Sana Biotechnology, Inc. (SANA) reported continued positive clinical results through 14 months from its first-in-human study evaluating islet-cell transplantation without immunosuppression, reinforcing the potential of its hypoimmune (HIP) cell-engineering platform.
The study, conducted at Uppsala University Hospital, involves transplanting UP421, an allogeneic primary islet-cell therapy engineered with Sana's HIP technology, into a patient with type 1 diabetes. The goal is to enable transplanted insulin-producing cells to survive and function without the need for lifelong immune-suppressing drugs.
14-Months Results
According to the company, the transplanted cells:
-Survived long-term and continued to producing insulin.
-Showed circulating C-peptide levels at month 14 comparable to the first six months.
-Demonstrated increased insulin secretion during a mixed-meal tolerance test.
-Showed no safety issues.
-Remained undetected by the immune system, indicating successful immune evasion.
Improved glycemic control between months 12 and 14 was associated with stronger beta-cell function, highlighting the importance of glucose management in optimizing transplanted-cell performance.
Next Steps: Advancing SC451 Toward the Clinic
Sana is now preparing to advance SC451, its HIP-modified, stem-cell-derived islet-cell therapy designed as a one-time treatment for type 1 diabetes. The company expects to file an IND application and begin a Phase 1 trial as early as this year.
SC451 aims to deliver durable, normal blood glucose without insulin injections or immunosuppression, offering a potentially transformative option for patients.
SANA has traded between $1.26 and $6.55 over the past year. The stock is currently trading at $3.30, up 7.06%.
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