Sipuleucel-T (Dendreon Corporation)

引言：细胞工厂开启普惠医疗新纪元‌2025年5月20日，国际制药巨头阿斯利康（AstraZeneca）以最高10亿美元（约72亿元人民币）完成对比利时生物技术公司EsoBiotec的收购，标志着细胞治疗领域正式进入产业整合深水区。根据Evaluate Pharma数据，全球细胞与基因治疗（CGT）市场规模已从2020年的42亿美元飙升至2025年的156亿美元，年复合增长率（CAGR）达30%。而阿斯利康自2022年入局以来，通过“收购+自研”双轮驱动，快速搭建覆盖体内CAR-T、无病毒载体、通用型产品的技术矩阵，其战略目标是：2030年前将CAR-T治疗成本从百万级降至10万元级，并突破实体瘤治疗的“最后堡垒”。一、跨国药企：百亿资本重构技术护城河‌跨国药企正以“资本+技术”双重垄断加速行业洗牌。根据GlobalData统计，2023年全球CGT领域并购总额突破480亿美元，其中诺华、百时美施贵宝（BMS）、阿斯利康三巨头占比超60%。其布局逻辑聚焦三大方向：1.1 技术升级：从体外到体内，从个体化到通用型‌成本革命‌：传统CAR-T依赖体外T细胞改造，单疗程成本高达40万-50万美元（美国市场）。而体内CAR-T技术（如EsoBiotec的慢病毒载体递送系统）通过直接激活患者体内T细胞，将成本压缩至1.5万-2万美元（约10万元级）。产能跃迁‌：据J.P. Morgan报告，通用型CAR-T（UCAR-T）的规模化生产可使单批次产能提升100倍，生产成本下降90%。目前，辉瑞与Allogene合作的UCAR-T疗法ALLO-501已在淋巴瘤II期试验中实现60%的完全缓解率（CR）。1.2 实体瘤突破：联合治疗打破肿瘤微环境屏障‌实体瘤占全球癌症病例的90%，但传统CAR-T对其有效率不足15%。阿斯利康的ESO-TX101疗法通过“T细胞+单核细胞”双改造策略，在胰腺癌模型中实现肿瘤体积缩小78%（数据来源：2024年ASCO年会）。无独有偶，科济药业的CT041（靶向Claudin18.2）在胃癌II期试验中客观缓解率（ORR）达61.1%，显著优于化疗组的31.5%（数据来源：Nature Medicine）。二、中国药企：双轨制突围慢性病与肿瘤蓝海‌中国CGT市场规模预计2028年达45亿美元（Frost & Sullivan数据），国内企业以“政策红利+差异化管线”构建竞争壁垒。2.1 西药巨头：CAR-T管线商业化提速‌复星凯特的阿基仑赛注射液（Yescarta）国内定价120万元/疗程，2023年销售额突破8亿元。其Claudin18.2 CAR-T疗法已在胃癌、胰腺癌领域进入II期临床试验，并与斯坦福大学合作开发无需体外扩增的TIL疗法，可将制备周期从6周缩短至10天。2.2 中药跨界：干细胞治疗重塑慢性病管理‌天士力通过“资本并购+技术引进”，构建覆盖心血管、神经退行性疾病的再生医学矩阵：爱萨尔生物‌：脐带间充质干细胞治疗膝骨关节炎，海南博鳌乐城真实世界数据显示，患者6个月疼痛评分下降67%（VAS评分）。吉美瑞生‌：自体气道干细胞修复慢性阻塞性肺病（COPD），II期试验中FEV1（肺功能指标）改善率达42%。三、跨界玩家：全产业链“降维打击”‌非医药企业以设备、数据、资本为支点，颠覆传统研发范式。3.1 制造业：从细胞工厂到自动化设备‌南京新百通过控股齐鲁干细胞、中国脐血库（CO集团），掌握国内53%的脐带血存储资源（超100万份）。其收购的Dendreon公司核心产品Provenge（自体DC细胞疗法）国内III期试验数据显示，前列腺癌患者中位生存期延长4.1个月（NEJM，2023）。3.2 互联网巨头：数据驱动的精准医疗‌百度风投‌：投资百奥智汇（单细胞测序）、深势科技（AI药物发现），构建从基因编辑到细胞治疗的AI优化闭环。京东健康‌：依托冷链物流网络，其细胞存储业务已覆盖全国30个城市，存储成本较传统模式下降40%。四、首富赌局：千亿资本押注“长寿革命”‌全球富豪正将细胞治疗视为“下一个特斯拉”。黄峥‌：投资1.5亿美元支持渐冻症（ALS）间充质干细胞疗法，临床前数据显示运动神经元存活率提升35%。马斯克‌：Neuralink秘密启动“细胞编程”项目，目标是通过基因编辑延长人类健康寿命至120岁（路透社，2024）。五、产业革命三重维度：普惠、实体瘤与生态战争‌5.1 成本革命：从百万天价到医保覆盖‌根据麦肯锡测算，通用型CAR-T若纳入医保，中国市场年治疗人数可从不足1000人增至10万人，治疗渗透率提升100倍。5.2 实体瘤突破：联合治疗打开百亿市场‌阿斯利康ESO-TX101、科济药业CT041等产品有望在2027年前获批，推动实体瘤CGT市场规模突破80亿美元（BCC数据）。5.3 生态战争：技术、资本与场景的终极博弈‌未来竞争将围绕三大维度展开：药企‌：阿斯利康“体内CAR-T+奥拉帕利（PARP抑制剂）”联合疗法，覆盖卵巢癌、胰腺癌等10+适应症。科技公司‌：字节跳动AI平台优化CAR-T靶点设计，将研发周期从3年缩短至9个月。跨界联盟‌：美的集团联合和祐国际医院打造“细胞治疗-质子重离子”肿瘤综合治疗中心，床位利用率超90%。结语：谁将主宰细胞治疗的下一个十年？‌当阿斯利康以72亿元收购案点燃战火，当京东、美的跨界构建“细胞存储-治疗-保险”闭环，这场革命已超越技术本身，成为资本、政策与生态的全面较量。唯一可以确定的是，最终胜出者必将属于那些既能突破科学边界，又能让技术普惠于民的企业。正如《自然》杂志所言：“21世纪的医学史，将由细胞治疗改写。”免责申明：文章来源网络仅供分享，不构成任何临床诊断建议，我们尊重原创，也注重分享，图文素材来源于网络，如有违规或侵权，请及时联系我们会立即做出删除

Industry leader in the development and application of cellular therapies, including CAR NK products, for cancer Led development of multiple clinical candidates from conception through IND and early clinical development Vast experience in technology licensing, correlation from “bench to bedside” and back and execution of scientific strategy SOUTH SAN FRANCISCO, Calif., April 10, 2025 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio” or the “Company”), a clinical-stage biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today announced the appointment of James B. Trager, Ph.D. to its Scientific Advisory Board (“SAB”). Dr. Trager is a well-established biotechnology leader deeply versed in the development and application of cellular therapies for cancer. He brings to Senti Bio over 25 years of technical expertise, strategic execution and development of novel cellular and biologic therapies. In addition to his industry positions, he also serves as an advisor for the Shoreline Community College Immunotherapy Biohub and SPARK at Stanford. Over the course of his career, he has contributed to nearly 50 publications, abstracts and patents. “James brings a wealth of leadership experience and scientific expertise to our SAB, that we believe will be invaluable as we continue to advance the development of our potential best-in-class oncology programs. We look forward to leveraging his decorated career in research and product development moving forward,” says Timothy Lu, MD, PhD, Chief Executive Officer and Co-Founder of Senti Bio. “Senti Bio’s Logic Gating technology has demonstrated encouraging potential to address the central challenge in oncology which is to precisely distinguish cancer vs healthy cells and maximize therapeutic potential. Additionally, the data seen to date from the SENTI-202 program for AML has shown a lot of promise as a potential treatment option in this indication where there remains significant unmet medical need. I am excited to be joining the Senti Bio SAB and look forward to working closely with the team to advance this important technology and pipeline of product candidates,” added Dr. Trager. Dr. Trager formerly served as the Chief Scientific Officer of Nkarta Therapeutics where he led the development of multiple discovery assets through IND and the creation of a pipeline of CAR NK product opportunities. Prior to his role at Nkarta, Dr. Trager held a number of increasing roles and responsibilities at Dendreon Pharmaceuticals, Inc., most recently having served as Vice President of Research and Product Development, where he was responsible for product and biomarker development development activities, supporting the late stage development of sipuleucel-T through clinical study, approval, and commercialization. Prior to that, Dr. Trager served as a Senior Scientist at Geron Corporation, where he was part of the team that cloned human telomerase, and enabled the manufacture and clinical development of a telomerase inhibitor. Across his career, he managed and integrated the efforts of over 100 scientists, engineers and technicians contributing to the invention and development of multiple cell therapies. Dr. Trager holds a BA from St. John’s College in Santa Fe New Mexico and his Ph.D. in Molecular Biology and Biochemistry from the University of California at Berkeley. About Senti Bio Senti Bio is a clinical-stage biotechnology company developing a new generation of cell and gene therapies for patients living with incurable diseases. To achieve this, Senti Bio is leveraging a synthetic biology platform called Gene Circuits to create therapies with enhanced precision and control. These Gene Circuits are designed to precisely kill cancer cells, spare healthy cells, increase specificity to target cells and control the expression of drugs even after administration. Senti Bio’s wholly-owned pipeline includes off-the-shelf CAR-NK cells, outfitted with Gene Circuits, to target challenging liquid and solid tumor indications. Senti Bio’s lead program SENTI-202, a Logic Gated CD33 and/or FLT3-targeting hematologic cancer therapeutic candidate, is currently enrolling patients in a Phase I clinical trial. Senti Bio has also preclinically demonstrated that its Gene Circuits can function in T cells, for example Logic Gates that enable selective targeting of solid tumors. Additionally, Senti Bio has preclinically demonstrated the potential breadth of Gene Circuits in other cell and gene therapy modalities, diseases outside of oncology, and continues to advance these capabilities through partnerships. Forward-Looking Statements This press release contains certain statements that are not historical facts and are considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally are identified by the words “believe,” “could,” “predict,” “continue,” “ongoing,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” “forecast,” “seek,” “target” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements are predictions, projections, and other statements about future events that are based on current expectations of Senti Bio’s management and assumptions, whether or not identified in this document, and, as a result, are subject to risks and uncertainties. Forward-looking statements include, but are not limited to, statements regarding future events, including the success of our future clinical development and ability to create shareholder value. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on by any investor as, a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Senti Bio. Many factors could cause actual future results to differ materially from the forward-looking statements in this document, including but not limited to: (i) changes in domestic and foreign business, market, financial, political and legal conditions, (ii) changes in the competitive and highly regulated industries in which Senti Bio operates, variations in operating performance across competitors, changes in laws and regulations affecting Senti Bio’s business, (iii) the ability to implement business plans, forecasts and other expectations, (iv) the risk of downturns and a changing regulatory landscape in Senti Bio’s highly competitive industry, (v) risks relating to the uncertainty of any projected financial information with respect to Senti Bio, (vi) risks related to uncertainty in the timing or results of Senti Bio’s clinical trial initiation and the progress of clinical trials, patient enrollment, and GMP manufacturing activities, (vii) Senti Bio’s dependence on fourth parties in connection with clinical trial startup, clinical studies, and GMP manufacturing activities, (viii) risks related to delays and other impacts from macroeconomic and geopolitical events, increasing rates of inflation and rising interest rates on business operations, (ix) risks related to the timing and utilization of Senti Bio’s grant from CIRM and net proceeds of the PIPE financing, and (x) the success of any future research and development efforts by Senti Bio. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of Senti Bio’s most recent Quarterly Report on Form 10-Q, filed with the U.S. Securities and Exchange Commission (“SEC”), and other documents filed by Senti Bio from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements in this document. There may be additional risks that Senti Bio does not presently know, or that Senti Bio currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements in this document. Forward-looking statements speak only as of the date they are made. Senti Bio anticipates that subsequent events and developments may cause Senti Bio’s assessments to change. Except as required by law, Senti Bio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events, or otherwise. Investor Contact: JTC Team, LLC Jenene Thomas (908) 824-0775 SNTI@jtcir.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/51b2998d-5e06-4e0c-90f4-5c75ab43f03e