On April 13, 2026 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, and Mayo Clinic reported a strategic collaboration to advance development of SC451, Sana’s investigational hypoimmune-modified pancreatic islet cell therapy for type 1 diabetes. SC451 is designed to allow a single administration of pancreatic islet cells to support long-term glucose control without the need for ongoing insulin therapy or immunosuppression for patients with type 1 diabetes.
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The collaboration will draw on Mayo Clinic’s multidisciplinary expertise to accelerate the development, validation, and standardization of protocols and processes for SC451, supporting safe, scalable, and consistent delivery across diverse clinical environments. These areas include:
End-to-end clinical and operational insight to optimize workflows, including product handling and delivery of SC451, and post-treatment care to enable broader adoption across Mayo Clinic and global care settings.
Surgical expertise, including refining procedural techniques.
Standardizing handling, delivery and post-treatment management.
Leadership in clinical trial design, including biomarker identification to guide patient selection and longitudinal monitoring.
Mayo Clinic will also look to advance its capabilities in the delivery of investigational islet cell therapies, further strengthening its leadership in innovative, multidisciplinary treatment approaches.
In connection with the collaboration, Mayo Clinic will make an equity investment in Sana Biotechnology, reflecting a shared commitment to advancing innovative approaches aimed at improving care for patients with type 1 diabetes. The organization also has the option to make an additional equity investment under the terms of the agreement.
"We are pleased to collaborate with Mayo Clinic as we advance SC451 toward a clinical trial that we are aiming to start this year," said Steve Harr, Sana President and Chief Executive Officer. "Mayo Clinic’s longstanding commitment to patient-centered care, combined with a depth of expertise in transplant medicine and immunology, will help guide the development and delivery of SC451. Recently presented data, showing that transplanted pancreatic islets modified with Sana’s hypoimmune platform technology survive and function without any immunosuppression for over a year in a patient with type 1 diabetes, make us optimistic about the potential for SC451 to transform the treatment of this disease."
"Mayo Clinic is committed to advancing innovative therapies that address significant unmet patient needs, and through this collaboration, we seek to advance potential treatment options for patients with type 1 diabetes," said Vijay Shah, MD, Mr. and Mrs. Ronald F. Kinney Executive Dean of Research, Mayo Clinic. "By bringing together complementary expertise in cell therapy development and transplant immunology, we aim to thoughtfully and rigorously evaluate this investigational approach with the goal of improving the lives of those living with the condition."
About SC451 – Sana’s Therapeutic Candidate for Type 1 Diabetes
SC451 is an investigational, gene-modified, stem-cell derived pancreatic islet cell therapy that Sana is advancing toward the clinic as a potential single treatment for patients with type 1 diabetes (T1D) that leads to euglycemia without the need for exogenous insulin or immunosuppression. SC451 is a potentially scalable solution, manufactured from cells that have been modified to overcome both allogeneic and autoimmune rejection through Sana’s proprietary hypoimmune (HIP) technology. An investigator-sponsored clinical study evaluating the transplantation of donor-derived, HIP-modified pancreatic islet cells into a patient with T1D show these cells are well-tolerated, survive, evade detection by the immune system, and continue to produce insulin in the patient through 14 months of follow-up to date. The company expects to file an Investigational New Drug application and initiate a Phase 1 clinical study of SC451 as early as this year.
(Press release, Sana Biotechnology, APR 13, 2026, View Source [SID1234664328])