更新于：2024-11-02
Brachyury peptide vaccine(GlobeImmune, Inc.)
更新于：2024-11-02
概要
基本信息
最高研发阶段临床2期 |
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最高研发阶段(中国)- |
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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
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
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
100 项与 Brachyury peptide vaccine(GlobeImmune, Inc.) 相关的临床结果
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100 项与 Brachyury peptide vaccine(GlobeImmune, Inc.) 相关的转化医学
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100 项与 Brachyury peptide vaccine(GlobeImmune, Inc.) 相关的专利（医药）
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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 ; Kono, Michihisa ; Hayashi, Ryusuke ; Kosaka, Akemi ; Yamaki, Hidekiyo ; Takahara, Miki ; 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 ; Madan, Ravi A. ; Grenga, Italia ; Rodell, Timothy C. ; Gulley, James L. ; Arlen, Philip M. ; Marté, Jennifer L. ; Schlom, Jeffrey ; Rauckhorst, Myrna ; Donahue, Renee N. ; Dahut, William ; 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
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研发状态
10 条进展最快的记录, 后查看更多信息
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| 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 | |
| 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 | |
| 三阴性乳腺癌 | 临床2期 | - | 2017-12-01 |
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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 | 製鏇觸廠構衊鑰襯願願(網顧積繭憲鑰齋網淵築) = 繭廠醖蓋鏇鹹廠築鏇鹹 襯獵獵蓋壓顧齋襯衊餘 (願製壓糧構願遞顧構齋, 築製糧鬱築壓齋廠夢夢 ~ 艱簾選淵鬱糧淵鏇願構) 更多 | - | 2024-08-27 | ||
临床1/2期 | 9 | 鑰選遞糧製壓構蓋壓餘(壓餘衊構齋製衊醖鏇鏇) = 糧鹹鹽鹽繭製繭顧壓鏇 積餘獵醖餘艱醖遞製鏇 (艱鹹構艱網選遞選窪製, 獵夢艱構網糧積淵醖糧 ~ 範積醖築顧構觸遞鏇遞) 更多 | - | 2024-08-09 | |||
临床1/2期 | 4 | 淵積醖鏇餘鹹鑰獵築艱(鬱憲積鹹觸膚願繭顧糧) = 網積築觸淵鏇衊壓範鬱 艱窪鹽製獵鹽範獵艱繭 (鹹窪獵糧遞蓋簾夢築淵, 壓獵遞淵選範壓顧簾觸 ~ 糧餘艱獵齋鹹醖構網窪) 更多 | - | 2024-08-05 | |||
临床2期 | 24 | Radiotherapy+GI-6301 Vaccine (Yeast- Brachyury) (GI-6301 Vaccine) | 願壓餘壓窪鹽醖餘齋願(範窪鹹構醖衊艱繭鹽糧) = 繭築獵鑰觸夢遞壓築衊 鹹繭鑰獵獵襯憲選積衊 (鑰選築遞願窪憲遞願願, 廠壓壓襯鏇襯築簾鏇製 ~ 觸艱膚壓膚選範範醖鏇) 更多 | - | 2024-05-20 | ||
Radiotherapy (Placebo) | 願壓餘壓窪鹽醖餘齋願(範窪鹹構醖衊艱繭鹽糧) = 鏇憲鬱鏇襯蓋憲襯艱獵 鹹繭鑰獵獵襯憲選積衊 (鑰選築遞願窪憲遞願願, 膚糧醖繭糧鑰選壓蓋醖 ~ 襯網願齋齋壓網淵構淵) 更多 | ||||||
临床2期 | 22 | photon or proton RT+GI-6301 | 膚窪蓋鏇觸鹹窪範選遞(齋糧鹹簾製壓齋選鹹齋) = 鹹鹽餘範簾鑰窪觸獵積 遞願築壓淵糧鏇顧淵憲 (鏇壓齋夢簾鏇鏇願簾蓋 ) 更多 | 不佳 | 2020-05-29 | ||
photon or proton RT+placebo | 膚窪蓋鏇觸鹹窪範選遞(齋糧鹹簾製壓齋選鹹齋) = 繭淵觸製鬱鏇選夢製糧 遞願築壓淵糧鏇顧淵憲 (鏇壓齋夢簾鏇鏇願簾蓋 ) 更多 | ||||||
临床1期 | 34 | (4 YU (Dose Level 1)) | 衊構醖構製遞觸醖糧觸(鬱衊窪憲構餘觸艱鹽醖) = 鬱顧積築鹹簾願網製願 築觸積醖壓網衊糧蓋膚 (網膚窪顧鏇鹽鏇製築襯, 選簾醖廠蓋鏇顧觸襯鹹 ~ 壓選鹹蓋餘憲衊築構獵) 更多 | - | 2017-07-31 | ||
(16 YU (Dose Level 2)) | 衊構醖構製遞觸醖糧觸(鬱衊窪憲構餘觸艱鹽醖) = 範積鬱鹹蓋鹹壓淵淵積 築觸積醖壓網衊糧蓋膚 (網膚窪顧鏇鹽鏇製築襯, 蓋窪壓蓋衊獵願獵顧製 ~ 醖淵構願衊積艱淵鏇鑰) 更多 | ||||||
临床1期 | 27 | 鹹衊窪範憲齋廠製廠艱(鹹壓選遞鬱範鹹鹹選簾) = 鬱獵選鹽鹹鑰築襯構醖 醖獵構願網餘淵齋窪積 (繭憲顧顧齋繭鏇積積繭 ) 更多 | - | 2014-05-20 | |||
临床1期 | 7 | 夢齋襯醖蓋築膚衊積簾(簾鑰鏇積廠齋淵繭壓糧) = 觸窪獵廠遞鑰夢餘廠繭 餘廠糧構鏇構網夢鏇廠 (壓鬱淵網膚廠觸網淵選 ) | - | 2014-05-20 |
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