SEATTLE, July 13, 2026
Sana Biotechnology announced the publication of long-term clinical findings in The New England Journal of Medicine (NEJM) demonstrating that its hypoimmune (HIP)-modified pancreatic islet cell technology continued to function safely for more than 14 months without the need for immunosuppressive therapy in a patient with Type 1 diabetes. The peer-reviewed Letter to the Editor, authored by clinicians at Uppsala University Hospital, expands upon data first published in 2025 and provides additional evidence that hypoimmune-modified insulin-producing cells can evade immune rejection while maintaining durable insulin production. The findings further support Sana’s advancement of SC451, its investigational stem cell-derived therapy, toward an Investigational New Drug (IND) filing and Phase 1/2 clinical trial expected as early as later this year.
Long-Term Data Demonstrate Durable Cell Survival and Insulin Production
The 14-month follow-up from the investigator-sponsored UP421 study showed that transplanted HIP-modified pancreatic islet cells remained viable and functional without immunosuppressive treatment. Researchers continued to detect circulating C-peptide, a biomarker indicating endogenous insulin production, with fasting and mixed meal tolerance test (MMTT) responses comparable to those observed during the first six months following transplantation. Investigators also reported improved insulin secretion alongside tighter blood glucose control between months 12 and 14, suggesting sustained beta-cell function over time. Additionally, PET-MRI imaging performed at 52 weeks confirmed the continued presence of transplanted islet cells at the forearm implantation site, with no new safety concerns identified during follow-up.
Hypoimmune Technology Supports Functional Cure Strategy
The study provides further validation of Sana’s proprietary Hypoimmune (HIP) technology, which is designed to enable transplanted cells to evade both autoimmune and allogeneic immune rejection without lifelong immunosuppressive therapy. The first-in-human UP421 trial evaluated donor-derived pancreatic islet cells engineered using the HIP platform and transplanted into patients with Type 1 diabetes. Although the low-dose study was primarily designed to establish safety, immune evasion, cell survival, and insulin production rather than improve glycemic control, the durable insulin secretion observed through 14 months supports the broader therapeutic potential of the platform. These results reinforce the possibility of developing regenerative cell therapies capable of restoring natural insulin production while avoiding many of the risks associated with conventional transplantation.
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Sana Advances SC451 Toward Clinical Development
Building on these encouraging clinical findings, Sana is preparing to advance SC451, a gene-modified, stem cell-derived pancreatic islet cell therapy manufactured using its proprietary HIP technology. Unlike donor-derived islet transplantation, SC451 is designed as a scalable, one-time treatment intended to achieve long-term normal blood glucose without the need for exogenous insulin or chronic immunosuppression. The company expects to submit an IND application and initiate a Phase 1/2 clinical trial as early as later this year. With durable clinical evidence now published in one of medicine’s leading peer-reviewed journals, Sana believes its hypoimmune cell platform represents a significant step toward developing a functional cure for Type 1 diabetes through engineered cell therapies.
Source:Sana Biotechnology press release
