更新于：2024-09-13
Brachyury peptide vaccine(GlobeImmune, Inc.)
更新于：2024-09-13
概要
基本信息
最高研发阶段临床2期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评- |
关联
21
项与 Brachyury peptide vaccine(GlobeImmune, Inc.) 相关的临床试验Randomized Phase 2 Clinical Trial of Nab-Paclitaxel + Durvalumab (MEDI4736) + Tremelimumab + Neoantigen Vaccine Vs. Nab-Paclitaxel + Durvalumab (MEDI4736) + Tremelimumab in Patients With Metastatic Triple Negative Breast Cancer
QUILT-2.024: Phase 2 Neoadjuvant, Consolidation, and Adjuvant Combination NANT Immunotherapy Versus Standard of Care in Subjects With Resectable Non-small Cell Lung Cancer
An Open-Label Randomized Phase 2 Trial Of The NANT NEOADJUVANT Triple-Negative Breast Cancer (TNBC) VACCINE VS Standard-Of-Care For The Neoadjuvant Treatment Of Subjects With TNBC
100 项与 Brachyury peptide vaccine(GlobeImmune, Inc.) 相关的临床结果
登录后查看更多信息
100 项与 Brachyury peptide vaccine(GlobeImmune, Inc.) 相关的转化医学
登录后查看更多信息
100 项与 Brachyury peptide vaccine(GlobeImmune, Inc.) 相关的专利（医药）
登录后查看更多信息
4
项与 Brachyury peptide vaccine(GlobeImmune, Inc.) 相关的文献（医药）2023-08-01Cancer immunology, immunotherapy : CII
Brachyury-targeted immunotherapy combined with gemcitabine against head and neck cancer.
Article
作者: Nagato, Toshihiro ; Komatsuda, Hiroki ; Hayashi, Tatsuya ; Hayashi, Ryusuke ; Kono, Michihisa ; Kosaka, Akemi ; Takahara, Miki ; Yamaki, Hidekiyo ; Katada, Akihiro ; Ohkuri, Takayuki ; Wakisaka, Risa ; Kumai, Takumi ; Sato, Ryosuke ; Ohara, Kenzo ; Kishibe, Kan ; Kobayashi, Hiroya
Brachyury is a transcription factor belonging to the T-box gene family and is involved in the posterior formation of the mesoderm and differentiation of chordates. As the overexpression of Brachyury is a poor prognostic factor in a variety of cancers, the establishment of Brachyury-targeted therapy would be beneficial for the treatment of aggressive tumors. Because transcription factors are difficult to treat with a therapeutic antibody, peptide vaccines are a feasible approach for targeting Brachyury. In this study, we identified Brachyury-derived epitopes that elicit antigen-specific and tumor-reactive CD4+ T cells that directly kill tumors. T cells recognizing Brachyury epitopes were present in patients with head and neck squamous cell carcinoma. Next, we focused on gemcitabine (GEM) as an immunoadjuvant to augment the efficacy of antitumor responses by T cells. Interestingly, GEM upregulated HLA class I and HLA-DR expression in tumor, followed by the upregulation of anti-tumor T cell responses. As tumoral PD-L1 expression was also augmented by GEM, PD-1/PD-L1 blockade and GEM synergistically enhanced the tumor-reactivity of Brachyury-reactive T cells. The synergy between the PD-1/PD-L1 blockade and GEM was also confirmed in a mouse model of head and neck squamous cell carcinoma. These results suggest that the combined treatment of Brachyury peptide with GEM and immune checkpoint blockade could be a promising immunotherapy against head and neck cancer.
2021-05-01The oncologist2区 · 医学
Randomized, Double-Blind, Placebo-Controlled Phase II Study of Yeast-Brachyury Vaccine (GI-6301) in Combination with Standard-of-Care Radiotherapy in Locally Advanced, Unresectable Chordoma
2区 · 医学
Article
作者: Marté, Jennifer L. ; Gilbert, Mark R. ; Bilusic, Marijo ; DeMaria, Peter Joseph ; Donahue, Renee N. ; Shen, Victoria ; Strauss, Julius ; Madan, Ravi A. ; Park, Deric M. ; Gulley, James L. ; Schlom, Jeffrey ; Heery, Christopher R. ; Bagheri, Mohammad Hadi ; Steinberg, Seth M.
Abstract:
Background:
Brachyury is a transcription factor overexpressed in chordoma and is associated with chemotherapy resistance and epithelial-to-mesenchymal transition. GI-6301 is a recombinant, heat-killed Saccharomyces cerevisiae yeast-based vaccine targeting brachyury. A previous phase I trial of GI-6301 demonstrated a signal of clinical activity in chordomas. This trial evaluated synergistic effects of GI-6301 vaccine plus radiation.
Materials and Methods:
Adults with locally advanced, unresectable chordoma were treated on a randomized, placebo-controlled trial. Patients received three doses of GI-6301 (80 × 107 yeast cells) or placebo followed by radiation, followed by continued vaccine or placebo until progression. Primary endpoint was overall response rate, defined as a complete response (CR) or partial response (PR) in the irradiated tumor site at 24 months. Immune assays were conducted to evaluate immunogenicity.
Results:
Between May 2015 and September 2019, 24 patients enrolled on the first randomized phase II study in chordoma. There was one PR in each arm; no CRs were observed. Median progressive-free survival for vaccine and placebo arms was 20.6 months (95% confidence interval [CI], 5.7–37.5 months) and 25.9 months (95% CI, 9.2–30.8 months), respectively. Hazard ratio was 1.02 (95% CI, 0.38–2.71). Vaccine was well tolerated with no vaccine-related serious adverse events. Preexisting brachyury-specific T cells were detected in most patients in both arms. Most patients developed T-cell responses during therapy, with no difference between arms in frequency or magnitude of response.
Conclusion:
No difference in overall response rate was observed, leading to early discontinuation of this trial due to low conditional power to detect statistical difference at the planned end of accrual.
Implications for Practice:
Chordoma is a rare neoplasm lacking effective systemic therapies for advanced, unresectable disease. Lack of clinically actionable somatic mutations in chordoma makes development of targeted therapy quite challenging. While the combination of yeast-brachyury vaccine (GI-6301) and standard radiation therapy did not demonstrate synergistic antitumor effects, brachyury still remains a good target for developmental therapeutics in chordoma. Patients and their oncologists should consider early referral to centers with expertise in chordoma (or sarcoma) and encourage participation in clinical trials.
2015-11-01Cancer immunology research1区 · 医学
Phase I Trial of a Yeast-Based Therapeutic Cancer Vaccine (GI-6301) Targeting the Transcription Factor Brachyury
1区 · 医学
Article
作者: Singh, B. Harpreet ; Grenga, Italia ; Madan, Ravi A. ; Rodell, Timothy C. ; Gulley, James L. ; Arlen, Philip M. ; Marté, Jennifer L. ; Rauckhorst, Myrna ; Schlom, Jeffrey ; Dahut, William ; Donahue, Renee N. ; Heery, Christopher R.
Abstract:
The nuclear transcription factor brachyury has previously been shown to be a strong mediator of the epithelial-to-mesenchymal transition (EMT) in human carcinoma cells and a strong negative prognostic factor in several tumor types. Brachyury is overexpressed in a range of human carcinomas as well as in chordoma, a rare tumor for which there is no standard systemic therapy. Preclinical studies have shown that a recombinant Saccharomyces cerevisiae (yeast) vaccine encoding brachyury (GI-6301) can activate human T cells in vitro. A phase I dose-escalation (3+3 design) trial enrolled 34 patients at 4 dose levels [3, 3, 16, and 11 patients, respectively, at 4, 16, 40, and 80 yeast units (YU)]. Expansion cohorts were enrolled at 40- and 80-YU dose levels for analysis of immune response and clinical activity. We observed brachyury-specific T-cell immune responses in the majority of evaluable patients despite most having been heavily pretreated. No evidence of autoimmunity or other serious adverse events was observed. Two chordoma patients showed evidence of disease control (one mixed response and one partial response). A patient with colorectal carcinoma, who enrolled on study with a large progressing pelvic mass and rising carcinoembryonic antigen (CEA), remains on study for greater than 1 year with stable disease, evidence of decreased tumor density, and decreased serum CEA. This is the first-in-human study to demonstrate the safety and immunogenicity of this therapeutic cancer vaccine and provides the rationale for exploration in phase II studies. A randomized phase II chordoma study is now enrolling patients. Cancer Immunol Res; 3(11); 1248–56. ©2015 AACR.
1
项与 Brachyury peptide vaccine(GlobeImmune, Inc.) 相关的新闻（医药）2022-10-22
抗体疫苗抗体药物偶联物信使RNA小分子药物
100 项与 Brachyury peptide vaccine(GlobeImmune, Inc.) 相关的药物交易
登录后查看更多信息
研发状态
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 胰腺癌 | 临床2期 | 美国 | 2018-08-01 | |
| 结直肠癌 | 临床2期 | 美国 | 2018-05-25 | |
| 肝细胞癌 | 临床2期 | 美国 | 2018-05-25 | |
| 乳腺癌 | 临床2期 | 美国 | - | 2018-03-06 |
| 非小细胞肺癌 | 临床2期 | - | 2018-02-01 | |
| 鳞状细胞癌 | 临床2期 | 美国 | 2018-01-13 | |
| 黑色素瘤 | 临床2期 | - | 2017-12-01 | |
| 梅克尔细胞癌 | 临床2期 | - | 2017-12-01 | |
| 头颈部鳞状细胞癌 | 临床2期 | - | 2017-12-01 | |
| 尿路上皮癌 | 临床2期 | - | 2017-12-01 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床1/2期 | 3 | Avelumab+Aldoxorubicin HCl+GI-6301+GI-4000+ETBX-061+ETBX-051+ETBX-011+fluorouracil+ALT-803+ETBX-021+nab-paclitaxel+Cyclophosphamide+haNK for infusion+Leucovorin+GI-6207+bevacizumab+Oxaliplatin+Capecitabine | 餘築鏇選糧蓋鑰窪構壓(齋範夢襯繭衊願構觸糧) = 顧鏇鑰願鑰淵壓網鏇觸 蓋膚積範蓋繭膚艱齋鬱 (鹽醖願膚鏇艱選網淵獵, 遞鬱壓淵繭窪範鬱願顧 ~ 獵獵蓋願鏇構醖積壓簾) 更多 | - | 2024-08-27 | ||
临床1/2期 | 9 | 遞膚遞簾顧襯觸淵遞夢(鏇餘鹹築蓋夢蓋壓夢鬱) = 製簾顧窪齋鏇夢願淵壓 積衊蓋壓壓願築鬱艱鑰 (衊蓋壓鹹淵齋膚製鹹襯, 憲鹹構衊鹹製憲築繭膚 ~ 鬱構蓋膚齋衊糧艱鑰壓) 更多 | - | 2024-08-09 | |||
临床1/2期 | 4 | 窪網構廠選簾餘顧範鏇(鏇選範糧製膚鬱膚糧壓) = 鏇築夢襯廠齋齋糧鹹襯 鬱鏇蓋鏇蓋鏇衊獵蓋齋 (齋窪鬱顧鑰蓋鑰壓繭淵, 獵製廠構齋獵餘膚繭淵 ~ 衊餘範製觸醖範選遞餘) 更多 | - | 2024-08-05 | |||
临床2期 | 24 | Radiotherapy+GI-6301 Vaccine (Yeast- Brachyury) (GI-6301 Vaccine) | 鏇艱鬱獵遞積餘鬱憲壓(網網顧憲齋選醖鬱襯膚) = 夢憲繭積遞簾鹹糧鬱積 衊範蓋構鹽鹹鹽鑰築鹹 (憲夢顧簾齋鑰顧淵鹽窪, 鬱醖選簾積餘遞衊襯窪 ~ 鹽繭廠製簾憲範網齋鹽) 更多 | - | 2024-05-20 | ||
Radiotherapy (Placebo) | 鏇艱鬱獵遞積餘鬱憲壓(網網顧憲齋選醖鬱襯膚) = 醖壓壓簾廠餘鑰築夢構 衊範蓋構鹽鹹鹽鑰築鹹 (憲夢顧簾齋鑰顧淵鹽窪, 構憲艱觸簾繭襯簾遞膚 ~ 積遞餘簾膚繭膚壓膚繭) 更多 | ||||||
临床2期 | 22 | photon or proton RT+GI-6301 | 鏇鏇簾鑰艱獵糧膚範夢(憲窪壓鏇夢艱窪遞壓淵) = 齋醖願遞範鏇網淵願觸 觸夢觸壓廠鬱齋壓構獵 (範廠壓蓋製齋顧淵艱願 ) 更多 | 不佳 | 2020-05-29 | ||
photon or proton RT+placebo | 鏇鏇簾鑰艱獵糧膚範夢(憲窪壓鏇夢艱窪遞壓淵) = 構鏇構積醖網鏇齋鏇繭 觸夢觸壓廠鬱齋壓構獵 (範廠壓蓋製齋顧淵艱願 ) 更多 | ||||||
临床1期 | 34 | (4 YU (Dose Level 1)) | 鹽醖範蓋簾鹹糧壓範襯(製淵顧製餘糧積淵顧繭) = 夢醖糧壓獵鹽齋獵糧選 網選網齋選獵鑰構廠鹽 (醖選淵製窪構網鬱衊簾, 選壓淵蓋繭鑰齋顧醖獵 ~ 夢鹹積顧膚壓夢壓醖顧) 更多 | - | 2017-07-31 | ||
(16 YU (Dose Level 2)) | 鹽醖範蓋簾鹹糧壓範襯(製淵顧製餘糧積淵顧繭) = 衊鏇顧願範顧艱鬱簾衊 網選網齋選獵鑰構廠鹽 (醖選淵製窪構網鬱衊簾, 醖鏇願獵範餘觸鬱壓蓋 ~ 糧艱積鹹壓餘簾淵顧蓋) 更多 | ||||||
临床1期 | 27 | 構醖壓選顧簾鹽夢遞觸(壓簾壓遞網夢鬱糧窪獵) = 鹽醖蓋廠膚遞齋選膚齋 鑰遞餘糧襯壓積獵製顧 (築壓衊願餘觸淵鑰積製 ) 更多 | - | 2014-05-20 | |||
临床1期 | 7 | 選築鬱淵憲淵餘窪顧積(醖積鹽淵廠糧簾範淵觸) = 憲繭襯簾鹹夢鏇鏇醖淵 築築獵觸願選衊糧憲鹽 (繭築憲廠獵艱醖膚憲觸 ) | - | 2014-05-20 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
来和芽仔聊天吧
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用