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CRISPR Therapeutics and ViaCyte, Inc. to Start Clinical Trial of the First Gene-Edited Cell Replacement Therapy for Treatment of Type 1 Diabetes
-Initiation of patient enrollment expected by year-end- -Initiation of patient enrollment expected by year-end- ZUG, Switzerland and CAMBRIDGE, Mass. and SAN
About this update from Crispr Therapeutics Ag
[{"type":"text","content":"-Initiation of patient enrollment expected by year-end-\n-Initiation of patient enrollment expected by year-end- ZUG, Switzerland and CAMBRIDGE, Mass. and SAN DIEGO, Nov. 16, 2021 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (NASDAQ: CRSP), a biopharmaceutical company focused on developing transformative gene-based medicines for serious diseases, and ViaCyte, Inc., a clinical-stage regenerative medicine company developing novel cell replacement therapies to address diseases with significant unmet needs, today announced that Health Canada has approved the companies’ Clinical Trial Application (CTA) for VCTX210, an allogeneic, gene-edited, immune-evasive, stem cell-derived therapy for the treatment of type 1 diabetes (T1D). Initiation of patient enrollment is expected by year-end. “With the approval of our CTA, we are excited to bring a first-in-class CRISPR-edited cell therapy for the treatment of type 1 diabetes to the clinic, an important milestone in enabling a whole new class of gene-edited stem cell-derived medicines,” said Samarth Kulkarni, Ph.D., Chief Executive Officer of CRISPR Therapeutics. “The combination of ViaCyte’s leading stem cell capabilities and CRISPR Therapeutics’ pre-eminent gene-editing platform has the potential to meaningfully impact the lives of patients living with type 1 diabetes.” “Being first into the clinic with a gene-edited, immune-evasive cell therapy to treat patients with type 1 diabetes is breaking new ground as it sets a path to potentially broadening the treatable population by eliminating the need for immunosuppression with implanted cell therapies,” said Michael Yang, President and Chief Executive Officer of ViaCyte. “This approach builds on previous accomplishments by both companies and represents a major step forward for the field as we strive to provide a functional cure for this devastating disease.” The Phase 1 clinical trial of VCTX210 is designed to assess its safety, tolerability, and immune evasion in patients with T1D. This program is being advanced by CRISPR Therapeutics and ViaCyte as part of a strategic collaboration for the discovery, development, and commercialization of gene-edited stem cell therapies for the treatment of diabetes. VCTX210 is an allogeneic, gene-edited, stem cell-derived product developed by applying CRISPR Therapeutics’ gene-editing technology to ViaCyte’s prop...