Characterization of the anti-PD-1 antibody REGN2810 and Its antitumor activity in Human PD-1 knock-in mice

Molecular Cancer Therapeutics

Volumn 16, Issue 5, 2017, Pages 861-870

  Burova, Elena ^a   Hermann, Aynur ^a   Waite, Janelle ^a   Potocky, T ^a   Lai, Venus ^a   Hong, Seongwon ^a   Liu, Matt ^a   Allbritton, Omaira ^a   Woodruff, Amy ^a   Wu, Qi ^a   D'Orvilliers, Amanda ^a   Garnova, Elena ^a   Rafique, Ashique ^a   Poueymirou, William ^a   Martin, Joel ^a   Huang, Tammy ^a   Skokos, Dimitris ^a   Kantrowitz, Joel ^a   Popke, Jon ^a   Mohrs, Markus ^a   MacDonald, Douglas ^a   Ioffe, Ella ^a   Olson, William ^a   Lowy, Israel ^a   Murphy, Andrew ^a   Thurston, Gavin ^a   more..

^a REGENERON PHARMACEUTICALS INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; PROGRAMMED DEATH 1 LIGAND 1; REGN 2810; T LYMPHOCYTE RECEPTOR; UNCLASSIFIED DRUG; MONOCLONAL ANTIBODY; PDCD1 PROTEIN, HUMAN; PROGRAMMED DEATH 1 RECEPTOR;

ANIMAL CELL; ANIMAL EXPERIMENT; ANIMAL MODEL; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ARTICLE; BINDING AFFINITY; CANCER IMMUNOTHERAPY; CELL ASSAY; CONTROLLED STUDY; DRUG BINDING; DRUG CLEARANCE; DRUG HALF LIFE; DRUG MEGADOSE; DRUG TOLERABILITY; EXPERIMENTAL MONKEY; HUMAN; HUMAN CELL; IMMUNOGENICITY; IN VIVO STUDY; MALIGNANT NEOPLASM; MAXIMUM PLASMA CONCENTRATION; MOUSE; NONHUMAN; PRIORITY JOURNAL; PROTEIN DOMAIN; SIGNAL TRANSDUCTION; SINGLE DRUG DOSE; T LYMPHOCYTE; ANIMAL; ANTAGONISTS AND INHIBITORS; CELL PROLIFERATION; DRUG EFFECTS; GENE KNOCK-IN; GENETICS; IMMUNOLOGY; IMMUNOTHERAPY; LYMPHOCYTE ACTIVATION; NEOPLASM; PATHOLOGY; TUMOR CELL LINE;

ANIMALS; ANTIBODIES, MONOCLONAL, HUMANIZED; CELL LINE, TUMOR; CELL PROLIFERATION; GENE KNOCK-IN TECHNIQUES; HUMANS; IMMUNOTHERAPY; LYMPHOCYTE ACTIVATION; MICE; NEOPLASMS; PROGRAMMED CELL DEATH 1 RECEPTOR; T-LYMPHOCYTES;

EID: 85019990847     PISSN: 15357163     EISSN: 15388514     Source Type: Journal    
DOI: 10.1158/1535-7163.MCT-16-0665     Document Type: Article

References (50)

1. Dunn GP, Old LJ, Schreiber RD. The three Es of cancer immunoediting. Ann Rev Immunol 2004;22:329-360.
2. Schumacher TN, Schreiber RD. Neoantigens in cancer immunotherapy. Science 2015;348:69-74.
3. Flies DB, Sandler BJ, Sznol M, Chen L. Blockade of the B7-H1/PD-1 pathway for cancer immunotherapy. Yale J Biol Med 2011;84:409-21.
4. Pardoll DM.The blockade of immune checkpoints in cancer immunotherapy. Nat Rev Cancer 2012;12:252-64.
5. Okazaki T, Chikuma S, Iwai Y, Fagarasan S, Honjo T. A rheostat for immune responses: The unique properties of PD-1 and their advantages for clinical application. Nature Immunology 2013;14: 1212-8.
6. Ishida Y, Agata Y, Shibahara K, Honjo T. Induced expression of PD-1, a novel member of the immunoglobulin gene superfamily, upon programmed cell death. EMBO J 1992;11:3887-95.
7. Agata Y, Kawasaki A, Nishimura H, Ishida Y, Tsubata T, Yagita H, et al. Expression of the PD-1 antigen on the surface of stimulated mouse T and B lymphocytes. Int Immunol 1996;8:765-72.
8. Freeman GJ, Long AJ, Iwai Y, Bourgue K, Chernova T, Nishimura H, et al. Engagement of the PD-1 immunoinhibitory receptor by a novel B7 family member leads to negative regulation of lymphocyte activation. J Exp Med 2000;192:1027-34.
9. Latchman Y, Wood CR, Chernova T, Chaudhary D, Borde M, Chernova I, et al. PD-L2 is a second ligand for PD-1 and inhibits T cell activation. Nat Immunol 2001;2:261-8.
10. Carter L, Fouser LA, Jussif J, Fitz L, Deng B, Wood CR, et al. PD-1:PD-L inhibitory pathway affects both CD4(+) and CD8(+) T cells and is overcome by IL-2. Eur J Immunol 2002;32:634-43.
11. Nishimura H, NoseM, Hiai H, Minato N, Honjo T. Development of lupuslike autoimmune diseases by disruption of the PD-1 gene encoding an ITIM motif-carrying immunoreceptor. Immunity 1999;11:141-51.
12. NishimuraH,Okazaki T, Tanaka Y,Nakatani K,Hara M, Matsumori A, et al. Autoimmune dilated cardiomyopathy in PD-1 receptor-deficient mice. Science 2001; 291:319-22.
13. Wang J, Okazaki IM, Yoshida T, Chikuma S, Kato Y, Nakaki F, et al. PD-1 deficiency results in the development of fatal myocarditis in MRL mice. Int Immunol 2010;22:443-52.
14. Dong H, Chen L. B7-H1 pathway and its role in the evasion of tumor immunity. J Mol Med 2003;81:281-7.
15. Blank C, Gajewski TF, Mackensen A. Interaction of PD-L1 on tumor cells with PD-1 on tumor-specific T cells as a mechanism of immune evasion: implications for tumor immunotherapy. Cancer Immunol Immunother 2005;54:307-14.
16. Curiel TJ, Wei S, Dong H, Alvarez X, Cheng P, Mottram P, et al. Blockade of B7-H1 improves myeloid dendritic cell-mediated antitumor immunity. Nat Med 2003;9:562-7.
17. Hirano F, Kaneko K, Tamura H, Dong H, Wang S, Ichikawa M, et al. Blockade of B7-H1 and PD-1 by monoclonal antibodies potentiates cancer therapeutic immunity. Cancer Res 2005;65:1089-96.
18. Iwai Y, IshidaM, Tanaka Y, Okazaki T, Honjo T, Minato N. Involvement of PD-L1 on tumor cells in the escape from host immune system and tumor immunotherapy by PD-L1 blockade. Proc Natl Acad Sci U S A 2002;99: 12293-7.
19. Brown JA, Dorfman DM, Ma FR, Sullivan EL, Munoz O, Wood CR, et al. Blockade of programmed death-1 ligands on dendritic cells enhances T cell activation and cytokine production. J Immunol 2003;170:1257-66.
20. Dong H, Strome SE, Salomao DR, Tamura H, Hirano F, Flies DB, et al. Tumor-associated B7-H1 promotes T-cell apoptosis: a potential mechanism of immune evasion. Nat Med 2002;8:793-800.
21. Zou W, Chen L. Inhibitory B7-family molecules in the tumour microenvironment. Nat Rev Immunol 2008;8:467-77.
22. Carbognin L, Pilotto S, Milella M, Vaccaro V, Brunelli M, Caliò A, et al. . Differential activity of nivolumab, pembrolizumab and MPDL3280A according to the tumor expression of programmed death-ligand-1 (PDL1): Sensitivity analysis of trials in melanoma, lung and genitourinary cancers. PLoS One 2015;10:1-16.
23. Sunshine J, Taube JM. PD-1/PD-L1 inhibitors. Current Opinion Pharmacol 2015;23:32-8.
24. Moreno BH, Ribas A. Anti-programmed cell death protein-1/ligand-1 therapy in different cancers. Br J Cancer 2015;112:1421-7.
25. Lipson EJ, Forde PM, Hammers HJ, Emens LA, Taube JM, Topalian SL. Antagonists of PD-1 and PD-L1 in cancer treatment. Semin Oncol 2015;42:587-600.
26. Topalian SL, Hodi FS, Brahmer JR, Gettinger SN, Smith DC, McDermottDF, et al. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med 2012;366:2443-54.
27. Topalian SL, Sznol M, McDermott DF, Kluger HM, Carvajal RD, Sharfman WH, et al. Survival, durable tumor remission, and long-term safety in patients with advanced melanoma receiving nivolumab. J Clin Oncol 2014;32:1020-30.
28. Hamid O, Robert C, Daud A, Hodi FS, Hwu WJ, Kefford R, et al. et al. Safety and tumor responses with lambrolizumab (anti-PD-1) in melanoma. N Engl J Med 2013;369:134-44.
29. Sundar R, Cho BC, Brahmer JR, Soo RA. Nivolumab in NSCLC: Latest evidence and clinical potential. Ther Adv Med Oncol 2015;7:85-96.
30. Choueiri TK, Fishman M, Escudier B,McDermott DF, Drake CG, KlugerHM, Staler WM, et al. Immunomodulatory activity of Nivolumab in metastatic renal cell carcinoma. Clin Cancer Res 2016;22:5461-71.
31. Wolchok JD, Kluger H, Callahan MK, Postow MA, Rizvi NA, Lesokhin AM, et al. Nivolumab plus ipilimumab in advanced melanoma. N Engl J Med 2013;369:122-33.
32. Postow MA, Chesney J, Pavlick AC, Robert C, Grossmann K, McDermott D, et al. Nivolumab and ipilimumab versus ipilimumab in untreated melanoma. N Engl J Med 2015;372:2006-17.
33. Baksh K, Weber J. Immune checkpoint protein inhibition for cancer: preclinical justification for CTLA-4 and PD-1 blockade and new combinations. Semin Oncol 2015;42:363-77.
34. Topalian SL, Drake CG, Pardoll DM. Immune checkpoint blockade: A common denominator approach to cancer therapy. Cancer Cell 2015;27: 450-61.
35. Murphy AJ, Macdonald LE, Stevens S, Karow M, Dore AT, Pobursky K, et al. Mice with megabase humanization of their immunoglobulin genes generate antibodies as efficiently as normal mice. Proc Natl Acad U S A 2014; 111:5153-8.
36. Macdonald LE, KarowM, Stevens S,Auerbach W,WilliamT. PoueymirouWT, Yasenchak J, et al. Precise and in situ genetic humanization of 6 Mb of mouse immunoglobulin genes. Proc Natl Acad SciUS A 2014;111:5147-52.
37. Okazaki T, Chikima S, Iwai Y, Fagarasan S, Honojo T.A rheostat forimmune responses: The unique properties of PD-1 and their advantages for clinical application. Nat Immunol 2013;14:1212-8.
38. Labrijn AF, Buijsse AO, van den Bremer ETJ, Verwilligen AYW, Bleeker WK, Thorpe SJ, et al. Therapeutic IgG4 antibodies engage in Fab-arm exchange with endogenous human IgG4 in vivo. Nat Biotechnol 2009;27:767-71.
39. Valenzuela DM, Murphy AJ, Frendewey D, Gale NW, Economides AN, Aurbach W, et al. High-throuput engineering of the mouse genome coupled with high-resolution expression analysis. Nat Biotechnol 2003;21:652-9.
40. Poueymirou WT, Auerbach W, Frendewey D, Hickey JF, Escaravage JM, Esau L, et al. F0 generationmice fully derived from gene-targeted embryonic stem cells allowing immediate phenotypic analyses. Nat Biotechnol 2007; 25:91-9.
41. Andorsky DJ, Yamada RE, Said J, Pinkus GS, Bettingan DJ, Timmerman JM. Programmed death ligand 1 is expressed by non-hodgkin lymphomas and inhibits the activity of tumor-associated cells. Clin Cancer Res 2011;17: 4232-44.
42. Parsons MS, Zipperlen K, Gallant M, GrantM. Killer cell immunoglobulinlike receptor 3DL1 licenses CD16-mediated effector functions of natural killer cells. J Leukocyte Biol 2010;88:905-12.
43. Li B, Zhao L, Guo H, Wang C, Zhang X, Wu L, et al. Characterization of a rituximab variantwith potent antitumor activity against rituximab-resistant B-cell lymphoma. Blood 2009;114:5007-15.
44. Iwai Y, Okazaki T, Nishimura H, Kawasaki A, Yagita H, Honjo T. Microanatomical localization of PD-1 in human tonsils. Immunol Lett 2002;83: 215-20
45. Stebbings R, Findlay L, Edwards C, Eastwood D, Bird C, North D, Mistry Y, et al. "Cytokine storm" in the phase I trial of monoclonal antibody TGN1412: Better understanding the causes to improve preclinical testing of immunotherapeutics. J Immunol 2007;179:3325-31.
46. Wang C, Thudium KB, Han M, Wang X -T, Huang H, Feingersh D, et al. In vitro characterization of the anti-PD-1 antibody nivolumab, BMS-936558, and in vivo toxicology in non-human primates. Cancer Immunol Res 2014;2:846-56.
47. Stewart R, Hammond SA,Oberst M, Wilkinson RW. The role of Fc gamma receptors in the activity of immunomodulatory antibodies for cancer. J Immunother Cancer 2014;2:29.
48. Curran MA, Montalvo W, Yagita H, Allison JP. PD-1 and CTLA-4 combination blockade expands infiltrating T cells and reduces regulatory T and myeloid cells within B16 melanoma tumors. Proc Natl Acad Sci U S A 2010;107:4275-80.
49. Duraiswamy J, Kaluza KM, Freeman GJ, Coukos G. Dual blockade of PD-1 and CTLA-4 combined with tumor vaccine effectively restores T-cell rejection function in tumors. Cancer Res 2013;73:3591-603.
50. Bugelski PJTreacy G Predictive power of preclinical studies in animals for the immunogenicity of recombinant therapeutic proteins in humans. Curr Opin Mol Ther 2004;6:10-6