Non-clinical safety evaluation of single and repeated intramuscular administrations of MAGE-A3 Cancer Immunotherapeutic in rabbits and cynomolgus monkeys

Journal of Applied Toxicology

Volumn 35, Issue 7, 2015, Pages 717-728

  Destexhe, Eric ^a   Grosdidier, Emilie ^b   Baudson, Nathalie ^a   Forster, Roy ^b   Gerard, Catherine ^a   Garçon, Nathalie ^a   Segal, Lawrence ^a  

^a GSK   (Belgium)

^b SOLVO BIOTECHNOLOGY   (Hungary)

Author keywords

Animal model; MAGE A3 Cancer Immunotherapeutic; Monkey; Non clinical study; Rabbit; Repeated dose; Single dose; Toxicology

Indexed keywords

MELANOMA ANTIGEN 3; MAGEA3 PROTEIN, HUMAN; TUMOR ANTIGEN; TUMOR PROTEIN;

ANIMAL EXPERIMENT; ANIMAL TISSUE; ARTICLE; AXILLARY LYMPH NODE; CELL INFILTRATION; CONTROLLED STUDY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; IMMUNE RESPONSE; INFLAMMATORY CELL; INGUINAL LYMPH NODE; INJECTION SITE BLEEDING; LYMPHADENOPATHY; MACACA FASCICULARIS; MALE; NONHUMAN; POPLITEAL LYMPH NODE; PRIORITY JOURNAL; RABBIT; T LYMPHOCYTE; ANIMAL; DRUG ADMINISTRATION; DRUG EFFECTS; IMMUNOTHERAPY; INTRAMUSCULAR DRUG ADMINISTRATION; NEOPLASMS; PHYSIOLOGY; PROCEDURES;

ANIMALIA; MACACA FASCICULARIS; ORYCTOLAGUS CUNICULUS;

ANIMALS; ANTIGENS, NEOPLASM; DRUG ADMINISTRATION SCHEDULE; FEMALE; IMMUNOTHERAPY; INJECTIONS, INTRAMUSCULAR; MACACA FASCICULARIS; MALE; NEOPLASM PROTEINS; NEOPLASMS; RABBITS; T-LYMPHOCYTES;

EID: 84929702421     PISSN: 0260437X     EISSN: 10991263     Source Type: Journal    
DOI: 10.1002/jat.3025     Document Type: Article

References (48)

1. Aldrich JF, Lowe DB, Shearer MH, Winn RE, Jumper CA, Kennedy RC. 2010. Vaccines and immunotherapeutics for the treatment of malignant disease. Clin. Dev. Immunol. 2010: 697158.
2. Atanackovic D, Altorki NK, Stockert E, Williamson B, Jungbluth AA, Ritter E, Santiago D, Ferrara CA, Matsuo M, Selvakumar A, Dupont B, Chen YT, Hoffman EW, Ritter G, Old LJ, Gnjatic S. 2004. Vaccine-induced CD4+ T cell responses to MAGE-3 protein in lung cancer patients. J. Immunol. 172: 3289-3296.
3. Atanackovic D, Altorki NK, Cao Y, Ritter E, Ferrara CA, Ritter G, Hoffman EW, Bokemeyer C, Old LJ, Gnjatic S. 2008. Booster vaccination of cancer patients with MAGE-A3 protein reveals long-term immunological memory or tolerance depending on priming. Proc. Natl. Acad. Sci. U. S. A. 105: 1650-1655.
4. Altschul SF, Gish W, Miller W, Myers EW, Lipman DJ. 1990. Basic local alignment search tool. J. Mol. Biol. 215(3): 403-410.
5. Bilusic M, Gulley JL. 2012. Endpoints, patient selection, and biomarkers in the design of clinical trials for cancer vaccines. Cancer Immunol. Immunother. 61: 109-117.
6. Boon T, Cerottini JC, Van den Eynde B, van der Bruggen P, Van Pel A. 1994. Tumor antigens recognized by T lymphocytes. Annu. Rev. Immunol. 12: 337-365.
7. Brasseur F, Rimoldi D, Lienard D, Lethé B, Carrel S, Arienti F, Suter L, Vanwijck R, Bourlond A, Humblet Y, et al. 1995. Expression of MAGE genes in primary and metastatic cutaneous melanoma. Int. J. Cancer. 63: 375-380.
8. Charoentong P, Angelova M, Efremova M, Gallasch R, Hackl H, et al. 2012. Bioinformatics for cancer immunology and immunotherapy. Cancer Immunol. Immunother. 61: 1885-1903.
9. Chaux P, Vantomme V, Coulie P, Boon T, Van der Bruggen P. 1998. Estimation of the frequencies of anti MAGE-3 cytolytic T-lymphocyte precursors in blood from individuals without cancer. Int. J. Cancer 77(4): 538-542.
10. Chiang CL, Benencia F, Coukos G. 2010. Whole tumor antigen vaccines. Semin. Immunol. 22: 132-143.
11. Dayoub EJ, Davis MM. 2011. Relationship of therapeutic cancer vaccine development to population disease burden and five-year survival. Hum. Vaccin. 7: 1124-1129.
12. De Pas T, Kim JH, Zarogoulidis K, Zielinski M, Dahabreh J, Vanakesa T, Nush A, Gonzalez EE, Hoffman H, Thongprasert S, Debois M, Douillard JY, Altorki N, Debruyne C, Vansteenkiste J. 2009. MAGRIT phase III trial in adjuvant NSCLC: MAGE-A3 gene expression frequency on the first 2150 patients screened and demographics of first patients randomized. Presented at 13th World Conference on Lung Cancer, July 31-August 4, 2009, San Francisco, CA, USA.
13. Dubensky TW, Reed SG. 2010. Adjuvants for cancer vaccines. Semin. Immunol. 22: 155-161.
14. European Agency for the Evaluation of Medicinal Products (EMA). Committee for Proprietary Medicinal Products (CPMP). Note for guidance on preclinical pharmacological and toxicological testing of vaccines. 1998. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004004.pdf (Accessed 29 April 2013).
15. European Medicines Agency (EMA). ICH Topic S 4 Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing). Note For Guidance On Duration Of Chronic Toxicity Testing In Animals (Rodent And Non Rodent Toxicity Testing (CPMP/ICH/300/95). 1999. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002800.pdf (Accessed 29 April 2013).
16. European Agency for the Evaluation of Medicinal Products (EMA). Committee for proprietary Medicinal Products (CPMP). Guideline on adjuvants in vaccines for human use. 2005. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003809.pdf (Accessed 14 February 2013).
17. European Agency for the Evaluation of Medicinal Products (EMA). Committee for proprietary Medicinal Products (CPMP). Note for guidance on repeated dose toxicity. 2009. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003102.pdf (Accessed 29 April 2013).
18. Finn OJ. 2008. Cancer immunology. N. Engl. J. Med. 358: 2704-2715.
19. Gérard C, Baudson N, Ory T, Louahed J. 2014. Tumor mouse model confirms MAGE-A3 Cancer Immunotherapeutic as an efficient inducer of long-lasting anti-tumoral responses. PLoS. DOI: 10.1371/journal.pone.0094883.
20. Hellstrom KE, Hellstrom I. 2003. Novel approaches to therapeutic cancer vaccines. Expert Rev. Vaccines 2: 517-532.
21. Hoebe K, Janssen E, Beutler B. 2004. The interface between innate and adaptive immunity. Nat. Immunol. 5: 971-974.
22. Jungbluth AA, Ely S, DiLiberto M, Niesvizky R, Williamson B, Frosina D, Chen YT, Bhardwaj N, Chen-Kiang S, Old LJ, Cho HJ. 2005. The cancer-testis antigens CT7 (MAGE-C1) and MAGE-A3/6 are commonly expressed in multiple myeloma and correlate with plasma-cell proliferation. Blood 106: 167-174.
23. Kantoff PW, Higano CS, Shore ND, Berger ER, Small EJ, Penson DF, Redfern CH, Ferrari AC, Dreicer R, Sims RB, Xu Y, Frohlich MW, Schellhammer PF; IMPACT Study Investigators. 2010. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N. Engl. J. Med. 363: 411-422.
24. Kirkwood JM, Butterfield LH, Tarhini AA, Zarour H, Kalinski P, Ferrone S. 2012. Immunotherapy of cancer in 2012. CA Cancer J. Clin. 62: 309-335.
25. Knuth A, Wolfel T, Klehmann E, Boon T, Meyer zum Buschenfelde KH. 1989. Cytolytic T-cell clones against an autologous human melanoma: specificity study and definition of three antigens by immunoselection. Proc. Natl. Acad. Sci. U. S. A. 86: 2804-2808.
26. Kruit WH, van Ojik HH, Brichard VG, Escudier B, Dorval T, Dréno B, Patel P, van Baren N, Avril MF, Piperno S, Khammari A, Stas M, Ritter G, Lethé B, Godelaine D, Brasseur F, Zhang Y, van der Bruggen P, Boon T, Eggermont AM, Marchand M. 2005. Phase 1/2 study of subcutaneous and intradermal immunization with a recombinant MAGE-3 protein in patients with detectable metastatic melanoma. Int. J. Cancer 117: 596-604.
27. Kruit WH, Suciu S, Dreno B, Mortier L, Robert C, Chiarion-Sileni V, Maio M, Testori A, Dorval T, Grob JJ, Becker JC, Spatz A, Eggermont AM, Louahed J, Lehmann FF, Brichard VG, Keilholz U. 2013. Selection of immunostimulant AS15 for active immunization with MAGE-A3 protein: Results of a randomized Phase II Study of the European Organisation for Research and Treatment of Cancer Melanoma Group in Metastatic Melanoma. J. Clin. Oncol. 31: 2413-2420.
28. Laheru DA, Pardoll DM, Jaffee EM. 2005. Genes to vaccines for immunotherapy: how the molecular biology revolution has influenced cancer immunology. Mol. Cancer Ther. 4: 1645-1652.
29. Lasaro MO, Ertl HC. 2010. Targeting inhibitory pathways in cancer immunotherapy. Curr. Opin. Immunol. 22: 385-390.
30. Marchand M, Punt CJ, Aamdal S, Escudier B, Kruit WH, Keilholz U, Håkansson L, van Baren N, Humblet Y, Mulders P, Avril MF, Eggermont AM, Scheibenbogen C, Uiters J, Wanders J, Delire M, Boon T, Stoter G. 2003. Immunisation of metastatic cancer patients with MAGE-3 protein combined with adjuvant SBAS-2: a clinical report. Eur. J. Cancer 39: 70-77.
31. Ministère de l'Emploi et de la Solidarité. 2000. ARRÊTÉ DU 14 MARS 2000 relatif aux bonnes pratiques de laboratoire. http://ansm.sante.fr/var/ansm_site/storage/original/application/dd4641e3edd1885e60f0337d4c385b5e.pdf (Accessed 29 April 2013).
32. Organisation for Economic Co-operation and Development. 1997. OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring. OECD Principles on Good Laboratory Practice (as revised in 1997).
33. Organisation for Economic Co-operation and Development. 2002. OECD Guidelines for Testing of Chemicals. 404 Acute Dermal Irritation/Corrosion. Adopted: 24 April 2002. http://ihcp.jrc.ec.europa.eu/our_labs/eurl-ecvam/validation-regulatory-acceptance/docs-skin-irritation-1/DOC2_OECD-TG-404.pdf
34. Pashine A, Valiante NM, Ulmer JB. 2005. Targeting the innate immune response with improved vaccine adjuvants. Nat. Med. 11: S63-S68.
35. Patard JJ, Brasseur F, Gil-Diez S, Radvanyi F, Marchand M, François P, Abi-Aad A, Van Cangh P, Abbou CC, Chopin D, Boon T. 1995. Expression of MAGE genes in transitional-cell carcinomas of the urinary bladder. Int. J. Cancer 64: 60-64.
36. Scanlan MJ, Gure AO, Jungbluth AA, Old LJ, Chen YT. 2002. Cancer/testis antigens: an expanding family of targets for cancer immunotherapy. Immunol. Rev. 188: 22-32.
37. Sharma P, Shen Y, Wen S, Bajorin DF, Reuter VE, Old LJ, Jungbluth AA. 2006. Cancer-testis antigens: expression and correlation with survival in human urothelial carcinoma. Clin. Cancer Res. 12: 5442-5447.
38. Siegrist CA. 2013. Vaccine immunology. http://www.who.int/immunization/documents/Elsevier_Vaccine_immunology.pdf (Accessed 3 May 2013).
39. Tefit JN, Serra V. 2011. Outlining novel cellular adjuvant products for therapeutic vaccines against cancer. Expert Rev. Vaccines 10: 1207-1220.
40. The Council of the European Communities. 1986. Council Directive of 24 November 1986. http://ec.europa.eu/food/fs/aw/aw_legislation/scientific/86-609-eec_en.pdf [29 April 2013].
41. The European Parliament and the Council of the European Union. 2004. Directive 2004/10/EC OF The European Parliament and of the Council of 11 February 2004. Official Journal of the European Union. L 50/59. http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02004L0010-20090420&qid=1399986582739&from=EN (Accessed 29 April 2013).
42. Thuilliez C, Dorso L, Howroyd P, Gould S, Chanut F, Burnett R. 2009. Histopathological lesions following intramuscular administration of saline in laboratory rodents and rabbits. Exp. Toxicol. Pathol. 61: 13-21.
43. Van den Eynde BJ, van der Bruggen P. 1997. T cell defined tumor antigens. Curr. Opin. Immunol. 9: 684-693.
44. van der Bruggen P, Traversari C, Chomez P, Lurquin C, De Plaen E, Van den Eynde B, Knuth A, Boon T. 1991. A gene encoding an antigen recognized by cytolytic T lymphocytes on a human melanoma. Science 254: 1643-1647.
45. van der Bruggen P, Zhang Y, Chaux P, Stroobant V, Panichelli C, Schultz ES, Chapiro J, Van den Eynde BJ, Brasseur F, Boon T. 2002. Tumor-specific shared antigenic peptides recognized by human T cells. Immunol. Rev. 188: 51-64.
46. Vergati M, Intrivici C, Huen NY, Schlom J, Tsang KY. 2010. Strategies for cancer vaccine development. J. Biomed. Biotechnol. 2010. pii: 596432.
47. World Health Organization (WHO). WHO guidelines on nonclinical evaluation of vaccines. 2003. http://www.who.int/biologicals/publications/nonclinical_evaluation_vaccines_nov_2003.pdf (Accessed 29 April 2013).
48. Yin B, Liu G, Wang XS, Zhang H, Song YS, Wu B. 2012. Expression profile of cancer-testis genes in transitional cell carcinoma of the bladder. Urol. Oncol. 30: 886-892.