Changes to International Nonproprietary Names for antibody therapeutics 2017 and beyond: of mice, men and more

References

• Burns R. To a mouse, on turning her up in her nest with the plough. 1785. The Complete Works of Robert Burns. http://www.robertburns.org/works/75.shtml
   Google Scholar
• Jones TD, Carter PJ, Plückthun A, Vasquez M, Holgate RG, Hotzel I, Popplewell AG, Parren PW, Enzelberger M, Rademaker HJ, et al. The INNs and outs of antibody nonproprietary names. MAbs 2016; 8:1-9; PMID:26716992; https://doi.org/10.1080/19420862.2015.1114320
   PubMed Web of Science ®Google Scholar
• World Health Organization. International non-proprietary names for pharmaceutical substances (INNs). RECOMMENDED international nonproprietary names: List 77. WHO Drug Inform 2017; 31(1): 1-150. http://www.who.int/medicines/publications/druginformation/issues/77_INN_Recommended_List.pdf?ua=1
   Google Scholar
• World Health Organization. 62nd Consultation on International Nonproprietary Names for Pharmaceutical Substances. Geneva, 12–15 April. 2016. INN Working Doc. 16.395. July 2016. http://www.who.int/medicines/services/inn/62nd_Executive_Summary.pdf?ua=1
   Google Scholar
• Gillies SD, Lo KM, Wesolowski J. High-level expression of chimeric antibodies using adapted cDNA variable region cassettes. J Immunol Methods 1989; 125:191-202; PMID:2514231; https://doi.org/10.1016/0022-1759(89)90093-8
   PubMed Web of Science ®Google Scholar
• Di Paolo J, Breckenridge D, Bates J, Tumas D. Combinations of the BTK inhibitor GS-4059 with inhibitors selected from a JAK, ASK1, BRD and/or MMP9 inhibitor to treat cancer, allergic disorders, autoimmune diseases or inflammatory diseases. 2017. WO 2017/059252.
   Google Scholar
• Reilly EB, Phillips AC, Buchanan FG, Kingsbury G, Zhang Y, Meulbroek JA, Cole TB, DeVries PJ, Falls HD, Beam C, et al. Characterization of ABT-806, a humanized tumor-specific anti-EGFR monoclonal antibody. Mol Cancer Ther 2015; 14:1141-51; PMID:25731184; https://doi.org/10.1158/1535-7163.MCT-14-0820
   PubMed Web of Science ®Google Scholar
• Finney HM, Lawson ADG, Shaw SG, Smith BJ, Tyson K, Kevorkian L. Anti-FcRn antibodies. 2014. WO2014/019727 A1.
   Google Scholar
• Holgate RG, Weldon R, Jones TD, Baker MP. Characterisation of a novel anti-CD52 antibody with improved efficacy and reduced immunogenicity. PLoS One 2015; 10:e0138123; PMID:26372145; https://doi.org/10.1371/journal.pone.0138123
   PubMed Web of Science ®Google Scholar
• Ehrenmann F, Kaas Q, Lefranc MP. IMGT/3Dstructure-DB and IMGT/DomainGapAlign: A database and a tool for immunoglobulins or antibodies, T cell receptors, MHC, IgSF and MhcSF. Nucleic Acids Res 2010; 38:D301-7; PMID:19900967; https://doi.org/10.1093/nar/gkp946
   PubMed Web of Science ®Google Scholar
• Ehrenmann F, Lefranc MP. IMGT/DomainGapAlign: IMGT standardized analysis of amino acid sequences of variable, constant, and groove domains (IG, TR, MH, IgSF, MhSF). Cold Spring Harb Protoc 2011; 2011:737-49; PMID:21632775; https://doi.org/10.1101/pdb.prot5636
   PubMedGoogle Scholar
• World Health Organization. International nonproprietary names for pharmaceutical substances (INNs). RECOMMENDED international nonproprietary names (Rec. INNs): List 45. WHO Drug Inform 2001; 15(1): 40. http://www.who.int/medicines/publications/druginformation/innlists/RL45.pdf?ua = 1
   Google Scholar
• World Health Organization. International nonproprietary names for pharmaceutical substances (INNs). RECOMMENDED international nonproprietary names: List 57. WHO Drug Inform 2007; 21:53-83. http://www.who.int/medicines/publications/druginformation/innlists/RL57.pdf?ua=1
   Google Scholar
• American Medical Association. United States Adopted Name (USAN) Drug Finder. 2017. https://searchusan.ama-assn.org/finder/usan/search/*/relevant/1
   Google Scholar
• Lacy SE, Wu C, Ambrosi DJ, Hsieh CM, Bose S, Miller R, Conlon DM, Tarcsa E, Chari R, Ghayur T, et al. Generation and characterization of ABT-981, a dual variable domain immunoglobulin (DVD-Ig(TM)) molecule that specifically and potently neutralizes both IL-1alpha and IL-1beta. MAbs 2015; 7:605-19; PMID:25764208; https://doi.org/10.1080/19420862.2015.1026501
   PubMed Web of Science ®Google Scholar
• Garrone P, Djossou O, Fossiez F, Banchereau J. Human monoclonal antibodies against human cytokines and methods of making and using such antibodies. 1995. WO95/14780.
   Google Scholar
• World Health Organization. 63rd Consultation on International Nonproprietary Names for Pharmaceutical Substances. Geneva, 18–21 October. 2016. INN Working Doc. 17.408. January 2017. http://www.who.int/medicines/services/inn/63rd_Executive_Summary.pdf?ua=1
   Google Scholar
• World Health Organization. Revised monoclonal antibody (mAb) nomenclature scheme. INN Working Doc. 17.416. May 2017. http://www.who.int/medicines/services/inn/Revised_mAb_nomenclature_scheme.pdf?ua=1
   Google Scholar
• European Medines Agency. Assessment report. Zinbryta. International non-proprietary name: daclizumab. 2016. EMA/458317/2016. Committee for Medicinal Products for Human Use (CHMP). http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/003862/WC500210601.pdf
   Google Scholar
• American Medical Association. Monoclonal Antibodies. 2017. https://www.ama-assn.org/about/monoclonal-antibodies
   Google Scholar
• Robak T, Windyga J, Trelinski J, von Depka Prondzinski M, Giagounidis A, Doyen C, Janssens A, Alvarez-Román MT, Jarque I, Loscertales J, et al. Rozrolimupab, a mixture of 25 recombinant human monoclonal RhD antibodies, in the treatment of primary immune thrombocytopenia. Blood 2012; 120:3670-6; PMID:22915649; https://doi.org/10.1182/blood-2012-06-438804
   PubMed Web of Science ®Google Scholar
• Food and Drug Administration. Nonproprietary Naming of Biological Products. Guidance for Industry. 2017. U.S. Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research (CDER). Center for Biologics Evaluation and Research (CBER). January 2017 Labeling. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM459987.pdf
   Google Scholar
• Institute for Safe Medication Practices. The National Alert Network. Confusion regarding the generic name of the HER2-targeted drug KADCYLA (ado-trastuzumab emtansine). 2013. https://www.ismp.org/NAN/files/20130417.pdf
   Google Scholar
• World Health Organization. Biological Qualifier An INN Proposal. Programme on International Nonproprietary Names (INNs). 2015. INN Working Doc. 14.342. Rev. Final October 2015. http://www.who.int/medicines/services/inn/WHO_INN_BQ_proposal_2015.pdf?ua=1
   Google Scholar
• Department of Health and Human Services. Food and Drug Adminstration. Nonproprietary naming of biological products; guidance of industry; availability. Federal Register 2017; 82(9):4345-7. https://www.gpo.gov/fdsys/pkg/FR-2017-01-13/pdf/2017-00694.pdf
   Google Scholar
• World Health Organization. International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 116. WHO Drug Inform 2016; 30(4):605-710. http://www.who.int/medicines/publications/druginformation/innlists/PL116.pdf?ua=1
   Google Scholar
• World Health Organization. International Nonproprietary Names (INN) for biological and biotechnological substances (a review). 2014. WHO/EMP/RHT/TSN/2014.1. http://www.who.int/medicines/services/inn/BioRev2014.pdf?ua=1
   Google Scholar
• World Health Organization. The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances. 2013. WHO/EMP/RHT/TSN/2013.1. http://www.who.int/medicines/services/inn/StemBook_2013_Final.pdf?ua=1
   Google Scholar
• Reichert JM. Therapeutic monoclonal antibodies approved or in review in the European Union or the United States. 2017. http://www.antibodysociety.org/news/approved-antibodies/
   Google Scholar
• World Health Organization. International non-proprietary names. WHO Drug Inform 2009; 23:193-9. http://www.who.int/medicines/publications/druginformation/issues/DrugInfo09_Vol23-3.pdf?ua=1
   Google Scholar
• World Health Organization. Guidelines on the Use of INNs for Pharmaceutical Substances. 1997. WHO/PHARMS/NOM 1570. http://apps.who.int/iris/bitstream/10665/63779/1/WHO_PHARM_S_NOM_1570.pdf
   Google Scholar
• American Medical Association. Naming Biologics. 2017. https://www.ama-assn.org/about/naming-biologics
   Google Scholar
• American Medical Association. New Monoclonal Antibody Rules. 2017. https://www.ama-assn.org/sites/default/files/media-browser/public/usan/2015-mab-rules_0.pdf
   Google Scholar
• The International Immunogenetics Information System. IMGT/mAb-DB query page. 2017. http://www.imgt.org/mAb-DB/query
   Google Scholar
• Poiron C, Wu Y, Ginestoux C, Ehrenmann F, Duroux P, Lefranc MP. IMGT/mAb-DB: The IMGT® database for therapeutic monoclonal antibodies. 2010. http://www.imgt.org/IMGTposters/SFI2010_IMGTmAb-DB.pdf
   Google Scholar
• Yuan J, Qu X, Lin J, Ye X, Cao G, Tao W, Zhang L, Zhang L, Yang L. PD-1 antibody, antigen-binding fragment thereof, and medical application thereof. 2016. US2016/0376367.
   Google Scholar
• Rollins S, Alvarez R, Rother R, Kawar Z, Mcever R. Anti-P-selectin antibodies and methods of their use and identification. 2012. WO2012/088265.
   Google Scholar
• Bhinder TK, Ford SK, Gemaschewski V, Lewis AP, Pepys MB. Antigen binding proteins specific for serum amyloid P component. 2011. WO2011/107480.
   Google Scholar
• Russo AF, Kaiser E, Recober A, Kuburas A, Raddant AC, Kovacevich BR, Latham JA, Smith JTL, Garcia-Martinez LF. Use of anti-CGRP or anti-CGRP-R antibodies or antibody fragments to treat or prevent chronic and acute forms of diarrhea. 2012. WO2012/162253.
   Google Scholar
• Poulsen KT, Shelton DL, Zeller J, Machin I, Corradini L. Methods for treating chronic pain. 2016. US 9,328,167 B1.
   Google Scholar
• Hamann PR, Hinman LM, Hollander I, Beyer CF, Lindh D, Holcomb R, Hallett W, Tsou HR, Upeslacis J, Shochat D, et al. Gemtuzumab ozogamicin, a potent and selective anti-CD33 antibody-calicheamicin conjugate for treatment of acute myeloid leukemia. Bioconjug Chem 2002; 13:47-58; PMID:11792178; https://doi.org/10.1021/bc010021y
   PubMed Web of Science ®Google Scholar
• Bebbington CR, Yarranton GT, Palath V. Treatment of leukemias and chronic myeloproliferative diseases with antibodies to EPHA3. 2010. WO2010/102244.
   Google Scholar
• Gurney AL, Bond CJ. RSPO3 binding agents and uses thereof. 2014. WO2014/012007.
   Google Scholar
• Cardillo TM, Govindan SV, Sharkey RM, Trisal P, Goldenberg DM. Humanized anti-Trop-2 IgG-SN-38 conjugate for effective treatment of diverse epithelial cancers: Preclinical studies in human cancer xenograft models and monkeys. Clin Cancer Res 2011; 17:3157-69; PMID:21372224; https://doi.org/10.1158/1078-0432.CCR-10-2939
   PubMed Web of Science ®Google Scholar
• Wang J, Goetsch L, Tucker L, Zhang Q, Gonzalez A, Vaidya KS, Oleksijew A, Boghaert E, Song M, Sokolova I, et al. Anti-c-Met monoclonal antibody ABT-700 breaks oncogene addiction in tumors with MET amplification. BMC Cancer 2016; 16:105; PMID:26879245; https://doi.org/10.1186/s12885-016-2138-z
   PubMed Web of Science ®Google Scholar
• Wang J, Anderson MG, Oleksijew A, Vaidya KS, Boghaert ER, Tucker L, Zhang Q, Han EK, Palma JP, Naumovski L, et al. ABBV-399, a c-Met antibody-drug conjugate that targets both MET-amplified and c-Met-overexpressing tumors, irrespective of MET pathway dependence. Clin Cancer Res 2017; 23:992-1000; PMID:27573171; https://doi.org/10.1158/1078-0432.CCR-16-1568
   PubMed Web of Science ®Google Scholar
• Hudziak RM, Lewis GD, Winget M, Fendly BM, Shepard HM, Ullrich A. p185HER2 monoclonal antibody has antiproliferative effects in vitro and sensitizes human breast tumor cells to tumor necrosis factor. Mol Cell Biol 1989; 9:1165-72; PMID:2566907; https://doi.org/10.1128/MCB.9.3.1165
   PubMed Web of Science ®Google Scholar
• Zhang L, Liu J, Cao G, Sun P. IL17A binding agent and uses thereof. 2016. US2016/0289321.
   Google Scholar
• Sommer A, Kopitz C, Schatz CA, Nising CF, Mahlert C, Lerchen HG, Stelte-Ludwig B, Hammer S, Greven S, Schuhmacher J, et al. Preclinical efficacy of the Auristatin-based antibody-drug conjugate BAY 1187982 for the treatment of FGFR2-positive solid tumors. Cancer Res 2016; 76:6331-9; PMID:27543601; https://doi.org/10.1158/0008-5472.CAN-16-0180
   PubMed Web of Science ®Google Scholar
• Yamazaki Y, Urakawa I, Yoshida H, Yamashita T, Shimada T, Hasegawa H. anti-FGF23 antibody and a pharmaceutical composition comprising the same. 2011. US 7,883,705 B2.
   Google Scholar
• Towne JE, Cheng JD, O'Neill JC, Zhang L, Sun Y, Cerne H, Piper DE, Ketchem RR. Human IL23 antigen binding proteins. 2014. US 8,722,033 B2.
   Google Scholar
• Kock K, Pan WJ, Gow JM, Horner MJ, Gibbs JP, Colbert A, Goletz TJ, Newhall KL, Rees WA, Sun Y, et al. Preclinical development of AMG 139, a human antibody specifically targeting IL-23. Br J Pharmacol 2015; 172:159-72; PMID:25205227; https://doi.org/10.1111/bph.12904
   PubMed Web of Science ®Google Scholar
• Shabanzadeh AP, Tassew NG, Szydlowska K, Tymianski M, Banerjee P, Vigouroux RJ, Eubanks JH, Huang L, Geraerts M, Koeberle PD, et al. Uncoupling Neogenin association with lipid rafts promotes neuronal survival and functional recovery after stroke. Cell Death Dis 2015; 6:e1744; PMID:25950474; https://doi.org/10.1038/cddis.2015.109
   PubMed Web of Science ®Google Scholar
• Willuda J, Linden L, Lerchen HG, Kopitz C, Stelte-Ludwig B, Pena C, Lange C, Golfier S, Kneip C, Carrigan PE, et al. Preclinical anti-tumor efficacy of BAY 1129980 - a novel Auristatin-based Anti-C4.4A (LYPD3) antibody-drug conjugate for the treatment of non-small cell lung cancer. Mol Cancer Ther 2017; 16:893-904; PMID:28292941; https://doi.org/10.1158/1535-7163.MCT-16-0474
   PubMed Web of Science ®Google Scholar
• Salfeld JG, Allen DJ, Hoogenboom HRJM, Kaymakcalan Z, Labkovsky B, Mankovich JA, McGuinness BT, Roberts AJ, Sakorafas P, Schoenhaut D, et al. Human antibodies that bind human TNFα. 2001. US 6,258,562 B2.
   Google Scholar
• Hsieh C-M, Cuff C, Tarcsa E, Hugunin M. Discovery and characterization of ABT-122, an anti-TNF/IL17 DVD-Ig molecule as potential therapeutic candidate for rheumatoid arthritis. Abstract number 1421. Arthritis Rheumatism 2013; 65: abstract 4676. http://acrabstracts.org/abstract/discovery-and-characterization-of-abt-122-an-anti-tnfil-17-dvd-ig-molecule-as-a-potential-therapeutic-candidate-for-rheumatoid-arth
   Google Scholar
• Gurnett-Bander A, Perez-Caballero D, Sivapalasingam S, Duan X, MacDonald D. Human antibodies to respiratory syncytial virus F protein and methods of use thereof. 2016. US 9,447,173 B2.
   Google Scholar
• Fisher TS, Kamperschroer C, Oliphant T, Love VA, Lira PD, Doyonnas R, Bergqvist S, Baxi SM, Rohner A, Shen AC, et al. Targeting of 4-1BB by monoclonal antibody PF-05082566 enhances T-cell function and promotes anti-tumor activity. Cancer Immunol Immunother 2012; 61:1721-33; PMID:22406983; https://doi.org/10.1007/s00262-012-1237-1
   PubMed Web of Science ®Google Scholar
• Gearing DP, Virtue ER, Gearing RP, Drew AC. A fully caninised anti-NGF monoclonal antibody for pain relief in dogs. BMC Vet Res 2013; 9:226; PMID:24206926; https://doi.org/10.1186/1746-6148-9-226
   PubMed Web of Science ®Google Scholar
• World Health Organization. 64th Consultation on International Nonproprietary Names for Pharmaceutical Substances. Geneva, 4–7 April. 2017. In Preparation. http://www.who.int/medicines/services/inn/meetings/en/
   Google Scholar