Troculeucel

PART 1iNKT细胞在晚期睾丸癌和胃癌中的突破性疗效7月12日，专注于NK细胞疗法的MiNK Therapeutics公司当日收盘股价暴增730%，报64.17美元/股，堪称“小小细胞，大大突破”！7月11日，MiNK Therapeutics在《Oncogene》上公布其iNKT细胞疗法 agenT‑797 的“重磅数据”：一位晚期、标准治疗全线失败的睾丸癌患者，在输注iNKT细胞后实现完全缓解，且两年内既没有复发，也没有后遗症。而另一位重度胃癌患者在相同方案后，肿瘤缩小约42%，无进展存活期超9个月！更令人振奋的是，输注后依然检测到供体iNKT细胞活跃存在，且全程未见免疫风暴（CRS）或移植物排异（GVHD），安全性极佳。PART 2自体NK细胞治疗轻度阿尔茨海默病（AD）首次应用而在前一天（7月10日），另一家企业NKGen Biotech宣布根据美国FDA批准的同情使用授权启动NK细胞治疗轻度AD的首例临床用药。治疗方案基于其SNK平台：提取NK细胞体外扩增，再输回去。研究者已证明在早期临床中无严重不良事件发生，50%～70%的研究对象认知评分稳定或略有改善，脑脊液中淀粉样蛋白、tau蛋白等病理指标出现下降趋势。这意味着——对既有药物疗效不佳的轻度阿尔茨海默人群，NK细胞疗法提供了另一条“补充路径”。PART 3到底为什么效果这么好？1｜iNKT vs 转移癌iNKT细胞是一类结合了NK细胞“见招拆招”的自然清除力和T细胞“长期记忆”的精准打击能力的混合型免疫细胞，无需HLA配型或预处理，即可对实体瘤发动稳定攻击。agenT‑797联合PD‑1抑制剂的组合，正是在这一基础上展现出既“能打”又“低毒”的双重优势。2｜NK & AD（阿尔兹海默）NK疗法（如troculeucel）则在神经系统疾病中展现出良好耐受性，尤其在穿越血脑屏障、调节炎症通路方面效果稳定，无需清髓预处理，风险更低、路径更清晰。并且通过标准化培养+靶向增强（如CAR-NK技术），NK细胞疗法正在成为临床中更具扩展性的选择，逐步从“辅助治疗”走向“免疫干预主力军”。PART 4重要意义与展望这些突破为何引爆市场？转移性睾丸癌、胃癌本身临床几无突破性治疗可用，agenT‑797 实现全缓解或显著缩小，意义非凡；AD领域长期卡在“减缓速度”层面，而NK疗法有望实现“治疗+修复”方向的组合干预；两者均无领衔提到的细胞因子风暴或排异风险，让“细胞疗法”变得更可靠、更可推广。PART 5未来路径：不是单打，而是组合打法免疫治疗的未来，不是某一种细胞的单打独斗，而是多路径、多机制的协同进攻。随着研究不断深入，我们正在看到这样的趋势逐渐明朗：多类型免疫细胞协同上场，例如 CAR-T 搭配 NK 或 iNKT，以“快速打击+持续记忆”组合构建更稳固的免疫清除；细胞疗法与抗体、小分子药物的联用，强化靶点识别、免疫激活与微环境调节的闭环反应；疗效边界不断拓展，从肿瘤末线治疗延伸至慢性病、神经退行性病变乃至免疫老化等场景。国内顶尖创新药企业已将 CAR-NK 技术从淋巴瘤拓展至实体瘤，同时探索通用型 NK 细胞在慢病和免疫调控中的标准化应用路径。这些药品级别的NK细胞注射液，正成为“组合疗法”落地的关键一环。小结在癌症治疗中，我们一直缺少彻底清除癌细胞的医疗手段；在阿尔茨海默病领域，最佳疗效也不过能延缓病情。如今，NK细胞疗法为解决这些难题提供了极具潜力的新方法。这些进展不只是科研上的成果，更意味着NK细胞疗法正在大步走出实验室，迈向临床应用，真正帮助到患者。你是否相信，细胞药物能成为解决癌症的终极治疗方案？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

Troculeucel, a cryopreserved, autologous enhanced natural killer cell therapy, has demonstrated preliminary clinical benefit without any drug-related adverse events in two Phase I clinical trials in Alzheimer’s Disease.Company receives expanded access protocol authorization from the U.S. Food and Drug Administration (FDA) for troculeucel granted to treat patients with known diagnoses of multiple neurodegenerative diseases. IND approval allows for up to 20 patients to be enrolled; first patient enrollment is anticipated in Q3 2025. SANTA ANA, Calif., July 21, 2025 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (OTC: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer (“NK”) cell therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Expanded Access Program (EAP) authorization for its IND for an open-label, non-randomized, multi-center intermediate size expanded access protocol for use of troculeucel for neurodegenerative diseases. This includes its use for the treatment of several neurodegenerative diseases, many of which currently have no effective therapy. While NKGen’s ongoing double-blind randomized Phase 2a trial is focused on moderate-stage Alzheimer’s disease (NCT06189963), this EAP IND marks the company’s exploration into the treatment of other less common neurodegenerative diseases. In addition to earlier stage Alzheimer’s Disease (AD), this IND includes the treatment of Parkinson’s Disease (PD), Amyotrophic Lateral Sclerosis (ALS), Multiple System Atrophy (MSA), Progressive Supranuclear Palsy (PSP), Frontotemporal Dementia (FTD), Corticobasal degeneration (CBD), Multiple Sclerosis (MS) and Lewy Body Dementia (LBD). This IND approval will allow NKGen to expand and explore the use of troculeucel in up to 20 patients. “There is a common element of autoimmune neuroinflammation in all of these neurodegenerative diseases due to autoreactive T cells, many in response to either an amyloid, alpha-synuclein, or tau protein deposition,” said Paul Y. Song, MD, Chairman and Chief Executive Officer of NKGen Biotech. “As we have demonstrated in two Phase I trials in Alzheimer’s Disease, troculeucel, given via a simple IV, appears to cross the blood brain barrier to reduce neuroinflammatory and protein biomarkers in CSF. We believe there is ample scientific and clinical rationale to offer this to patients with other neurodegenerative diseases for which there is no effective therapy and little hope. We will begin enrolling patients as soon as possible, but the speed of enrollment will depend on funding.” About NKGen Biotech NKGen is a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic NK cell therapeutics. NKGen is headquartered in Santa Ana, California, USA. For more information, please visit www.nkgenbiotech.com. About Troculeucel Troculeucel is a novel cell-based, patient specific, ex vivo expanded autologous NK cell immunotherapeutic drug candidate. NKGen is developing troculeucel for the treatment of neurodegenerative disorders and a broad range of cancers. Troculeucel is the International Nonproprietary Name (“INN”) for SNK01 assigned by the World Health Organization (“WHO”). The WHO INN approval of troculeucel establishes a universally recognized nonproprietary drug name for SNK01 and marks a significant step on NKGen’s journey toward bringing this therapy to market. Forward-Looking Statements Statements contained in this press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “could”, “continue”, “expect”, “estimate”, “may”, “plan”, “outlook”, “future” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Because such statements are subject to risks and uncertainties, many of which are outside of the Company’s control, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the Company’s plans and expected timing for developing troculeucel and SNK02, including the expected timing of completing and announcing further results from its ongoing clinical studies; and the Company’s expected timing for developing its product candidates and potential benefits of its product candidates. Risks that contribute to the uncertain nature of the forward-looking statements include: the Company’s ability to execute its plans and strategies; risks related to performing clinical studies; the risk that initial and interim results of a clinical study do not necessarily predict final results and that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data become available; potential delays in the commencement, enrollment and completion of clinical studies and the reporting of data therefrom; the risk that studies will not be completed as planned; the risk that the abstract will not be published as planned including delays in timing, format, or accessibility; and NKGen’s ability to raise additional funding to complete the development of its product candidates. These and other risks and uncertainties are described more fully under the caption “Risk Factors” and elsewhere in the Company’s filings and reports, which may be accessed for free by visiting the Securities and Exchange Commission’s website at www.sec.gov and on the Company’s website under the subheading “Investors—Financial and Filings”. Investors should take such risks into account and should not rely on forward-looking statements when making investment decisions. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. Internal Contact: Denise Chua, MBA, CLS, MLS (ASCP)SVP, Corporate Affairs949-396-6830dchua@nkgenbiotech.com External Contact: Kevin GardnerManaging DirectorLifeSci Advisors, LLCkgardner@lifesciadvisors.com