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SEATTLE - Sana Biotechnology (NASDAQ:SANA), a $636 million market cap biotechnology company whose shares have surged over 60% in the past six months, announced six-month follow-up results from a first-in-human study showing that pancreatic islet cells modified with its hypoimmune technology survived and produced insulin in a type 1 diabetes patient without requiring immunosuppression. According to InvestingPro data, the company's stock has shown strong momentum despite being in development stage.
The study, conducted in partnership with Uppsala University Hospital, demonstrated the presence of circulating C-peptide, a biomarker of insulin production, at six months post-transplantation. The modified cells also showed increased C-peptide levels during a mixed meal tolerance test, indicating insulin secretion in response to food intake. While the clinical results are promising, InvestingPro analysis indicates the company maintains a healthy liquidity position with a current ratio of 3.4, though it is currently not profitable and burning through cash - typical for biotechnology companies in the development phase.
PET-MRI scans at 12 weeks confirmed the presence of islet cells at the transplant site in the patient's forearm muscle. No safety issues were identified, and the modified cells successfully evaded immune responses.
"These results continue to suggest that a functional cure for type 1 diabetes without immunosuppression is possible," said Per-Ola Carlsson, MD, Study Principal Investigator at Uppsala University Hospital, according to the press release.
The study involved intramuscular surgical transplantation of donor-derived islet cells engineered with Sana's hypoimmune platform. This initial low-dose study was designed to establish safety and function rather than demonstrate glycemic improvement or reduced insulin needs.
Sana is now developing SC451, a stem cell-derived therapy incorporating the same immune evasion technology, with plans to file an investigational new drug application as early as next year.
Type 1 diabetes affects over nine million people globally. Current islet cell transplantation procedures require immunosuppression to prevent rejection of donor cells.
The study is supported by a grant from The Leona M. and Harry B. Helmsley Charitable Trust, with results presented at the American Diabetes Association Scientific Sessions.
In other recent news, Sana Biotechnology has maintained its Buy rating and an $11 price target from H.C. Wainwright. This follows the company's recent presentation at the New York Stem Cell Foundation Conference, where they shared updated 12-week data for their innovative therapy, UP421, aimed at treating Type 1 diabetes. The therapy, a hypoimmune-modified pancreatic islet cell treatment, is notable for not requiring immunosuppression. The ongoing trial, conducted in collaboration with Uppsala University Hospital, showed that the patient initially had undetectable C-peptide levels, which are a biomarker for insulin production. At 12 weeks post-transplantation, these levels were sustained, indicating continued insulin secretion in response to food intake. The study also confirmed a favorable safety profile for UP421, with no signs of inflammation or graft rejection. Sana Biotechnology plans to release additional follow-up data from the ongoing study throughout the year. These updates will be shared through peer-reviewed publications and presentations at scientific conferences.
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