Sana Biotechnology reported that transplanted insulin-producing pancreatic cells remained alive and functional 14 months after treatment in a patient with type 1 diabetes without the use of immunosuppression, as the company prepares to advance a related cell therapy into clinical testing.
The investigator-sponsored study uses UP421, an allogeneic primary pancreatic islet cell therapy modified with Sana’s hypoimmune technology. The technology is designed to allow transplanted cells to evade immune detection, potentially eliminating the need for chronic immunosuppressive therapy.
At 14 months after transplantation, circulating C-peptide continued to demonstrate that the transplanted beta cells were producing insulin. C-peptide also increased in response to mixed-meal tolerance tests, and fasting and meal-stimulated C-peptide levels at month 14 were comparable with those observed during the first six months.
PET-MRI scans performed at weeks 12 and 52 also demonstrated the presence of islet cells at the transplant site in the patient’s forearm. Sana said the study had identified no safety issues and that the HIP-modified cells continued to evade immune detection. The 14-month findings were also discussed in a peer-reviewed letter published in The New England Journal of Medicine.
Sana is using the same hypoimmune technology in SC451, an O-negative, HIP-modified, iPSC-derived pancreatic islet cell therapy. SC451 is being developed as a potential one-time treatment intended to produce long-term normal blood glucose without insulin therapy or immunosuppression. Sana expects to file an IND and potentially begin a Phase 1/2 study as early as 2026.
The program is being supported by a strategic collaboration with Mayo Clinic focused on developing, validating and standardizing protocols for SC451 so it can potentially be delivered consistently across different clinical settings. Mayo Clinic made a $25 million equity investment in Sana in connection with the collaboration.
Sana raised aggregate net proceeds of $93.3 million during Q2 through its at-the-market offering and the Mayo Clinic investment. It ended the quarter with $160.5 million of cash, cash equivalents and marketable securities, which is expected to fund operations into mid-2027.
KEY QUOTES:
“Our team is executing on our goals of beginning clinical studies soon for both SC451 in type 1 diabetes and SG293 in non-Hodgkin lymphoma. Proof of concept data for these programs, including the recent update for UP421 in The New England Journal of Medicine and for an SG293 surrogate at the ASGCT meeting, are encouraging.”
“If all goes as we anticipate, we expect to gain valuable insight into the clinical profiles and potential of both SC451 and SG293 over the next 6-9 months, and we look forward to sharing our progress.”
Steve Harr, President And Chief Executive Officer Of Sana Biotechnology