Sana Biotechnology Announces Follow-On Publication in The New England Journal of Medicine (NEJM) Highlighting Groundbreaking Long-Term Data and Durability of Hypoimmune-Modified Islet Cell Transplantation Without Immunosuppression in Type 1 Diabetes
Peer-Reviewed Letter to the Editor Describes Updated Long-Term Findings Consistent with Initial Trial Data Featured in NEJM Article Published in 2025
Seminal Study Successfully Achieved Primary and Secondary Endpoints, Demonstrating that Hypoimmune (HIP)-Modified Islets are Safe, Evade Detection by the Immune System, Survive, and Function Long-Term and Continue to Produce Insulin in the Patient for Over One Year Following Administration Without Immunosuppression
Sana Expects to File Investigational New Drug (IND) Application and Initiate Phase 1/2 Trial as Early as This Year for SC451, a HIP-Modified, Stem Cell-Derived Therapy Designed as a One-Time Treatment for Patients with Type 1 Diabetes, with a Goal of Long-Term Normal Blood Glucose Without the Need for Insulin Therapy or Immunosuppression
SEATTLE, July 13, 2026 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, today announced that The New England Journal of Medicine (NEJM) has published a peer-reviewed Letter to the Editor by clinicians at Uppsala University Hospital highlighting 14-month follow-up data from an investigator-sponsored study of UP421, an allogeneic primary human pancreatic islet cell therapy engineered with Sana’s hypoimmune platform (HIP) technology, showing that the transplantation of HIP-modified insulin-secreting cells has the potential to treat type 1 diabetes without the use of immunosuppressants.
“We are excited to have our study data once again highlighted in The New England Journal of Medicine,” said Per-Ola Carlsson, MD, Study Principal Investigator, Senior Physician and Professor at the Clinic for Endocrinology and Diabetology at Uppsala University Hospital. “After a century of relying on insulin, people living with type 1 diabetes deserve more than incremental improvements. With this 14-month follow-up data using the hypoimmune technology, we believe that a functional cure for type 1 diabetes without immunosuppression is possible.”
The long-term findings provide further evidence that HIP-modified cells are safe and can evade both allogeneic and autoimmune rejection with durable function, supporting the potential of Sana’s HIP-modified, stem cell-derived pancreatic islet cell therapy, SC451, as a broadly accessible one-time treatment for patients with type 1 diabetes, with the goal of long-term normal blood glucose without the need for insulin therapy or immunosuppression.
Gary Meininger, MD, Sana’s Executive Vice President, Chief Medical Officer, added, “We continue to be encouraged by these results, which demonstrate the promise of our HIP-modified cells and their potential as a significant medical breakthrough for people living with type 1 diabetes. The recognition by the NEJM of the importance of these longer-term follow-up data is notable. As we advance SC451 toward a Phase 1/2 study, we are inspired by the opportunity to move beyond lifelong disease management and toward restoring natural glucose control. Our goal is to make a one-time, functional cure without the need for immunosuppression for individuals living with type 1 diabetes.”
Results of the study at 14 months after islet cell transplantation demonstrate the continued safety of the transplanted pancreatic beta cells, as well as continued survival and function of these cells as measured by the presence of circulating C-peptide, a biomarker indicating that transplanted beta cells are producing insulin. C-peptide levels also increase during a mixed meal tolerance test (MMTT), consistent with insulin secretion in response to a meal. At baseline, the patient had undetectable C-peptide both fasting and during an MMTT.
Fasting and MMTT-stimulated C-peptide levels at month 14 are comparable to those observed in the first six months of the study and exceed levels measured at months 9 and 12. Between months 12 and 14, the patient achieved tighter glycemic control, and the improved insulin secretion at month 14 underscores the importance of glucose control in optimizing pancreatic beta cell function. 52-week PET-MRI scanning also demonstrated islet cells at the transplant site, a forearm muscle. No safety issues were identified in the study.
About the Uppsala University Hospital Investigator-Sponsored Study of UP421 in Type 1 Diabetes
The investigator-sponsored study of UP421 is supported by a grant from The Leona M. and Harry B. Helmsley Charitable Trust. The study evaluates whether HIP-modified insulin-producing pancreatic islet cells can be transplanted safely and help to regain insulin production in individuals with type 1 diabetes without the need of simultaneous treatment with immunosuppressive medicines. To do this, UP421 is engineered using Sana’s HIP technology at Oslo University Hospital. The study involves intramuscular surgical transplantation of HIP-modified primary islet cells into the forearm of patients with type 1 diabetes. The primary objective of the study is to investigate the safety of UP421 transplantation in patients with type 1 diabetes, with secondary endpoints including immune evasion, cell survival, and C-peptide production. Circulating C-peptide is a measure of endogenous insulin production. This first-in-human study examines a low dose of HIP-modified primary islets to initially establish the safety and function of HIP-modified islets without immunosuppression and, as a result, is not intended to show improvement in glycemia and/or reduction in exogenous insulin administration.
About SC451 – Sana’s Product Candidate for Type 1 Diabetes
SC451 is an investigational, gene-modified, stem cell-derived pancreatic islet cell therapy that Sana is advancing toward the clinic as a potential one-time treatment for patients with type 1 diabetes (T1D) that leads to euglycemia without the need for exogenous insulin or immunosuppression. SC451 is a potentially scalable solution, manufactured from cells that have been modified to overcome both allogeneic and autoimmune rejection through Sana’s proprietary hypoimmune (HIP) technology. An investigator-sponsored clinical study evaluating the transplantation of donor-derived, HIP-modified pancreatic islet cells into a patient with T1D show these cells are well-tolerated, evade detection by the immune system, survive, and continue to produce insulin in the patient through 14 months of follow-up to date.
About Sana Biotechnology
Sana Biotechnology, Inc. is focused on creating and delivering engineered cells as medicines for patients. We share a vision of repairing and controlling genes, replacing missing or damaged cells, and making our therapies broadly available to patients. We are a passionate group of people working together to create an enduring company that changes how the world treats disease. Sana has operations in Seattle, WA, Cambridge, MA, and South San Francisco, CA.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements about Sana Biotechnology, Inc. (the “Company,” “we,” “us,” or “our”) within the meaning of the federal securities laws, including those related to the Company’s vision, progress, and business plans; expectations for its development programs, product candidates, and technology platforms, including its preclinical, clinical, and regulatory development plans and timing expectations, including the potential timing of INDs and clinical trials for its SC451 program; the potential impact of SC451 for individuals living with type 1 diabetes, including the ability to provide a scalable solution, to be a broadly accessible one-time treatment, to achieve long-term normal blood glucose without exogenous insulin or immunosuppression, and to provide a functional cure and move beyond lifelong disease management toward restoring natural glucose control; the potential impact and significance of data from the UP421 study of islet cell transplantation without immunosuppression in a patient with type 1 diabetes (“Study”), including the potential for transplantation of HIP-modified insulin-secreting cells to treat and provide a functional cure for type 1 diabetes without the use of immunosuppressants; the potential safety and long-term survival, durable function, and evasion of allogeneic and autoimmune rejection of HIP-modified cells, including the potential impact of glucose control on beta cell function; the potential application of the learnings from the Study to the Company’s SC451 program; and statements made by Study Principal Investigator, Senior Physician and Professor at the Clinic for Endocrinology and Diabetology at Uppsala University Hospital and statements made by the Company’s Executive Vice President, Chief Medical Officer. All statements other than statements of historical facts contained in this press release, including, among others, statements regarding the Company’s strategy, expectations, cash runway and future financial condition, future operations, and prospects, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would,” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results to vary materially, including, among others: the risks inherent in drug development such as those associated with the initiation, cost, timing, progress, and results of the Company’s current and future research and development programs and preclinical and clinical trials, including that the timing of an IND submission and clinical development for SC451 is subject to change, IND acceptance is subject to the discretion of the U.S. Food and Drug Administration, IND acceptance and initiation of clinical development for SC451 are not predictive of clinical trial results or whether clinical trials will successfully enroll or dose patients, results of preclinical or clinical studies may not be predictive of results of potential future studies, including clinical trials, of SC451 or other product candidates, and Sana’s product candidates may not be successfully developed or commercialized in any indication; and risks related to economic, market, and other disruptions, which could cause delays in the Company’s business plans, impede the Company’s access to additional capital, and impede the clinical development of SC451, among other things. For a detailed discussion of the risk factors that could affect the Company’s actual results, please refer to the risk factors identified in the Company’s SEC reports, including but not limited to its Quarterly Report on Form 10-Q dated May 11, 2026. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason.
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