NHS-IL12, a Tumor-Targeting Immunocytokine

References

• Colombo MP, Trinchieri G. Interleukin-12 in anti-tumor immunity and immunotherapy. Cytokine Growth Factor Rev. 2002;13(2):155–168. doi:10.1016/s1359-6101(01)00032-6
   PubMed Web of Science ®Google Scholar
• Lu X. Impact of IL-12 in cancer. Curr Cancer Drug Targets. 2017;17(8):682–697. doi:10.2174/1568009617666170427102729
   PubMed Web of Science ®Google Scholar
• Del Vecchio M, Bajetta E, Canova S, et al. Interleukin-12: biological properties and clinical application. Clin Cancer Res. 2007;13(16):4677–4685. doi:10.1158/1078-0432.Ccr-07-0776
   PubMed Web of Science ®Google Scholar
• Brunda MJ, Luistro L, Rumennik L, et al. Antitumor activity of interleukin 12 in preclinical models. Cancer Chemother Pharmacol. 1996;38(Suppl):S16–S21. doi:10.1007/s002800051031
   PubMed Web of Science ®Google Scholar
• Nakajima C, Uekusa Y, Iwasaki M, et al. A role of interferon-gamma (IFN-gamma) in tumor immunity: t cells with the capacity to reject tumor cells are generated but fail to migrate to tumor sites in IFN-gamma-deficient mice. Cancer Res. 2001;61(8):3399–3405.
   Web of Science ®Google Scholar
• Nastala CL, Edington HD, McKinney TG, et al. Recombinant IL-12 administration induces tumor regression in association with IFN-gamma production. J Immunol. 1994;153(4):1697–1706.
   PubMed Web of Science ®Google Scholar
• Chowdhury FZ, Ramos HJ, Davis LS, Forman J, Farrar JD. IL-12 selectively programs effector pathways that are stably expressed in human CD8+ effector memory T cells in vivo. Blood. 2011;118(14):3890–3900. doi:10.1182/blood-2011-05-357111
   Web of Science ®Google Scholar
• Schmitt N, Bustamante J, Bourdery L, et al. IL-12 receptor β1 deficiency alters in vivo T follicular helper cell response in humans. Blood. 2013;121(17):3375–3385. doi:10.1182/blood-2012-08-448902
   PubMed Web of Science ®Google Scholar
• Aste-Amezaga M, D’Andrea A, Kubin M, Trinchieri G. Cooperation of natural killer cell stimulatory factor/interleukin-12 with other stimuli in the induction of cytokines and cytotoxic cell-associated molecules in human T and NK cells. Cell Immunol. 1994;156(2):480–492. doi:10.1006/cimm.1994.1192
   Web of Science ®Google Scholar
• Xu C, Zhang Y, Rolfe PA, et al. Combination therapy with NHS-muIL12 and avelumab (anti-PD-L1) enhances antitumor efficacy in preclinical cancer models. Clin Cancer Res. 2017;23(19):5869–5880. doi:10.1158/1078-0432.Ccr-17-0483
   PubMed Web of Science ®Google Scholar
• Cheever MA. Twelve immunotherapy drugs that could cure cancers. Immunol Rev. 2008;222:357–368. doi:10.1111/j.1600-065X.2008.00604.x
   PubMed Web of Science ®Google Scholar
• Haicheur N, Escudier B, Dorval T, et al. Cytokines and soluble cytokine receptor induction after IL-12 administration in cancer patients. Clin Exp Immunol. 2000;119(1):28–37. doi:10.1046/j.1365-2249.2000.01112.x
   PubMed Web of Science ®Google Scholar
• Leonard JP, Sherman ML, Fisher GL, et al. Effects of single-dose interleukin-12 exposure on interleukin-12-associated toxicity and interferon-gamma production. Blood. 1997;90(7):2541–2548.
   PubMed Web of Science ®Google Scholar
• Nguyen KG, Vrabel MR, Mantooth SM, et al. Localized Interleukin-12 for cancer immunotherapy. Front Immunol. 2020;11:575597. doi:10.3389/fimmu.2020.575597
   PubMed Web of Science ®Google Scholar
• Zaharoff DA, Hance KW, Rogers CJ, Schlom J, Greiner JW. Intratumoral immunotherapy of established solid tumors with chitosan/IL-12. J Immunother. 2010;33(7):697–705. doi:10.1097/CJI.0b013e3181eb826d
   PubMed Web of Science ®Google Scholar
• Grabnar I, Bogataj M, Mrhar A. Influence of chitosan and polycarbophil on permeation of a model hydrophilic drug into the urinary bladder wall. Int J Pharm. 2003;256(1–2):167–173. doi:10.1016/s0378-5173(03)00074-7
   PubMed Web of Science ®Google Scholar
• Zaharoff DA, Hoffman BS, Hooper HB, et al. Intravesical immunotherapy of superficial bladder cancer with chitosan/interleukin-12. Cancer Res. 2009;69(15):6192–6199. doi:10.1158/0008-5472.Can-09-1114
   PubMed Web of Science ®Google Scholar
• Gillies SD, Lan Y, Wesolowski JS, et al. Antibody-IL-12 fusion proteins are effective in SCID mouse models of prostate and colon carcinoma metastases. J Immunol. 1998;160(12):6195–6203.
   Web of Science ®Google Scholar
• Yu L, Ju DW, Chen W, et al. 131I-chTNT radioimmunotherapy of 43 patients with advanced lung cancer. Cancer Biother Radiopharm. 2006;21(1):5–14. doi:10.1089/cbr.2006.21.5
   Web of Science ®Google Scholar
• Sharifi J, Khawli LA, Hu P, King S, Epstein AL. Characterization of a phage display-derived human monoclonal antibody (NHS76) counterpart to chimeric TNT-1 directed against necrotic regions of solid tumors. Hybrid Hybridomics. 2001;20(5–6):305–312. doi:10.1089/15368590152740707
   Google Scholar
• Eckert F, Schmitt J, Zips D, et al. Enhanced binding of necrosis-targeting immunocytokine NHS-IL12 after local tumour irradiation in murine xenograft models. Cancer Immunol Immunother. 2016;65(8):1003–1013. doi:10.1007/s00262-016-1863-0
   PubMed Web of Science ®Google Scholar
• Fallon J, Tighe R, Kradjian G, Guzman W, Bernhardt A, Neuteboom B, Lan Y, Sabzevari H, Schlom J, Greiner JW. The immunocytokine NHS-IL12 as a potential cancer therapeutic. Oncotarget. 2014;5(7):1869–1884.
   Google Scholar
• Mariani G, Lasku A, Balza E, et al. Tumor targeting potential of the monoclonal antibody BC-1 against oncofetal fibronectin in nude mice bearing human tumor implants. Cancer. 1997;80(12 Suppl):2378–2384.
   Web of Science ®Google Scholar
• Rudman SM, Jameson MB, McKeage MJ, et al. A phase 1 study of AS1409, a novel antibody-cytokine fusion protein, in patients with malignant melanoma or renal cell carcinoma. Clin Cancer Res. 2011;17(7):1998–2005. doi:10.1158/1078-0432.Ccr-10-2490
   Web of Science ®Google Scholar
• Morillon YMII, Su Z, Schlom J, Greiner JW. Temporal changes within the (bladder) tumor microenvironment that accompany the therapeutic effects of the immunocytokine NHS-IL12. J Immunother Cancer. 2019;7(1):150. doi:10.1186/s40425-019-0620-2
   Web of Science ®Google Scholar
• Vandeveer AJ, Schlom J, Greiner JW. Systemic immunotherapeutic efficacy of an immunocytokine, NHS-muIL12, in a superficial murine orthotopic bladder cancer model (abstr 1480). Cancer Res. 2016;76(14 Suppl):. doi:10.1158/1538-7445.AM2016-1480
   Web of Science ®Google Scholar
• Maeda H, Wu J, Sawa T, Matsumura Y, Hori K. Tumor vascular permeability and the EPR effect in macromolecular therapeutics: a review. J Control Release. 2000;65(1–2):271–284. doi:10.1016/s0168-3659(99)00248-5
   PubMed Web of Science ®Google Scholar
• Macatonia SE, Hosken NA, Litton M, et al. Dendritic cells produce IL-12 and direct the development of Th1 cells from naive CD4+ T cells. J Immunol. 1995;154(10):5071–5079.
   PubMed Web of Science ®Google Scholar
• Newton MR, Askeland EJ, Andresen ED, et al. Anti-interleukin-10R1 monoclonal antibody in combination with bacillus Calmette–Guérin is protective against bladder cancer metastasis in a murine orthotopic tumour model and demonstrates systemic specific anti-tumour immunity. Clin Exp Immunol. 2014;177(1):261–268. doi:10.1111/cei.12315
   PubMed Web of Science ®Google Scholar
• Stromnes IM, Brockenbrough JS, Izeradjene K, et al. Targeted depletion of an MDSC subset unmasks pancreatic ductal adenocarcinoma to adaptive immunity. Gut. 2014;63(11):1769–1781. doi:10.1136/gutjnl-2013-306271
   PubMed Web of Science ®Google Scholar
• Strauss J, Heery CR, Kim JW, et al. First-in-human phase I trial of a tumor-targeted cytokine (NHS-IL12) in subjects with metastatic solid tumors. Clin Cancer Res. 2019;25(1):99–109. doi:10.1158/1078-0432.Ccr-18-1512
   PubMed Web of Science ®Google Scholar
• Gumperz JE. CD1d-restricted “NKT” cells and myeloid IL-12 production: an immunological crossroads leading to promotion or suppression of effective anti-tumor immune responses? J Leukoc Biol. 2004;76(2):307–313. doi:10.1189/jlb.0104038
   Web of Science ®Google Scholar
• Cha E, Fong L. Shuffling the deck with CTLA-4 therapy: deep sequencing of rearranged TCRB genes demonstrates T cell repertoire remodeling in cancer patients. Oncoimmunology. 2018;7(4):e956016. doi:10.4161/21624011.2014.956016
   PubMed Web of Science ®Google Scholar
• Sheikh N, Cham J, Zhang L, et al. Clonotypic diversification of intratumoral T cells following sipuleucel-T treatment in prostate cancer subjects. Cancer Res. 2016;76(13):3711–3718. doi:10.1158/0008-5472.Can-15-3173
   PubMed Web of Science ®Google Scholar
• Samuel J, Budzynski WA, Reddish MA, et al. Immunogenicity and antitumor activity of a liposomal MUC1 peptide-based vaccine. Int J Cancer. 1998;75(2):295–302. doi:10.1002/(sici)1097-0215(19980119)75:2<295::aid-ijc20>3.0.co;2-b
   PubMed Web of Science ®Google Scholar
• Reits EA, Hodge JW, Herberts CA, et al. Radiation modulates the peptide repertoire, enhances MHC class I expression, and induces successful antitumor immunotherapy. J Exp Med. 2006;203(5):1259–1271. doi:10.1084/jem.20052494
   PubMed Web of Science ®Google Scholar
• Eckert F, Jelas I, Oehme M, et al. Tumor-targeted IL-12 combined with local irradiation leads to systemic tumor control via abscopal effects in vivo. Oncoimmunology. 2017;6(6):e1323161. doi:10.1080/2162402x.2017.1323161
   PubMed Web of Science ®Google Scholar
• Farsaci B, Higgins JP, Hodge JW. Consequence of dose scheduling of sunitinib on host immune response elements and vaccine combination therapy. Int J Cancer. 2012;130(8):1948–1959. doi:10.1002/ijc.26219
   PubMed Web of Science ®Google Scholar
• Burris HA 3rd, Moore MJ, Andersen J, et al. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol. 1997;15(6):2403–2413. doi:10.1200/jco.1997.15.6.2403
   PubMed Web of Science ®Google Scholar
• Hodge JW, Garnett CT, Farsaci B, et al. Chemotherapy-induced immunogenic modulation of tumor cells enhances killing by cytotoxic T lymphocytes and is distinct from immunogenic cell death. Int J Cancer. 2013;133(3):624–636. doi:10.1002/ijc.28070
   PubMed Web of Science ®Google Scholar
• Fallon JK, Vandeveer AJ, Schlom J, Greiner JW. Enhanced antitumor effects by combining an IL-12/anti-DNA fusion protein with avelumab, an anti-PD-L1 antibody. Oncotarget. 2017;8(13):20558–20571. doi:10.18632/oncotarget.16137
   PubMedGoogle Scholar
• Love MI, Huber W, Anders S. Moderated estimation of fold change and dispersion for RNA-seq data with DESeq2. Genome Biol. 2014;15(12):550. doi:10.1186/s13059-014-0550-8
   PubMed Web of Science ®Google Scholar
• Balkwill F. Tumor necrosis factor or tumor promoting factor? Cytokine Growth Factor Rev. 2002;13(2):135–141. doi:10.1016/s1359-6101(01)00020-x
   PubMed Web of Science ®Google Scholar
• Roberts NJ, Zhou S, Diaz LA, Holdhoff M, Systemic use of tumor necrosis factor alpha as an anticancer agent. Oncotarget. 2011;2(10):739–751. doi:10.18632/oncotarget.344
   PubMedGoogle Scholar
• Kanegane C, Sgadari C, Kanegane H, et al. Contribution of the CXC chemokines IP-10 and Mig to the antitumor effects of IL-12. J Leukoc Biol. 1998;64(3):384–392. doi:10.1002/jlb.64.3.384
   Web of Science ®Google Scholar
• Yang JC, Perry-Lalley D. The envelope protein of an endogenous murine retrovirus is a tumor-associated T-cell antigen for multiple murine tumors. J Immunother. 2000;23(2):177–183. doi:10.1097/00002371-200003000-00001
   PubMed Web of Science ®Google Scholar
• Bianchi R, Grohmann U, Vacca C, Belladonna ML, Fioretti MC, Puccetti P. Autocrine IL-12 is involved in dendritic cell modulation via CD40 ligation. J Immunol. 1999;163(5):2517–2521.
   Web of Science ®Google Scholar
• Lee KL, Benz SC, Hicks KC, et al. Efficient tumor clearance and diversified immunity through neoepitope vaccines and combinatorial immunotherapy. Cancer Immunol Res. 2019;7(8):1359–1370. doi:10.1158/2326-6066.Cir-18-0620
   Web of Science ®Google Scholar
• Smalley Rumfield C, Pellom ST, Morillon IYM, Schlom J, Jochems C. Immunomodulation to enhance the efficacy of an HPV therapeutic vaccine. J Immunother Cancer. 2020;8(1):e000612. doi:10.1136/jitc-2020-000612
   PubMed Web of Science ®Google Scholar
• Strauss J, Vugmeyster Y, Sznol M, et al. Phase 1b, open-label, dose-escalation study of M9241 (NHS-IL12) plus avelumab in patients (pts) with advanced solid tumors (abstr 4062). Ann Oncol. 2019;30(suppl_5):v475–v532. doi:10.1093/annonc/mdz253
   Google Scholar