Sana Biotechnology and Mayo Clinic Partner Up on Type 1 Diabetes Stem Cell-Derived Therapy, Phase 1 Potentially This Year
The partnership hopes to speed up the scalable development of SC451 for type 1 diabetes by standardizing treatment protocols, improving clinical delivery and post-care, and preparing the therapy for broader use across care sites.
Key Points
- Sana Biotechnology and Mayo Clinic have partnered on advancing Sana’s hypoimmune-modified pancreatic cell therapy for type 1 diabetes.
- The work will center on clinical workflows, product handling, delivery procedures, post-treatment care, and trial design to support broader use across clinical sites.
- Mayo Clinic will also make an equity investment in Sana as part of the agreement.
Sana Biotechnology and Mayo Clinic have announced they’re partnering to develop SC451, Sana’s investigational hypoimmune-modified pancreatic islet cell therapy for type 1 diabetes.
What’s SC451?
SC451 is an investigational, gene-modified, stem cell-derived pancreatic islet cell therapy for type 1 diabetes. It’s designed to achieve euglycemia without exogenous insulin or immunosuppression, administered as a single dose.
The previous version of this therapy, UP421, was sourced from cadaveric human donors and served as a proof-of-concept. In March, Sana announced that after 14 months, UP421 demonstrated tighter glycemic control and improved insulin secretion, with no safety issues. It appears that this method was difficult to scale, given that there are over 9 million type 1 diabetes patients worldwide, and they’ve since switched the platform to use gene-edited stem cells from a master cell bank to scale it (and changed the name to SC451).
Mayo Clinic’s Role
Sana expects to file an Investigational New Drug application and begin a Phase 1 study as early as this year, and it sounds like Mayo Clinic will help them accomplish that.
Mayo Clinic will help develop, validate, and standardize protocols and processes across clinical settings. The initial work includes:
- Optimizing workflows for product handling, delivery of SC451, and post-treatment care
- Refining surgical techniques related to the procedure
- Standardizing handling, delivery, and post-treatment management
- Supporting clinical trial design, including biomarker identification for patient selection and long-term monitoring
Additionally, it appears Mayo will help administer the therapies.
Additional Investment
Mayo Clinic will also make an equity investment in Sana Biotechnology and has the option to make an additional equity investment as they move along.
“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. “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.”
The company expects to file
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