A Randomized, Double-blind, Placebo-Controlled Phase II Trial of an Allogeneic Myeloma GM-CSF Vaccine With Lenalidomide in Multiple Myeloma Patients in Complete or Near Complete Remission

This study seeks to determine whether addition of an allogeneic myeloma vaccine can augment clinical responses to lenalidomide in patients with near complete remission (nCR), or complete remission (CR) leading to a significant improvement in progression-free survival.This main objective of this study is to compare the 2-year progression free survival of patients with multiple myeloma in CR or nCR, treated with lenalidomide plus an allogeneic myeloma vaccine in combination with lenalidomide (with or without Prevnar vaccine) or versus placebo in combination with lenalidomide (control arm).

开始日期2019-09-23

申办/合作机构

The Sidney Kimmel Comprehensive Cancer Center

[+2]

EUCTR2007-000934-38-GR / Not yet recruiting临床2期

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

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

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

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107

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 ; Dhar, Pronab ; Ompreethi, B. ; Manu, M. ; Singha Mahapatra, Chayna

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.

项与 GM-CSF vaccine(Aduro Biotech) 相关的新闻（医药）

2022-06-06

·PRNewswire

Aduro Promotes Accomplished Software Executives Justin Jed and Cliff Drane to Chief Operating Officer, Chief Experience Officer

Former Limeade Executives Jed and Drane Join Executive Leadership Team at Aduro® REDMOND, Wash., June 6, 2022 /PRNewswire/ -- Aduro®, a SaaS provider of employee wellbeing solutions, has promoted Justin Jed and Cliff Drane to their Executive Leadership Team, as Chief Operating Officer and Chief Experience Officer, respectively. Both Jed and Drane have extensive software and agency leadership experience, bringing a combined 50+ years in product development, user experience, and employee wellbeing technology to Aduro's Executive Leadership Team. About Justin Jed: Jed's extensive experience in employee wellbeing and software company leadership will guide his new role as Chief Operating Officer at Aduro. Justin started at Aduro as General Manager of the New Markets division, and formerly worked as the Vice President of Product Management at employee wellbeing company Limeade, as Head of Product, Platforms and UX at background check software company Sterling, and Director of Product Management and Planning at Microsoft. About Cliff Drane: Prior to his promotion to Chief Experience Officer, Cliff joined Aduro in 2021 as Vice President of Product & Design for the New Markets division. Drane previously worked as Vice President of Design & UX, Connected Fitness at Under Armour, Group Creative Director at the agency Razorfish, and Vice President of Creative & User Experience, and VP of Global Expansion for Limeade. As Chief Operating Officer, Jed is tasked with leading the Aduro Client and Member Experience Teams and Business Operations Team. With many years of executive software company experience, Jed will also take on many intra-team related aspects of running the Aduro business, including managing the company's Objectives and Key Results process and spearheading the newly created Quality Council. As Chief Experience Officer, Drane will lead Marketing, PR and Brand for Aduro, as well as provide vision for the comprehensive customer and user experience across the entire range of Aduro solutions. As a cross-disciplinary marketing, creative and user-experience leader, Drane will apply his expertise to growing the Aduro business through lead generation, product marketing, press and media relations and more. About Aduro® Based in Redmond, WA, Aduro® is a leading SaaS provider of corporate wellness solutions that drive Human Performance – existing at the intersection of well-being and performance. Aduro® unlocks human potential in the workplace by providing expert coaching, interactive content, meaningful incentives, and personalized insights in a fun, inspiring way. The Aduro® Connect™ platform ignites cultures, creates inclusivity and builds social connections that promote growth and flourishing for all people. When people flourish, organizations thrive . For several years, Aduro® has been named to the Inc. 5000 list of the fastest-growing private companies in America and 2021 6th Most Equitable Workplaces in Washington state by the Puget Sound Business Journal. In addition, the Aduro® Human Performance Training Program is accredited by the National Board for Health & Wellness Coaching (NBHWC). More information can be found at adurolife.com and on LinkedIn, Facebook, Twitter, and Instagram. SOURCE Aduro

100 项与 GM-CSF vaccine(Aduro Biotech) 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
残留肿瘤	药物发现	美国	Aduro BioTech, Inc.	2019-09-23
残留肿瘤	药物发现	美国	Celgene Corp.	2019-09-23

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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


ASCO2011	N/A	HER2阳性转移性乳腺癌	20	GM-CSF-secreting breast tumor vaccine	願構襯膚觸蓋壓糧襯築(簾築鏇醖鹽願齋獵製衊) = 艱製觸糧廠壓製簾遞廠築齋選築壓夢遞艱鹹蓋 (繭壓鏇廠顧願壓夢築膚 )	-	2011-05-20
ASCO2007	临床2期	卵巢癌	21	Subcutaneous peptide admixed with ISA-51 and GM-CSF adjuvants	壓淵窪構顧蓋壓餘膚獵(廠繭繭簾膚鑰窪壓鬱鏇) = 淵簾鏇獵顧憲簾糧衊觸繭積鑰鹽餘鑰鏇廠簾觸 (製衊獵鬱鑰醖繭製蓋憲 ) 更多	-	2007-06-20
ASCO2007	临床2期	卵巢癌	21	p53 vaccine (Peptide-pulsed dendritic cells given intravenously)	壓淵窪構顧蓋壓餘膚獵(廠繭繭簾膚鑰窪壓鬱鏇) = 餘壓觸築鏇鑰積夢壓積繭積鑰鹽餘鑰鏇廠簾觸 (製衊獵鬱鑰醖繭製蓋憲 ) 更多	-	2007-06-20
Pubmed \| Ann Surg Oncol	N/A	乳腺癌 HER2/neu+	16	E75+GM-CSF vaccine	(鏇廠鑰簾醖憲窪構膚艱) = 築鹽膚憲鑰艱廠壓獵壓醖願襯鏇艱願衊鹹鹽網 (選遞積窪齋夢鏇壓鬱憲 ) 更多	-	2007-12-01