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Physicochemical and biological characterization of 1E10 anti-idiotype vaccine.

ABSTRACT: BACKGROUND: 1E10 monoclonal antibody is a murine anti-idiotypic antibody that mimics N-glycolyl-GM3 gangliosides. This antibody has been tested as an anti-idiotypic cancer vaccine, adjuvated in Al(OH)3, in several clinical trials for melanoma, breast, and lung cancer. During early clinical development this mAb was obtained in vivo from mice ascites fluid. Currently, the production process of 1E10 is being transferred from the in vivo to a bioreactor-based method. RESULTS: Here, we present a comprehensive molecular and immunological characterization of 1E10 produced by the two different production processes in order to determine the impact of the manufacturing process in vaccine performance. We observed differences in glycosylation pattern, charge heterogeneity and structural stability between in vivo-produced 1E10 and bioreactor-obtained 1E10. Interestingly, these modifications had no significant impact on the immune responses elicited in two different animal models. CONCLUSIONS: Changes in 1E10 primary structure like glycosylation; asparagine deamidation and oxidation affected 1E10 structural stability but did not affect the immune response elicited in mice and chickens when compared to 1E10 produced in mice.

SUBMITTER: Machado YJ

PROVIDER: S-EPMC3238287 | biostudies-literature | 2011

REPOSITORIES: biostudies-literature

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Physicochemical and biological characterization of 1E10 anti-idiotype vaccine.

Machado Yoan J YJ Rabasa Yamilet Y Montesinos Raquel R Cremata José J Besada Vladimir V Fuentes Dasha D Castillo Adolfo A de la Luz Kathya R KR Vázquez Ana M AM Himly Martin M

BMC biotechnology 20111122

<h4>Background</h4>1E10 monoclonal antibody is a murine anti-idiotypic antibody that mimics N-glycolyl-GM3 gangliosides. This antibody has been tested as an anti-idiotypic cancer vaccine, adjuvated in Al(OH)3, in several clinical trials for melanoma, breast, and lung cancer. During early clinical development this mAb was obtained in vivo from mice ascites fluid. Currently, the production process of 1E10 is being transferred from the in vivo to a bioreactor-based method.<h4>Results</h4>Here, we p ...[more]

PMID: 22108317

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Project description:Interventions: Onco-specific treatment: -Surgical treatment in resectable tumors (liver, lung), followed by first-line systemic chemotherapy four weeks later. -First-line systemic chemotherapy in non-resectable tumors. First-line chemotherapy: Six cycles every 4 weeks of: - Leucovorine (folinic acid) 20 mg/ m2/ daily, intravenously, for 5 days. Leucovorine will be administered after dilution in 50 cc of a 0.9% sodium chloride solution, intravenously, 20 minutes before 5-FU. - 5-Fluoracyl (5-FU): 375 mg/ m2/ daily, intravenously, for 5 days. The 5-FU will be administered either in a 5% dextrose solution or a 0.9% sodium chloride solution, 500 cc in 24 hour continuous infusion. Schemes containing Oxaliplatino, Irinotecan or a similar drug authorized for this purpose can also be used in combination with those nationally and internationally authorized and regulated. In conjunction with chemotherapy, the following can be administered: - 100 mg Dimenhydrate, either intravenously or in the chemotherapy infusion flask. - 20 mg Metoclopramide, either intravenously or in the chemotherapy infusion flask. Vaccine preparation: Patients will be administered a total of 15 vaccines, beginning 4 weeks after latest onco-specific treatment. The first 5 vaccines will be administered at 14 day intervals, and the other 10 every month until reaching one year immunization. Each vaccine will contain 1 ml of the vaccine preparation, at a 2 mg/ ml concentration of the 1E10 antibody. The total dose will be subdivided into 4 equal sub-doses, administering 250 µl (0.25 ml) at each inoculation site. The 1E10 anti-idiotype vaccine will be intradermally injected. The potential immunization sites are: deltoid region, anterior surface of forearm, provided that no resection has been performed, and posteri;Leucovorin;Fluorouracil;Vaccines ;Antibodies, Anti-Idiotypic;Antibodies ;Surgical Procedures, Operative;Antineoplastic Combined Chemotherapy Protocols;Infusions, Intravenous;Injections, Intradermal;Oxaliplatino Irinotecan 1E10 anti-idiotype vaccine Primary outcome(s): Survival time. Measuring time: 16 months Study Design: Allocation: N/A: single arm study. Masking: Open. Control group: Uncontrolled. Assignment: Single group. Purpose: Treatment

Project description:Pine honey is a honeydew honey produced in the East Mediterranean region (Greece and Turkey) from the secretions of the plant sucking insect Marchalina hellenica (Gennadius) (Coccoidea: Marchalini-dae) feeding on living parts of Pinus species. Nowadays, honeydew honey has attracted great attention due to its biological activities. The aim of this study was to study unifloral pine honey samples produced in Greece regarding their physicochemical parameters and antioxidant and antibacterial activity against five nosocomial and foodborne pathogens. These honeys showed physicochemical and microscopic characteristics within the legal limits, except for diastase activity, a parameter known to be highly variable, depending on various factors. Substantially higher levels of H2O2 were estimated compared to other types of honeydew honey, whereas protein content was similar. The total phenolic content was 451.38 ± 120.38 mg GAE/kg and antiradical activity ranged from 42.43 to 79.33%, while FRAP values (1.87 to 9.43 mmol Fe+2/kg) were in general higher than those reported in the literature. Various correlations could be identified among these parameters. This is the first attempt to investigate in depth the antibacterial activity of pine honey from Greece and correlate it with honey quality parameters. All tested honeys exerted variable but significant antibacterial activity, expressed as MIC and MBC values, comparable or even superior to manuka honey for some tested samples. Although honey antibacterial activity is mainly attributed to hydrogen peroxide and proteins in some cases (demonstrated by elevated MICs after catalase and Proteinase K treatment, respectively), no strong correlation between the antibacterial activity and hydrogen peroxide concentration or total protein content was demonstrated in this study. However, there was a statistically significant correlation of moisture, antioxidant and antibacterial activity against Klebsiella pneuomoniae, as well as antioxidant and antibacterial activity against Salmonella ser. Typhimurium. Interestingly, a statistically significant negative correlation has been observed between diastase activity and Staphylococcus aureus antibacterial activity. Overall, our data indicate multiple mechanisms of antibacterial activity exerted by pine honey.

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Physicochemical and biological characterization of 1E10 anti-idiotype vaccine.

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Physicochemical and biological characterization of 1E10 anti-idiotype vaccine.

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