Sana Biotechnology is looking to start clinical development for its type 1 diabetes therapy SC451 this year.
Sana Biotechnology’s investigational allogeneic islet cell therapy has survived and secreted insulin for more than one year after transplantation in a patient.
Sana closed Friday’s trading session at $3.36 per share, up 7.78% from its ending price of $3.09 on Thursday.
The cell therapy, dubbed UP421, is based on islet cells derived from a deceased donor, which are processed through Sana’s hypoimmune platform to avoid triggering the recipient’s immune response. This approach, according to the biotech, removes the need to subject patients to immunosuppression, which would expose them to a heightened risk of infections.
Researchers from the Uppsala University Hospital in Sweden launched an investigator-sponsored first-in-human study to assess the efficacy and safety of UP421 in one patient with type 1 diabetes. Results, released on Friday, showed that the transplant was safe even though the patient was not on immunosuppressive medication. Sana’s cells survived for 14 months and were able to evade detection by the immune system.
The announcement additionally noted that throughout 14 months of follow-up, UP421 maintained its pancreatic islet cell function and continued producing insulin, as measured by circulating levels of C-peptide. The biomarker spiked in response to a mixed meal tolerance test, suggesting that UP421 indeed produces insulin after a meal.
The patient was also able to attain “tighter glycemic control” between 12 and 14 months of follow-up, according to Sana. Based on the new data, the biotech will lean further into its preclinical candidate SC451, which uses the same hypoimmune platform and delivers stem cell-derived islet cells, for which a Phase 1 study is planned as early as this year, according to the Friday release.
“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.
Sana’s diabetes data comes amid a broader pullback in the cell therapy space. In March 2025, for instance, Vertex Pharmaceuticals pulled the plug on its own islet cell-based therapy for type 1 diabetes, absorbing a $400 million impairment charge. The cut asset made use of a proprietary coating to protect the therapeutic cells from the patient’s immune system. In a Phase 1/2 study, it failed to meet Vertex’s bar for C-peptide increase.
Other big names have pulled back from cell therapies in recent months, including Takeda and Novo Nordisk. The latter had also been advancing a type 1 diabetes program.
But other major pharmas are doubling down. Bristol Myers Squibb bought Orbital Therapeutics for $1.5 billion in October 2025, adding a cluster of RNA cell therapies. Johnson & Johnson plans to spend $1 billion on cell therapy manufacturing facilities in Pennsylvania. AstraZeneca has pledged $15 billion to bolster its capabilities in cell therapy and radiopharmaceuticals in China.
