Sana Biotechnology Announces Publication of Preclinical Diabetes Data in Cell Stem Cell Demonstrating Insulin Independence Following Transplantation of Hypoimmune Allogeneic Primary Islet Cells Without Immunosuppression in a Diabetic NHP

Transplant of HIP-modified pancreatic islet cells provided lasting glucose control in a fully immunocompetent non-human primate (NHP), enabling the achievement of exogenous insulin independence without immunosuppression for six month study duration

Administration of anti-CD47 antibody after six months demonstrated the principle of graft ablation and a potential safety strategy

SEATTLE, Feb. 13, 2024 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, today announced that Cell Stem Cell has published a paper titled “Hypoimmune islets achieve insulin independence after allogeneic transplantation in a fully immunocompetent non-human primate.” The paper evaluated a transplant of Sana’s engineered allogeneic, hypoimmune (HIP)-modified pancreatic islet cells into a fully immunocompetent, diabetic non-human primate (NHP). These modified islet cells, which cluster into effective endocrine organoids, are termed “pseudo islet grafts” (p-islets). The results demonstrated that the HIP-modified p-islets engrafted following intramuscular injection and provided stable endocrine function, enabling insulin independence in the absence of immunosuppression.

“The results of this preclinical study are remarkable, and if they translate into the clinic, we have the potential to profoundly change the way that type 1 diabetes is addressed, potentially eliminating the need for insulin injections or immunosuppression,” said Sonja Schrepfer, MD, PhD, Sana’s Head of Hypoimmune Platform. “We look forward to insights from an investigator-sponsored trial (IST), a first-in-human study of HIP-modified, allogeneic primary islet cells later this year, which would serve as clinical proof-of-concept to assess the safety, cell survival, immune evasion, and C-peptide production of transplanted HIP-modified primary islet cells without immunosuppression into a patient with type 1 diabetes. This publication, along with the ongoing IST, will provide invaluable insights toward our stem cell derived product candidate, SC451. With more than 8 million patients with type 1 diabetes worldwide, there is an enormous need to cure – rather than simply manage – this disease.”