[2023. 11. 17.][NASDAQ:SANA]Uppsala University Hospital and Sana Biotechnology Announce Authorization of the First-in-Human Clinical Trial Application for a Primary Islet Cell Treatment for Patients with Type 1 Diabetes

[2023. 11. 17.][NASDAQ:SANA]Uppsala University Hospital and Sana Biotechnology Announce Authorization of the First-in-Human Clinical Trial Application for a Primary Islet Cell Treatment for Patients with Type 1 Diabetes

Sana Biotechnology, Inc. and Uppsala University Hospital in Sweden are set to revolutionize the field of medical transplantation with their groundbreaking UP421 islet cell therapy. This innovative treatment, engineered using Sana's hypoimmune (HIP) technology, aims to provide proof of concept for transplanting functional islet cells without the need for immunosuppression, offering hope to patients with type 1 diabetes.

In a historic move, the Swedish Medical Products Agency has granted authorization for Uppsala University's Clinical Trial Application (CTA) to commence an investigator-sponsored, first-in-human study of UP421. This therapy has been designed to evade both allogeneic and autoimmune rejection, a major breakthrough in the world of transplantation.

The primary objectives of this study include assessing the safety of UP421, monitoring cell survival, evaluating immune evasion capabilities, and measuring C-peptide production. Success in these areas could pave the way for Sana's SC451, a hypoimmune-modified stem-cell derived islet cell therapy that holds immense promise for individuals with type 1 diabetes.

Traditional islet cell transplantation has long been a beacon of hope for type 1 diabetes patients, but the requirement for concurrent immunosuppression has been a limiting factor, leading to side effects and reduced effectiveness. Sana's hypoimmune technology, with its unique modifications, has demonstrated the potential to circumvent both allogeneic and autoimmune rejection in preclinical models, offering a glimpse of hope for a future where cell transplantation can occur without the need for immunosuppression.

Steve Harr, Sana's President and CEO, expressed excitement about the collaboration with Uppsala University and the potential to transform the landscape of type 1 diabetes treatment. He highlighted the extensive experience of the Uppsala team in islet cell transplantation and clinical care, emphasizing the importance of this clinical study's results in advancing the development of SC451.

Per-Ola Carlsson, Study Principal Investigator and Senior Physician at Uppsala University Hospital, underlined the significance of this groundbreaking research, stating that their long-term goal is to cure type 1 diabetes by replacing damaged insulin-producing cells with new ones, ultimately eliminating the need for immunosuppression.

The core challenge in islet cell transplantation has been immune rejection, primarily due to human leukocyte antigen (HLA) class I and class II expression, which UP421 aims to disrupt. Furthermore, overexpression of CD47 allows these cells to evade the innate immune cell system, including macrophages and natural killer (NK) cells. If UP421 can successfully overcome immunologic rejection, it may open the door to engraftment, survival, and C-peptide production without the burden of immune suppression.

Sana's hypoimmune platform is at the heart of this groundbreaking research, offering the potential to create cells ex vivo that can be transplanted without the need for immunosuppression. This technology is being applied to various cell types, including donor-derived allogeneic T cells and pluripotent stem cells, with promising results in evading both innate and adaptive immune responses while retaining their functionality.

Sana Biotechnology, Inc. is dedicated to changing the landscape of medicine by delivering engineered cells as therapies to patients. Their vision encompasses repairing and controlling genes, replacing damaged cells, and making these groundbreaking therapies accessible to all. With operations spanning Seattle, Cambridge, South San Francisco, and Rochester, Sana is at the forefront of innovation in the field of biotechnology.

As we eagerly await the results of the UP421 clinical trial, the world watches with bated breath, hoping that this pioneering approach will usher in a new era of transplantation and treatment for patients with type 1 diabetes.