Phase I, Open-label, Single-center Proof of Concept Study Designed to Test the Safety and Tolerability of PGV001-based Personalized Multi-peptide Vaccines in Combination With CDX-301 in Subjects With a History of Prostate Cancer, in the Adjuvant Setting

This proof of concept study is designed to test the safety and tolerability of PGV001-based personalized multi-peptide vaccines in combination with CDX-301 in subjects with a history of aggressive prostate cancer, in the tumor free adjuvant setting.

开始日期2022-01-05

申办/合作机构

Icahn School of Medicine at Mount Sinai

NCT03359239

/ Completed临床1期IIT

Pilot Study of Atezolizumab Plus PGV001, a Multipeptide Personalized Neoantigen Vaccine, in Patients With Locally Advanced or Metad or Metastatic Urothelial Cancer

The purpose of this study is to determine the good and bad effects of atezolizumab given in combination with a personalized cancer vaccine in patients with urothelial cancer either after surgery to remove organ where the tumor arose (for example, removal of the bladder) or for urothelial cancer that has spread to other organs.

开始日期2019-05-08

申办/合作机构

Icahn School of Medicine at Mount Sinai

[+1]

NCT02721043

/ Completed临床1期IIT

Study Of Pgv001 A Multi-Peptide Therapeutic Vaccine Platform For Use In The Treatment Of Malignancies In The Adjuvant Setting

The purpose of this study is to test the safety, tolerability, and immunogenicity of Personalized Genomic Vaccine 001 (PGV001) in subjects with advanced non-hematologic malignancies. PGV001 is a peptide vaccine that is based on a patient's own tumor sequence. Each patient's tumor is sequenced and peptides that correspond to the tumors are made. These peptides combined with the adjuvant Poly-ICLC (Hiltonol®, Oncovir) make PGV001. The adjuvant Poly-ICLC is added to boost the immune response to the peptides and together will expand immune cells to target cancer.

开始日期2016-04-01

申办/合作机构

Icahn School of Medicine at Mount Sinai

100 项与 PGV-001 相关的临床结果

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100 项与 PGV-001 相关的转化医学

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100 项与 PGV-001 相关的专利（医药）

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项与 PGV-001 相关的文献（医药）

2025-05-02·Cancer Discovery

PGV001, a Multi-Peptide Personalized Neoantigen Vaccine Platform: Phase I Study in Patients with Solid and Hematologic Malignancies in the Adjuvant Setting

Article

作者: Wolf, Andrea ; Hammerbacher, Jeff ; Irie, Hanna Y. ; Friedlander, Philip ; Brody, Rachel ; Posner, Marshall R. ; Sabado, Rachel Lubong ; Kodysh, Julia ; Rubinsteyn, Alexander ; Tiersten, Amy ; Bicak, Mesude ; Mandeli, John ; Gimenez, Gustavo ; Acuna-Villaorduna, Ana ; Blasquez, Ana ; Onkar, Sayali ; Salazar, Andres M. ; Saxena, Mansi ; Cimen Bozkus, Cansu ; Meseck, Marcia ; Marron, Thomas U. ; Guo, Ruiwei ; O’Donnell, Timothy J. ; Gnjatic, Sacha ; Sebra, Robert P. ; Kaminska, Anna ; Tuballes, Kevin ; Misiukiewicz, Krzysztof J. ; Parekh, Samir ; Galsky, Matthew D. ; Miles, Brett A. ; Delbeau-Zagelbaum, Daniela ; Finnigan, John P. ; Bhardwaj, Nina ; Rodriguez, Denise ; Doroshow, Deborah B. ; Schadt, Eric

Abstract:

Immunotherapies like immune checkpoint inhibitors (ICI) have changed the standard of care for patients with cancer, often leading to durable responses. However, many patients remain or become refractory to ICIs owing to factors such as a lack of primed neoantigen-reactive T cells. We developed a peptide-based vaccination platform that utilizes fully personalized genome vaccines (PGV) and targets neoantigens predicted by our OpenVax computational pipeline. In this study, we report results from the PGV001 study (NCT02721043) targeting up to 10 neoantigens, administered in the adjuvant setting to patients with both solid and hematologic malignancies who have high risk of recurrence. Our data indicate that PGV001 is feasible and safe, with 13 of 14 enrolled patients receiving the vaccine and 11 completing the treatment. 100% of vaccinated patients developed targeted T-cell and B-cell responses, highlighting the capacity of OpenVax to predict immunogenic neoantigens and the potential of PGV001 for safely inducing targeted immunity.

Significance::

The PGV001 platform is feasible, safe, and immunogenic. The OpenVax pipeline predicted immunogenic neoantigens in tumors with wide-ranging mutational burdens. Data from this study prompted three additional PGV001 trials, one in newly diagnosed glioblastoma, one in urothelial cancer in combination with an ICI, and another in prostate cancer.

2024-10-10·Advanced Pharmaceutical Bulletin

PGV-1 Causes Disarrangement of Spindle Microtubule Organization Resulting in Aberrant Mitosis in HLF and HuH6 Cells Associated with Altered MYCN Status

Article

作者: Utomo, Rohmad Yudi ; Hapsari, Novia Permata ; Nugraheni, Nadzifa ; Suenaga, Yusuke ; Hippo, Yoshitaka ; Zulfin, Ummi Maryam ; Lestari, Beni ; Meiyanto, Edy ; Ikawati, Muthi

Purpose: The HLF and HuH-6 cell lines represent hepatocellular carcinoma (HCC) with different characteristics in chromosome content that may give different drug responses. Here, PGV-1 was intended to challenge the growth-suppressing effect on HLF and HuH-6 and trace the molecular target mechanism of action compared to sorafenib. Methods: We applied MTT cytotoxic assay, colony forming assay, flow cytometry analysis, immunofluorescence assay and western blot assay. Results: PGV-1 exhibited cytotoxic effects on HLF and HuH-6 with IC-50 values of 1 µM and 2 µM, respectively, whereas sorafenib showed less cytotoxicity with IC-50 values of 5 µM and 8 µM respectively. PGV-1 suppressed the cell growth permanently but not for sorafenib. Sorafenib did not change the cell cycle profiles on both cells, but PGV-1 arrested the cells at G2/M with the characteristic of senescent cells and mitotic disarrangement. PGV-1 and sorafenib showed the same effect in downregulating p-EGFR, indicating that both compounds have the same target on EGFR activation or as Tyrosine kinase inhibitors. PGV-1 suppressed the MYCN expression in HuH-6 and HLF cells but stabilized cMYC-T58 indicating that even though the MYCN was downregulated, the cells maintained the active form of cMYC. In this regard, PGV-1 also stabilized the expression of PLK-1 and AurA. Conclusion: PGV-1 elicits stronger cytotoxic properties compared to sorafenib. The lower the MYCN expression, the higher the cytotoxic effect of PGV-1. PGV-1 abrogates cell cycle progression of both cells in mitosis through EGFR inhibition and stabilizes PLK-1 and AurA in correlation with the suppression of MYCN expression.

2024-01-01·Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society

Pentagamavunone-1 inhibits aggressive breast cancer cell proliferation through mitotic catastrophe and ROS-mediated activities: in vitro and in vivo studies

Article

作者: Kato, Jun-Ya ; Nakamae, Ikuko ; Novitasari, Dhania ; Meiyanto, Edy ; Istighfari Jenie, Riris ; Yoneda-Kato, Noriko

Pentagamavunone-1 (PGV-1), an analog of curcumin, has been studied for its cytotoxic effects in 4T1, MCF7, MCF7/HER2, and T47D breast cancer cells. Its antiproliferative effect is partly mediated through G2/M arrest; however, its molecular mechanism during cell cycle progression remains unknown. In this study, we aimed to determine whether PGV-1 has any anticancer effects on highly aggressive breast cancer cells, with a focus on cell cycle regulatory activity, reactive oxygen species (ROS) generation, and their mediated effects on cancer cells. MDA-MB-231 (triple-negative) and HCC1954 (overexpressed HER2) immortalized human breast cancer cells were used in the study. PGV-1 exhibited cytotoxic activity with an irreversible antiproliferative impact on treated cells and had good selectivity when tested in fibroblast cells. Oral PGV-1 administration suppressed tumor growth in a cell-derived xenograft mouse model. PGV-1 induced the phosphorylation of Aurora A kinase and PLK1 in MDA-MB-231 cells, while PLK1 and cyclin B1 phosphorylation were enhanced in the PGV-1-treated HCC1954 cells during prometaphase arrest. Intracellular ROS production was substantially higher upon PGV-1 treatment following mitotic arrest, and this activity caused impairment of mitochondrial respiration, induced senescence, and subsequently triggered early-to-late apoptosis. Collectively, these results suggest that the molecular mechanism of PGV-1 involves the regulation of mitotic kinases to cause cell cycle arrest and the enhancement of ROS production to impair mitochondrial activity and induce cellular senescence. The therapeutic activities demonstrated by PGV-1 in this study show its potential as an appealing candidate for chemotherapy in breast cancer treatment.

项与 PGV-001 相关的新闻（医药）

2025-04-09

·癌度

《癌度早报2025年4月9日》

癌度临床试验病友交流群（点击）一、新药快讯1、癌症疫苗PGV001在肺癌、乳腺癌等5种癌症起效根据一项一期临床试验结果，美国癌症治疗疫苗PGV001在在非小细胞肺癌、头颈癌、尿路上皮癌、乳腺癌和多发性骨髓瘤患者中引发了强烈的免疫反应，并且耐受性良好。13名患者入组用药，五年后的随访结果显示，13名患者中有6人仍存活，其中3人肿瘤完全消失且未复发，初步显示出PGV001疫苗可能具备持久的临床益处。2、日本批准抗体偶联药替索单抗治疗宫颈癌日本厚生劳动省近日批准了抗体偶联药替索单抗上市，用于治疗在化疗后病情仍出现进展的晚期或复发性宫颈癌患者。该药也是日本目前仅有的获批治疗宫颈癌的抗体偶联药物。基于一项三期临床试验结果，对照组化疗的中位总生存时间是9.5个月，替索单抗的中位总生存时间是11.5个月，相比化疗该药将患者死亡风险降低了30%。3、前沿抗癌药SNS-101治疗PD-L1耐药肿瘤产生积极疗效近日，美国前沿抗癌药Solnerstotug（代号SNS-101）单独使用或联合PD-L1抑制剂西米普利单抗，在PD-L1抑制剂耐药的肿瘤产生积极疗效，SNS-101诱导的治疗应答率为14%，受益的肿瘤类型包括默克尔细胞癌、结直肠癌等多种实体瘤类型。二、抗癌前沿1、难治性肺癌疾病控制率接近100%，免疫双抗药BNT327公布研究结果欧洲肺癌大会上，一款在研的双抗药BNT327又名PM8002公布了研究结果，该药与化疗联合使用，一线治疗广泛期小细胞肺癌的二期临床试验结果表明，可以达到97.9%的疾病控制率和85.4%的客观缓解率。BNT327是一款靶向PD-L1和VEGF-A的双特异性抗体，该药的临床试验中位无进展生存时间为6.9个月，中位总生存时间尚未达到。72.7%的患者存活超过1年。

临床2期临床3期上市批准疫苗

2025-03-31

·癌度

PD-1和化疗都无效了，适用于驱动基因阴性肺癌的AL2846联合TQB2450来了，确证有效！

癌度医学临床招募资讯微信群（点击）肺癌是我们国家发病率和死亡率非常高的恶性肿瘤，肺癌分为小细胞肺癌和非小细胞肺癌两种亚型，其中非小细胞肺癌占肺癌的85%左右。非小细胞肺癌又会分为肺腺癌、肺鳞癌、大细胞肺癌等等。根据目前的数据统计，非小细胞肺腺癌经过基因检测有75%到80%的概率能找到靶向药，肺鳞癌则是15%左右可以找到靶向药。如果没有靶向药的治疗机会，非小细胞肺癌患者的一线标准治疗就是化疗联合PD-1抑制剂治疗，根据PD-L1表达情况可以选择是否免于化疗，如果PD-L1表达低于50%则需要联合化疗。但是任何的治疗都是存在耐药的问题，如果没有靶向药治疗机会的非小细胞肺癌PD-1和化疗都用过了，后面怎么治疗呢？其实现如今的办法是比较少的，今天癌度给大家介绍一项国内三期临床试验，试验组用药为AL2846和TQB2450。1、AL2846和TQB2450都是什么药物？由于药物没有批准上市，所以只能以代号的形式表达。AL2846胶囊一款多靶点的酪氨酸激酶受体抑制剂，在分子水平对c-MET、c-KIT、VEGFR1和RET均具有明显的抑制作用，对KDR、PDGFRβ、VEGFR3也有抑制活性，作用机制和强度与卡博替尼相当（卡博替尼是一款大家很熟悉的靶向药）。TQB2450则是一款人源化PD-L1单克隆抗体，可阻止PD-L1与免疫T细胞表面的PD-1和B7.1受体结合，使免疫T细胞恢复杀肿瘤细胞的活性，从而增强免疫应答。早期多项探索临床数据证明TQB2450注射液联合盐酸安罗替尼胶囊在多个瘤种（如非小细胞肺癌、软组织肉瘤、肾细胞癌、子宫内膜癌、卵巢癌、肝细胞癌、胆管癌等）起到协同增效作用。这两款药治疗肝细胞癌等恶性肿瘤的结果已经刊登在国际学术期刊。AL2846联合TQB2450治疗食管癌和肝癌的研究报道2、双药二线治疗非小细胞肺癌有效吗？由于癌度给大家介绍的临床试验是针对非小细胞肺癌，所以我们做了文献调研，AL2846联合TQB2450治疗非小细胞肺癌是有研究数据报道的。相应的临床试验入组的非小细胞肺癌都是经过了PD-1抑制剂/PD-L1抑制剂单药、或者是与铂类化疗联合治疗后病情进展（患者之前系统治疗的线数为1到3），也就是这两个药物的治疗是属于二线以后。截止到2024年1月31日，44名患者入组用药治疗，39名患者可评估治疗效果，初步的结果表明，25.6%的患者可评估肿瘤病灶缩小超过30%以上（治疗应答率），中位无进展生存时间为5.72个月，疾病控制率达到了94.9%，中位缓解持续时间达到了5.54个月。临床研究结果数据发布在国际学术期刊。AL2846联合TQB2450治疗非小细胞肺癌研究报道3、要不要参加临床试验？目前，AL2846联合TQB2450治疗非小细胞肺癌的三期临床试验正在开展，由于这两个药物都是非化疗药物，所以如果患者筛选入组后，后面不能从这两个药物获益还能去使用临床的标准二线治疗药物，相当于手里多了一副牌，所以从这个层面理解这两个药物联合治疗的临床试验是值得去申请的。下面是简单的入排标准，更为详细的入组要求欢迎联系癌度咨询！病理诊断为非小细胞肺癌，排除：EGFR突变、ALK融合、ROS1融合等有意义的驱动基因突变(鳞癌无需检测基因突变）；经过一种以上系统治疗后病情进展，最多不能超过二种系统治疗后进展。之前接受过含铂化疗和免疫检查点抑制剂治疗，既往治疗仅接受过一种抗PD-1 (L1)抗体（可靶向PD-1/(L1)的双特异性抗体视为一种抗PD-1/(L1)抗体)）治疗。有可测量肿瘤病灶，直径大于1厘米。患者之前没有使用过多西他赛或卡博替尼，也没有使用过安罗替尼等多靶点抗血管生成靶向药。这项临床试验的对照组是临床的标准二线治疗方案多西他赛，患者入组以后不管是用药组还是对照组都是免费的，非常值得大家考虑，肿瘤用药基因检测、临床试验免费用药大家可以关注并联系咨询癌度。参考文献：D. Huang, et al., P4.11E.03 Safety and Efficacy of AL2846 Combined with TQB2450 In NSCLC Patients with Previous PD-(L)1 Inhibitor Treated (NCT06116240), Journal of Thoracic Oncology, 2024. 往期推荐癌症治疗疫苗系列：树突状细胞疫苗治疗乳腺癌，部分患者病灶完全消失！大长见识，EGFR基因黄金突变19号外显子缺失分4类，用靶向药的总生存时间相差3倍！总生存时间翻倍了，西米普利单抗治疗PD-L1高表达肺癌，几乎所有指标翻倍了！癌症治疗疫苗PGV001人体临床试验，50%的患者活过5年，25%的患者体内无病灶！

临床3期免疫疗法临床结果

2025-03-28

·癌度

癌症治疗疫苗系列：树突状细胞疫苗治疗乳腺癌，部分患者病灶完全消失！

癌度医学临床招募资讯微信群（点击）之前的研究表明，随着乳腺癌从原位癌向转移性晚期癌症转变，关键的基因和肿瘤对免疫系统抑制的增加是起到关键作用，也就是说如果人体免疫系统工作比较好，那么其实癌细胞不应该很容易就扩散和转移。如果对肿瘤病灶穿刺的样本进行分析，以肿瘤病灶里面是否有人体免疫细胞的浸润为判断标准，如果没有免疫细胞浸润的肿瘤属于“冷”肿瘤，这部分患者的预后不是很好。而如果存在免疫细胞浸润的肿瘤患者预后则会好一些。其实肿瘤浸润淋巴细胞治疗（TILS）的原理就是将肿瘤病灶里的浸润免疫细胞提取出来，在体外扩增再次回输，这解决了体外扩增的免疫细胞不能识别肿瘤细胞的难题。1、树突状细胞疫苗的原理和疗效树突状细胞（DC细胞）是人体免疫系统抗原呈递细胞，在启动和调节免疫反应中起到了关键作用。比如癌细胞崩裂向人体的血液里释放了细胞碎片，这些碎片就被树突状细胞抓住并悬挂起来（呈递），另外的人体免疫细胞则进行辨别和启动后续反应，专门针对这些特别的癌细胞抗原进行杀灭，也就是携带这些抗原的癌细胞就能被识别出来并杀死了。之前的研究表明，通过将患者体内的树突状细胞和针对HER2的小片段一起进行体外刺激，从而产生针对HER2的癌症治疗疫苗，HER2是乳腺癌比较常见的突变基因，部分乳腺癌患者HER2蛋白是高表达的。为此有了这么一项人体临床试验，针对二期、三期激素受体阴性HER2阳性乳腺癌进行标准新辅助治疗之前使用这种疫苗，以判断能不能提高治疗效果。本文参考文献刊例示意图这是一项在美国莫菲特癌症中心开展的研究，从2018年6月到2023年2月期间，一共31名患者接受了治疗。入组的患者共分为3组，截止到2023年11月中位随访时间为32.8个月。2名患者脑部出现进展而去世，总体无病生存率和总生存率达到了93.3%。接种疫苗的患者具有显著的免疫活性，在相当一部分病例中观察到肿瘤完全消失。莫菲特乳腺肿瘤科医学肿瘤学家、该研究的主要作者Hatem Soliman医学博士感慨：“这种方法可能为增强乳腺癌治疗和患者预后提供一种新方法。”参加临床试验患者的分子检测2、给到我们的启发癌度之前有多篇关于癌症治疗疫苗的文章，大多数是基于基因序列的癌症治疗疫苗，比如mRNA疫苗等等，树突状细胞疫苗则是第一次为大家介绍，而且这款疫苗是在HRE2阳性激素受体阴性乳腺癌手术之前、化疗之前使用。目前的数据看效果相当不错。除去脑进展的患者之外其他的患者都在近3年内没有复发。希望这篇内容给到部分患者一些参考，尤其是在能手术之前的患者可以去尝试参加一些临床试验，而不是着急立即切除。也许手术之前使用一些疫苗、免疫治疗将肿瘤病灶缩小或打压一下，则可能真是达到了治愈，而不是简单地将病灶切除，但是留下来部分残留癌细胞，后面复发之后变成了晚期肿瘤，导致治疗被动和生存时间受限。肿瘤诊断和治疗相关问题欢迎大家加入癌度病友群交流！参考文献：Hatem Soliman, et al., A pilot study incorporating HER2-directed dendritic cells into neoadjuvant therapy of early stage HER2+ER- breast cancer, npj Breast Cancer, (2025)11:29. 往期推荐大长见识，EGFR基因黄金突变19号外显子缺失分4类，用靶向药的总生存时间相差3倍！总生存时间翻倍了，西米普利单抗治疗PD-L1高表达肺癌，几乎所有指标翻倍了！癌症治疗疫苗PGV001人体临床试验，50%的患者活过5年，25%的患者体内无病灶！变天了？肺癌EGFR基因四代药组合比奥希替尼延长病人50%的无进展生存期，降低35%死亡风险！

疫苗信使RNA临床结果临床2期细胞疗法

100 项与 PGV-001 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
前列腺腺癌	临床1期	美国	Icahn School of Medicine at Mount Sinai	2022-01-05
遗传性前列腺癌7型	临床1期	美国	Icahn School of Medicine at Mount Sinai	2022-01-05
膀胱癌	临床1期	美国	Genentech, Inc.	2019-05-08
局部晚期尿路上皮癌	临床1期	美国	Genentech, Inc.	2019-05-08
晚期恶性实体瘤	临床1期	美国	Icahn School of Medicine at Mount Sinai	2016-04-01
非小细胞肺癌	临床1期	美国	Icahn School of Medicine at Mount Sinai	2016-04-01
卵巢浆液性腺癌	临床1期	美国	Icahn School of Medicine at Mount Sinai	2016-04-01
肾盂和输尿管尿路上皮癌	临床1期	美国	Icahn School of Medicine at Mount Sinai	2016-04-01
口咽部鳞状细胞癌	临床1期	美国	Icahn School of Medicine at Mount Sinai	2016-04-01

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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


NCT02721043 (Pubmed \| Cancer Discov) 人工标引	临床1期	实体瘤 \| 血液肿瘤辅助	11	PGV001	憲鏇襯網願願製獵築構(構憲顧繭繭選鑰鬱顧衊) = 100% of vaccinated patients developed targeted T cell and B cell responses highlighting the capacity of OpenVax to predict immunogenic neoantigens and the potential of PGV001 for safely inducing targeted immunity. 構醖築選餘遞簾窪齋構 (製壓齋製鏇醖範範製構 )	积极	2025-03-17
NCT03359239 (AACR2024) 人工标引	临床1期	尿路上皮癌辅助 PD-L1	9	Atezolizumab plPGV-001001	壓鏇鬱網願襯獵廠鬱憲(鏇繭糧鹽齋蓋醖齋簾築) = 憲齋齋襯壓襯範蓋築簾醖艱鏇願艱遞簾鏇齋壓 (壓築餘衊壓選夢積鏇鑰 ) 更多	积极	2024-04-05
NCT02721043 (AACR2023) 人工标引	临床1期	肿瘤	13	PGV-001	網積鹹遞衊淵夢築餘蓋(夢蓋選鏇鏇廠繭鹹簾構) = reached 範選蓋遞網壓範範築鏇 (鹹醖壓廠遞鹽廠鏇繭觸 ) 达到更多	积极	2023-04-14
NCT02721043 (PGV-001, AACR2021)	临床1期	肿瘤辅助	15	PGV-001	願衊鹹鹹淵獵糧壓構積(願鑰選願觸襯廠餘憲膚) = 糧壓築膚夢襯夢顧遞襯夢築廠觸衊鹽淵蓋鏇夢 (築顧衊鹽築鏇壓鬱構蓋 ) 更多	-	2021-07-01
NCT02721043 (PGV001, SITC2018)	临床1期	实体瘤 \| 血液肿瘤辅助 HLA profile	5	multi-peptide personalized genomic vaccine (PGV001)	鹹憲鬱築鑰衊選齋顧蓋(顧艱艱積鏇獵繭齋憲淵) = 壓艱艱膚顧餘範憲築窪艱積獵觸製膚簾窪獵襯 (繭鏇醖淵構積餘積鑰積 ) 更多	积极	2018-11-06