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Bermekimab

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From Wikipedia, the free encyclopedia

Monoclonal antibody

Pharmaceutical compound

Bermekimab
Monoclonal antibody
Type	Whole antibody
Source	Human
Target	IL1A
Clinical data
Trade names	Xilonix
Other names	MABp1
Routes of administration	intravenous
ATC code	L01FX11 (WHO)
Identifiers
CAS Number	1401965-15-8
DrugBank	DB14947
ChemSpider	none
UNII	N6SVN735GY
KEGG	D11253
Chemical and physical data
Formula	C₆₄₆₄H₁₀₀₂₄N₁₇₃₆O₂₀₀₀S₄₄
Molar mass	145468.09 g·mol⁻¹

Bermekimab^[1] (MABp1, trade nameXilonix) is a humanmonoclonal antibody ofIgG1k isotype targeting Interleukin 1 alpha (IL1A).^[2]

Bermekimab was developed byXBiotech Inc.^[3]

After Phase III trials in Poland failed to show significant improvement in either lean body mass or quality of life, theEuropean Medicines Agency (EMA) rejected the drug application^[4].

The companyJanssen Pharmaceutical acquired the license for the drug from XBiotech^[5] for the treatment ofatopic dermatitis andhidradenitis suppurativa for $750 million.

As of June 2021^[update], bermekimab was also terminated in phase IIIclinical trials as animmunotherapy for advancedcolorectal cancer^[6]. The original aim was to treat the debilitating symptoms seen in patients with advanced colorectal cancer, such asmuscle wasting. The study was terminated as it had crossed the prospective futility boundary of primary endpoint.

As of March 2021^[update] an additional phase II clinical trial for the treatment ofatopic dermatitis was completed^[7]. Janessen andJohnson & Johnson announced was ending development of bermekimab in eczema but said it will continue to work on the previously rejected XBiotech drug in hidradenitis suppurativa (HS). The move resulted in a $610 million pretax impairment charge^[8].

References

[edit]

^Statement On A Nonproprietary Name Adopted By The USAN Council - Bermekimab,American Medical Association.
^Hong DS, Hui D, Bruera E, Janku F, Naing A, Falchook GS, et al. (May 2014). "MABp1, a first-in-class true human antibody targeting interleukin-1α in refractory cancers: an open-label, phase 1 dose-escalation and expansion study".The Lancet. Oncology.15 (6):656–66.doi:10.1016/S1470-2045(14)70155-X.PMID 24746841.
^"Xilonix True Human monoclonal antibody by Xbiotech oncology".www.xbiotech.com. XBiotech. Retrieved3 March 2017.
^https://www.fiercebiotech.com/biotech/xbiotech-s-worst-fears-come-true-as-ema-rejects-colorectal-cancer-drug
^https://www.jnj.com/media-center/press-releases/janssen-to-acquire-investigational-bermekimab-from-xbiotech
^Clinical trial numberNCT01767857 for "A Phase III Study of Xilonix in Patients With Advanced Colorectal Cancer (XCITE)" atClinicalTrials.gov
^Clinical trial numberNCT03496974 for "A Phase II Study of Bermekimab (MABp1) in Patients With Moderate to Severe Atopic Dermatitis" atClinicalTrials.gov
^https://www.fiercebiotech.com/biotech/j-j-discontinues-work-eczema-drug-leading-to-610m-impairment-charges-for-ex-xbiotech-asset

Targeted cancer therapy /antineoplastic agents (L01)

CI monoclonal antibodies ("-mab")

Receptor tyrosine kinase	ErbB:HER1/EGFR (Cetuximab Panitumumab) HER2/neu (Pertuzumab Trastuzumab (+hyaluronidase) Trastuzumab emtansine Trastuzumab deruxtecan Zanidatamab )
Others for solid tumors	EpCAM (Catumaxomab Edrecolomab) VEGF-A (Bevacizumab)
Leukemia/lymphoma	lymphoid:CD3 (Glofitamab,Elranatamab,Mosunetuzumab),CD20 (Glofitamab Ibritumomab Mosunetuzumab Obinutuzumab Ofatumumab Rituximab Tositumomab),CD30 (Brentuximab),CD52 (Alemtuzumab) myeloid:CD33 (Gemtuzumab ozogamicin)
Other	Amivantamab Atezolizumab (+hyaluronidase) Avelumab Axatilimab Belantamab mafodotin Bermekimab Blinatumomab Cemiplimab Cosibelimab Daratumumab Dinutuximab beta Dostarlimab Durvalumab Elotuzumab Enfortumab vedotin Epcoritamab Inotuzumab ozogamicin Ipilimumab Isatuximab Linvoseltamab Loncastuximab tesirine Mirvetuximab soravtansine Mogamulizumab Moxetumomab pasudotox Naxitamab Necitumumab Nivolumab (+hyaluronidase,+relatlimab) Olaratumab Oportuzumab monatox Pembrolizumab (+berahyaluronidase alfa) Penpulimab Polatuzumab vedotin Prolgolimab Ramucirumab Retifanlimab Sabatolimab Sacituzumab govitecan Serplulimab Sugemalimab Tafasitamab Talquetamab Tarlatamab Teclistamab Tislelizumab Tisotumab vedotin Toripalimab Tremelimumab Zenocutuzumab Zolbetuximab

Tyrosine kinase inhibitors ("-nib")

Receptor tyrosine kinase

HER1/EGFR andHER2/neu

BRAF

RTK class III:C-kit andPDGFR (Avapritinib
Axitinib
Masitinib
Pazopanib
Ripretinib
Sorafenib
Sunitinib
Toceranib)
FLT3 (Lestaurtinib,Gilteritinib (AXL, ALK, LTK))

VEGFR

ALK

RET inhibitors:Entrectinib (ALK, ROS1, NTRK),Futibatinib (FGFR2),Infigratinib,Larotrectinib (NTRK),Pemigatinib (FGFR),Pralsetinib,Repotrectinib (ROS1, TRK, ALK),Selpercatinib (VEGFR, FGFR),Taletrectinib (ROS1),Vandetanib (VEGFR, EGFR).

c-MET inhibitors:Cabozantinib (VEGFR),Capmatinib,Crizotinib (ALK)

Non-receptor

bcr-abl

Src (Bosutinib
Dasatinib)

Janus kinase (JAK)

MAP2K (MEK)

EML4-ALK

Bruton's (BTK)

Other

fusion protein againstVEGF (Aflibercept)

proapoptotic peptide againstANXA2 andprohibitin (Adipotide)

exotoxin againstIL-2 (Denileukin diftitox)

mTOR inhibitors

hedgehog inhibitors

CDK inhibitors

KRAS inhibitors
- Adagrasib
- Sotorasib

Pi3K inhibitors

Menin inhibitors
- Revumenib
- Ziftomenib

Fibroblast growth factor receptor (FGFR) inhibitors
Erdafitinib
Futibatinib
Infigratinib
Pemigatinib

Monoclonal antibodies for tumors

Tumor

Human	Adecatumumab^§ Amivantamab Ascrinvacumab^§ Balstilimab^† Botensilimab Cixutumumab^§ Conatumumab^§ Cosibelimab Daratumumab Drozitumab^§ Duligotumab^§ Dusigitumab^§ Enfortumab vedotin Enoticumab^§ Figitumumab^§ Flanvotumab^§ Ganitumab^† Glembatumumab vedotin^† Intetumumab^§ Ipilimumab Iratumumab^§ Istiratumab Icrucumab^§ Lexatumumab^§ Linvoseltamab Lucatumumab^§ Mapatumumab^§ Narnatumab^§ Necitumumab Nesvacumab^§ Nivolumab^# (+hyaluronidase,+relatlimab) Ofatumumab Olaratumab^† Panitumumab Patritumab^§ Pritumumab^§ Radretumab^§ Ramucirumab Rilotumumab^† Robatumumab^§ Seribantumab^§ Sugemalimab Tarextumab^§ Tisotumab vedotin Teprotumumab^† Tovetumab^§ Vantictumab^§ Votumumab^§ Zalutumumab^†
Mouse	Abagovomab Altumomab pentetate Anatumomab mafenatox Arcitumomab Bectumomab Blinatumomab Capromab pendetide Detumomab Edrecolomab Ibritumomab tiuxetan Igovomab Lilotomab Minretumomab Mitumomab Nacolomab tafenatox Moxetumomab pasudotox Naptumomab estafenatox Oregovomab Pemtumomab^† Racotumomab Satumomab pendetide Solitomab Taplitumomab paptox Nofetumomab merpentan Pintumomab Tenatumomab Tositumomab
Chimeric	Amatuximab^§ Bavituximab^§ Brentuximab vedotin Carotuximab^† Cetuximab Derlotuximab biotin^§ Dinutuximab Ecromeximab^§ Ensituximab^§ Futuximab^§ Girentuximab^† Indatuximab ravtansine^§ Isatuximab Loncastuximab tesirine Margetuximab Mirvetuximab soravtansine Rituximab^# Siltuximab Ublituximab Zolbetuximab
Humanized	Abituzumab^§ Alemtuzumab Atezolizumab (+hyaluronidase) Axatilimab Belantamab mafodotin Bevacizumab Bivatuzumab mertansine^§ Brontictuzumab^§ Cantuzumab mertansine^§ Cantuzumab ravtansine^§ Cirmtuzumab Citatuzumab bogatox^§ Clivatuzumab tetraxetan Cofetuzumab pelidotin Dacetuzumab^§ Demcizumab^§ Dalotuzumab^§ Datopotamab deruxtecan Denintuzumab mafodotin^§ Elotuzumab Emactuzumab Emibetuzumab^§ Enoblituzumab^§ Epcoritamab Etaracizumab^§ Farletuzumab^§ Ficlatuzumab^§ Flotetuzumab^§ Gemtuzumab ozogamicin Glofitamab Imgatuzumab^§ Inotuzumab ozogamicin Labetuzumab^§ Lifastuzumab vedotin^§ Lintuzumab^§ Lorvotuzumab mertansine^§ Lumretuzumab^§ Matuzumab^§ Milatuzumab^§ Naxitamab Nimotuzumab^† Obinutuzumab Ocaratuzumab^§ Odronextamab Otlertuzumab^§ Onartuzumab^§ Oportuzumab monatox^† Parsatuzumab^§ Pembrolizumab^# (+berahyaluronidase alfa) Penpulimab Pertuzumab Pinatuzumab vedotin^§ Polatuzumab vedotin Rosmantuzumab Rovalpituzumab tesirine^† Sacituzumab govitecan Sibrotuzumab^§ Simtuzumab^§ Sofituzumab vedotin^§ Tacatuzumab tetraxetan^§ Tigatuzumab^§ Trastuzumab^# (+deruxtecan /+emtansine) Tucotuzumab celmoleukin^§ Vandortuzumab vedotin^§ Vanucizumab^§ Veltuzumab^§ Vorsetuzumab mafodotin^§ Zenocutuzumab
Rat/mouse hybrid	Catumaxomab Ertumaxomab^§
Chimeric + humanized	Depatuxizumab mafodotin^† Duvortuxizumab Ontuxizumab^§

^#WHO-EM
^‡Withdrawn from market
Clinical trials:
- ^†Phase III
- ^§Never to phase III

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