The goal of this clinical trial is to test SNK01 in participants with moderate Alzheimer's Disease. The main questions it aims to answer are:
1. Is SNK01 safe and tolerable when administered every 3 weeks for up to 1 year as an intravenous infusion
2. Can SNK01 administration improve cognitive assessment scores and biomarkers

开始日期2023-11-21

申办/合作机构

NKGen Biotech, Inc.

NCT05099549

/ Terminated临床1/2期

A Phase 1/2a, Open-Label, Multi-Center Study Evaluating the Safety, Tolerability, and Anti-Tumor Activity of AFM24 in Combination With Ex Vivo Expanded Autologous Natural Killer Cells (SNK01) in Subjects With Advanced/Metastatic EGFR-Expressing Cancers

This is an open-label, multi-center study to evaluate the safety, tolerability, and anti-tumor activity of SNK01 in combination with AFM24 in subjects with advanced or metastatic EGFR-expressing cancers.

开始日期2021-11-03

申办/合作机构

NKGen Biotech, Inc.

[+1]

NCT04872634

/ Unknown status临床1/2期

A Phase I/IIa, Open, Single-Center Clinical Trial Evaluating the Safety and Anti-Tumor Activity of SNK01 (Natural Killer Cells) Administered in Combination With Gemcitabine/Carboplatin or Gemcitabine/Carboplatin/Cetuximab to Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients Who Have Failed Prior Tyrosine Kinase Inhibitor (TKI) Therapy (SNK_ASTER)

This clinical trial is a Single-Center, Open, Phase I/IIa Clinical Trial conducted to evaluate the safety and anti-tumor activity of SNK01 and GC +/- Cetuximab administered in combination to Locally advanced or Metastatic Non-small Cell Lung Cancer Patients who have failed prior Tyrosine Kinase Inhibitor (TKI) therapy at least once.
After the start of the clinical trial, the first 3 subjects complete the enrollment in Cohort 1 in serial order and then 3 subjects are enrolled in Cohort 2 in serial order. After this, Cohorts 1, 3 and Cohorts 2, 4 are independently processed and subjects are enrolled in serial order when new cohorts start and/or replacement subjects are required. For the subjects who are additionally enrolled after the DLT evaluation and the MTD is determined in each dose cohort, no DLT evaluation is conducted.
The subjects allotted to each cohort are administered with the SNK01 manufactured from peripheral blood mononuclear cells total 8 times over a period of about 10 weeks. Combined administration of SNK01 starts from the Cycle 2 (Week 4) of Cytotoxic Chemotherapy and SNK01 is administered at an interval of 1 week starting from the day after the administration of Cytotoxic Chemotherapy and/or Cetuximab (Visit 5-1, D23).
When no disease progression is confirmed at EOT (End of Treatment), disease progression is checked until the clinical trial is over. The adverse events which have occurred during the study period are monitored until the date when the investigator judges that no monitoring is required as the symptom has disappeared or there is no further change in the symptom or the 30th day (±3 d) from the latest date of the administration among Gemcitabine, Carboplatin and Cetuximab after the EOT, whichever comes first.
For all the subjects enrolled in the present clinical trial, safety is checked in accordance with CTCAE V5.0 and effectiveness is checked in accordance with RECIST V1.1 through the vital signs, laboratory test, adverse events, etc. during the study period.

开始日期2021-07-08

申办/合作机构

NKMAX Co., Ltd.

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项与 Troculeucel 相关的文献（医药）

2024-03-01·Journal for immunotherapy of cancer

Safety and efficacy of SNK01 (autologous natural killer cells) in combination with cytotoxic chemotherapy and/or cetuximab after failure of prior tyrosine kinase inhibitor in non-small cell lung cancer: non-clinical mouse model and phase I/IIa clinical study

Article

作者: Kim, Yong Man ; Son, Gun Woo ; Jo, Jong-Min ; Lee, Jae Cheol ; Ko, Dae-Hyun ; Rho, Jin Kyung ; Yoon, Byeong Gon ; Choi, Mi Young ; Jung, Jae Seob ; Ji, Wonjun ; Choi, Myeong Geun ; Choi, Chang-Min

Background:

Choosing treatments for epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) patients with osimertinib resistance is challenging. We evaluated the safety and efficacy of SNK01 (autologous natural killer (NK) cells) in combination with cytotoxic chemotherapy and/or cetuximab (an anti-EGFR monoclonal antibody) in treating EGFR-mutated NSCLC in this non-clinical and phase I/IIa clinical trial.

Methods:

We developed a cell line-derived xenograft-humanized mouse model with an osimertinib-resistant lung cancer cell line. The mice were divided into four groups based on treatment (no treatment, cetuximab, SNK01, and combination groups) and treated weekly for 5 weeks. In the clinical study, 12 patients with EGFR-mutated NSCLC who failed prior tyrosine kinase inhibitor (TKI) received SNK01 weekly in combination with gemcitabine/carboplatin (n=6) or cetuximab/gemcitabine/carboplatin (n=6) and dose escalation of SNK01 following the “3+3” design.

Results:

In the non-clinical study, an increase in NK cells in the blood and enhanced NK cell tumor infiltration were observed in the SNK01 group. The volume of tumor extracted after treatment was the smallest in the combination group. In the clinical study, 12 patients (median age, 60.9 years; all adenocarcinoma cases) received SNK01 weekly for 7–8 weeks (4×109cells/dose (n=6); 6×109cells/dose (n=6)). The maximum feasible dose of SNK01 was 6×109cells/dose without dose-limiting toxicity. Efficacy outcomes showed an objective response rate of 25%, disease control rate of 100%, and median progression-free survival of 143 days.

Conclusion:

SNK01 in combination with cytotoxic chemotherapy, including cetuximab, for EGFR-mutated NSCLC with TKI resistance was safe and exerted a potential antitumor effect.

Trial registration number:

NCT04872634.

2022-10-15·Cancer Research and Treatment2区 · 医学

A Phase I/IIa Randomized Trial Evaluating the Safety and Efficacy of SNK01 Plus Pembrolizumab in Patients with Stage IV Non-Small Cell Lung Cancer

2区 · 医学

Article

作者: Kim, Dong Ha ; Do, Eun-Ju ; Lee, Jae Cheol ; Choi, Chang-Min ; Cho, Yong-Hee ; Ji, Wonjun ; Kim, Eo Jin ; Jung, Jae Seob ; Kang, Yoonmi ; Kim, Yong Man ; Ko, Dae-Hyun ; Choi, Myeong Geun ; Kim, Sang-Yeob ; Rho, Jin Kyung

Purpose The aim of this study is to evaluate the safety and efficacy of ex vivo activated and expanded natural killer (NK) cell therapy (SNK01) plus pembrolizumab in a randomized phase I/IIa clinical trial.Materials and Methods Overall, 18 patients with advanced non–small cell lung cancer (NSCLC) and a programmed death ligand 1 tumor proportion score of 1% or greater who had a history of failed frontline platinum-based therapy were randomized (2:1) to receive pembrolizumab every 3 weeks +/– 6 weekly infusions of SNK01 at either 2×10⁹ or 4×10⁹ cells per infusion (pembrolizumab monotherapy vs. SNK01 combination). The primary endpoint was safety, whereas the secondary endpoints were the objective response rate (ORR), progression-free survival (PFS), overall survival, and quality of life.Results Since no dose-limiting toxicity was observed, the maximum tolerated dose was determined as SNK01 4×10⁹ cells/dose. The safety data did not show any new safety signals when SNK01 was combined with pembrolizumab. The ORR and the 1-year survival rate in the NK combination group were higher than those in patients who underwent pembrolizumab monotherapy (ORR, 41.7% vs. 0%; 1-year survival rate, 66.7% vs. 50.0%). Furthermore, the median PFS was higher in the SNK01 combination group (6.2 months vs. 1.6 months, p=0.001).Conclusion Based on the findings of this study, the NK cell combination therapy may consider as a safe treatment method for stage IV NSCLC patients who had a history of failed platinum-based therapy without an increase in adverse events.

2022-07-01·Thoracic cancer

Two‐year efficacy of SNK01 plus pembrolizumab for non‐small cell lung cancer: Expanded observations from a phase I/IIa randomized controlled trial

Article

作者: Park, Hyung Jun ; Lee, Jae Cheol ; Choi, Chang‐Min ; Kim, Yong Man ; Jung, Jae Seob ; Ji, Wonjun

Abstract:

Background:

A previous trial showed that autologous ex‐vivo expanded NK cell (SNK01) treatment combined with pembrolizumab showed better efficacy than pembrolizumab monotherapy in advanced non‐small cell lung cancer (NSCLC). This study was a 2‐year follow‐up of that previous study to determine the long‐term efficacy of the combination treatment.

Methods:

This trial included 20 patients with advanced NSCLC with a PD‐L1 tumor proportion score of 1% or greater who failed prior to front‐line platinum‐based therapy. The patients received pembrolizumab with low‐dose SNK01 (2 × 109 cells/dose) or high‐dose SNK01 (4 × 109 cells/dose), or pembrolizumab monotherapy. The primary study endpoint was overall survival (OS), and the secondary endpoint was progression‐free survival (PFS).

Results:

Two patients were excluded following serious adverse events. Among the 11 patients who died, five were from the NK groups (41.6%, n = 5/12), and six received pembrolizumab monotherapy (100%, n = 6/6). The estimated 2‐year survival rate was 58.3% versus 16.7% (pembrolizumab plus SNK01 vs. pembrolizumab monotherapy). The hazard ratio of pembrolizumab plus SNK01 compared with pembrolizumab monotherapy was 0.32 (95% CI: 0.1, 1.08, p‐value: 0.066). Although the median PFS was significantly higher in the pembrolizumab plus SNK01 group than in the pembrolizumab alone group, OS and PFS did not differ statistically between patients who received low doses of NK cells and those who received high doses of NK cells.

Conclusions:

Autologous NK cells can enhance the long‐term OS and PFS for NSCLC. A larger study is needed to confirm this result.Clinical Research Information Service number: KCT0003463.

104

项与 Troculeucel 相关的新闻（医药）

2025-01-06

·今日头条

《2025肺癌患者必看指南》，27款抗癌新药与5大新技术全解析

肺癌，作为全球范围内发病率与死亡率居高不下的癌症类型，严重威胁着人类的健康与生命安全，在我国城市人口的恶性肿瘤死因中更是位居首位。其中，非小细胞肺癌最为常见，约占所有肺癌病例的80%。在2025年的开端，每一位肺癌病友都值得为自己喝彩。凭借着坚强与勇敢，大家成功走过2024年，朝着5年临床治愈的目标又迈进了坚实一步。回首 2024 年，中国和美国批准了众多新药上市，同时还有多项新技术处于研发阶段。这些积极的进展让我们有充足的理由相信，在2025年，将会有更多病友迎来全新的治疗方法，看到治愈的希望。全球肿瘤医生网医学部精心为大家准备了《2025年肺癌必看指南》，其中涵盖了2024国内外获批上市的抗癌新药介绍、2025值得期待的抗癌新技术全面盘点、肺癌饮食指导等内容。以帮助各位癌友，在2025年乃至未来的抗癌征程中，始终怀揣希望，勇敢前行。一、2025最新版非小细胞肺癌NCCN指南推荐检测的10大靶点根据美国国家综合癌症网络（NCCN）近期发布的“2025年第一版非小细胞肺癌（NSCLC）临床实践指南”，推荐肺癌患者应检测的几大靶点为： EGFR exon19del、L858R突变、EGFR S768I、L861Q、G719X突变、EGFR exon20ins突变、KRAS G12C突变、ALK、ROS1、RET、BRAF V600E突变、NTRK1/2/3基因融合、MET ex14跳跃突变、ERBB2（HER2）、NRG1基因融合（新增）、FGFR（新增）、PD-L1。 ▲图源“NCCN”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除二、2024年最新获批的肺癌靶向药及免疫药物全面盘点截至2024年12月底，经中国国家药品监督管理局（NMPA）与美国食品药品监督管理局（FDA）批准的肺癌靶向药及免疫药物已达27款。其中，中国获批19款，美国获批8款；针对非小细胞肺癌的有22款，针对小细胞肺癌的有5款。这无疑为部分幸运的肺癌患者带来了全新的希望与更多治疗选择。（一）2024年美国FDA批准上市的非小细胞肺癌新药 1、特泊替尼（Tepmetko，Tepotinib）研发公司：默克公司。适应证：非小细胞肺癌。获批时间： 2024年2月15日。药物介绍： 2024年2月15日，特泊替尼获美国FDA批准，用于MET外显子14（MET ex14）跳跃突变的转移性非小细胞肺癌（NSCLC）成年患者的治疗。该药早在2020年3月25日，就曾获日本厚生劳动省批准上市，是全球首款获批用于治疗携带MET基因突变的晚期非小细胞肺癌患者的口服MET抑制剂。阅读原文了解详情：速递|缓解率43%！肺癌迎新药，FDA加速批准特普替尼上市！ 2、奥希替尼（osimertinib，泰瑞莎®）研发公司：阿斯利康（AstraZeneca）。适应证：非小细胞肺癌。获批时间： 2024年2月16日、2024年9月25日。药物介绍：奥希替尼是一款不可逆的第三代表皮生长因子受体（EGFR）-酪氨酸激酶抑制剂（TKI），可克服T790M耐药突变，2024年2月16日获批，用于成人局部晚期或转移性EGFR突变的非小细胞肺癌的治疗（与含铂化疗联合）；2024年9月25日再度获批，用于成人携带exon21 L858R或EGFR exon19del突变的局部晚期（III期）不可切除的非小细胞肺癌的治疗，这些患者在同步或序贯铂类为基础的放化疗期间或之后，疾病未继续进展。 3、埃万妥单抗（Rybrevant®）研发公司：强生公司。适应证：非小细胞肺癌。获批时间： 2024年3月1日。药物介绍：埃万妥单抗是一款针对EGFR和MET受体的全人双特异性抗体，可抑制肿瘤生长，并导致肿瘤细胞死亡：2024年3月1日获批，与卡铂+培美曲塞化疗药联合，用于EGFR 20 ins插入突变的局部晚期或转移性非小细胞肺癌的一线治疗。2024年8月19日再度获批，与拉泽替尼联合，用于EGFR exon19（EGFR外显子19）缺失，或exon21（外显子21）L858R突变的局部晚期或转移性非小细胞肺癌的一线治疗。 4、纳武利尤单抗（nivolumab，欧狄沃®）研发公司：百时美施贵宝公司。适应证：尿路上皮癌、非小细胞肺癌。获批时间： 2024年10月3日。药物介绍：纳武利尤单抗（Opdivo）是一种程序性死亡受体-1（PD-1）阻断抗体，2024年10月3日获批，与铂类双药化疗联合，用于成人无EGFR突变或ALK重排的可切除（肿瘤≥4cm和/或淋巴结阳性）的非小细胞肺癌的围术期治疗。 5、阿来替尼（Alectinib，Alecensa，艾乐替尼）研发公司：罗氏制药。适应证：非小细胞肺癌。获批时间： 2024年4月18日。药物介绍：阿来替尼是一款第二代ALK抑制剂，号称“肺癌最强靶向药”，具有更强的疗效和更佳的入脑效果，已成为国内ALK阳性患者首选的一线治疗方案。2024年4月18日，获FDA批准用于ALK阳性非小细胞肺癌的辅助治疗。阅读原文了解详情：肺癌靶向药艾乐替尼药品信息总览 6、恩沙替尼（Ensartinib，X-396，贝美纳®）研发公司：贝达药业控股子公司Xcovery。适应证： ALK阳性非小细胞肺癌。获批时间： 2024年12月18日。药物介绍：恩沙替尼于2024年12月18日获美国FDA批准，用于成人先前未接受过ALK抑制剂治疗的间变性淋巴瘤激酶（ALK）阳性局部晚期或转移性非小细胞肺癌的治疗。（二）2024年美国FDA批准上市的小细胞肺癌新药 7、塔拉妥单抗（Tarlatamab）研发公司：安进公司。适应证：小细胞肺癌。获批时间： 2024年5月16日。药物介绍：塔拉妥单抗是安进公司研发的一种首创的DLL3靶向双特异性T细胞接合剂（BiTE）®。2024年5月16日获美国FDA加速批准，用于成人在铂类化疗期间或之后疾病进展的广泛期小细胞肺癌（ES-SCLC）的治疗，该药是首个也是目前唯一获批用于治疗侵袭性肺癌的DLL3靶向双特异性T细胞接合疗法，是小细胞肺癌治疗领域的一个重要里程碑！阅读原文了解详情：FDA终于批了！小细胞肺癌迎来重磅新药Tarlatamab！生存期延长2倍！更多疗法暴击肺癌 8、度伐利尤单抗（Durvalumab，英飞凡®）获批时间： 2024年12月4日。研发公司：阿斯利康。适应证：小细胞肺癌。药物介绍：度伐利尤单抗是一款程序性死亡配体1（PD-L1）阻断抗体，2024年12月4日获批，用于成人在同时进行铂类化疗和放疗后病情未进展的局限期小细胞肺癌（LS-SCLC）的治疗。（三）2024年中国NMPA批准上市的非小细胞肺癌新药全盘点 1、伊鲁阿克（代号为WX-0593）研发公司：齐鲁制药。适应证： ALK阳性非小细胞肺癌。获批时间： 2024年1月16日。药物介绍： 2024年1月16日，伊鲁阿克的新适应证申请获中国药品食品监督管理局（NMPA）批准，用于治疗间变性淋巴瘤激酶（ALK）阳性的局部晚期或转移性非小细胞肺癌（NSCLC）。 2、富马酸安奈克替尼（安奈克替尼）研发公司：正大天晴。适应证：非小细胞肺癌。获批时间： 2024年4月24日。药物介绍： 2024年4月24日，富马酸安奈克替尼在中国获批上市，用于治疗成人ROS1阳性的局部晚期或转移性非小细胞肺癌（NSCLC）。 3、瑞普替尼（奥凯乐®，Repotrectinib）研发公司：百时美施贵宝公司。适应证：非小细胞肺癌。获批时间： 2024年5月13日。药物介绍： 2024年5月13日，瑞普替尼获中国NMPA批准，用于成人ROS1阳性的局部晚期或转移性非小细胞肺癌（NSCLC）的治疗。阅读原文了解详情：疾病控制率高达94%！新一代“传奇”抗癌药瑞普替尼为ROS1肺癌患者点亮希望。 4、甲磺酸瑞齐替尼胶囊（瑞齐替尼，瑞必达®）研发公司：倍而达药业。适应证：非小细胞肺癌。获批时间： 2024年5月20日。药物介绍：甲磺酸瑞齐替尼是一款三代表皮生长因子受体-酪氨酸激酶抑制剂（EGFR-TKI），2024年5月20日获批，用于成人EGFR T790M突变阳性的局部晚期或转移性非小细胞肺癌（NSCLC）的治疗。2024年10月29日，该药新适应证再度获批，作为EGFR敏感突变的局部晚期或复发转移性非小细胞肺癌的一线治疗。 5、依沃西单抗（Ivonescimab，AK112）获批时间： 2024年5月24日。研发公司：康方生物。适应证： EGFR突变的非鳞状非小细胞肺癌。药物介绍：依沃西单抗是一款PD-1/VEGFA双抗类药物，2024年5月24日在我国获批，与化疗（培美曲塞+卡铂）联合，用于治疗EGFR突变的局部晚期或转移性非鳞状非小细胞肺癌（nsq-NSCLC），该药是全球首个获批上市的“肿瘤免疫+抗血管生成”机制的双特异性抗体新药。 6、盐酸卡马替尼（卡马替尼，Capmatinib）研发公司：诺华制药。适应证：非小细胞肺癌。获批时间： 2024年6月12日。药物介绍：盐酸卡马替尼是一款MET（间质上皮转化因子）-TKI药物，2024年6月12日，在我国获批上市，用于治疗成人携带MET外显子14跳跃突变的局部晚期或转移性非小细胞肺癌（NSCLC）。阅读原文了解详情：速递|FDA今日批准首款METex14抑制剂-Capmatinib上市。 7、甲磺酸瑞厄替尼片（瑞厄替尼，圣瑞沙®）研发公司：圣和药业。适应证：非小细胞肺癌。获批时间： 2024年6月17日、2024年9月3日。药物介绍：瑞厄替尼是一款表皮生长因子受体-酪氨酸激酶抑制剂（EGFR-TKI），在我国两度获批。2024年6月17日获批，用于治疗成人EGFR T790M突变阳性的局部晚期或转移性非小细胞肺癌；2024年9月3日获批，作为成人EGFR外显子19缺失或外显子21（L858R）置换突变的局部晚期或转移性非小细胞肺癌的一线治疗。 8、枸橼酸依奉阿克（依奉阿克，Envonalkib）研发公司：正大天晴。适应证：非小细胞肺癌。获批时间： 2024年6月17日。药物介绍：依奉阿克是由正大天晴研发的一款ALK-TKI，2024年6月17日在我国获批，用于既往未接受过ALK抑制剂治疗的ALK阳性的局部晚期或转移性非小细胞肺癌的治疗。 9、奥希替尼（Tagrisso）研发公司：阿斯利康。适应证：非小细胞肺癌。获批时间： 2024年6月25日。药物介绍： 2024年6月25日在中国获批，与含铂化疗联合，作为成人具有（EGFR 19号外显子缺失突变或21号外显子置换突变（L858R）的局部晚期或转移性非小细胞肺癌（NSCLC）的一线治疗。 10、帕博利珠单抗（Pembrolizumab，派姆单抗）研发公司：默沙东（MSD）。适应证：非小细胞肺癌。获批时间： 2024/2/4、2024/6/25、2024/9/10、2024/12/3。药物介绍：帕博利珠单抗是一款“不限癌种”的重磅抗PD-1抑制剂，号称“K药卷王”，同时也是我国首个获批上市的PD-1抑制剂！2024年12月3日该药新适应证获中国NMPA批准，用于治疗手术切除的II、IIIA及IIIB期非小细胞肺癌（联合含铂化疗新辅助治疗，并在术后继续帕博利珠单抗单药辅助治疗）。阅读原文了解详情：刚刚！K药卷王-帕博利珠单抗新适应症在华获批！肺癌3年生存率高达71%。 11、氟泽雷塞（GFH925、IBI351，达伯特®）获批时间： 2024年8月21日。研发公司：信达生物。适应证：非小细胞肺癌。药物介绍：氟泽雷塞片这款针对KRAS突变的革命性国研抗癌药，终于在2024年8月21日，获得中国NMPA批准上市，用于既往既往至少接受过一种系统性治疗的成人KRAS G12C突变型晚期非小细胞肺癌的治疗。阅读原文了解详情：里程碑！中国第一款肺癌KRAS G12C抑制剂氟泽雷塞震撼上市 12、德曲妥珠单抗（Enhertu，优赫得®）研发公司：第一三共与阿斯利康。适应证：非小细胞肺癌。获批时间： 2024年8月5日、2024年10月14日。药物介绍：德曲妥珠单抗是一种新型的抗体偶联药物（ADC），通过将靶向HER2的抗体与高效的细胞毒性药物连接在一起，同时杀伤目标肿瘤细胞及邻近的肿瘤细胞。2024年10月14日该药的新适应证在我国获批，用于HER2突变的非小细胞肺癌（NSCLC）的治疗。这是首个针对HER2突变转移性非小细胞肺癌患者的HER2靶向疗法，成功填补了我国肺癌ADC治疗领域的空白，为肺癌患者带来新的希望与选择！ 13、格索雷塞（Garsorasib，安方宁®）研发公司：益方生物+正大天晴。适应证： KRAS G12C突变的非小细胞肺癌。获批时间： 2024年11月8日。药物介绍：格索雷塞是一种强效且选择性的口服KRAS G12C抑制剂，它是我国第2款获批上市的国产KRAS G12C抑制剂。2024年11月8日在中国获批上市，用于治疗成人既往至少接受过一种系统性治疗的KRAS G12C突变型的晚期非小细胞肺癌（NSCLC）。 14、己二酸他雷替尼胶囊（Taletrectinib，达伯乐®）获批时间： 2024年12月20日。研发公司：葆元生物。适应证： ROS1阳性的非小细胞肺癌。药物介绍：己二酸他雷替尼胶囊是全新一代ROS1/NTRK抑制剂，2024年12月20日在中国获批，用于成人经ROS1-TKI治疗后进展的ROS1阳性局部晚期或转移性非小细胞肺癌（NSCLC）的治疗。 15、替雷利珠单抗（百泽安®，TEVIMBRA®）获批时间： 2024年10月16日。研发公司：百济神州。适应证：非小细胞肺癌。药物介绍：替雷利珠单抗是我国自主研发的一款PD-1抑制剂，2024年10月16日该药新适应证再度获中国NMPA批准，用于II或III期非小细胞肺癌的围手术期治疗，这是我国首个获批用于治疗II~III期NSCLC新辅助+辅助免疫治疗的PD-1药物！ 16、特瑞普利单抗（Toripalimab，拓益®）研发公司：君实生物。适应证：非小细胞肺癌。获批时间： 2024年1月2日。药物介绍：特瑞普利单抗是我国自主研发的一款PD-1单抗，2024年1月2日在我国获批，与化疗联合作为成人可切除的ⅢA-ⅢB期非小细胞肺癌的围手术期疗法，这是我国首个、全球第二个获批的肺癌围手术期疗法。（四）2024年中国NMPA批准上市的小细胞肺癌新药全盘点 17、贝莫苏拜单抗（Benmelstobart，安得卫®）研发公司：正大天晴药业。适应证：小细胞肺癌。获批时间：2024年5月9日。药物介绍：贝莫苏拜单抗是正大天晴药业集团自主研发的一款全新序列的创新人源化PD-L1单克隆抗体，属于1类创新药范畴。2024年5月9日该药获中国NMPA批准，与安罗替尼及化疗（卡铂、依托泊苷）联合，用于广泛期小细胞肺癌（ES-SCLC）的一线治疗。阅读原文了解详情：晚期肺癌有救了，疾病控制率高达87.3%！贝莫苏拜单抗Ⅲ期临床重大进展！ 18、替雷利珠单抗（百泽安®，TEVIMBRA®）获批时间： 2024年4月24日。研发公司：百济神州。适应证：小细胞肺癌。药物介绍： 2024年4月24日，替雷利珠单抗获中国NMPA批准，与依托泊苷和铂类化疗联合用于广泛期小细胞肺癌（ES-SCLC）的一线治疗！ 19、特瑞普利单抗（Toripalimab，拓益®）研发公司：君实生物。适应证：小细胞肺癌。获批时间： 2024年6月12日。药物介绍： 2024年6月12日，特瑞普利单抗的新适应证再度获NMPA批准，与依托泊苷和铂类联合，用于广泛期小细胞肺癌（ES-SCLC）的一线治疗。三、2025年新增26款肺癌医保药物 2025年1月1日，全新医保目录正式落地实施，这对于肺癌患者而言无疑是一个重磅喜讯！此次医保目录涵盖的靶向及免疫药物多达36种，其中11款在国内获批不久的热门药物，更是首次被纳入医保范畴。这意味着肺癌病友们正身处一个前所未有的黄金时代，治疗费用将大幅降低，抗癌之路将迎来更多曙光！阅读原文了解详情：2025年1月医保新目录即将执行！36款救命又省钱的肺癌医保药物来了 ▼36款医保报销的肺癌靶向及免疫药物四、2025肺癌患者必须要了解的抗癌新技术在2025年，除了已获批上市或被纳入医保的抗癌新药带来惊喜外，还有多款在癌友圈中备受瞩目的抗癌新技术同样令人满怀期待。这些新技术凭借显著的疗效，成功获得突破性治疗指定以及优先审批资格，有望为肺癌患者带来新的希望与曙光！ PART.01 TIL细胞疗法助近半数肺癌患者，达到病情稳定 “TIL细胞疗法”即“肿瘤浸润细胞疗法”是从癌症患者手术切除的肿瘤组织中，分离出的免疫细胞“敢死队”。其中，Lifileucel（Amtagvi，LN-144）作为全球首款获批上市的TIL细胞药物，同时也是目前唯一获FDA批准的实体瘤TIL疗法，已于2024年2月16日获美国FDA批准，用于治疗既往接受过PD-1抗体治疗的不可切除或转移性黑色素瘤的成年患者。近期研发发现，Lifileucel对非小细胞肺癌也有效，2期临床研究结果显示，79.2%的患者肿瘤负荷减少，42.9%的患者达到病情稳定（SD），客观缓解率(ORR)达到21.4%，部分缓解（PR）率达到17.9%！值得一提的是，其中一位41岁KRASG12D突变的IV期粘液性肺腺癌男性患者，在TIL细胞治疗12周后，RECISTv1.1及CT扫描显示，该患者部分缓解（PR）率高达81%（详见下图）！ ▼该患者在TIL治疗前、治疗后6周的CT对比 ▲图源“Cancer Discov”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除 PART.02 NK细胞联合化疗和/或西妥昔单抗，非小细胞肺癌疾病控制率竟达100% NK细胞即自然杀伤细胞，是人体抗癌及抗病毒的第一道防线，它在治疗非小细胞肺癌领域疗法依然抗打！《癌症免疫治疗杂志》近期报道了应用“SNK01 NK细胞联合化疗和/或西妥昔单抗，治疗EGFR突变型非小细胞肺癌”I/IIa期临床研究（NCT04872634）的惊艳数据！结果显示：全部入组患者（n=12）的疾病控制率（DCR）竟达100%（详见下图）！中位无进展生存期（PFS）长达143天。此外，SNK01联合西妥昔单抗/吉西他滨/卡铂组的客观缓解率（ORR）高达50%。 ▲图源“BMJ”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除 PART.03 γδT细胞暴击难治性非小细胞肺癌，中位总生存期长达418.0天 γδT细胞是T淋巴细胞中特有的一个亚群，兼具先天特征和适应性特征，具有很强的抗肿瘤能力，可用于肺癌、乳腺癌、胰腺癌等癌种的治疗。一项应用“唑来膦酸扩增的自体Vγ9Vδ2 T细胞（γδT细胞的一种），治疗难治性非小细胞肺癌”的2期临床研究结果显示：疾病控制率（DCR）高达68.0%，中位总生存期（OS）长达418天（详见下图），中位无进展生存期（PFS）为95.0天。 ▲图源“J Immunother Cancer”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除值得一提的是，其中一位66岁的左上叶原发性肺癌且伴脑转移的男性患者（TU-2844），接受Vγ9Vδ2 T细胞治疗后，胸部X光和CT扫描图像显示，患者肺部肿瘤和淋巴结肿大明显缩小（详见下图）。 ▼该患者在基线（治疗前）、第二次注射Vγ9Vδ2 T细胞4周后的胸部X光和CT扫描对比 ▲图源“J Immunother Cancer”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除 PART.04 电场疗法助转移性非小细胞肺癌，中位总生存时间显著提升肿瘤电场疗法（TTFields）是一种便捷且无创的局部物理治疗方法，其运作原理是在癌症患者的皮肤表层，放置特殊的绝缘电极贴片，以此生成能够穿透皮肤与身体组织的低强度、中频电场，通过干扰或抑制导致癌细胞扩散或转移的类似“马达”的微型构件，进而实现遏制癌细胞扩散与转移的目的。该疗法的突出优势在于使用便利，患者可在家中自行佩戴并完成治疗，避免了患者需要频繁往返医院的不便，对日常生活的影响较小。 2024年10月15日，电场疗法也迎来了突破性进展，美国FDA批准了由Novocure公司研发的一款电场疗法——Optune Lua®的上市申请，用于铂类疗法期间或之后病情进展的转移性非小细胞肺癌（mNSCLC）的治疗（与多西他赛或PD-1/PD-L1抑制剂同时使用）！这也意味着肺癌患者在家就能完成治疗了！阅读原文了解详情：重大突破！电场疗法新适应证获FDA批准，肺癌居家治疗有戏，总生存期显著延长 Optune Lua®本次获批主要是基于《柳叶刀》报道的一项3期临床研究（NCT02973789）的惊艳数据，结果显示：与标准治疗相比，接受电场治疗的转移性非小细胞肺癌患者，其总生存期（OS）显著提高，中位OS分别为13.2个月（电场疗法联合标准治疗组）vs 9.9个月（标准治疗组）。 ▲图源“Lancet”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除 PART.05 树突状细胞疫苗联合化疗，助肺癌全身转移患者无进展生存超577天树突状细胞（dendriticcell，DC）是一类多功能抗原提呈细胞，可被用作刺激细胞毒性抗肿瘤免疫反应的疫苗。全球知名期刊《Cureus》曾报道过一个“复发性和多发性肺癌全身转移患者，应用WT1树突状细胞疫苗（WT1-DC）治疗后，无进展生存超577天”的振奋案例！该患者为一位69岁患右肺中叶IV期鳞状细胞癌的男性患者，同时伴多发性肝转移、双侧肾上腺转移、多发性骨转移等。因无法耐受手术及放疗，遂入组接受WT1树突状细胞疫苗（WT1-DC）联合化疗（卡铂AUC6+紫杉醇）治疗。结果显示：该患者无进展生存期（PFS）＞577天，体能状态为1，临床状况良好，可正常生活。在WT1-DC治疗后第114天，肺部原发病灶几乎消失；在WT1-DC治疗第479天PET-CT显示，全身转移灶明显改善，除肝脏转移病灶（直径为1.7cm）、右肺转移病灶（直径为1.0cm）外，未见其他转移灶（详见下图）。 ▼该患者在WT1-DC治疗前后的全身PET-CT对比 ▲图源“Cureus”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除四、关乎肺癌患者康复：怎么吃才能提升免疫力，助力战胜癌症？肺癌患者可能因癌症本身，造成免疫功能本身处于失常状态，而手术，放疗，化疗等抗肿瘤治疗，也会对人体的免疫功能造成一定损伤，从而影响身体对营养物质的吸收，轻则出现食欲不振等厌食表现，重则可能影响机体免疫力、无法耐受放化疗等，从而增加肿瘤复发或转移风险。因此，肺癌患者应在抗癌过程中及癌症治疗后，通过积极的饮食调理，尽快恢复免疫功能，从而有助于改善临床结局。 PART.01 常规营养素的补充肺癌患者需要通过日常饮食，积极补充维生素（如维生素C、维生素E、维生素D等）、微量元素、碳水化合物、糖类与脂肪等。阅读原文了解详情：好好吃饭也能抗癌！全面盘点癌细胞惧怕的八大营养素，及时补充巩固抗癌防线 PART.02 特殊营养素的补充对于免疫功能低下或异常的患者，临床医生会建议注射胸腺肽类的药物、干扰素、应用益生菌或益生元等特殊营养素，帮助患者提升机体免疫力、促进癌症恢复等。 1、益生菌益生菌是一类“活的非病原性微生物”，适量补充益生菌，有助于提高机体免疫功能、提高抗肿瘤治疗的有效性、降低放化疗的副作用，改善肺癌、肝癌、肾癌、结直肠癌等多种癌症的预后。《癌症免疫学研究》报道了一项“晚期非小细胞肺癌患者接受益生菌丁酸梭菌疗法（CBT）治疗后，中位无进展生存期长达250天”的惊艳临床研究数据！本研究共入组118例晚期非小细胞肺癌（NSCLC）患者，结果显示：与不使用益生菌CBT相比，使用益生菌CBT患者的中位无进展生存期（PFS）显著延长，分别为250天（使用益生菌CBT组）vs 101天（不使用益生菌CBT组），P=0.005（详见下图）。 ▲图源“Cancer Immunol Res”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除 2、益生元益生元是一类不被宿主消化吸收，但却能被肠道内有益菌种分解吸收的有机物，常见包括双歧因子、人参多糖、膳食纤维等。益生元可改善宿主健康、促进益生菌的生长繁殖；同时，促进肠道菌群代谢，转变至有利于抗癌治疗方向，从而有助于提高癌症免疫治疗的效果。 3、胸腺肽胸腺，作为体内兼具内分泌与免疫功能的重要器官，在人体生理机制中扮演着关键角色。胸腺肽，是从胸腺提取的一类具有生理活性的多肽物质，常见的有胸腺五肽、胸腺素α-1等。它属于免疫调节疗法的范畴，凭借其独特的免疫调节作用，已被广泛应用为一种辅助性治疗手段。有研究显示，胸腺肽能够有效改善患者的长期预后，助力患者更好地恢复健康。 4、舞茸多糖 “舞茸”属于药食两用的菇类，原产于日本北部山区，我国习惯称之为“灰树花”。据日本国际癌症研究中心数据显示，与香菇等提取物相比，舞茸提取物在提高机体免疫应答能力上，具有强大且持久的特性。 5、人参皂苷人参皂苷Rh2具有保护免疫系统的作用，可通过多种途径调节并增强机体的免疫功能；还可提高巨噬细胞的吞噬功能、NK细胞的杀伤活性、IL-2（白介素-2）的活性，从而发挥抗肿瘤的功效。 6、破壁灵芝孢子粉破壁灵芝孢子粉中含有灵芝多糖、三萜类灵芝酸等活性成分，具有增强NK细胞活性，促进T淋巴细胞增殖及T细胞介导的免疫反应等功效。五、2025肺癌全球会诊，中、日肺癌专科医院排行榜对于所有的肺癌患者来说，在确诊后及目前治疗效果不理想时最想了解的就是哪些肺癌专家能提供更好的诊疗方案，获得更好的治疗结局。2023全球肺癌专家将为病友提供会诊或第二医疗意见，可以帮助患者了解更多治疗选择，并作出明智的决定。 ▼2024复旦版中国最新呼吸科医院排名 ▼2024复旦版中国最新胸外科医院排名 ▼2024日本专科医院排名六、小编寄语在过去十年间，肺癌治疗领域取得了令人瞩目的长足进步，逆转了晚期患者的生存期。除了前文提及的内容外，目前还有众多肺癌新药与新技术正处于紧锣密鼓的研发进程中。但鉴于篇幅限制，本文无法详尽介绍每一项在研的新药或新技术。大家可先收藏以备不时之需，也可将治疗经历等提交至全球肿瘤医生网医学部，进行初步评估或了解抗癌新药或新技术的更多内容。小编也希望，2025年能迎来更多抗癌新药与新技术获批上市的喜讯，助力肺癌患者成功战胜病魔，勇敢跨越一个又一个充满希望的十年！七、参考资料 [1]Schoenfeld A J,et al.Lifileucel, an autologous tumor-infiltrating lymphocyte monotherapy, in patients with advanced non–small cell lung cancer resistant to immune checkpoint inhibitors[J]. Cancer discovery, 2024, 14(8): 1389-1402. https://aacrjournals-org.libproxy1.nus.edu.sg/cancerdiscovery/article/14/8/1389/746508/Lifileucel-an-Autologous-Tumor-Infiltrating?searchresult=1 [2]Choi M G,et al.Safety and efficacy of SNK01 (autologous natural killer cells) in combination with cytotoxic chemotherapy and/or cetuximab after failure of prior tyrosine kinase inhibitor in non-small cell lung cancer: non-clinical mouse model and phase I/IIa clinical study[J]. Journal for Immunotherapy of Cancer, 2024, 12(3). https://jitc-bmj-com.libproxy1.nus.edu.sg/content/12/3/e008585 [3]Kakimi K,et al.Adoptive transfer of zoledronate-expanded autologous Vγ9Vδ2 T-cells in patients with treatment-refractory non-small-cell lung cancer: a multicenter, open-label, single-arm, phase 2 study. J Immunother Cancer. 2020 Sep;8(2):e001185. https://pmc-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/articles/PMC7511646/ [4]Leal T,et al.Tumor Treating Fields therapy with standard systemic therapy versus standard systemic therapy alone in metastatic non-small-cell lung cancer following progression on or after platinum-based therapy (LUNAR): a randomised, open-label, pivotal phase 3 study[J]. The Lancet Oncology, 2023, 24(9): 1002-1017. https://www-thelancet-com.libproxy1.nus.edu.sg/journals/lanonc/article/PIIS1470-2045(23)00344-3/abstract [5]Nagai H,et al.WT1 Dendritic Cell Vaccine Therapy Improves Immune Profile and Prolongs Progression-Free Survival in End-Stage Lung Cancer[J].Cureus,2023,15(10). https://www.cureus.com/articles/193305-wt1-dendritic-cell-vaccine-therapy-improves-immune-profile-and-prolongs-progression-free-survival-in-end-stage-lung-cancer#!/ [6]Tomita Y,et al.Association of Probiotic Clostridium butyricum Therapy with Survival and Response to Immune Checkpoint Blockade in Patients with Lung Cancer. Cancer Immunol Res. 2020 Oct;8(10):1236-1242. https://aacrjournals-org.libproxy1.nus.edu.sg/cancerimmunolres/article/8/10/1236/466810/Association-of-Probiotic-Clostridium-butyricum 本文为全球肿瘤医生网原创，未经授权严禁转载

上市批准免疫疗法

2024-12-02

·GlobeNewswire-Health Care

NKGen Biotech Selected as Stalking Horse Bidder for NKMax

Upon closing, the transaction would secure global IP rights for NKGen.NKGen and its partners can begin to commercialize troculeucel in Korea, Japan and other markets where natural-killer (“NK”) cell therapy is already legal.NKGen proposal included up to $18 million in committed funding.Closing expected in 1Q 2025. SANTA ANA, Calif., Dec. 02, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer cell therapeutics, today announced it has been selected as the preferred stalking horse bidder for NKMax Co., Ltd. (“NKMax”) in NKMax’s court-managed rehabilitation process in South Korea. NKMax filed for rehabilitation in South Korea, roughly similar to Chapter 11 in the US, on April 18, 2024, and currently holds an approximate 25% equity interest in NKGen. NKGen’s proposal included up to $18 million in committed funding from a third-party investor. As is typical in US bankruptcies, there will now be a public offering process, with NKGen having final right of first refusal on any other qualified offers, with the final decision and ultimate rehabilitation plan approved by NKMax’s creditors and the court expected in February 2025 and closing thereafter (the “Acquisition”). NKGen and its financing partners expect to hold a majority of the equity of NKMax at closing. NKMax currently holds master global rights to the intellectual property (“IP”) for troculeucel (formerly known as SNK01) and other proprietary IP that is licensed to NKGen for markets outside Asia. Such an acquisition is expected to put global rights under the control of NKGen. Prior to entering into the rehabilitation process, NKMax announced plans and commenced initial groundwork to commercialize the troculeucel treatment for Alzheimer’s and other neurodegenerative diseases in Japan and South Korea, where such NK cell treatment is legal already. Additional production capacity at NKMax’s GMP facility will be an added benefit which could help accelerate production for US trials. “As we have made tremendous progress in our clinical program especially with the launch of our phase II trial for moderate stage Alzheimer’s disease, we felt that it was essential for us to preserve the very close scientific and clinical partnership with the NKMax team, rather than have NKMax acquired by someone without any cell therapy knowledge or experience”, commented Paul Y. Song, MD, Chairman and CEO of NKGen Biotech. “As we continue to work towards US FDA approval, we will be able to begin to commercialize troculeucel in countries like Japan, Thailand, Malaysia, Mexico and others where an autologous non-genetically modified cell therapy is considered as a legal treatment and already readily available. We believe that we will be much stronger and will deliver more value for our patients and shareholders when operated as one global team.” NKGen does not believe the NKMax rehabilitation process has had any material negative impact on NKGen’s business or prospects. About Troculeucel Troculeucel is a novel cell-based, patient specific ex vivo expanded autologous natural killer (“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 our journey toward bringing this therapy to market. About NKMax Founded in 2002 and headquartered in Seoul, South Korea, NKMax Co., Ltd. is a clinical-stage biotechnology company focused on advancing immune cell therapies. In addition to its therapeutic innovations, NKMax develops and commercializes bioreagents and immunodiagnostic kits, with revenues derived from these products as well as health supplements. In 2016, NKMax completed its GMP-certified manufacturing facility, and obtained approval from the Korean MFDS (Ministry of Food and Drug Safety) in 2018, strengthening its capabilities in high-quality cell therapy production. Listed on the KOSDAQ, a South Korean stock exchange, NKMax's trading has since been suspended during the course of ongoing rehabilitation efforts. 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. 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, the closing of the Acquisition, which may not close on the terms or timing anticipated, or at all, the satisfaction or waiver of any conditions to the closing of the Acquisition, the anticipated impacts or benefits of the Acquisition, the closing of the expected funding for the Acquisition, the risk of shareholder litigation in connection with the Acquisition, including resulting expense or delay; the risk that NKMax’s business will not be integrated successfully or that such integration may be more difficult, time-consuming or costly than expected, the successful and timely completion and the commercialization of troculeucel, 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 Contacts:Chris CalabreseManaging DirectorLifeSci Advisors, LLCccalabrese@lifesciadvisors.com Kevin GardnerManaging DirectorLifeSci Advisors, LLCkgardner@lifesciadvisors.com

细胞疗法临床2期并购免疫疗法

2024-11-26

·GlobeNewswire-Health Care

NKGen Biotech Receives Notifications From Nasdaq Related to Delayed Quarterly Report and Decision of the Nasdaq Hearings Panel

SANTA ANA, Calif., Nov. 26, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), today announced it received a notice (the “Notice”) on November 20, 2024 from the Listing Qualifications Department of The Nasdaq Stock Market (“Nasdaq”) stating that the Company is not in compliance with Nasdaq Listing Rule 5250(c)(1) (the “Rule”) because it had not timely filed its Quarterly Report on Form 10-Q for the period ended September 30, 2024 (the “Form 10-Q”) with the Securities and Exchange Commission (the “SEC”) on or before November 19, 2024, the extended period provided for the filing under Rule 12b-25(b) of the Securities Exchange Act of 1934, as amended. The delay is in part due to the additional time required for valuation and review of various derivative securities as the Company has taken on more reporting responsibility internally. The Notice from Nasdaq has no immediate effect on the listing or trading of the Company’s common stock on the Nasdaq Global Market. The Company is actively working with its auditors and advisors and intends to file the Form 10-Q as promptly as possible. On November 20, 2024, subsequent to the Company’s receipt of the Notice, the Company received a letter from Nasdaq (the “Decision Letter”) granting a temporary exception to the Rule and the minimum market value of listed securities requirement in Nasdaq Listing Rule 5450(b)(2)(A) (the “MVLS Rule”) until January 7, 2025. The Seoul Bankruptcy Court (the “Court”) is expected to announce its decision on the rehabilitation of NKMax Co. Ltd (“NKMax”) and the Company’s proposal to acquire a majority interest in NKMax on or before such date. In accordance with the Decision Letter, the Company must advise the Nasdaq Hearings Panel (the “Panel”) of the outcome of the Court’s decision. If the Company is successful in its bid to acquire a majority interest in NKMax, the Company must advise the Panel no later than January 7, 2025, on its plan for regaining compliance with the Rule and MVLS Rule, for the Panel’s further consideration. The Company may request that the Nasdaq Listing and Hearing Review Council (the “Council”) review the Panel’s determination in the Decision Letter, by written request received by the Council by December 5, 2024. In such event, the Company would be required to submit a fee of $15,000.00 to Nasdaq to cover the cost of the review. The Council may determine to review any Panel decision by January 4, 2025. The Company does not intend to appeal the Decision Letter at this time and intends to deliver an updated plan of compliance to the Panel no later than January 7, 2025. For additional information regarding the Nasdaq notifications and related terms, please see the Current Report on Form 8-K the Company filed with the SEC on November 26, 2024, which is available at sec.gov. 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 SNK01, 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, MT (ASCP)SVP Corporate Affairs949-396-6830dchua@nkgenbiotech.com External Contacts:Chris CalabreseManaging DirectorLifeSci Advisors, LLCccalabrese@lifesciadvisors.com Kevin GardnerManaging DirectorLifeSci Advisors, LLCkgardner@lifesciadvisors.com

100 项与 Troculeucel 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
阿尔茨海默症	临床2期	美国	NKGen Biotech, Inc.	2023-11-21
转移性结直肠癌	临床2期	美国	NKGen Biotech, Inc.	2021-11-03
非小细胞肺癌	临床2期	美国	NKGen Biotech, Inc.	2021-11-03
局部晚期非小细胞肺癌	临床2期	韩国	NKMAX Co., Ltd.	2021-07-08
晚期恶性实体瘤	临床2期	-	NKGen Operating Biotech, Inc.初创企业	2021-03-01
膀胱癌	临床2期	-	NKGen Operating Biotech, Inc.初创企业	2021-03-01
结直肠癌	临床2期	-	NKGen Operating Biotech, Inc.初创企业	2021-03-01
EGFR阳性非小细胞肺癌	临床2期	-	NKGen Operating Biotech, Inc.初创企业	2021-03-01
子宫内膜癌	临床2期	-	NKGen Operating Biotech, Inc.初创企业	2021-03-01
食管癌	临床2期	-	NKGen Operating Biotech, Inc.初创企业	2021-03-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04678453 (GlobeNewswire) 人工标引	临床1期	阿尔茨海默症	11	Troculeucel	醖築積築壓夢繭積鏇蓋(壓鑰蓋積廠壓繭範願糧) = 90% of all evaluable subjects had either stable or improved (±0.1). 網壓簾鏇齋遞選窪積範 (壓選構鬱窪顧鑰簾遞簾 ) 更多	积极	2024-10-29
NCT06189963 (GlobeNewswire) 人工标引	临床1/2期	阿尔茨海默症	3	SNK01	衊醖遞齋襯願齋鏇艱範(築醖蓋遞選繭繭鏇觸獵) = 願鏇衊襯艱積顧繭窪獵獵製廠醖窪餘鬱壓艱壓 (齋鏇膚鏇鑰糧壓範夢艱 ) 更多	积极	2024-10-29
NCT04872634 (Pubmed \| J Immunother Cancer) 人工标引	临床1/2期	EGFR突变的非小细胞肺癌 EGFR Mutation	12	SNK01 + cytotoxic chemotherapycetuximab	鏇艱鏇網網簾簾醖鏇觸(獵鏇艱襯範鑰鬱壓觸選) = 簾衊襯憲艱選構衊衊糧網餘選廠鑰簾膚願鏇願 (醖廠繭鏇鹽齋獵鏇淵膚 ) 更多	积极	2024-03-27
NCT04678453 (GlobeNewswire \| Corporate Publications) 人工标引	临床1期	阿尔茨海默症 cerebral spinal fluid (“CSF”) and plasma Tau proteins	11	SNK01	醖淵遞夢襯壓鏇廠襯網(築遞膚艱膚齋構獵襯襯) = 壓網鹽獵鹹獵製窪鹽鹹齋蓋醖製簾構獵壓願鹹 (淵糧齋獵製簾構願鹽糧 ) 更多	积极	2024-03-25
Corporate Publications 人工标引	临床1期	阿尔茨海默症	10	SNK01	鏇簾醖廠衊範鏇齋鹹餘(鏇選簾網廠鹹鑰襯醖餘) = 顧鑰鹹範築遞鹽淵齋獵餘淵襯觸醖築蓋獵築夢 (選齋壓網繭衊顧窪願遞 ) 更多	积极	2023-10-26
NCT05099549 (ASCO_Breakthrough2023) 人工标引	临床1期	EGFR 突变实体瘤 EGFR Expressing	6	AFM24+SNK01	繭餘醖蓋廠蓋製壓壓廠(壓選願構淵糧憲網鹹選) = 鏇獵夢淵製夢憲齋築餘鹹醖築選艱窪製繭壓壓 (積獵鏇鬱積蓋艱鬱窪積 )	积极	2023-08-03
ESMO2022	N/A	肉瘤	8	SNK01 + Pembrolizumab	範遞壓艱鏇壓鏇壓壓糧(壓選醖蓋糧範夢淵蓋衊) = 蓋廠築廠獵鏇簾蓋蓋艱顧淵膚構膚鹽鹽構築鑰 (齋築鏇襯網構繭齋壓繭 )	-	2022-09-10
WCLC2022	临床1/2期	非小细胞肺癌	20	Pembrolizumab + SNK01 (2 x 10^9 cells/dose)	鹽夢築簾膚餘鹽窪製齋(餘壓壓艱衊憲廠膚觸齋): HR = 0.32 (95% CI, 0.1 ~ 1.08), P-Value = 0.066 更多	-	2022-08-06
WCLC2022	临床1/2期	非小细胞肺癌	20	Pembrolizumab monotherapy		-	2022-08-06
NCT03941262 (ASCO2022) 人工标引	临床1期	HR阳性/HER2低表达实体瘤	10	SNK01	鹹選範簾壓蓋製範鏇鬱(夢窪鑰鑰選積願顧廠鹹) = 醖襯鑰壓鬱鹽膚鬱憲鹽窪餘鹽選構簾繭廠構簾 (糧鬱願觸顧選選鹽糧窪 ) 更多	积极	2022-06-02
NCT03941262 (ASCO2022)	临床1期	难治性软组织肉瘤	15	SNK01 + Avelumab	鹹鹹顧選顧衊醖廠觸糧(艱簾鏇簾膚鏇選鬱構襯) = 鹽繭築廠選製觸糧遞膚選鹽願構壓餘遞築窪膚 (遞夢夢範糧顧餘夢鬱鏇 ) 更多	-	2022-06-02