyte. “We look forward to delivering effective new treatments for this difficult disease.”
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 first-in-class cell replacement therapy for the treatment of type 1 diabetes is currently being evaluated in a Phase 1/Phase 2 clinical trial called STEP ONE (Safety, Tolerability, and Efficacy of VC-01 Combination Product in Type One Diabetes). If successful, the VC-01 product candidate has the potential to provide a functional therapeutic for type 1 diabetes and to become an important 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. Results presented at Biotech Showcase™ 2016 in San Francisco last month demonstrated that the company is making progress translating the promising results observed in pre-clinical models to patients.
“JDRF has been a long time, proud supporter of the work that ViaCyte is doing to transform the way we treat type 1 diabetes,” said Derek Rapp, JDRF President and CEO. “The recent clinical data, while preliminary, are encouraging and move us closer to our goal of a world without type 1 diabetes.”
Randal Mills, PhD, President and CEO of the California Institute for Regenerative Medicine (CIRM), which is supporting ViaCyte’s clinical trial, said “At CIRM, our mission is to accelerate stem cell therapies to patients with unmet medical needs, which is perfectly aligned with the excellent work being done by our partners at ViaCyte. Finding an effective treatment for a disease like type 1 diabetes would be transformational for millions of people around the world, so the latest clinical data from ViaCyte are very encouraging and a clear sign of progress.”
The combination of the ViaCyte and BetaLogics regenerative medicine platforms enhances ViaCyte’s already robust intellectual property. 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. The BetaLogics team will work closely with ViaCyte to ensure an effective integration. ViaCyte remains independent and no commercialization rights to future products were conveyed as a result of this transaction.
Type 1 diabetes remains a challenging disease that, despite insulin treatment, often leads to long term complications, including premature death. In addition, continuously monitoring blood glucose, diet, and exercise, and managing insulin administration has a substantial impact on quality of life. Cell replacement therapy has the potential to transform the way the disease is managed, potentially reducing or eliminating the reliance on constant glucose monitoring and insulin injections, while providing a more physiological regulation of blood glucose.
The STEP ONE clinical trial is underway in both the United States and Canada. For more info on the clinical trial, visit www.clinicaltrials.gov.
ViaCyte is a privately-held regenerative medicine company focused on developing a novel cell replacement therapy for the treatment of diabetes. ViaCyte is conducting a Phase 1/2 clinical trial of the Company’s lead VC-01 product candidate in patients with type 1 diabetes who have minimal to no insulin-producing beta cell function. ViaCyte’s VC-01 combination product candidate is based on the production of pancreatic progenitor cells derived from human pluripotent stem cells. These progenitor cells are implanted in a durable and retrievable encapsulation device. Once implanted and matured, these cells are designed to secrete insulin and other regulatory factors in response to blood glucose levels. The VC-01 product candidate is being developed as a potential long-term diabetes treatment with the goal of reducing the risk of hypoglycemia and diabetes-related complications without requiring long-term immune suppression.