Antibodies to watch in 2017

mAbs

Volumn 9, Issue 2, 2017, Pages 167-181

  Reichert, Janice M ^a  

^a Antibody Society   (United States)

Author keywords

Antibody therapeutics; cancer; European Medicines Agency; Food and Drug Administration; immune mediated disorders

Indexed keywords

ANETUMAB RAVTANSINE; AVELUMAB; BRODALUMAB; CAPLACIZUMAB; DECITABINE; DUPILUMAB; DURVALUMAB; EMAPALUMAB; EMICIZUMAB; EPTINEZUMAB; FASINUMAB; FREMANEZUMAB; GALCANEZUMAB; GLEMBATUMUMAB VEDOTIN; GUSELKUMAB; IBALIZUMAB; IBRUTINIB; INOTUZUMAB OZOGAMICIN; LANADELUMAB; MONOCLONAL ANTIBODY; OCRELIZUMAB; PRO 140; ROMOSOZUMAB; SARILUMAB; SIRUKUMAB; TICILIMUMAB; TILDRAKIZUMAB; TRALOKINUMAB; UBLITUXIMAB; UNINDEXED DRUG; ANTINEOPLASTIC AGENT;

ACUTE MYELOID LEUKEMIA; ANGIONEUROTIC EDEMA; ASTHMA; ATOPIC DERMATITIS; BLADDER CANCER; BREAST CANCER; CELL MEDIATED CYTOTOXICITY; COLORECTAL CANCER; CYTOGENETICS; DISEASE COURSE; DRUG EFFICACY; EUROPEAN MEDICINES AGENCY; FOOD AND DRUG ADMINISTRATION; HEMOPHAGOCYTIC SYNDROME; HUMAN; IMMUNOGENICITY; INFLAMMATION; LEUKEMIA CELL; MERKEL CELL TUMOR; MESOTHELIOMA; MIGRAINE; MULTIPLE SCLEROSIS; NEOPLASM; NONHUMAN; NOTE; OSTEOARTHRITIS; OSTEOPOROSIS; OVERALL SURVIVAL; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PHASE 4 CLINICAL TRIAL (TOPIC); PRIMARY TUMOR; PROGRESSION FREE SURVIVAL; PSORIASIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); RHEUMATOID ARTHRITIS; WESTERN ONTARIO AND MCMASTER UNIVERSITIES OSTEOARTHRITIS INDEX; UNITED STATES;

ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; HUMANS; NEOPLASMS; UNITED STATES;

EID: 85009967888     PISSN: 19420862     EISSN: 19420870     Source Type: Journal    
DOI: 10.1080/19420862.2016.1269580     Document Type: Note

References (55)

1. Reichert JM. Antibodies to watch in 2016. MAbs 2016; 8(2)197-204; PMID:26651519; http://dx.doi.org/10.1080/19420862.2015.1125583
2. Reichert JM. Antibodies to watch in 2015. MAbs 2015; 7(1):1-8; PMID:25484055; http://dx.doi.org/10.4161/19420862.2015.988944
3. Reichert JM. Antibodies to watch in 2014:Mid-year update. MAbs 2014; 6(4):799-802; PMID:24846335; http://dx.doi.org/10.4161/mabs.29282
4. Reichert JM. Antibodies to watch in 2014. MAbs 2014; 6(1):5-14; PMID:24284914; http://dx.doi.org/10.4161/mabs.27333
5. Reichert JM. Antibodies to watch in 2013:Mid-year update. MAbs 2013; 5(4):513-7; PMID:23727858; http://dx.doi.org/10.4161/mabs.24990
6. Reichert JM. Which are the antibodies to watch in 2013? MAbs 2013; 5(1):1-4; PMID:23254906; http://dx.doi.org/10.4161/mabs.22976
7. Reichert JM. Which are the antibodies to watch in 2012? MAbs 2012; 4(1):1-3; PMID:22327425; http://dx.doi.org/10.4161/mabs.4.1.18719
8. Reichert JM. Antibody-based therapeutics to watch in 2011. MAbs 2011; 3(1):76-99; PMID:21051951; http://dx.doi.org/10.4161/mabs.3.1.13895
9. Reichert JM. Antibodies to watch in 2010. MAbs 2010; 2(1):84-100; PMID:20065640; http://dx.doi.org/10.4161/mabs.2.1.10677
10. US Food and Drug Administration. FDA grants accelerated approval to new treatment for advanced soft tissue sarcoma. October19, 2016 press release. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm525878.htm
11. Hoffmann-La Roche F. Phase III efficacy results of investigational medicine OCREVUS® (ocrelizumab) reinforced by exploratory analyses in two forms of multiple sclerosis. September14, 2016 press release. http://www.roche.com/media/store/releases/med-cor-2016-09-14.htm
12. Kaufman HL, Russell J, Hamid O, Bhatia S, Terheyden P, D'Angelo SP, Shih KC, Lebbé, C, Linette GP, Milella M, et al. Avelumab in patients with chemotherapy-refractory metastatic Merkel cell carcinoma:a multicentre, single-group, open-label, phase 2 trial. Lancet Oncology 2016; 17:1374-85; PMID:27592805; http://dx.doi.org/10.1016/S1470-2045(16)30364-3
13. XBiotech Inc. XBiotech presents pivotal Phase III data showing Xilonix™ demonstrated significant clinical response in advanced colorectal cancer patients refractory to further treatment. July2, 2016 press release. http://investors.xbiotech.com/phoenix.zhtml?c=253990&p=irol-newsArticle&ID=2181642.
14. Kantarjian HM, DeAngelo DJ, Stelljes M, Martinelli G, Liedtke M, Stock W, Gökbuget N, O'Brien S, Wang K, Wang T, et al. Inotuzumab ozogamicin versus standard therapy for acute lymphoblastic leukemia. N Engl J Med 2016; 375:740-53; PMID:27292104; http://dx.doi.org/10.1056/NEJMoa1509277
15. Simpson EL, Bieber T, Guttman-Yassky E, Beck LA, Blauvelt A, Cork MJ, Silverberg JI, Deleuran M, Kataoka Y, Lacour JP, et al. Two Phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med 2016 Sep 30; 375:2335-48.
16. Janssen. Anti-interleukin-6 monoclonal antibody sirukumab efficacy and safety findings from SIRROUND-H and SIRROUND-T trials presented for the first time at the 2016 ACR/ARHP annual meeting. November16, 2016 press release. http://www.janssen.com/new-phase-3-monotherapy-study-sirukumab-versus-humira-and-sirukumab-data-anti-tnf-refractory
17. Regeneron Pharmaceuticals, Inc. Regeneron and Sanofi present results from Phase 3 MONARCH study of investigational sarilumab at American College of Rheumatology annual meeting. November16, 2016 press release. http://newsroom.regeneron.com/releasedetail.cfm?ReleaseID=999699
18. Burmester GR, Lin Y, Patel R, van Adelsberg J, Mangan EK, Graham NM, van Hoogstraten H, Bauer D, Ignacio Vargas J, Lee EB. Efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy for the treatment of patients with active rheumatoid arthritis (MONARCH):a randomised, double-blind, parallel-group phase III trial. Ann Rheum Dis 2016 Nov 17. pii:annrheumdis-2016-210310. http://dx.doi.org/10.1136/annrheumdis-2016-210310. [Epub ahead of print].
19. Janssen. New Phase 3 data show significant efficacy versus placebo and superiority of guselkumab versus Humira® in treatment of moderate to severe plaque psoriasis. October1, 2016 press release. www.janssen.com/new-phase-3-data-show-significant-efficacy-versus-placebo-and-superiority-guselkumab-versus-humira
20. Cosman F, Crittenden DB, Adachi JD, Binkley N, Czerwinski E, Ferrari S, Hofbauer LC, Lau E, Lewiecki EM, Miyauchi A, et al. Romosozumab treatment in postmenopausal women with osteoporosis. N Engl J Med 2016; 375:1532-1543; PMID:27641143; http://dx.doi.org/10.1056/NEJMoa1607948
21. Beck A, Reichert JM. Marketing approval of mogamulizumab:a triumph for glyco-engineering. MAbs 2012; 4:419-25; doi:10.4161/mabs.20996; PMID:22699226; http://dx.doi.org/10.4161/mabs.20996
22. Bleecker ER, FitzGerald JM, Chanez P, Papi A, Weinstein SF, Barker P, Sproule S, Gilmartin G, Aurivillius M, Werkström V, et al. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting β2-agonists (SIROCCO):a randomised, multicentre, placebo-controlled phase 3 trial. Lancet 2016; 388:2115-27; http://dx.doi.org/10.1016/S0140-6736(16)31324-1
23. FitzGerald JM, Bleecker ER, Nair P, Korn S, Ohta K, Lommatzsch M, Ferguson GT, Busse WW, Barker P, Sproule S, et al. Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA):a randomised, double-blind, placebo-controlled phase 3 trial. Lancet 2016; 388:2128-41; http://dx.doi.org/10.1016/S0140-6736(16)31322-8
24. Papp K, Thaçi D, Reich K, Riedl E, Langley RG, Krueger JG, Gottlieb AB, Nakagawa H, Bowman EP, Mehta A, et al. Tildrakizumab (MK-3222), an anti-interleukin-23p19 monoclonal antibody, improves psoriasis in a phase IIb randomized placebo-controlled trial. Br J Dermatol 2015; 173:930-9; PMID:26042589; http://dx.doi.org/10.1111/bjd.13932
25. Sun Pharma. Sun Pharma to announce late-breaking results for investigational IL-23p19 inhibitor, tildrakizumab, achieves primary endpoint in both Phase 3 studies in patients with moderate-to-severe plaque psoriasis. October1, 2016 press release. http://www.sunpharma.com/media/press-releases
26. Shima M, Hanabusa H, Taki M, Matsushita T, Sato T, Fukutake K, Fukazawa N, Yoneyama K, Yoshida H, Nogami K. Factor VIII-mimetic function of humanized bispecific antibody in hemophilia A. N Engl J Med 2016; 374:2044-53; PMID:27223146; http://dx.doi.org/10.1056/NEJMoa1511769
27. Sampei Z, Igawa T, Soeda T, Funaki M, Yoshihashi K, Kitazawa T, Muto A, Kojima T, Nakamura S, Hattori K. Non-antigen-contacting region of an asymmetric bispecific antibody to factors IXa/X significantly affects factor VIII-mimetic activity. MAbs 2015; 7:120-8; PMID:25524207; http://dx.doi.org/10.4161/19420862.2015.989028
28. Chugai. Chugai's proprietary technologies. http://www.chugai-pharm.co.jp/profile/pdf/eChugaiProprietaryTechnologies.pdf
29. Dodick DW, Goadsby PJ, Spierings EL, Scherer JC, Sweeney SP, Grayzel DS. Safety and efficacy of LY2951742, a monoclonal antibody to calcitonin gene-related peptide, for the prevention of migraine:a phase 2, randomised, double-blind, placebo-controlled study. Lancet Neurol 2014; 13:885-92; PMID:25127173; http://dx.doi.org/10.1016/S1474-4422(14)70128-0
30. Eli Lilly and Company. R&D update for the investment community. May24, 2016. http://files.shareholder.com/downloads/LLY/1558197365x0x893471/8F87B4E7-9E11-4894-BA1A-446062715EED/LLY_RandD_Update_AM_Session.pdf
31. Theratechnologies Inc. Phase III study primary endpoint results show ibalizumab significantly reduced viral load in patients with multi-drug resistant HIV-1. October28, 2016. http://theratech.com/sites/default/files/news_release_en/nr-th-20161028-en.pdf
32. CytoDyn. PRO140:First self-administered antibody therapy for HIV in late-stage clinical trial. Investor presentation, October11, 2016. http://content.equisolve.net/cytodyn/media/a142a8575db88331c0585a336ca2ebfd.pdf
33. Stewart R, Morrow M, Hammond SA, Mulgrew K, Marcus D, Poon E, Watkins A, Mullins S, Chodorge M, Andrews J, et al. Identification and characterization of MEDI4736, an antagonistic anti-PD-L1 monoclonal antibody. Cancer Immunol Res 2015; 3(9):1052-62; PMID:25943534; http://dx.doi.org/10.1158/2326-6066.CIR-14-0191
34. Planchard D, Yokoi T, McCleod MJ, Fischer JR, Kim YC, Ballas M, Shi K, Soria JC. A Phase III study of durvalumab (MEDI4736) with or without tremelimumab for previously treated patients with advanced NSCLC:Rationale and protocol design of the ARCTIC study. Clin Lung Cancer 2016; 17(3):232-236.e1; http://dx.doi.org/10.1016/j.cllc.2016.03.003
35. Lazar GA, Dang W, Karki S, Vafa O, Peng JS, Hyun L, Chan C, Chung HS, Eivazi A, Yoder SC, et al. Engineered antibody Fc variants with enhanced effector function. Proc Natl Acad Sci U S A 2006; 103(11):4005-10; PMID:16537476; http://dx.doi.org/10.1073/pnas.0508123103
36. Busfield SJ, Biondo M, Wong M, Ramshaw HS, Lee EM, Ghosh S, Braley H, Panousis C, Roberts AW, He SZ, et al. Targeting of acute myeloid leukemia in vitro and in vivo with an anti-CD123 mAb engineered for optimal ADCC. Leukemia 2014; 28(3):2213-21; PMID:24705479; http://dx.doi.org/10.1038/leu.2014.128
37. Broughton SE, Hercus TR, Hardy MP, McClure BJ, Nero TL, Dottore M, Huynh H, Braley H, Barry EF, Kan WL, et al. Dual mechanism of interleukin-3 receptor blockade by an anti-cancer antibody. Cell Rep 2014; 8(2):410-9; PMID:25043189; http://dx.doi.org/10.1016/j.celrep.2014.06.038
38. Oon S, Huynh H, Tai TY, Ng M, Monaghan K, Biondo M, Vairo G, Maraskovsky E, Nash AD, Wicks IP, et al. A cytotoxic anti-IL-3Rα antibody targets key cells and cytokines implicated in systemic lupus erythematosus. JCI Insight 2016; 1(6):e86131; PMID:27699260; http://dx.doi.org/10.1172/jci.insight.86131
39. Peyvandi F, Scully M, Kremer Hovinga JA, Cataland S, Knöbl P, Wu H, Artoni A, Westwood JP, Mansouri Taleghani M, Jilma B, et al. Caplacizumab for acquired thrombotic thrombocytopenic purpura. N Engl J Med 2016; 374(6):511-22; PMID:26863353; http://dx.doi.org/10.1056/NEJMoa1505533
40. Chyung Y, Vince B, Iarrobino R, Sexton D, Kenniston J, Faucette R, TenHoor C, Stolz LE, Stevens C, Biedenkapp J, et al. A phase 1 study investigating DX-2930 in healthy subjects. Ann Allergy Asthma Immunol 2014; 113(4):460-6.e2; http://dx.doi.org/10.1016/j.anai.2014.05.028
41. Yver A, Homery MC, Fuseau E, Guemas E, Dhainaut F, Quagliaroli D, Beliard R, Prost JF. Pharmacokinetics and safety of roledumab, a novel human recombinant monoclonal anti-RhD antibody with an optimized Fc for improved engagement of FCγRIII, in healthy volunteers. Vox Sang 2012; 103(3):213-22; PMID:22568808; http://dx.doi.org/10.1111/j.1423-0410.2012.01603.x
42. Brightling CE, Chanez P, Leigh R, O'Byrne PM, Korn S, She D, May RD, Streicher K, Ranade K, Piper E. Efficacy and safety of tralokinumab in patients with severe uncontrolled asthma:a randomised, double-blind, placebo-controlled, phase 2b trial. Lancet Respir Med 2015; 3(9):692-701; PMID:26231288; http://dx.doi.org/10.1016/S2213-2600(15)00197-6
43. Panettieri RA, Jr, Brightling C, Sjobring U, Péterffy A, Tornling G, Daoud SZ, Ranade K, Hollis S, Colice G. STRATOS 1 and 2:considerations in clinical trial design for a fully human monoclonal antibody in severe asthma. Clin Invest 2015; 5:701-11; http://dx.doi.org/10.4155/cli.15.38
44. Haraya K, Tachibana T, Iwayanagi Y, Maeda A, Ozeki K, Nezu J, Ishigai M, Igawa T. PK/PD analysis of a novel pH-dependent antigen-binding antibody using a dynamic antibody-antigen binding model. Drug Metab Pharmacokinet 2016; 31(2):123-32; PMID:26944099; http://dx.doi.org/10.1016/j.dmpk.2015.12.007
45. Jordan MB, Locatelli F, Allen C, De Benedetti F, Grom A, Ballabio M, Ferlin W, De Min C, on behalf of the NI-0501-04 Study Group. A novel targeted approach to the treatment of hemophagocytic lymphohistiocytosis (HLH) with NI-0501, an anti-IFNγ monoclonal antibody:First results from a pilot Phase 2 study in children with primary HLH. http://www.novimmune.com/temp/ASH2015Final.pdf
46. Sivapalasingam S, Caballero-Perez D, Houghton M, Yang F, Davis J, Gao B, Geba G. Phase 1 study evaluating safety, tolerability, pharmacokinetics and immunogenicity of REGN2222 in healthy adults:a new human monoclonal RSV-F antibody for RSV prevention. ID Week 2015. Poster Abstract Session:Clinical Trials. October 7-11, 2015, San Diego. https://idsa.confex.com/idsa/2015/webprogram/Paper53399.html
47. Novartis. Novartis announces Phase III study shows AMG 334 significantly reduces monthly migraine days in people with episodic migraine. September28, 2016 press release. https://www.novartis.com/news/media-releases/novartis-announces-phase-iii-study-shows-amg-334-significantly-reduces-monthly
48. Amgen. Amgen Announces erenumab significantly reduces monthly migraine days in patients with episodic migraine in second Phase 3 study. November16, 2016 press release. http://www.amgen.com/media/news-releases/2016/11/amgen-announces-erenumab-significantly-reduces-monthly-migraine-days-in-patients-with-episodic-migraine-in-second-phase-3-study/
49. Dodick D, Goadsby P, Silberstein S, Lipton R, Chakava G, O'Brien T, Hill R, Krause R, Bonner J, Koltun W, et al. Randomized, double-blind, placebo-controlled trial of ALD403, an anti-CGRP antibody in the prevention of chronic migraine. http://www.alderbio.com/wp-content/uploads/2016/09/Smith-EHMTIC2016poster08Sept2016_FINAL2.pdf
50. Bigal ME, Dodick DW, Krymchantowski AV, VanderPluym JH, Tepper SJ, Aycardi E, Loupe PS, Ma Y, Goadsby PJ. EV-48125 for the preventive treatment of chronic migraine:Efficacy at early time points. Neurology 2016; 87(1):41-8; PMID:27281531; http://dx.doi.org/10.1212/WNL.0000000000002801
51. Regeneron Pharmaceuticals, Inc. Regeneron announces positive topline results from phase 2/3 fasinumab study in patients with osteoarthritis pain. May2, 2016 press release. http://files.shareholder.com/downloads/REGN/959746525x0x889001/920E5C9C-AA16-4E97-98B7-8EFC55D0BD35/REGN_News_2016_5_2_General_Releases.pdf
52. Roche. Roche's lampalizumab phase II data shows benefit in patients with the advanced form of dry age-related macular degeneration. August27, 2013 press release. http://www.roche.com/investors/updates/inv-update-2013-08-27.htm
53. Brinkmann U, Kontermann RE. The making of bispecific antibodies. MAbs 2017; 9:in press.
54. Eli Lilly and Company. Lilly announces top-line results of solanezumab Phase 3 clinical trial. November23, 2016 press release. https://investor.lilly.com/releasedetail.cfm?ReleaseID=1000871
55. Pfizer Inc. Pfizer discontinues global development of bococizumab, its investigational PCSK9 inhibitor. November1, 2016 press release. http://www.pfizer.com/news/press-release/press-release-detail/pfizer_discontinues_global_development_of_bococizumab_its_investigational_pcsk9_inhibitor