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

Daniela Fenoglio, Paolo Traverso, Alessia Parodi, Laura Tomasello, Simone Negrini, Francesca Kalli, Florinda Battaglia, Francesca Ferrera, Stefania Sciallero, Giuseppe Murdaca, Maurizio Setti, Alberto Sobrero, Francesco Boccardo, Giuseppe Cittadini, Francesco Puppo, Domenico Criscuolo, Giorgio Carmignani, Francesco Indiveri, Gilberto Filaci

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)1041-1052
Number of pages12
JournalCancer Immunology, Immunotherapy
Volume62
Issue number6
DOIs
Publication statusPublished - Jun 2013

Fingerprint

Kidney Neoplasms
Telomerase
Prostatic Neoplasms
Vaccines
imiquimod
Peptides
Neoplasms
Abdomen
Disease-Free Survival
Immunization
Vaccination
Research Design
Safety
Skin
Injections
Survival
Therapeutics
montanide ISA 51

Keywords

  • Adjuvants
  • Cancer vaccine
  • Prostate cancer
  • Renal cancer
  • Telomerase

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Immunology
  • Immunology and Allergy

Cite this

A multi-peptide, dual-adjuvant telomerase vaccine (GX301) is highly immunogenic in patients with prostate and renal cancer. / Fenoglio, Daniela; Traverso, Paolo; Parodi, Alessia; Tomasello, Laura; Negrini, Simone; Kalli, Francesca; Battaglia, Florinda; Ferrera, Francesca; Sciallero, Stefania; Murdaca, Giuseppe; Setti, Maurizio; Sobrero, Alberto; Boccardo, Francesco; Cittadini, Giuseppe; Puppo, Francesco; Criscuolo, Domenico; Carmignani, Giorgio; Indiveri, Francesco; Filaci, Gilberto.

In: Cancer Immunology, Immunotherapy, Vol. 62, No. 6, 06.2013, p. 1041-1052.

Research output: Contribution to journalArticle

Fenoglio, D, Traverso, P, Parodi, A, Tomasello, L, Negrini, S, Kalli, F, Battaglia, F, Ferrera, F, Sciallero, S, Murdaca, G, Setti, M, Sobrero, A, Boccardo, F, Cittadini, G, Puppo, F, Criscuolo, D, Carmignani, G, Indiveri, F & Filaci, G 2013, 'A multi-peptide, dual-adjuvant telomerase vaccine (GX301) is highly immunogenic in patients with prostate and renal cancer', Cancer Immunology, Immunotherapy, vol. 62, no. 6, pp. 1041-1052. https://doi.org/10.1007/s00262-013-1415-9
Fenoglio, Daniela ; Traverso, Paolo ; Parodi, Alessia ; Tomasello, Laura ; Negrini, Simone ; Kalli, Francesca ; Battaglia, Florinda ; Ferrera, Francesca ; Sciallero, Stefania ; Murdaca, Giuseppe ; Setti, Maurizio ; Sobrero, Alberto ; Boccardo, Francesco ; Cittadini, Giuseppe ; Puppo, Francesco ; Criscuolo, Domenico ; Carmignani, Giorgio ; Indiveri, Francesco ; Filaci, Gilberto. / A multi-peptide, dual-adjuvant telomerase vaccine (GX301) is highly immunogenic in patients with prostate and renal cancer. In: Cancer Immunology, Immunotherapy. 2013 ; Vol. 62, No. 6. pp. 1041-1052.
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T1 - A multi-peptide, dual-adjuvant telomerase vaccine (GX301) is highly immunogenic in patients with prostate and renal cancer

AU - Fenoglio, Daniela

AU - Traverso, Paolo

AU - Parodi, Alessia

AU - Tomasello, Laura

AU - Negrini, Simone

AU - Kalli, Francesca

AU - Battaglia, Florinda

AU - Ferrera, Francesca

AU - Sciallero, Stefania

AU - Murdaca, Giuseppe

AU - Setti, Maurizio

AU - Sobrero, Alberto

AU - Boccardo, Francesco

AU - Cittadini, Giuseppe

AU - Puppo, Francesco

AU - Criscuolo, Domenico

AU - Carmignani, Giorgio

AU - Indiveri, Francesco

AU - Filaci, Gilberto

PY - 2013/6

Y1 - 2013/6

N2 - 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.

AB - 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.

KW - Adjuvants

KW - Cancer vaccine

KW - Prostate cancer

KW - Renal cancer

KW - Telomerase

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