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A multi-peptide, dual-adjuvant telomerase vaccine (GX301) is highly immunogenic in patients with prostate and renal cancer

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Abstract

Background

Anti-tumor vaccination is a new frontier in cancer treatment applicable to immunogenic neoplasms such as prostate and renal cancers. GX301 is a vaccine constituted by four telomerase peptides and two adjuvants, Montanide ISA-51 and Imiquimod.

Objective

The aim of this study was to analyze safety and tolerability of GX301 in an open-label, phase I/II trial. Immunological and clinical responses were also evaluated as secondary endpoints.

Experimental design

GX301 was administered by intradermally injecting 500 μg of each peptide (dissolved in Montanide ISA-51) in the skin of the abdomen. Imiquimod was applied as a cream at the injection sites. The protocol included 8 administrations at days 1, 3, 5, 7, 14, 21, 35, 63. Eligible patients were affected with stage IV prostate or renal cancer resistant to conventional treatments. Patients were clinically and immunologically monitored up to 6 months from the first immunization.

Results

No grade 3–4 adverse events were observed. Evidence of vaccine-specific immunological responses was detected in 100 % of patients. Disease stabilization occurred in 4 patients. Prolonged progression-free survival and overall survival were observed in patients showing a full pattern of vaccine-specific immunological responses.

Conclusion

GX301 demonstrated to be safe and highly immunogenic. Further studies are needed to determine its clinical efficacy.

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Acknowledgments

This study was supported by grants from Genovax s.r.l. and Compagnia di San Paolo, Torino. Neither of the two sponsors of the study had any role in the study design, data collection, analysis, data interpretation, or writing of the manuscript.

Conflict of interest

GX301 is patented by Genovax s.r.l. Domenico Criscuolo is the President of Genovax; Gilberto Filaci, Francesco Indiveri, and Daniela Fenoglio are the stockholders of Genovax, while Francesco Boccardo is the member of the advisory board of Genovax; however, they worked at the project as academics so that they did not receive any payment by Genovax. All the other authors do not have any conflict of interest to declare.

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Author notes

  1. Domenico Criscuolo

    Present address: Mediolanum Farmaceutici Spa, Milan, Italy

Authors and Affiliations

  1. Centre of Excellence for Biomedical Research (CEBR), University of Genoa, Viale Benedetto XV n. 7, 16132, Genoa, Italy

    Daniela Fenoglio, Paolo Traverso, Alessia Parodi, Simone Negrini, Francesca Kalli, Florinda Battaglia, Francesca Ferrera, Francesco Indiveri & Gilberto Filaci

  2. Department of Internal Medicine, University of Genoa, Genoa, Italy

    Daniela Fenoglio, Giuseppe Murdaca, Francesco Boccardo, Francesco Puppo, Francesco Indiveri & Gilberto Filaci

  3. Department of Surgical Sciences, University of Genoa, Genoa, Italy

    Paolo Traverso & Giorgio Carmignani

  4. Istituto Nazionale per la Ricerca sul Cancro, IRCCS Azienda Ospedaliero Universitaria San Martino—IST, Genoa, Italy

    Laura Tomasello, Stefania Sciallero, Maurizio Setti, Alberto Sobrero, Francesco Boccardo & Giuseppe Cittadini

  5. Genovax srl, Colleretto Giacosa, Italy

    Domenico Criscuolo

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  1. Daniela Fenoglio
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Corresponding author

Correspondence to Gilberto Filaci.

Additional information

Daniela Fenoglio and Paolo Traverso contributed equally to this work.

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Fenoglio, D., Traverso, P., Parodi, A. et al. A multi-peptide, dual-adjuvant telomerase vaccine (GX301) is highly immunogenic in patients with prostate and renal cancer. Cancer Immunol Immunother 62, 1041–1052 (2013). https://doi.org/10.1007/s00262-013-1415-9

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