Sana, Mayo Clinic Partner on Diabetes Cell Therapy Development
Sana Biotechnology has announced a strategic collaboration with Mayo Clinic to accelerate the development of SC451, an investigational cell therapy aimed at transforming treatment for patients with Type 1 Diabetes.
The partnership brings together Sana’s expertise in engineered cell therapies with Mayo Clinic’s multidisciplinary capabilities in clinical research, transplant medicine, and patient care. At the center of the collaboration is SC451, a hypoimmune-modified pancreatic islet cell therapy designed to restore insulin production through a single administration. The therapy aims to eliminate the need for lifelong insulin injections and immunosuppressive drugs—two major burdens for patients living with type 1 diabetes.
Under the agreement, Mayo Clinic will contribute end-to-end clinical and operational insights to help optimize workflows related to SC451. This includes improving product handling, refining delivery techniques, and enhancing post-treatment care protocols to ensure consistent and scalable implementation across diverse healthcare settings. Surgical expertise will also play a key role, with efforts focused on refining procedures associated with islet cell transplantation.
In addition, the collaboration will emphasize the standardization of processes, from therapy preparation to patient management, to support broader clinical adoption. Mayo Clinic will also take a leading role in clinical trial design, including identifying biomarkers to guide patient selection and enable long-term monitoring of treatment outcomes.
The initiative reflects a broader push to make advanced cell therapies more accessible and practical in real-world clinical environments. Mayo Clinic is expected to further expand its capabilities in delivering investigational islet cell therapies as part of the collaboration, reinforcing its leadership in innovative treatment approaches.
As part of the agreement, Mayo Clinic will also make an equity investment in Sana Biotechnology, signaling a shared commitment to advancing new therapeutic options for patients. The deal includes provisions for potential additional investment in the future.
Sana’s President and CEO, Steve Harr, highlighted the importance of the collaboration as the company prepares to move SC451 into clinical trials, which are expected to begin this year. He pointed to recent data demonstrating that transplanted pancreatic islet cells modified using Sana’s hypoimmune technology were able to survive and function for over a year without immunosuppression in a patient, underscoring the therapy’s potential.
Vijay Shah, a senior research leader at Mayo Clinic, emphasized the organization’s commitment to addressing unmet medical needs through innovation. By combining expertise in cell therapy development and transplant immunology, both organizations aim to rigorously evaluate SC451 and potentially redefine treatment paradigms for type 1 diabetes.
If successful, the collaboration could mark a significant step toward a functional cure for the disease, offering patients a long-term solution beyond traditional insulin therapy.