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

Start Date30 Oct 2007

Sponsor / Collaborator

Generex Biotechnology Corp.

100 Clinical Results associated with GM-CSF vaccine(Aduro Biotech)

100 Translational Medicine associated with GM-CSF vaccine(Aduro Biotech)

100 Patents (Medical) associated with GM-CSF vaccine(Aduro Biotech)

108

Literatures (Medical) associated with GM-CSF vaccine(Aduro Biotech)

01 Apr 2023·Virology

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

Article

Author: 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.

01 Jan 2023·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

Author: 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.

01 Dec 2022·Cancer Immunology, ImmunotherapyQ2 · MEDICINE

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

Q2 · MEDICINE

Article

Author: 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 Deals associated with GM-CSF vaccine(Aduro Biotech)

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Residual Neoplasm	Phase 2	US	Celgene Corp.	23 Sep 2019
Residual Neoplasm	Phase 2	US	Aduro BioTech, Inc.	23 Sep 2019

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2011	Not Applicable	Metastatic human epidermal growth factor 2 positive carcinoma of breast	20	GM-CSF-secreting breast tumor vaccine	meofjzfzbr(btihddhzce) = srwqpnlkak yhngxobuhs (eyipvxiccn )	-	20 May 2011
ASCO2007	Phase 2	Ovarian Cancer	21	Subcutaneous peptide admixed with ISA-51 and GM-CSF adjuvants	nuyxyhksvn(urvpkwbhmv) = sgbbywqwng xwyqfwvlqk (srzzvyjxbt ) View more	-	20 Jun 2007
ASCO2007	Phase 2	Ovarian Cancer	21	p53 vaccine (Peptide-pulsed dendritic cells given intravenously)	nuyxyhksvn(urvpkwbhmv) = rglwjalfyg xwyqfwvlqk (srzzvyjxbt ) View more	-	20 Jun 2007

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