Announcement • May 14
Sana Biotechnology Presents Preclinical Data for in Vivo Car T Cell Therapy Sg293 Surrogate Demonstrating Cell-Specific Delivery, Potent Car T Cell Generation, and Deep B Cell Depletion in Nhps Sana Biotechnology, Inc. announced the presentation of preclinical data demonstrating that a surrogate SG293, an in vivo CAR T cell therapy, achieved cell-specific delivery, robust and dose-dependent CAR T cell generation, and deep B cell depletion in non-human primates (NHPs) without the use of lymphodepleting chemotherapy. SG293 is a CD8-targeted fusosome that delivers the genetic material to make CD19-directed CAR T cells. In an NHP model, a one-time intravenous administration of the surrogate SG293 led to potent CAR T cell generation, dose-dependent CAR T cell expansion, and complete peripheral B cell depletion. At 3 weeks, B cells were undetectable or minimally detectable in lymph nodes, and as B cells returned after depletion, the vast majority exhibited a naïve phenotype indicative of a “reset” of the B cell compartment. The targeted fusogen used in SG293 demonstrates a differentiated level of protection from off-target delivery risks in vitro when compared to other targeted fusogen technologies. The specific delivery and favorable on-target safety profile were confirmed in vivo in NHPs with surrogate SG293. Post-necropsy analysis of tissues showed no evidence of delivery to non-target cells, including hepatocytes, heart, or gonadal tissue. Post-infusion symptoms were mild and managed with acetaminophen, and CAR T-associated toxicities were manageable and consistent with autologous CAR T toxicities in this NHP model. The novel transgene design used in SG293 diminishes CAR protein incorporation onto the vector during manufacturing, which mitigates anti-CAR immunogenicity in NHPs and may enable improved durability of in vivo CAR T cells. SG293, which uses Sana’s proprietary fusogen-based in vivo delivery technology, is a CD8-targeted fusosome that delivers to CD8+ T cells the genetic material to make CD19-directed CAR T cells while avoiding potentially troublesome delivery to tissues such as the liver, heart, and gonadal tissue. Sana intends to explore SG293 in both B cell cancers and B cell-mediated autoimmune diseases. SG227, which uses Sana’s proprietary fusogen-based in vivo delivery technology, is a CD8-targeted fusosome that delivers to CD8+ T cells the genetic material to make BCMA-directed CAR T cells while avoiding potentially troublesome delivery to tissues such as the liver, heart, and gonadal tissue. Sana intends to explore SG227 as a potential therapy for the treatment of multiple myeloma. Fusogens are a well-studied and widespread class of proteins whose biology mediates membrane fusion in the trillions of cell-to-cell and intracellular interactions, including the delivery of complex materials to specific cell types. Drawing on Sana’s deep expertise in fusogen biology and protein engineering, its fusogen in vivo delivery platform leverages engineered fusogens, combined with optimized delivery vehicles, to enable targeted and efficient delivery of therapeutic payloads to specific cells in vivo. This modular system is designed to target diverse cell surface receptors, enabling cell-specific delivery, and deliver a wide range of therapeutic payloads across multiple cell types, including gene-editing machinery or integrating DNA. This flexibility supports tailored therapeutic approaches for different diseases, while highly specific delivery vehicles expand the potential of in vivo therapies. Announcement • Apr 27
Sana Biotechnology, Inc., Annual General Meeting, Jun 04, 2026 Sana Biotechnology, Inc., Annual General Meeting, Jun 04, 2026. Announcement • Mar 13
Sana Biotechnology Announces Continued Positive Clinical Results From Type 1 Diabetes Study Of Islet Cell Transplantation Without Immunosuppression Sana Biotechnology, Inc. announced 14-month follow-up results from an investigator-sponsored, first-in-human study transplanting UP421, an allogeneic primary islet cell therapy engineered with Sana’s hypoimmune platform (HIP) technology, into a patient with type 1 diabetes without any immunosuppression. Results from more than 1 year after cell transplantation demonstrate sustained survival and function of pancreatic beta cells, as measured by the presence of circulating C-peptide, a biomarker of endogenous insulin production by the transplanted beta cells. C-peptide levels also increase in response to a mixed meal tolerance test (MMTT), consistent with insulin secretion in response to a meal. 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. No safety issues were identified in the study. Sana is leveraging validated HIP technology to develop SC451, a HIP-modified, stem cell-derived therapy, designed as a one-time treatment for patients with type 1 diabetes, with a goal of normal blood glucose without insulin or immunosuppression. Sana expects to file investigational new drug (IND) application for SC451 in type 1 diabetes and initiate Phase 1 trial as early as this year. Primary islet cell transplantation with immunosuppression is an established procedure in type 1 diabetes in which allogeneic pancreatic islet cells are isolated from a deceased donor’s pancreas and transplanted into a patient with a goal of normal blood glucose and insulin independence. As with whole-organ transplants, suppression of the patient’s immune system has historically been required to prevent immune rejection of allogeneic transplanted cells and resurgence of the inciting autoimmune attack. Sana’s HIP technology is designed to overcome immunologic rejection of allogeneic cells and, in type 1 diabetes, to also evade autoimmune rejection of pancreatic beta cells. UP421 was derived from the islet cells of a deceased donor and transplanted with no immunosuppression, and the survival of the UP421 cells provides evidence that they evade both allogeneic and autoimmune detection. 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 cells can be transplanted safely and help to regain insulin production in individuals with type 1 diabetes without need of simultaneous treatment with immunosuppressive medicines. To do this, UP421 is engineered using Sana’s HIP platform 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 cell survival, immune evasion, 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. Results of the study at 14 months after islet cell transplantation demonstrate the survival and function of pancreatic beta 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 an MMTT, consistent with insulin secretion in response to a meal. At baseline, the patient had undetectable C-peptide both fasting and during an MMTT. 52-week PET-MRI scanning also demonstrated islet cells at the transplant site, a forearm muscle. The HIP platform has not only achieved proof-of-concept in humans but has also shown continuation of effect with long-term evasion of immune recognition, supporting its potential broad application for allogeneic transplantation without immunosuppression. Sana’s HIP platform is designed to generate cells ex vivo that can evade the patient’s immune system to enable the transplantation of allogeneic cells without the need for immunosuppression. Sana is applying HIP technology to develop therapeutic candidates at scale, including pluripotent stem cells, which can then be differentiated into multiple cell types, including pancreatic islet cells. Early clinical data from Phase 1 trials and preclinical data published in peer-reviewed journals demonstrate across a variety of cell types that these transplanted allogeneic cells can evade both the adaptive and innate arms of the immune system while retaining their activity. Sana’s most advanced program using this platform is its stem cell-derived pancreatic islet cell program for type 1 diabetes. 
