Sana Biotechnology announced a strategic collaboration with Mayo Clinic to accelerate the development of SC451, an investigational cell therapy aimed at treating type 1 diabetes.
The partnership is focused on advancing SC451, a hypoimmune-modified pancreatic islet cell therapy designed to enable long-term glucose control through a single administration, potentially eliminating the need for ongoing insulin therapy or immunosuppression.
Through the collaboration, Mayo Clinic will contribute multidisciplinary expertise to support the development, validation, and standardization of clinical protocols for SC451. The effort will include optimizing workflows for product handling and delivery, refining surgical techniques, standardizing post-treatment care, and supporting clinical trial design, including biomarker identification and patient monitoring.
The initiative is intended to enable scalable and consistent delivery of the therapy across Mayo Clinic facilities and potentially other global clinical settings, helping broaden access to next-generation cell therapies for patients with type 1 diabetes.
As part of the agreement, Mayo Clinic will also make an equity investment in Sana Biotechnology, with the option to increase its investment over time. The investment reflects a shared commitment to advancing innovative treatment approaches for patients with significant unmet medical needs.
SC451 is being developed as a potentially curative therapy, leveraging gene-modified, stem cell-derived pancreatic islet cells engineered to evade immune detection. Early data from investigator-sponsored research suggests the modified cells can survive, function, and produce insulin for extended periods without immunosuppression.
Sana Biotechnology plans to file an Investigational New Drug application and initiate a Phase 1 clinical trial for SC451 as early as this year.
KEY QUOTES:
“We are pleased to collaborate with Mayo Clinic as we advance SC451 toward a clinical trial that we are aiming to start this year. 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.”
Steve Harr, President And Chief Executive Officer, Sana Biotechnology
“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. 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.”
Vijay Shah, MD, Mr. And Mrs. Ronald F. Kinney Executive Dean Of Research, Mayo Clinic
