ViaCyte is leading the charge in stem cell research and regenerative medicine. Their goal? Cell-based long-term diabetes treatments — a “functional cure” for Type 1 diabetes. Today, ViaCyte announced $80 million Series D financing led by Bain Capital Life Sciences and joined by TPG and RA Capital Management, as well as existing investor, Sanderling Ventures, and several individual supporters.
Over the last three months, ViaCyte has secured $100 million in financing. All this to drive forward what they’re calling a “human cell therapy platform”. This includes ViaCyte’s clinical-stage islet cell replacement products, both derived from stem cells — the PEC-Direct and the PEC-Encap.
The PEC-Direct product candidate is being developed as a transformative therapy for high-risk Type 1 diabetes patients and is currently being studied in the second stage of a Phase 1/2 trial, with the first data expected as early as mid-2019. PEC-direct is a non‐immunoprotective delivery device that permits direct vascularization of the cell therapy. Because the patient’s immune system will identify the cells as foreign, PEC‐Direct requires long‐term immunosuppression drugs to avoid the body rejecting the cell delivery device. This is why PEC‐Direct will only be used for a group of Type 1 diabetes patients at high risk for acute complications.
The PEC-Encap product, on the other hand, is being developed for all patients with Type 1 diabetes. Enrollment in the PEC-Encap clinical trial, known as STEP ONE, is currently paused as the Company is making product improvements in collaboration with W.L. Gore & Associates. Their recent improvements to the implantable product have shown improved engraftment. They expect clinical evaluation to resume next year.
“We have made important scientific progress with both PEC-Direct and PEC-Encap. A major part of this financing will support our continued clinical development efforts with both product candidates to evaluate efficacy,” said Paul Laikind, Ph.D., President and CEO of ViaCyte. “In addition, we have begun our collaboration with CRISPR Therapeutics to discover, develop, and commercialize gene-edited allogeneic stem cell therapies which could be a next-generation cure for diabetes.”
Fall 2018 has been an exciting time for ViaCyte. This financial news comes after the announcement of a collaboration with CRISPR Therapeutics, a Switzerland-based biotechnology company focused on gene-editing technologies that could one day be used to avoid an immune system response to an implanted cell product. In September, ViaCyte announced a $10 million grant from W.L. Gore & Associates.
Beyond Type 1 will keep you updated on developments on the path to cure.