A Phase II Trial of the Immunogenicity of a DNA Plasmid-Based Vaccine (STEMVAC) Encoding Th1 Selective Epitopes From Five Antigens Associated With Breast Cancer Stem Cells (MDM2, YB1, SOX2, CDH3, CD105) in Patients With Metastatic Triple-Negative Breast Cancer

This phase II trial studies how well a cancer vaccine called STEMVAC works in combination with chemotherapy in treating patients with PD-L1 negative, triple-negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). STEMVAC is designed to target proteins that are expressed on breast cancer stem cells, and it is believed to work by boosting the immune system to recognize and destroy the invader tumor cells that are causing the disease. The allowable combination chemotherapy includes: (1) Paclitaxel is in a class of chemotherapy medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. (2) Docetaxel is in a class of chemotherapy medications called taxanes. It stops tumor cells from growing and dividing and may kill them. (3) Cisplatin is in a class of chemotherapy medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. (4) Carboplatin is in a class of chemotherapy medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. (5) Doxorubicin is in a class of chemotherapy medications called anthracyclines. Doxorubicin damages the cell's deoxyribonucleic acid (DNA) and may kill tumor cells. It also blocks a certain enzyme needed for cell division and DNA repair. (6) Liposomal doxorubicin is a form of the anticancer drug doxorubicin that is contained inside very tiny, fat-like particles. Liposomal doxorubicin may have fewer side effects and work better than other forms of the drug. (7) Eribulin is in a class of chemotherapy medications called microtubule dynamics inhibitors. It works by stopping the growth and spread of tumor cells. Giving STEMVAC in combination with chemotherapy may be an effective treatment for PD-L1 negative metastatic triple-negative breast cancer.

开始日期2025-12-01

申办/合作机构

University of Washington

NCT07112053

/ Recruiting临床2期IIT

A Phase II Study of STEMVAC Vaccine Therapy for Patients With Hormone Receptor Positive Metastatic Breast Cancer

This phase II trial studies how well a vaccine, STEMVAC, works in combination with standard endocrine-based therapy (ET) or chemotherapy (CDK4/6 inhibitor or capecitabine) in treating patients with hormone receptor (HR) positive, HER2 negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). STEMVAC is designed to target proteins that are expressed on breast cancer stem cells, and it is believed to work by boosting the immune system to recognize and destroy the invader tumor cells that are causing the disease. Standard ET is treatment that adds, blocks, or removes hormones in order to slow or stop the growth of cancer. Standard CDK4/6 inhibitors may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for cell growth. Capecitabine is in a class of medications called antimetabolites. It is taken up by tumor cells and breaks down into fluorouracil, a substance that kills tumor cells. Giving STEMVAC in combination with standard ET or chemotherapy may be an effective treatment for metastatic HR positive, HER2 negative breast cancer.

开始日期2025-11-24

申办/合作机构

University of Washington

NCT05242965

/ Active, not recruiting临床2期IIT

A Phase II Randomized Study of Safety and Efficacy of a Multiple Antigen Vaccine (STEMVAC) in Non-Small-Cell Lung Cancer Patients

This phase II trial tests whether CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope plasmid DNA vaccine (STEMVAC) works to shrink tumors in patients with stage IV non-small cell lung cancer. STEMVAC targets specific immunogenic proteins that help lung cancer cells to grow. STEMVAC is made up of deoxyribonucleic acid (DNA), which is a natural substance in every living organism. DNA acts like a blueprint that tells all the cells in your body how to function. The DNA used in this study contains instructions for your body to produce parts of the 5 proteins the investigators identified (CDH3, CD105, YB-1, MDM2 and SOX2). STEMVAC is given with granulocyte-macrophage colony stimulating factor (GM-CSF) which is being used as an adjuvant to help create a stronger immune response. Giving STEMVAC with GM-CSF to patients while on maintenance therapy for non-small cell lung cancer (NSCLC) may help activate certain immune cells to recognize and kill lung cancer cells.

开始日期2023-03-24

申办/合作机构

University of Washington

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100 项与 STEMVAC(EpiThany) 相关的临床结果

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100 项与 STEMVAC(EpiThany) 相关的专利（医药）

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项与 STEMVAC(EpiThany) 相关的文献（医药）

2025-12-31·Expert Review of Vaccines

Montanide ISA-51: a promising adjuvant in cancer vaccine immunotherapy

Review

作者: Li, Shaowei ; Ziyi, Li ; Xia, Ningshao ; Nan, Liu ; Zhang, Xiuli

INTRODUCTION:

Cancer vaccine immunotherapy has shifted from traditional cytotoxic treatments toward strategies aimed at enhancing anti-tumor immunity, offering new therapeutic possibilities. Montanide ISA-51, a water-in-oil (W/O) emulsion, has shown considerable promise as an adjuvant in cancer vaccines.

AREAS COVERED:

This review examines the current applications of Montanide ISA-51 in cancer vaccines, explores its immunoregulatory mechanisms, highlights the challenges in its use as a vaccine adjuvant, and proposes avenues for future optimization.

EXPERT OPINION:

Montanide ISA-51 enhances anti-tumor immune responses by improving antigen release and facilitating immune cell aggregation and activation, thereby boosting the effectiveness of vaccines against melanoma, glioma, and HPV-related cancers. When combined with TLR agonists or other immunomodulatory agents, Montanide ISA-51 further amplifies the immune response. However, despite its potential, the precise mechanisms underlying its effects in the complex immune environment remain to be fully understood. These insights will accelerate the translation of Montanide ISA-51 into clinical use as an adjuvant for cancer vaccines.

2025-12-01·MOLECULAR BIOLOGY REPORTS

Advancement insights in cancer vaccines: mechanisms, types, and clinical applications

Review

作者: Salama, Lamiaa A ; Kamel, Gellan Alaa Mohamed ; Attia, Rasha A ; Al-Noman, Hifaa G

Immunotherapy can treat cancer by boosting the immune system to mark and destroy cancer cells. Cancer vaccine is a promising therapeutic strategy in immunotherapy. Cancer vaccines are divided into four groups according to different preparation techniques: cell-based vaccine, virus-based vaccine, peptide-based vaccine, and nucleic acid-based vaccine. Cancer vaccines can be given with traditional treatments or another immunotherapy to give better results and overcome tumor resistance. The cancer vaccine is a promising immunotherapy that could stimulate the immune response to kill cancer cells and create immune surveillance. However, much work is still needed to identify neoantigens, optimize the vaccination platform, and develop combination therapy to improve the efficacy of immunotherapy. This review highlights the mechanism of action of cancer vaccines, the main four groups of cancer vaccines regarding their development, research progress, and clinical applications, and how to assess immune response following cancer vaccination.

2025-11-01·ESMO Open

Innovative therapeutic cancer vaccine PDC∗lung01 with or without anti-PD-1: an open-label, dose-escalation phase I/II study in non-small-cell lung cancer

Article

作者: Theelen, W S M E ; De Vos, B ; Vansteenkiste, J ; Borm, F J ; Cantero, F ; Renard, F ; Cuppens, K ; Duchayne, C ; Laulagnier, K ; Dedry, C ; Levy, L ; Moro-Sibilot, D ; Genin, M ; Pérol, M ; Biesma, B ; Michel, S ; Althoff, F C ; Van De Kerkhove, C ; Wauters, E ; Buchmeier, E ; Skrzypski, M ; Adriaenssens, S ; Derijcke, S ; Sibille, A ; Colinet, B ; Pons-Tostivint, E ; Plumas, J ; Collodoro, M ; Demedts, I ; Halioua, E

BACKGROUND:

While immune checkpoint inhibitors have revolutionized the treatment of non-small-cell lung cancer (NSCLC), many patients still suffer from either primary or acquired treatment resistance. Stimulation of antitumor cellular immunity with a therapeutic cancer vaccine in combination with anti-programmed cell death (ligand) protein 1 [PD-(L)1] may improve outcome. PDC^∗lung01 is a cancer vaccine made of irradiated plasmacytoid dendritic cells loaded with six NSCLC tumor antigens (NY-ESO-1, MAGE-A3, MAGE-A4, Multi-MAGE-A, MUC1, and Survivin), and available as a ready-to-use product.

PATIENTS AND METHODS:

This open-label, dose-escalation, multicenter, phase I/II study assessed the safety profile, clinical activity, and immunogenicity of PDC^∗lung01 at low or high doses, either as a single agent in resected NSCLC (cohorts A) or with anti-PD-1 in metastatic NSCLC with PD-L1 ≥ 50% (cohorts B). The primary objective was vaccine-related dose-limiting toxicities (DLTs). Secondary objectives included safety profile, T-cell response against vaccine antigens in all cohorts, and clinical activity in cohort B2 (high-dose PDC∗lung01 with anti-PD-1): objective response rate (ORR) and 9-month progression-free survival (9mPFS).

RESULTS:

Median follow-up was 20 months [95% confidence interval (CI) 14-26 months] in all enrolled patients (N = 73). Most adverse events were mild to moderate; only one patient (2%) in cohort B2 reported a related DLT. In the combination of PDC∗lung01 (high-dose) with anti-PD-1 (N = 45), the confirmed ORR was 51% (80% CI 41% to 62%), the 9mPFS estimate was 47% (80% CI 37% to 57%), and the median PFS was 9 months (95% CI 5.0-24 months). PDC^∗lung01 elicited tumor antigen-specific T-cell expansions in 50%-67% of patients and PFS duration correlated positively with immune response intensity (P = 0.04).

CONCLUSIONS:

PDC^∗lung01 was immunogenic and had a manageable safety profile in all cohorts and met the predefined clinical objectives when combined with anti-PD-1 in metastatic NSCLC. Median PFS was positively correlated with antigen-specific T-cell expansions.

项与 STEMVAC(EpiThany) 相关的新闻（医药）

2025-10-28

·今日头条

福克斯爆料：mRNA疫苗训练免疫“灭癌”，多癌种三年生存率翻倍

据“福克斯新闻（foxnews）”2025年10月23日报道，由德克萨斯大学MD安德森癌症中心主导、佛罗里达大学参与的新研究显示：接受免疫检查点抑制剂治疗的癌症患者，若在治疗开始后100天内接种mRNA新冠疫苗，其三年生存率是未接种者的近两倍。该研究结果已于2025年10月19日在柏林举行的欧洲肿瘤内科学会（ESMO）大会（摘要LBA54）公布，并同步发表于《自然》杂志。研究人员表示，mRNA新冠疫苗可训练免疫系统清除癌症，与免疫检查点抑制剂结合能产生强效抗肿瘤反应。由于数据收集时部分患者仍存活，疫苗的实际效果可能更显著。这种协同作用或将彻底改变肿瘤治疗格局，为个性化癌症治疗提供全新工具，更有望扩大免疫疗法的受益患者群体。这不仅是mRNA技术在抗癌领域的重大突破，更给无数与癌症抗争的患者带来了新的生机与希望！ ▲截图源自“foxnews” mRNA疫苗与免疫疗法协同抗癌，肺癌、黑色素瘤生存率大幅提升超23% mRNA疫苗具有强大的免疫激活能力，在临床前模型中，研究人员发现其作用机制类似“警报器”，可使人体免疫系统处于高度戒备状态，进而识别并攻击癌细胞。面对免疫系统的攻击，癌细胞会生成免疫检查点蛋白PD-L1作为防御机制，以此对抗免疫细胞。而专门设计的免疫检查点抑制剂能阻断PD-L1，恰好为免疫系统释放抗癌能力创造了理想环境。这些临床前观察结果已在后续临床研究中得到证实。文章开篇福克斯报道的这项III期临床试验，涵盖多种癌症类型的多个队列，重点评估免疫治疗开始后100天内接种mRNA疫苗的患者情况。结果显示如下： 1、晚期非小细胞肺癌队列：180例接种疫苗患者的中位生存期（OS）为37.33个月，704例未接种患者为20.6个月； 3年总生存（OS）率分别为55.7% vs 30.8% （HR=0.51，95%CI=0.37–0.71，P<0.0001，详见下图a）。 ▲图源“Nature”，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、转移性黑色素瘤队列：167例未接种患者的中位生存期为26.67个月，43例接种患者的中位生存期尚未达到，显示出生存期显著改善； 36个月OS率分别为44.1% vs 67.6% （HR=0.37，95%CI=0.18–0.74，P=0.0048，详见下图d）。 ▲图源“Nature”，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 Vx-001癌症疫苗精准靶向TERT，让晚期肺癌患者中位生存期提升近8个月 Vx-001是一款以TERT（端粒酶逆转录酶）抗原为靶点的治疗性癌症疫苗。一项随机双盲IIb期临床试验（NCT01935154），专门评估了该疫苗作为维持治疗，对一线铂类化疗后未出现疾病进展的晚期非小细胞肺癌患者的疗效。该研究共纳入221例符合上述条件的患者，随机分为两组：101例进入安慰剂组，89例进入Vx-001治疗组。结果显示：疫苗诱导的免疫反应与临床结局呈强相关性，在29%产生Vx-001特异性免疫反应的患者中，总生存期（OS）显著更长，中位OS分别为21.3个月（免疫应答者）vs13.4个月（无免疫应答者）（p=0.004）。尤其在从不吸烟且无天然免疫力的患者中，Vx-001治疗带来的OS获益更显著，中位OS分别为8.6个月（安慰剂组）vs16.2个月（Vx-001组）（p=0.0008）。综上，Vx-001的疗效具有明确的人群特异性，尤其对无天然免疫力的患者可能有效，其中从不吸烟及短期吸烟的患者获益最为突出。好消息是，目前这款疫苗已启动临床招募。阅读原文了解详情：【mRNA癌症疫苗免费招募】Vx-001注射液终于启动临床啦！现正急招肺癌/实体瘤患者！ ▲截图源自“ESMO” “侦察兵”WT1-DC疫苗精准狙击胰腺癌，七成患者肿瘤缓解，中位生存期突破3.5年胰腺导管腺癌（PDAC）因恶性程度高、常规治疗耐药性强，一直是癌症治疗的难点。研究发现，转录因子WT1在PDAC肿瘤细胞中广泛表达，堪称癌基因的“助推器”，可驱动肿瘤侵袭转移，是极具潜力的治疗靶点。而树突状细胞（DC）作为免疫系统的“侦察兵”，在启动肿瘤抗原特异性免疫反应中起关键作用。基于此，科研团队研发出新型WT1肽脉冲树突状细胞（WT1-DC）疫苗，相关成果已发表于《癌症免疫治疗杂志》。该研究共纳入10例不可切除PDAC患者，包括6例局部晚期（III期）、3例转移性及1例术后复发患者。所有患者先接受白蛋白结合型紫杉醇联合吉西他滨治疗，随后回输WT1-DC疫苗。结果显示：9例患者的中位无进展生存期（PFS）达2.23年（详见下图A），中位总生存期（OS）达3.52年（详见下图B）。经CE-CT评估，所有患者肿瘤负荷均有下降（降幅0.0%~57.4%），其中 7例（6例局部晚期+1例转移性）达到部分缓解（PR），3例实现病情长期稳定。 ▲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，在4例接受R0切除的局部晚期患者中， 3例持续呈现WT1-DTH阳性，且自治疗开始均存活超4.5年。下图展示了1例代表性PDAC患者经WT1-DC疫苗治疗前后的影像对比。 ▲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 BNT122个体化mRNA疫苗暴击肠癌/肾癌等多类实体瘤，超3年生存+缩瘤10倍！ BNT122（商品名Cevumeran，代号RO7198457）是一款创新型个体化新抗原mRNA疫苗，基于患者肿瘤体细胞突变数据定制设计，可编码20余种肿瘤特异性新抗原，刺激机体产生针对这些新抗原的T细胞免疫反应，进而降低肿瘤复发风险、延长患者生存期。临床研究表明，该疫苗对乳腺癌、黑色素瘤、肾细胞癌、尿路上皮癌、非小细胞肺癌、直肠癌等多种实体瘤均展现出治疗潜力。全球顶尖期刊《Nature Medicine》近期公布了BNT122治疗晚期实体瘤的1期GO39733临床试验（NCT03289962）的振奋数据。值得一提的是，两例突破性临床案例展现出尤为显著的治疗潜力：其中一例38号肾癌患者，入组前已接受4线治疗（含纳武单抗），初期病情进展后，经BNT122治疗实现部分缓解（PR），胸膜靶病灶最长直径总和从基线108mm缩小至10mm ，肿瘤显著缩小近10倍（退缩幅度达90%）。 ▲图源“nature”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除另一例为微卫星稳定（MSS）、PD-L1低表达的21号直肠癌患者，二线治疗后肺部仍有1.1cm病灶。接受9剂BNT122联合阿替利珠单抗治疗后，肿瘤达到完全缓解（CR），且缓解持续8.2个月；截至数据统计时，该患者已存活超3年（40.7个月）（详见下图）。 ▲图源“nature”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除小编寄语作为新型抗癌疗法的代表，癌症疫苗历经数十载发展，已从早期基础研究逐步迈向临床试验阶段，更已有古巴肺癌疫苗等正式获批产品问世——其将患者5年生存率从0提升至23%，尽显临床价值。而我国在癌症疫苗领域同样成果频出，多款候选疫苗处于火热研发阶段。以针对肝细胞癌的LK101为例，其首次人体临床研究（NCT03674073）中，12名入组患者生存期均超过4年！种种进展无不表明，癌症疫苗已离我们越来越近，“打一针唤醒免疫系统，重新识别并杀伤癌细胞”的设想，或将很快从愿景变为现实，而非遥不可及的天方夜谭！参考资料 [1]Grippin A J,et al.SARS-CoV-2 mRNA vaccines sensitize tumours to immune checkpoint blockade[J]. Nature, 2025: 1-10. https://www.nature.com/articles/s41586-025-09655-y [2]Gridelli C,et al. Randomized double blind phase IIb trial in advanced NSCLC patients who did not progress after first line platinum based chemotherapy: Vx-001, a therapeutic cancer vaccine, vs placebo as maintenance therapy[J]. Annals of Oncology, 2017, 28: v638. https://www.annalsofoncology.org/article/S0923-7534(20)39155-9/fulltext [3]Koido S,et al.Dendritic cells pulsed with multifunctional Wilms' tumor 1 (WT1) peptides combined with multiagent chemotherapy modulate the tumor microenvironment and enable conversion surgery in pancreatic cancer. J Immunother Cancer. 2024 Oct 8;12(10):e009765. https://jitc.bmj.com/content/12/10/e009765.long [4]Lopez J,et al.Autogene cevumeran with or without atezolizumab in advanced solid tumors: a phase 1 trial[J]. Nature Medicine, 2025: 1-13. https://www.nature.com/articles/s41591-024-03334-7 [5]https://www.foxnews.com/health/cancer-survival-appears-double-common-vaccine-researchers-say 本文为全球肿瘤医生网原创，未经授权严禁转载

疫苗信使RNA免疫疗法临床3期临床结果

2025-10-27

·国际肿瘤医讯

据“福克斯新闻（foxnews）”2025年10月23日报道，由德克萨斯大学MD安德森癌症中心主导、佛罗里达大学参与的新研究显示：接受免疫检查点抑制剂治疗的癌症患者，若在治疗开始后100天内接种mRNA新冠疫苗，其三年生存率是未接种者的近两倍。该研究结果已于2025年10月19日在柏林举行的欧洲肿瘤内科学会（ESMO）大会（摘要LBA54）公布，并同步发表于《自然》杂志。研究人员表示，mRNA新冠疫苗可训练免疫系统清除癌症，与免疫检查点抑制剂结合能产生强效抗肿瘤反应。由于数据收集时部分患者仍存活，疫苗的实际效果可能更显著。这种协同作用或将彻底改变肿瘤治疗格局，为个性化癌症治疗提供全新工具，更有望扩大免疫疗法的受益患者群体。这不仅是mRNA技术在抗癌领域的重大突破，更给无数与癌症抗争的患者带来了新的生机与希望！ ▲截图源自“foxnews” mRNA疫苗与免疫疗法协同抗癌，肺癌、黑色素瘤生存率大幅提升超23% mRNA疫苗具有强大的免疫激活能力，在临床前模型中，研究人员发现其作用机制类似“警报器”，可使人体免疫系统处于高度戒备状态，进而识别并攻击癌细胞。面对免疫系统的攻击，癌细胞会生成免疫检查点蛋白PD-L1作为防御机制，以此对抗免疫细胞。而专门设计的免疫检查点抑制剂能阻断PD-L1，恰好为免疫系统释放抗癌能力创造了理想环境。这些临床前观察结果已在后续临床研究中得到证实。文章开篇福克斯报道的这项III期临床试验，涵盖多种癌症类型的多个队列，重点评估免疫治疗开始后100天内接种mRNA疫苗的患者情况。结果显示如下： 1、晚期非小细胞肺癌队列：180例接种疫苗患者的中位生存期（OS）为37.33个月，704例未接种患者为20.6个月；3年总生存（OS）率分别为55.7% vs 30.8%（HR=0.51，95%CI=0.37–0.71，P<0.0001，详见下图a）。 ▲图源“Nature”，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、转移性黑色素瘤队列：167例未接种患者的中位生存期为26.67个月，43例接种患者的中位生存期尚未达到，显示出生存期显著改善；36个月OS率分别为44.1% vs 67.6%（HR=0.37，95%CI=0.18–0.74，P=0.0048，详见下图d）。 ▲图源“Nature”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除中国患者如何寻求癌症疫苗帮助？目前，癌症疫苗中临床疗效及预防复发效果较突出的是树突状细胞疫苗、mRNA癌症疫苗、古巴肺癌疫、个性化新抗原疫苗等。 1、mRNA癌症疫苗：正在针对肺鳞癌、肝癌、结直肠癌、黑色素瘤、食道癌、三阴性乳腺癌、头颈部肿瘤等多款恶性实体瘤，开展临床研究。 2、树突状细胞（DC）疫苗：在日本、德国等，用于临床辅助治疗多种癌症，包括皮肤癌、肝癌、肺癌、肾癌、乳腺癌等，是癌症患者的新希望！ 3、古巴肺癌疫苗（CIMAvax-EGF）：中国患者现无需出国，可通过全球肿瘤医生网医学部，向古巴医疗部门申请肺癌疫苗，以延长生存期，提高生活质量！想寻求国内外癌症疫苗或其他治疗新技术帮助的患者，可先将治疗经历、病理报告、出院小结等资料，提交到全球肿瘤医生网医学部（400-666-7998），进行初步评估或了解详细的入排标准。 Vx-001癌症疫苗精准靶向TERT，让晚期肺癌患者中位生存期提升近8个月 Vx-001是一款以TERT（端粒酶逆转录酶）抗原为靶点的治疗性癌症疫苗。一项随机双盲IIb期临床试验（NCT01935154），专门评估了该疫苗作为维持治疗，对一线铂类化疗后未出现疾病进展的晚期非小细胞肺癌患者的疗效。该研究共纳入221例符合上述条件的患者，随机分为两组：101例进入安慰剂组，89例进入Vx-001治疗组。结果显示：疫苗诱导的免疫反应与临床结局呈强相关性，在29%产生Vx-001特异性免疫反应的患者中，总生存期（OS）显著更长，中位OS分别为21.3个月（免疫应答者）vs13.4个月（无免疫应答者）（p=0.004）。尤其在从不吸烟且无天然免疫力的患者中，Vx-001治疗带来的OS获益更显著，中位OS分别为8.6个月（安慰剂组）vs16.2个月（Vx-001组）（p=0.0008）。综上，Vx-001的疗效具有明确的人群特异性，尤其对无天然免疫力的患者可能有效，其中从不吸烟及短期吸烟的患者获益最为突出。好消息是，目前这款疫苗已启动临床招募。阅读原文了解详情：【mRNA癌症疫苗免费招募】Vx-001注射液终于启动临床啦！现正急招肺癌/实体瘤患者！ ▲截图源自“ESMO” “侦察兵”WT1-DC疫苗精准狙击胰腺癌，七成患者肿瘤缓解，中位生存期突破3.5年胰腺导管腺癌（PDAC）因恶性程度高、常规治疗耐药性强，一直是癌症治疗的难点。研究发现，转录因子WT1在PDAC肿瘤细胞中广泛表达，堪称癌基因的“助推器”，可驱动肿瘤侵袭转移，是极具潜力的治疗靶点。而树突状细胞（DC）作为免疫系统的“侦察兵”，在启动肿瘤抗原特异性免疫反应中起关键作用。基于此，科研团队研发出新型WT1肽脉冲树突状细胞（WT1-DC）疫苗，相关成果已发表于《癌症免疫治疗杂志》。该研究共纳入10例不可切除PDAC患者，包括6例局部晚期（III期）、3例转移性及1例术后复发患者。所有患者先接受白蛋白结合型紫杉醇联合吉西他滨治疗，随后回输WT1-DC疫苗。结果显示：9例患者的中位无进展生存期（PFS）达2.23年（详见下图A），中位总生存期（OS）达3.52年（详见下图B）。经CE-CT评估，所有患者肿瘤负荷均有下降（降幅0.0%~57.4%），其中7例（6例局部晚期+1例转移性）达到部分缓解（PR），3例实现病情长期稳定。 ▲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，在4例接受R0切除的局部晚期患者中，3例持续呈现WT1-DTH阳性，且自治疗开始均存活超4.5年。下图展示了1例代表性PDAC患者经WT1-DC疫苗治疗前后的影像对比。 ▲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 BNT122个体化mRNA疫苗暴击肠癌/肾癌等多类实体瘤，超3年生存+缩瘤10倍！ BNT122（商品名Cevumeran，代号RO7198457）是一款创新型个体化新抗原mRNA疫苗，基于患者肿瘤体细胞突变数据定制设计，可编码20余种肿瘤特异性新抗原，刺激机体产生针对这些新抗原的T细胞免疫反应，进而降低肿瘤复发风险、延长患者生存期。临床研究表明，该疫苗对乳腺癌、黑色素瘤、肾细胞癌、尿路上皮癌、非小细胞肺癌、直肠癌等多种实体瘤均展现出治疗潜力。全球顶尖期刊《Nature Medicine》近期公布了BNT122治疗晚期实体瘤的1期GO39733临床试验（NCT03289962）的振奋数据。值得一提的是，两例突破性临床案例展现出尤为显著的治疗潜力：其中一例38号肾癌患者，入组前已接受4线治疗（含纳武单抗），初期病情进展后，经BNT122治疗实现部分缓解（PR），胸膜靶病灶最长直径总和从基线108mm缩小至10mm，肿瘤显著缩小近10倍（退缩幅度达90%）。 ▲图源“nature”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除另一例为微卫星稳定（MSS）、PD-L1低表达的21号直肠癌患者，二线治疗后肺部仍有1.1cm病灶。接受9剂BNT122联合阿替利珠单抗治疗后，肿瘤达到完全缓解（CR），且缓解持续8.2个月；截至数据统计时，该患者已存活超3年（40.7个月）（详见下图）。 ▲图源“nature”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除小编寄语作为新型抗癌疗法的代表，癌症疫苗历经数十载发展，已从早期基础研究逐步迈向临床试验阶段，更已有古巴肺癌疫苗等正式获批产品问世——其将患者5年生存率从0提升至23%，尽显临床价值。而我国在癌症疫苗领域同样成果频出，多款候选疫苗处于火热研发阶段。以针对肝细胞癌的LK101为例，其首次人体临床研究（NCT03674073）中，12名入组患者生存期均超过4年！种种进展无不表明，癌症疫苗已离我们越来越近，“打一针唤醒免疫系统，重新识别并杀伤癌细胞”的设想，或将很快从愿景变为现实，而非遥不可及的天方夜谭！更振奋人心的是，我国目前已有多款癌症疫苗临床试验陆续开展，且正式启动患者招募。有意向参与的癌友，可将治疗经历、近期病理检查结果等，提交至全球肿瘤医生网医学部（400-666-7998），了解详细入排标准并进行初步评估。参考资料 [1]Grippin A J,et al.SARS-CoV-2 mRNA vaccines sensitize tumours to immune checkpoint blockade[J]. Nature, 2025: 1-10. https://www.nature.com/articles/s41586-025-09655-y [2]Gridelli C,et al. Randomized double blind phase IIb trial in advanced NSCLC patients who did not progress after first line platinum based chemotherapy: Vx-001, a therapeutic cancer vaccine, vs placebo as maintenance therapy[J]. Annals of Oncology, 2017, 28: v638. https://www.annalsofoncology.org/article/S0923-7534(20)39155-9/fulltext [3]Koido S,et al.Dendritic cells pulsed with multifunctional Wilms' tumor 1 (WT1) peptides combined with multiagent chemotherapy modulate the tumor microenvironment and enable conversion surgery in pancreatic cancer. J Immunother Cancer. 2024 Oct 8;12(10):e009765. https://jitc.bmj.com/content/12/10/e009765.long [4]Lopez J,et al.Autogene cevumeran with or without atezolizumab in advanced solid tumors: a phase 1 trial[J]. Nature Medicine, 2025: 1-13. https://www.nature.com/articles/s41591-024-03334-7 [5]https://www.foxnews.com/health/cancer-survival-appears-double-common-vaccine-researchers-say 本文为全球肿瘤医生网原创，未经授权严禁转载扫描添加病友群抗癌资讯｜新技术｜新药研发｜权威专家入群免费领取抗癌资料患者关心

疫苗信使RNA免疫疗法临床结果临床3期

100 项与 STEMVAC(EpiThany) 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
转移性三阴性乳腺癌	临床2期	美国	University of Washington	2025-12-01
PD-L1阴性三阴性乳腺癌	临床2期	美国	University of Washington	2025-12-01
HER2 阴性乳腺癌	临床2期	美国	University of Washington	2025-11-24
HR阳性乳腺腺癌	临床2期	美国	University of Washington	2025-11-24
HR阳性乳腺癌	临床2期	美国	University of Washington	2025-11-24
HR阳性/HER2阴性乳腺癌	临床2期	美国	University of Washington	2025-11-24
乳腺癌	临床1期	美国	EpiThany, Inc.	2022-08-18

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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


NCT02157051 (SITC2022) 人工标引	临床1期	晚期乳腺癌	-	STEMVAC 150mcg/300mcg/600mcg	壓餘壓淵壓餘範遞窪鏇(廠齋觸鹽艱願範窪餘膚) = 簾膚憲壓鏇簾膚膚範顧艱壓淵艱鹽觸範鹽壓獵 (鑰獵壓築簾積鹹衊壓艱 ) 更多	积极	2022-11-01