Sana Biotechnology announced on Mar. 16 that its investigational allogeneic islet cell therapy, UP421, has survived and secreted insulin for more than one year after transplantation in a patient with type 1 diabetes.
The development is significant as it suggests the potential for long-term insulin production without the need for immunosuppression, which can increase infection risk. The results could mark an important step forward in treating type 1 diabetes.
UP421 uses islet cells from a deceased donor that are processed through Sana’s hypoimmune platform to avoid triggering the recipient’s immune response. This approach removes the need for patients to undergo immunosuppressive treatment. Researchers at Uppsala University Hospital in Sweden conducted a first-in-human study to assess UP421's safety and efficacy in one patient. According to Sana, "the transplant was safe even though the patient was not on immunosuppressive medication." The company reported that its cells survived for 14 months and evaded detection by the immune system.
Throughout the follow-up period, UP421 maintained pancreatic islet cell function and continued producing insulin, as measured by circulating C-peptide levels. These levels increased after a mixed meal tolerance test, indicating active insulin production following meals. Sana also said the patient achieved "tighter glycemic control" between 12 and 14 months of follow-up.
Based on these findings, Sana plans to advance its preclinical candidate SC451—which uses the same hypoimmune platform but delivers stem cell-derived islet cells—into a Phase 1 study as early as this year. "Our goal is to offer patients a single treatment that delivers durable, normal blood glucose without the need for exogenous insulin or immunosuppression," Sana CEO Steve Harr said in the announcement.
The news comes amid broader changes in the cell therapy sector. In March 2025, Vertex Pharmaceuticals discontinued its own islet cell-based therapy program after disappointing trial results and took a $400 million impairment charge. Other companies such as Takeda and Novo Nordisk have also scaled back their efforts in this area recently. However, some pharmaceutical firms are increasing investment: Bristol Myers Squibb acquired Orbital Therapeutics for $1.5 billion; Johnson & Johnson plans $1 billion in new manufacturing facilities; AstraZeneca has pledged $15 billion toward expanding capabilities in China.
