Sana Biotechnology Inc. (NASDAQ: SANA) reported 14-month follow-up data from a clinical study examining islet cell transplantation in a type 1 diabetes patient without immunosuppression drugs.

The investigator-sponsored study at Uppsala University Hospital transplanted UP421, pancreatic islet cells modified with Sana's hypoimmune platform technology, into a patient's forearm muscle. Results showed continued presence of C-peptide, a biomarker indicating the transplanted cells remain alive and produce insulin 14 months after transplantation.

C-peptide levels at month 14 were comparable to those observed in the first six months of the study and exceeded levels measured at months 9 and 12. The patient showed C-peptide increases during a mixed meal tolerance test, indicating insulin secretion in response to food. The patient had undetectable C-peptide levels before transplantation.

The study reported no safety issues. PET-MRI scanning at 52 weeks confirmed islet cells remained at the transplant site.

"These findings build upon previously presented data and continue to show no safety issues, along with continued immune evasion, survival, and function of the transplanted cells," said Per-Ola Carlsson, the study's principal investigator at Uppsala University Hospital.

Sana plans to file an investigational new drug application for SC451, a stem cell-derived therapy using the same hypoimmune technology, and initiate a Phase 1 trial as early as this year. The company presented the full 14-month data at the Advanced Technologies & Treatments for Diabetes Conference.

The study examined a low dose of modified islet cells to establish safety and function without immunosuppression and was not designed to demonstrate glycemic improvement or reduced insulin administration. The research is supported by a grant from The Leona M. and Harry B. Helmsley Charitable Trust.