Transplantation of HIP-modified islet cells provides sustained glycemic control in fully immunocompetent non-human primates (NHPs) and maintains exogenous insulin independence without immunosuppression during a 6-month study period. Sexual achievement is now possible.
Administration of anti-CD47 antibody after 6 months demonstrated the principle and potential safety strategy of graft resection
SEATTLE, Feb. 13, 2024 (GLOBE NEWSWIRE) — Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on transforming patient potential through genetically engineered cells, announced today that: We announced that. cell stem cells published a paper titled “Immune-compromised islets achieve insulin independence after allogeneic transplantation in fully immunocompetent non-human primates.” In this paper, we evaluated the transplantation of Sana genetically engineered allogeneic hypoimmune (HIP) modified pancreatic islet cells into fully immunocompetent diabetic nonhuman primates (NHPs). These modified islet cells are clustered into effective endocrine organoids and are called “pseudo-islet grafts” (p-islets). The results demonstrated that HIP-modified HerP islets engrafted after intramuscular injection, provided stable endocrine function, and enabled insulin independence in the absence of immunosuppression.
“The results of this preclinical study are remarkable and, if translated into the clinic, could revolutionize the treatment of type 1 diabetes, potentially eliminating the need for insulin injections and immunosuppression. Yes,” said Sonya Schlepfer, MD. , PhD, Head of Sana’s Low Immunity Platform. “We look forward to insights from an investigator-initiated trial (IST) later this year, a first-in-human study of HIP-modified allogeneic primary islet cells that will serve as a clinical proof of concept to assess safety. Cell survival, immune evasion, and C-peptide production in HIP-modified primary islet cells transplanted into type 1 diabetic patients without immunosuppression. This publication provides valuable insight into our stem cell-derived product candidate, her SC451, along with her ongoing IST. There are over 8 million people with type 1 diabetes worldwide, and there is a great need to treat this disease, not just manage it. ”
“JDRF is dedicated to leveraging the power of research, advocacy and community engagement to advance life-changing breakthroughs in type 1 diabetes,” said JDRF Chief Scientific Officer. said Dr. Sanjoy Dutta. “The development of cell therapies that replace the loss of insulin-producing cells may one day provide a cure for type 1 diabetes. A key area of focus for JDRF is to eliminate the use of extensive immunosuppression. , to develop strategies to protect these cells after transplantation. As supporters and investors in Sana through the JDRF T1D Fund, we hope that the results described in this paper will represent meaningful advances in the treatment of type 1 diabetes. I look forward to seeing what it means to people.”
The transplant setting was intentionally designed to create high immunological hurdles by maximizing donor-recipient mismatch. Diabetes mellitus was chemically induced in the recipient, as indicated by the development of severe glycemic instability and the need for daily insulin injections to control blood sugar. Following glucose stabilization with insulin treatment, diabetic NHPs underwent HIPβ islet transplantation without induction or maintenance of immunosuppression, and insulin dosage was tapered to zero over 9 days. Immediately after HIP p islet transplantation, his diabetic NHP recipients exhibited tightly controlled blood glucose levels, were completely insulin-independent and continued to be healthy, and remained physically or physically active during the 6-month study period. No behavioral abnormalities were shown. C-peptide levels, a marker of endogenous insulin production and release, reached normal levels observed before the induction of diabetes. Furthermore, there was no indication at any time that the allogeneic HIPβ islet grafts elicited any immune recognition or immune response of any kind.
To demonstrate that there was no regeneration or recovery of endogenous islet cell populations in diabetic NHPs, anti-CD47 antibodies were used to deplete HIP p-islets. This antibody blocked the CD47 protective signal and triggered a “self-deficient” innate immune cell response, leading to rapid destruction of HIP β islet grafts. After anti-CD47 treatment, the diabetic NHP’s blood sugar levels began to fluctuate and increased significantly, requiring him to restart insulin injections. Thus, we demonstrated that tightly controlled blood glucose levels and insulin independence are due to fully functional HIP p islets.
This publication is available online at https://doi.org/10.1016/j.stem.2024.02.001.
About the immunocompromised platform
Sana’s hypoimmune platform is designed to create cells ex vivo This may evade the patient’s immune system and allow transplantation of allogeneic cells without the need for immunosuppression. With the aim of generating potent and long-lasting CAR T cells at scale, we developed donor-derived allogeneic T cells and pluripotent cells that can subsequently be differentiated into multiple cell types at scale. We apply low-immunity technology to both stem cells. Preclinical data published in peer-reviewed journals demonstrate across a variety of cell types that these transplanted allogeneic cells can evade both the innate and adaptive arms of the immune system while maintaining their activity. doing. Our most advanced programs utilizing this platform include an allogeneic CAR T program for CD19+ cancers, an allogeneic CAR T program for B cell-mediated autoimmune diseases, and an allogeneic CAR T program for CD22+ cancers. , and stem cell-derived islet cells for patients with the disease. Type 1 diabetes.
About Sana Biotechnology
Sana Biotechnology, Inc. focuses on creating genetically engineered cells and delivering them as medicines to patients. We share a vision to repair and regulate genes, replace defective or damaged cells, and make our treatments widely available to patients. We are a group of passionate people working together to create a lasting company that changes the way the world treats disease. Sana has operations in Seattle, Cambridge, South San Francisco, and Rochester. For more information about Sana Biotechnology, please visit https://sana.com/.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements about Sana Biotechnology, Inc. (the “Company”, “we”, “us”, “us”, “us”, “our”, “us”, “our”) within the meaning of the federal securities laws (our vision). (including content related to). Progress and business plan. expectations for development programs, product candidates and technology platforms, including expectations for preclinical, clinical and regulatory development plans and timing; Potential for anti-CD47 antibodies to serve as a safety strategy for Sana’s genetically engineered allogeneic hypoimmune (HIP) engineered islet cells. Potential impact of preclinical data translated into clinical practice. Sana’s publications providing insight into his SC451 program and his IST potential. Potential of Sana’s hypoimmune technology as a treatment for diabetes. Ability to create cells using the HIP platform ex vivo It can bypass the patient’s immune system and allow transplantation of allogeneic cells without the need for immunosuppression, with the associated potential benefits. HIP technology can then be applied to allogeneic T cells to generate potent and long-lasting CAR T cells at scale, and to pluripotent stem cells to differentiate into multiple cell types at scale. can. All statements other than statements of historical fact contained in this press release, including, among other things, statements regarding our strategy, expectations, cash runway and future financial condition, future operations and prospects, are forward-looking statements. In some cases, the words “aim,” “anticipate,” “anticipate,” “believe,” “consider,” “continue,” “may,” “design,” and “plan.” You can identify forward-looking statements by terms such as: “estimate”, “expect”, “goal”, “intend”, “may”, “objective”, “plan”, “position”, “could”, “predict”, “seek,” “should,” “target,” “will,” “would,” and other similar expressions that predict or indicate future events or future trends, or their equivalents. Negation of the term. We believe that most of these forward-looking statements are based on our current expectations and estimates regarding future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. , based on predictions and predictions. These forward-looking statements are subject to significant uncertainties and you should not rely on them as predictions of future events. These statements are subject to risks and uncertainties that could cause actual results to vary materially, including risks inherent in drug development, including those related to our current and future initiation, costs, timing, progress and results. Affected by certainty. Research and development programs, preclinical studies and clinical trials. For more information about the risk factors that could affect our actual results, please see our SEC filings, including, but not limited to, our quarterly report on Form 10-Q dated November 8, 2023. See identified risk factors. As required by law, we undertake no obligation to publicly update any forward-looking statements for any reason.
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nicole keith
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media@sana.com
