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Groundbreaking First-in-Human Study Establishes Potential to Treat Type 1 Diabetes by Transplanting Insulin-Secreting Cells Without Immunosuppression

开创性的人体首次研究确立了通过移植胰岛素分泌细胞治疗1型糖尿病的潜力，且无需免疫抑制。

Six-Month Patient Follow-up Results Demonstrate that Sana’s Transplanted Pancreatic Islet Cells Modified with its Hypoimmune (HIP) Technology are Safe and Well-tolerated, Survive, Evade Detection by the Immune System, and Continue to Produce Insulin in the Patient

六个月的患者随访结果显示，Sana公司使用其低免疫（HIP）技术改造的移植胰岛细胞安全、耐受性良好，在患者体内存活、逃避免疫系统检测，并持续产生胰岛素。

Function and Persistence of Pancreatic Islets Were Detectable by Production of Consistent Levels of Circulating C-Peptide, a Marker of Insulin Production, and Increased C-Peptide Levels with a Mixed Meal Tolerance Test (MMTT)

通过产生一致水平的循环C肽（胰岛素生产的标志物）以及混合餐耐受试验（MMTT）中C肽水平的增加，可以检测到胰岛的功能和持久性。

MRI Show Signals Consistent with Graft Survival Six Months after Transplantation

移植六个月后，MRI显示与移植物存活一致的信号

Study Continues to Evaluate Safety, Survival, and Function of Transplanted Cells

研究继续评估移植细胞的安全性、存活率和功能

Data Shared at an Invited Presentation at the 85

在第85届特邀演讲中分享的数据

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Annual American Diabetes Association (ADA) Scientific Sessions Today

美国糖尿病协会（ADA）年度科学会议今天

Sana is Incorporating the Tested Immune Evasion Technology to Develop SC451, a HIP-modified, Stem Cell-Derived Therapy as a One-Time Treatment for Patients with Type 1 Diabetes, with a Goal of Normal Blood Glucose, with No Insulin and No Immunosuppression

Sana公司正在将经过测试的免疫逃逸技术应用于开发SC451，这是一种经过HIP修饰、源自干细胞的疗法，作为1型糖尿病患者的一次性治疗手段，目标是实现正常血糖水平，无需使用胰岛素且无需免疫抑制。

SEATTLE, June 23, 2025 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, today announced six-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 (HIP) technology, into a patient with type 1 diabetes without any immunosuppression.

西雅图，2025年6月23日（环球新闻社）——Sana生物技术公司（纳斯达克股票代码：SANA），一家专注于通过工程细胞为患者改变可能性的公司，今天宣布了由研究者发起的首次人体研究的六个月随访结果，该研究将使用Sana的低免疫（HIP）技术改造的同种异体原代胰岛细胞疗法UP421移植到一名1型糖尿病患者体内，且未使用任何免疫抑制。

The study is being conducted in partnership with Uppsala University Hospital. The results are consistent with and build upon the previously reported four-week and 12-week clinical results. Results of the study at six months after 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.

该研究正在与乌普萨拉大学医院合作进行。结果与之前报告的四周和十二周临床结果一致并有所建立。细胞移植后六个月的研究结果显示，通过循环C肽的存在测量，胰岛β细胞的存活和功能得以证明，C肽是一种表明移植的β细胞正在产生胰岛素的生物标志物。

C-peptide levels also increase with a mixed meal tolerance test (MMTT), consistent with insulin secretion in response to a meal. 12-week PET-MRI scanning also demonstrated islet cells at the transplant site, a forearm muscle. The study identified no safety issues, and the HIP-modified islet cells evaded immune responses..

C肽水平在混合餐耐受试验（MMTT）中也有所增加，这与餐后胰岛素分泌一致。12周后的PET-MRI扫描还显示移植部位——前臂肌肉中存在胰岛细胞。研究未发现任何安全问题，且经过HIP修饰的胰岛细胞成功规避了免疫反应。

“As an endocrinologist who has dedicated my career to improving outcomes for patients with type 1 diabetes, I am pleased to share these exciting results. Consistent with the previously reported four-week and 12-week data, we believe today’s six-month update continues to suggest that a functional cure for type 1 diabetes without immunosuppression is possible,” said Per-Ola Carlsson, MD, Study Principal Investigator, Senior Physician and Professor at the Clinic for Endocrinology and Diabetology at Uppsala University Hospital.

“作为一名致力于改善1型糖尿病患者预后的内分泌学家，我很高兴分享这些令人兴奋的结果。与之前报告的四周和十二周数据一致，我们相信今天的六个月更新继续表明，无需免疫抑制的功能性治愈1型糖尿病是可能的，”乌普萨拉大学医院内分泌与糖尿病科首席研究员、资深医生和教授佩尔-奥拉·卡尔森医学博士表示。

“These groundbreaking results build upon the extensive preclinical and translational studies of Dr. Sonja Schrepfer and the team at Sana and provide hope for a cure. We look forward to continued follow-up, with study results submitted for publication in a peer-reviewed journal.”.

“这些突破性的结果建立在 Sonja Schrepfer 博士以及 Sana 团队广泛的临床前和转化研究的基础上，为治愈提供了希望。我们期待继续跟进，并将研究结果提交给同行评审的期刊发表。”

“Durable survival, function, and immune evasion of transplanted allogeneic pancreatic islet cells with no immunosuppressive medicines, particularly in the context of a pre-existing autoimmune response to these cells, represents a transformative and necessary step to making cellular and transplant medicine more accessible,” said Steve Harr, MD, Sana’s President and CEO.

“在无需免疫抑制药物的情况下，移植的同种异体胰岛细胞能够实现持久的存活、功能维持及免疫逃逸，尤其是在预先存在针对这些细胞的自身免疫反应的情况下，这代表了使细胞和移植医学更具可及性的变革性且必要的一步，”Sana公司总裁兼首席执行官史蒂夫·哈尓（Steve Harr）博士表示。

“Type 1 diabetes currently impacts over nine million people globally, and there have been relatively few transformational advances in this disease since the discovery of insulin over 100 years ago. The data presented today bring our vision—treating diabetes with a broadly available therapy leading to normal blood glucose control without either insulin or immunosuppression—closer to reality.

“1型糖尿病目前在全球影响着超过九百万人，自一百多年前胰岛素被发现以来，该疾病治疗领域相对较少出现突破性进展。今天公布的数据让我们离实现愿景更近一步——通过广泛可用的疗法，在无需使用胰岛素或免疫抑制的情况下实现血糖的正常控制。”

We are incorporating the immune evasion learnings and technology from the current UP421 trial to develop SC451, a HIP-modified, stem cell-derived islet cell therapy, for which we intend to file an investigational new drug application (IND) as soon as next year.”.

我们正在将当前UP421试验中的免疫逃逸研究成果和技术应用于开发SC451，这是一种经过HIP修饰的干细胞衍生胰岛细胞疗法，我们计划最快在明年提交研究性新药申请（IND）。

Aaron J. Kowalski, Ph.D., CEO of Breakthrough T1D (previously known as JDRF), added, “A paradigm shift in the treatment of diabetes is long overdue. For more than a century, exogenous insulin administration has remained the only therapy for this chronic disease. Significant improvements in insulin therapy, like automated insulin delivery systems, have improved outcomes for many living with this disease.

突破性T1D（前身为JDRF）首席执行官Aaron J. Kowalski博士补充道：“糖尿病治疗的范式转变早就该发生了。一个多世纪以来，外源性胰岛素注射一直是这种慢性病唯一的治疗方法。胰岛素治疗的重大改进，例如自动化胰岛素输送系统，已经为许多患者改善了治疗效果。

Yet, most people with type 1 diabetes are still unable to achieve ideal glucose levels, heightening the risk of many complications, including cardiovascular disease, kidney disease, and more. The prospect of administering insulin-producing cells into people with this disease—enabling stable glycemic control without lifelong injections, drugs that suppress their immune system, or constant daily management—represents a transformative and potentially life-changing breakthrough.

然而，大多数 1 型糖尿病患者仍然无法达到理想的血糖水平，这增加了许多并发症的风险，包括心血管疾病、肾病等等。将产生胰岛素的细胞注入这种疾病患者体内的前景——在无需终身注射、抑制免疫系统的药物或持续的日常管理的情况下实现稳定的血糖控制——代表了一种变革性且可能改变生活的突破。

We are extremely grateful for the collaborative efforts of the research teams at Sana, Uppsala University Hospital, and all those involved, for their dedication to this work. The entire team at Breakthrough T1D looks forward to working with Sana and others to ensure all members of the T1D community can benefit from these life-changing breakthroughs.”.

我们对Sana、乌普萨拉大学医院的研究团队以及所有相关人员的协作努力深表感谢，感谢他们对这项工作的奉献。Breakthrough T1D的全体团队期待与Sana及其他机构合作，确保T1D社区的所有成员都能从这些改变生命的突破中受益。”

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 control and insulin independence. As with whole-organ transplants, suppression of the recipient’s immune system has historically been required to prevent immune rejection of the allogeneic transplanted cells and resurgence of the inciting autoimmune attack.

原发性胰岛细胞移植联合免疫抑制是1型糖尿病的既定程序，其中从已故捐赠者的胰腺中分离出同种异体胰岛细胞，并将其移植到患者体内，目标是实现正常的血糖控制和胰岛素独立性。与整个器官移植一样，历史上一直需要抑制接受者的免疫系统，以防止对同种异体移植细胞的免疫排斥以及诱发自身免疫攻击的复发。

Sana’s HIP technology is designed to overcome immunologic rejection of allogeneic cells, and in type 1 diabetes, to evade the autoimmune rejection of pancreatic beta cells as well. UP421 cells were transplanted with no immunosuppression, and the survival of those islet cells provides evidence that they evade both allogeneic and autoimmune detection..

Sana的HIP技术旨在克服同种异体细胞的免疫排斥，在1型糖尿病中，还能逃避胰岛β细胞的自身免疫排斥。UP421细胞在没有免疫抑制的情况下移植，这些胰岛细胞的存活证明它们能够逃避同种异体和自身免疫的检测。

About the Uppsala University Hospital Investigator-Sponsored Study of UP421 in Type 1 Diabetes

关于乌普萨拉大学医院研究者发起的UP421在1型糖尿病中的研究

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-engineered 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.

UP421 的研究者发起的研究得到了 Leona M. 和 Harry B. Helmsley 慈善信托基金的资助。该研究评估了 HIP 工程胰岛素生成胰腺细胞是否可以安全移植，并帮助 1 型糖尿病患者恢复胰岛素分泌，且无需同时使用免疫抑制药物。

To do this, UP421 is engineered using Sana’s HIP platform at Oslo University Hospital. The study involves intramuscular surgical transplantation of primary, or donor-derived, HIP-engineered islet cells into the forearm of patients with type 1 diabetes. The primary objective of the study is to investigate safety of UP421 transplantation in patients with type 1 diabetes, with secondary endpoints including cell survival, immune evasion, and C-peptide production.

为此，UP421利用奥斯陆大学医院的Sana公司的HIP平台进行开发。该研究涉及将原代或供体来源的HIP工程胰岛细胞通过肌肉内手术移植到1型糖尿病患者的前臂中。这项研究的主要目的是评估UP421移植在1型糖尿病患者中的安全性，次要终点包括细胞存活、免疫逃逸和C肽生成。

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..

循环C肽是内源性胰岛素分泌的指标。这项首次人体研究考察了低剂量HIP修饰的原代胰岛，以初步评估在无免疫抑制的情况下HIP修饰胰岛的安全性和功能，因此并不旨在显示血糖改善和/或外源性胰岛素用量的减少。

Results of the study over six months after islet cell transplantation demonstrate the survival and function of pancreatic beta cells through the latest timepoint at month 6, as measured by the presence of circulating C-peptide, a biomarker indicating that transplanted beta cells are producing insulin.

六个月后的胰岛细胞移植研究表明，通过测量循环 C 肽（一种表明移植的 β 细胞正在产生胰岛素的生物标志物）的存在，证实了胰腺 β 细胞在第六个月这一最新时间点的存活和功能。

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. 12-week PET-MRI scanning also demonstrated islet cells at the transplant site, a forearm muscle. The HIP platform has achieved proof-of-concept in humans, showing evasion of immune recognition with the potential broad application for allogeneic transplantation without immunosuppression..

C肽水平在混合餐耐受试验（MMTT）期间也会增加，这与进餐后胰岛素分泌一致。在基线时，患者在空腹和MMTT期间均检测不到C肽。12周的PET-MRI扫描还显示移植部位——前臂肌肉中存在胰岛细胞。HIP平台已在人类中实现了概念验证，显示出避免免疫识别的能力，并有潜力广泛应用于无需免疫抑制的同种异体移植。

About the Sana Biotechnology Hypoimmune (HIP) Platform

关于Sana生物技术低免疫（HIP）平台

Sana’s HIP platform is designed to generate cells

Sana的HIP平台旨在生成细胞

ex vivo

离体

that can evade the patient’s immune system to enable the transplantation of allogeneic cells without the need for immunosuppression. We are applying the 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, and donor-derived allogeneic CAR T cells.

可以逃避患者免疫系统，从而实现同种异体细胞移植而无需免疫抑制。我们正在应用HIP技术大规模开发治疗候选药物，包括多能干细胞，这些细胞可以进一步分化为多种细胞类型，包括胰岛细胞，以及供体来源的同种异体CAR T细胞。

We and our collaborators have generated significant foundational intellectual property in the area. 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 are able to evade both the innate and adaptive arms of the immune system while retaining their activity.

我们和我们的合作者在该领域已经创造了重要的基础知识产权。早期的I期临床试验数据和发表在同行评审期刊上的临床前数据表明，在多种细胞类型中，这些移植的同种异体细胞能够逃避先天性和适应性免疫系统的攻击，同时保留其活性。

Sana’s most advanced programs using this platform include a stem cell-derived pancreatic islet cell program for type 1 diabetes, an allogeneic CAR T program for B-cell mediated autoimmune diseases, and an allogeneic CAR T program targeting CD22+ cancers..

Sana使用该平台最先进的项目包括一个用于1型糖尿病的干细胞衍生胰岛细胞项目，一个针对B细胞介导的自身免疫性疾病的同种异体CAR-T项目，以及一个靶向CD22+癌症的同种异体CAR-T项目。

About Sana Biotechnology

关于Sana生物技术

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生物技术公司专注于为患者创造和提供工程细胞作为药物。我们怀有修复和控制基因、替换缺失或受损细胞以及让我们的疗法广泛惠及患者的愿景。我们是一群充满热情的人，齐心协力打造一家改变世界治疗疾病方式的持久公司。

Sana has operations in Seattle, WA, Cambridge, MA, South San Francisco, CA, and Bothell, WA. For more information about Sana Biotechnology, please visit .

Sana在华盛顿州西雅图、马萨诸塞州剑桥、加利福尼亚州南旧金山以及华盛顿州博塞尔均有业务。如需更多关于Sana生物技术的信息，请访问。

https://sana.com/

https://sana.com/

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Cautionary Note Regarding Forward-Looking Statements

关于前瞻性陈述的警示性说明

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 with respect to the timing and substance of potential INDs, and the Company’s SC451 program, including the potential ability of SC451 to be administered as a broadly available, one-time treatment for patients with type 1 diabetes and to achieve normal blood glucose without insulin injections or immunosuppression; the potential impact and significance of data from the UP421 study of islet cell transplantation without immunosuppression in type 1 diabetes (“Study”), including with respect to the potential to transplant insulin-secreting cells and develop a functional cure for the treatment of type 1 diabetes without immunosuppression and the accessibility of cellular and transplant medicines; expectations regarding the presentation at the 85.

本新闻稿包含关于Sana生物技术公司（“公司”、“我们”或“我们的”）的前瞻性声明，符合联邦证券法的含义，包括与公司的愿景、进展和业务计划相关的声明；对其开发计划、候选产品和技术平台的预期，包括其临床前、临床和监管开发计划及时间预期，包括潜在IND的时间和内容，以及公司的SC451计划，包括SC451作为广泛可用的一次性治疗1型糖尿病患者的潜力，能够实现无需胰岛素注射或免疫抑制的正常血糖；UP421研究中关于不使用免疫抑制剂的胰岛细胞移植在1型糖尿病中的潜在影响和数据意义（“研究”），包括移植胰岛素分泌细胞和发展功能性治愈1型糖尿病的潜力，以及细胞和移植药物的可及性；关于第85届会议报告的预期。

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Annual American Diabetes Association Scientific Sessions; the ability of the HIP platform to generate cells

美国糖尿病协会年度科学会议；HIP平台生成细胞的能力

ex vivo

离体

that can evade the patient’s immune system to enable the transplantation of allogeneic cells without the need for immunosuppression and, in type 1 diabetes, enable transplanted pancreatic beta cells to avoid autoimmune rejection, to have broad application for allogeneic transplantation without immunosuppression, and to be applied to develop therapeutic candidates at scale, including pluripotent stem cells that can be differentiated into multiple cell types and donor-derived allogeneic CAR T cells; expectations with respect to Study follow-up and submission and publication of Study results; the potential safety and survival, function, and evasion of immune detection of HIP-modified primary pancreatic islet cells transplanted intramuscularly with no immunosuppression; the potential impact of administering insulin-producing cells to enable stable glycemic control without lifelong injections, immune-suppressing drugs, or constant daily management, including the potential to benefit members of the type 1 diabetes community; the potential application of the learnings from the Study to the Company’s SC451 program; the potential significance of the survival of UP421 cells in the Study; and statements made by Study Principal Investigator, Senior Physician and Professor at the Clinic for Endocrinology and Diabetology at Uppsala University Hospital, statements made by the Company’s President and CEO, and statements made by the CEO of Breakthrough T1D (previously known as JDRF).

能够逃避患者免疫系统，从而实现同种异体细胞移植而无需免疫抑制，并在1型糖尿病中使移植的胰腺β细胞避免自身免疫排斥，广泛应用于无需免疫抑制的同种异体移植，并用于大规模开发治疗候选药物，包括可分化为多种细胞类型的多能干细胞和供体来源的同种异体CAR-T细胞；关于研究随访以及研究结果提交和发表的预期；HIP修饰的原代胰岛细胞移植到肌肉内后无免疫抑制情况下的潜在安全性、存活率、功能及免疫逃逸能力；给予胰岛素生成细胞以实现稳定血糖控制而无需终身注射、免疫抑制药物或每日持续管理的潜在影响，包括造福1型糖尿病群体的可能性；本研究的学习成果对该公司SC451项目的潜在应用；UP421细胞在研究中的存活潜在意义；以及乌普萨拉大学医院内分泌与糖尿病科首席研究员、资深医生和教授的声明，公司总裁兼首席执行官的声明，以及Breakthrough T1D（前身为JDRF）首席执行官的声明。

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 .

本新闻稿中包含的所有非历史事实的声明，包括但不限于有关公司战略、预期、现金跑道、未来财务状况、未来运营和前景的声明，均为前瞻性声明。在某些情况下，您可以。

Investor Relations & Media:

投资者关系与媒体：

Nicole Keith

尼科尔·基思

investor.relations@sana.com

投资者关系@sana.com

media@sana.com

媒体@sana.com