Prospective, Randomized, Single-Blinded, Multi-Center Phase II Trial of the HER2/neu Peptide GP2 + GM-CSF Vaccine versus GM-CSF Alone in HLA-A2+ OR the Modified HER2/neu Peptide AE37 + GM-CSF Vaccine versus GM-CSF Alone in HLA-A2- Node-Positive and High-Risk Node-Negative Breast Cancer Patients to Prevent Recurrence - BR-HER-GP2-AE37

开始日期2007-10-30

申办/合作机构

Generex Biotechnology Corp.

100 项与 GM-CSF vaccine(Aduro Biotech) 相关的临床结果

登录后查看更多信息

100 项与 GM-CSF vaccine(Aduro Biotech) 相关的转化医学

登录后查看更多信息

100 项与 GM-CSF vaccine(Aduro Biotech) 相关的专利（医药）

登录后查看更多信息

108

项与 GM-CSF vaccine(Aduro Biotech) 相关的文献（医药）

2023-04-01·Virology

Evaluation of an alternative method for determination of Protective Dose50 of Classical swine fever vaccines

Article

作者: Pachauri, Richa ; Ompreethi, B ; Singha Mahapatra, Chayna ; Dhar, Pronab ; Manu, M

Classical Swine Fever (CSF) is still one of the most economically important viral diseases of pigs. The disease is controlled by vaccination in the endemic countries. Hence, availability or supply of efficacious and potent vaccine in the field settings is of utmost importance. Currently, as per requirement of any Pharmacopoea, a CSF vaccine must contain 100 PD₅₀/dose which is determined by vaccinating pigs at 1/40^th and 1/160^th dilution of each dose followed by virulent challenge at 28 days post vaccination (dpv). Here, the control and the unprotected groups succumb to disease and need to be euthanized. Moreover, such challenge experiments are not feasible for each batch of the vaccine. In this communication, an alternate method of PD₅₀ dose calculation of live-attenuated CSF vaccines by measuring Serum Neutralizing Titre i.e Fluorescent Antibody Virus Neutralization (FAVN) titre of the vaccinated pigs at 28 dpv was established. This alternative method do not require the vaccinated pigs to be challenged. Serum samples, generated out of QC testing of eight batches of CSF vaccines in the laboratory, were tested and found that pigs having FAVN titre ≥10 were protected against challenge. Initially this test was optimized in serum samples of 12 animals and then validated with another 56 serum samples. It was found that the alternate method is 100% correlating with the challenge experiment. Thus, based on FAVN titre of the vaccinated animal serum, it can be predicted whether the pigs would or would not come through the challenge infection. Using the predicted status (protected/succumbed), PD50 can be calculated by applying Reed and Muench formula, hence alternate method can be used as routine QC test for potency of CSF vaccines. The newly developed assay was specific since no signal was observed in controls.

2023-01-01·Journal of Veterinary Medical Science

Establishment of guinea pig kidney cell lines with potential application in the production of a classical swine fever live GPE<sup>−</sup> vaccine

Article

作者: AOKI, Hiroshi ; SHIOKAWA, Mai ; SHIODA, Moe

Classical swine fever (CSF) live vaccine used in Japan, GPE^- strain, is produced using guinea pig kidney (GPK)-derived primary culture cells. This means that a large number of guinea pigs are used to generate the primary GPK cells needed to produce the CSF live vaccine, and alternative solution is desired. Hence, we established two GPK cell lines capable of culturing the GPE^- strain: spontaneously immortalized GPK (GPK-SI) cells were generated by repeated passaging of primary GPK cells, and the other cell line, artificially immortalized GPK (GPK-AI) cells, were obtained by introducing the SV40 large T antigen gene into primary GPK cells. Both cell lines were susceptible to the GPE^- virus, and the virus grew more efficiently in GPK-SI cells at 37°C. When the culture temperature was set to 30°C, the virus titer reached 10^4.8 50% Tissue Culture Infectious Dose (TCID₅₀)/mL in GPK-SI cells 7 days after virus inoculation at a multiplicity of infection (MOI) of 1, which was equivalent to that in cells cultured at 37°C. When the virus was inoculated at MOI <1, the virus titer 7 days after inoculation was higher when cultured at 30°C than when cultured at 37°C in both cell lines, reaching 10^5.63 TCID₅₀/mL in GPK-SI cells. These results indicate that GPK-SI and GPK-AI cells can potentially replace primary GPK cells for the production of CSF live vaccines. This could also contribute to stable CSF vaccine production and animal welfare.

2022-12-01·Cancer Immunology, Immunotherapy2区 · 医学

Invariant NKT cell-augmented GM-CSF-secreting tumor vaccine is effective in advanced prostate cancer model

2区 · 医学

Article

作者: Dranoff, Glenn ; Kissick, Haydn T ; Varghese, Bindu ; Balk, Steven P ; Lynch, Lydia ; Arredouani, M Simo ; Exley, Mark A ; Vriend, Lianne E ; Clark, Justice M ; Varghese, Sharlin ; Sanda, Martin G ; Draganov, Dobrin

Invariant natural killer T cells (iNKT cells) express a semi-invariant T cell receptor that recognizes certain glycolipids (including α-galactosylceramide, αGC) bound to CD1d, and can induce potent antitumor responses. Here, we assessed whether αGC could enhance the efficacy of a GM-CSF-producing tumor cell vaccine in the transgenic SV40 T antigen-driven TRAMP prostate cancer model. In healthy mice, we initially found that optimal T cell responses were obtained with αGC-pulsed TRAMP-C2 cells secreting GM-CSF and milk fat globule epidermal growth factor protein-8 (MFG-E8) with an RGD to RGE mutation (GM-CSF/RGE TRAMP-C2), combined with systemic low dose IL-12. In a therapeutic model, transgenic TRAMP mice were then castrated at ~ 20 weeks, followed by treatment with the combination vaccine. Untreated mice succumbed to tumor by ~ 40 weeks, but survival was markedly prolonged by vaccine treatment, with most mice surviving past 80 weeks. Prostates in the treated mice were heavily infiltrated with T cells and iNKT cells, which both secreted IFNγ in response to tumor cells. The vaccine was not effective if the αGC, IL-12, or GM-CSF secretion was eliminated. Finally, immunized mice were fully resistant to challenge with TRAMP-C2 cells. Together these findings support further development of therapeutic vaccines that exploit iNKT cell activation.

100 项与 GM-CSF vaccine(Aduro Biotech) 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

适应症	最高研发状态	国家/地区	公司	日期
残留肿瘤	临床2期	美国	Celgene Corp.	2019-09-23
残留肿瘤	临床2期	美国	Aduro BioTech, Inc.	2019-09-23

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ASCO2011	N/A	HER2阳性转移性乳腺癌	20	GM-CSF-secreting breast tumor vaccine	製觸製壓淵窪鬱鹹餘壓(觸網簾遞製獵獵糧夢積) = 構夢憲積鹽窪鏇網壓顧鑰壓選構膚窪繭壓鑰鬱 (憲範膚鹹餘顧範醖壓築 )	-	2011-05-20
ASCO2007	临床2期	卵巢癌	21	Subcutaneous peptide admixed with ISA-51 and GM-CSF adjuvants	獵壓遞壓獵範夢壓鬱遞(憲醖鹽鹹築淵鑰製鑰製) = 窪獵艱鑰築製積願壓糧獵夢艱築鹽築膚膚簾憲 (憲鹹遞齋鏇構鏇鹽壓鹹 ) 更多	-	2007-06-20
ASCO2007	临床2期	卵巢癌	21	p53 vaccine (Peptide-pulsed dendritic cells given intravenously)	獵壓遞壓獵範夢壓鬱遞(憲醖鹽鹹築淵鑰製鑰製) = 艱繭鏇糧築夢繭鹹鑰遞獵夢艱築鹽築膚膚簾憲 (憲鹹遞齋鏇構鏇鹽壓鹹 ) 更多	-	2007-06-20