业绩总结 - 公司在全球范围内每年在1型糖尿病（T1D）上的支出达到810亿美元，较2008年增长了3.5倍[17] - 每年因T1D导致的死亡人数为201,600人，且每年以3%的速度上升[17] - 预计到2040年，全球将有1640万人患有T1D[13] 用户数据 - 目前美国有超过100万人患有狼疮，显示出对自身免疫疾病治疗的高未满足需求[69][70] 新产品和新技术研发 - 公司预计在2026年尽早提交IND申请，推进SC451项目，该项目为无免疫抑制的干细胞衍生胰岛细胞疗法[61] - SC291在GLEAM研究中显示出深度B细胞耗竭的潜力，适用于B细胞介导的自身免疫疾病[114] - SC451预计将在2026年申请IND，作为一种无免疫抑制的胰腺胰岛治疗方案[114] - SC262在VIVID研究中针对CD19 CAR T失败患者，起始剂量为9000万CAR T细胞[113] - SC291的制造过程提供高产量的成功编辑细胞，MHC I和II的全敲除率约为85%[78][79] - 预计SC291和SG299将在2026年之前提交IND申请，针对自身免疫疾病和B细胞癌症[114] 临床试验和市场展望 - 在Uppsala大学医院进行的临床试验中，初步的12周结果显示所有主要和次要终点均已达成[25] - C-peptide水平在移植后12周内稳定存在，表明细胞存活和功能[28] - 公司在T1D患者中进行的HIP修饰胰岛细胞移植试验显示出积极的4周结果[25] - HIP修饰的干细胞分化的胰岛细胞在小鼠中持续控制血糖超过15个月[64] - 经过5小时禁食后，胰岛素c-peptide水平在移植后30分钟达到525 pM，显示出对葡萄糖的反应[65][66] - 预计2025年及以后将获得多种疾病的有意义临床数据，展示HIP平台的潜力[114] 负面信息 - 公司在胰岛细胞移植中克服了异体免疫排斥，这是移植和细胞医学中的关键限制[6] - 预计2027年约有12,000名B细胞恶性肿瘤患者接受CD19 CAR T治疗，且每年约有7,500名CAR T失败患者[106]

文章核心观点 - Sana公司公布将UP421同种异体原代胰岛细胞疗法移植到1型糖尿病患者体内的六个月随访结果 显示移植细胞安全且耐受 能存活、逃避免疫系统检测并持续产生胰岛素 为无免疫抑制治疗1型糖尿病带来希望 公司还将利用相关技术开发SC451疗法 [1][2] 研究情况 研究背景 - 1型糖尿病全球影响超900万人 自胰岛素发现100多年来该疾病变革性进展较少 传统胰岛细胞移植需免疫抑制以防止免疫排斥和自身免疫攻击 [2][3] 研究内容 - 由乌普萨拉大学医院合作开展的研究 评估HIP工程化胰岛素产生胰腺细胞能否安全移植并帮助1型糖尿病患者恢复胰岛素生产 无需免疫抑制药物 研究将UP421细胞通过肌肉手术移植到患者前臂 主要目标是研究移植安全性 次要终点包括细胞存活、免疫逃避和C肽产生 [1][4] 研究结果 - 六个月随访结果显示 移植的胰腺β细胞存活且有功能 循环C肽存在表明细胞产生胰岛素 混合餐耐量测试中C肽水平增加 12周PET - MRI扫描显示移植部位有胰岛细胞 未发现安全问题 HIP修饰的胰岛细胞逃避了免疫反应 [1][5] 公司技术与规划 HIP平台 - Sana的HIP平台旨在体外生成能逃避患者免疫系统的细胞 实现无免疫抑制的同种异体移植 已在多种细胞类型上证明移植细胞能逃避免疫系统并保持活性 公司最先进项目包括用于1型糖尿病的干细胞衍生胰岛细胞项目等 [6] 后续规划 - 公司将结合UP421试验的免疫逃避技术开发SC451疗法 目标是实现正常血糖控制 无需胰岛素和免疫抑制药物 并计划最早明年提交研究性新药申请 [2] 各方观点 研究负责人 - 研究负责人Per - Ola Carlsson认为六个月更新结果表明无免疫抑制治疗1型糖尿病可能实现 期待后续随访并将结果发表 [2] 公司CEO - 公司总裁兼CEO Steve Harr表示移植细胞无免疫抑制存活、功能和免疫逃避是变革性一步 此次数据让治疗糖尿病愿景更接近现实 [2] 突破T1D组织CEO - 突破T1D首席执行官Aaron J. Kowalski称糖尿病治疗范式转变早该到来 此次成果是变革性且可能改变生活的突破 [3]

Sana Biotechnology (SANA) FY Conference June 10, 2025 08:40 AM ET Speaker0 Great. Good morning, everyone. Thank you so much for joining us. Really pleased to have with us this morning Doctor. Steve Haar, who's the President and CEO of Sana Therapeutics. I'm Salveen Richter. I cover the biotechnology sector. Steve, before we jump into the programs here, perhaps level set us with where the company stands today regarding the portfolio strategy and key priorities and walk us through what we should look to from ...

Presentation to highlight updated six-month clinical results of a hypoimmune-modified primary pancreatic islet cell therapy for patients with type 1 diabetesSEATTLE, June 09, 2025 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, today announced an upcoming podium presentation highlighting ongoing clinical data from the investigator-sponsored, first-in-human study transplanting UP421, an allogeneic primary islet cel ...

Sana Biotechnology (SANA) 2025 Conference June 04, 2025 02:35 PM ET Speaker0 everyone. Thank you so much for joining us for the SANA presentation. My name is ChaCha. I'm a biotech equity research senior associate based out of Boston. Really excited to introduce you to Sana and also, of course, to Steve Haar, our CEO. So, Steve, take it away. Is the presentation not working? Alright. Speaker1 It's the wrong company you have up there. So I'll start. Just first of all, thank you ChaCha and thank you Jeffries f ...

SEATTLE, May 28, 2025 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, today announced that it will webcast its presentations at two investor conferences in June. The presentations will feature a business overview and update. Sana will present at the Jefferies Global Healthcare Conference at 2:35 p.m. ET on Wednesday, June 4, 2025.Sana will present at the Goldman Sachs 46th Annual Global Healthcare Conference at 8: ...

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NEW YORK, May 19, 2025 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in Sana Biotechnology, Inc. ("Sana Biotechnology, Inc." or the "Company") (NASDAQ: SANA) of a class action securities lawsuit. CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Sana Biotechnology, Inc. investors who were adversely affected by alleged securities fraud between March 17, 2023 and November 4, 2024. Follow the link below to get more information and be contacted by a member of our team: https://zl ...

NEW YORK, May 19, 2025 (GLOBE NEWSWIRE) -- WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Sana Biotechnology, Inc. (NASDAQ: SANA) between March 17, 2023 and November 4, 2024, inclusive (the “Class Period”), of the important May 20, 2025 lead plaintiff deadline. SO WHAT: If you purchased Sana securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement. WHAT TO DO N ...

NEW YORK, May 19, 2025 /PRNewswire/ --The Gross Law Firm issues the following notice to shareholders of Sana Biotechnology, Inc. (NASDAQ: SANA).Shareholders who purchased shares of SANA during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery.CONTACT US HERE:https://securitiesclasslaw.com/securities/sana-biotechnology-inc-loss-submission-form/?id=148815&from=4CLASS PERIOD: March 1 ...