DK2888280T3 - Humane antistoffer mod GFR3 og fremgangsmåder til anvendelse heraf - Google Patents
Humane antistoffer mod GFR3 og fremgangsmåder til anvendelse heraf Download PDFInfo
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Claims (15)
1. Isoleret antistof eller antigenbindingsfragment deraf, der specifikt binder til human GFRa3, hvor antistoffet omfatter de tre tungkæde-CDR’er (HCDR1, HCDR2 og HCDR3) og de tre letkæde-CDR’er (LCDR1, LCDR2 og LCDR3) indeholdt i et HCVR/LCVR-aminosyresekvenspar valgt fra gruppen bestående af SEQ ID NO: 2/10, 18/26, 34/42, 50/58, 66/74, 82/90, 98/106, 114/122, 130/138, 146/154, 162/170, 178/186, 194/202, 210/218, 226/234, 242/250, 258/266, 274/282, 290/298, 306/314, 322/330, 338/346, 354/362, 381/389 og 397/405.
2. Isoleret antistof eller antigenbindingsfragment ifølge krav 1, der omfatter et HCVR/LCVR-aminosyresekvenspar valgt fra gruppen bestående af SEQ ID NO: 2/10, 18/26, 34/42, 50/58, 66/74, 82/90, 98/106, 114/122, 130/138, 146/154, 162/170, 178/186, 194/202, 210/218, 226/234, 242/250, 258/266, 274/282, 290/298, 306/314, 322/330, 338/346, 354/362, 381/389 og 397/405.
3. Isoleret antistof eller antigenbindingsfragment ifølge krav 2, der omfatter et HCVR/LCVR aminosyresekvenspar valgt fra gruppen bestående af SEQ ID NO: 50/58, 146/154, 210/218 og 290/298.
4. Isoleret monoklonalt antistof eller antigenbindingsfragment deraf ifølge et hvilket som helst af de foregående krav, der har én eller flere af følgende karakteristika: (i) har et Kd i intervallet fra ca. 10'8 M til ca. 10'13 M målt ved overfladeplasmonresonans; (ii) udviser evne til at blokere ca. 50-100 % af bindingen af GFRa3 til dens ligand, artemin, med en IC50-værdi i intervallet fra ca. 40 pM til ca. 15 nM; (iii) udviser evne til at blokere ca. 20 % til ca. 100 % af bindingen af GFRa3 til en fast bærer belagt med en blanding af artemin og RET; (iv) blokerer eller hæmmer artemin-afhængig aktivering af RET med en ICso i intervallet fra ca. 200 pM til ca. 50 nM; (v) hæmmer eller reducerer ét eller flere nociceptive responser hos en in vivo model af knoglecancersmerte; (vi) hæmmer eller reducerer artemin-sensitiseret termisk hyperalgesi in vivo; (vii) hæmmer eller reducerer allodyni hos en in vivo model af osteoarthritis; eller (viii) ikke krydsreagerer med andre GFR-co-receptorer for RET.
5. Isoleret monoklonalt antistof eller antigenbindingsfragment deraf ifølge et hvilket som helst af de foregående krav, hvor: (a) antistoffet er valgt fra gruppen bestående af et kimærisk antistof og et humant antistof, og/eller; (b) hvor antistoffet ikke krydsreagerer med human GFRal eller human GFRa2, og/eller; (c) hvor antistoffet er et humant monoklonalt antistof, der omfatter (a) en variabel tungkæderegion (HCVR) med en aminosyresekvens valgt fra gruppen bestående af SEQ ID NO: 2, 18, 34, 50, 66, 82, 98, 114, 130, 146, 162, 178, 194, 210, 226, 242, 258, 274, 290,306, 322, 338, 354, 381 og 397 og (b) en variabel letkæderegion (LCVR) med en aminosyresekvens valgt fra gruppen bestående af SEQ ID NO: 10, 26, 42, 58, 74, 90, 106, 122, 138, 154, 170, 186, 202, 218, 234, 250, 266, 282, 298, 314, 330, 346, 362, 389 og 405.
6. Isoleret monoklonalt antistof eller antigenbindingsfragment deraf ifølge et hvilket som helst af de foregående krav, hvor: (a) antistoffet udviser evne til at blokere ca. 50-95 % af bindingen af human GFRa3 til dens ligand, artemin, med en ICso-værdi i intervallet fra ca. 40 pM til ca. 750 pM; (b) antistoffet eller antigenbindingsfragmentet deraf blokerer ca. 75-100 % af bindingen af human GFRa3 til dens ligand, artemin, med en ICso-værdi i intervallet fra ca. 400 pM til ca. 15 nM; (c) antistoffet eller antigenbindingsfragmentet deraf blokerer eller hæmmer artemin-afhængig aktivering af human RET med en ICso i intervallet fra ca. 300 pM til ca. 5 nM; eller (d) antistoffet eller antigenbindingsfragmentet deraf blokerer eller hæmmer artemin-afhængig aktivering af cynomolgus RET med en ICso i intervallet fra ca. 0,7 nM til ca. 2,5 nM.
7. Isoleret nukleinsyremolekyle, der koder for antistoffet eller antigenbindingsfragmentet ifølge et hvilket som helst af kravene 1-6.
8. Ekspressionsvektor, der omfatter nukleinsyremolekylet ifølge krav 7.
9. Fremgangsmåde til fremstilling af et anti-GFRa3-antistof eller antigenbindingsfragment deraf, hvilken Fremgangsmåde omfatter trinnene med indføring af ekspressionsvektoren ifølge krav 8 i en isoleret værtscelle, dyrkning af cellen under forhold, der muliggør fremstilling af antistoffet eller fragmentet deraf, og genvinding af det således fremstillede antistof.
10. Farmaceutisk sammensætning, der omfatter antistoffet eller antigenbindingsfragmentet deraf ifølge et hvilket som helst af kravene 1-6 og en farmaceutisk acceptabel bærer eller fortynder.
11. Farmaceutisk sammensætning, der omfatter et antistof eller antigenbindingsfragment deraf ifølge et hvilket som helst af kravene 1 -6 og et andet terapeutisk middel valgt fra gruppen bestående af et opioid, en COX-2-hæmmer, et lokalanæstetikum, en NMDA-modulator, en cannabinoid receptoragonist, en modulator af P2X-familien, en VR1-antagonist, en stof P-antagonist, en anden GFRa3-antagonist, en cytokin- eller cytokinreceptorantagonist, en nervevækstfaktor- (NGF) hæmmer (en lille molekylær hæmmer eller et anti-NGF-antistof), en hæmmer af BDNF, TrkA, TrkB eller p75, aspirin, et NSAID, et steroid, morfin, en selektiv serotoningenoptagelseshæmmer (SSRI), en serotonin-norepinephrin-genoptagelseshæmmer (SNRI), et tricyklisk stof, en hæmmer af en spændingsafhængig natriumkanal (Nav), en calciumkanalhæmmer, en kaliumkanalhæmmer, en tumornekrosefaktor (TNF) eller TNF-receptorhæmmer, en hæmmer af TWEAK (TNF-relateret WEAK-inducer af apoptose), en RET-hæmmer, en hæmmer af en ligand af GDNF-familien, en hæmmer af GFRal, GFRa2 eller GFRa4, en hæmmer af en syreregistrerende ionkanal (ASIC1 eller ASIC3), et antikonvulsivum (gabapentin eller pregabalin), en hæmmer af en prekineticinreceptor (PROK1 og PROK2), en caspase-hæmmer, en p38-hæmmer, en IKK1/2-hæmmer, CTLA-4lg og et kortikosteroid og en farmaceutisk acceptabel bærer eller fortynder; eventuelt hvor den anden GFRa3-antagonist er et lille organisk molekyle, en polypeptidantagonist, et andet antistof, der er specifikt for GFRa3, et siRNA eller et antisensemolekyle, der er specifikt for GFRa3; eller hvor cytokin- eller cytokinreceptorantagonisten er en interleukin-1(IL-1)-antagonist, en IL-6-antagonist eller en IL-18-antagonist.
12. Isoleret antistof eller antigenbindingsfragment deraf ifølge et hvilket som helst af kravene 1-6, eller farmaceutisk sammensætning ifølge enten krav 10 eller 11, til anvendelse i behandling af en GFRa3-relateret tilstand eller sygdom, eller smerten forbundet med den GFRa3-relaterede tilstand eller sygdom, hvor den GFRa3-relaterede tilstand eller sygdom forebygges, bedres eller reduceres i sværhedsgrad eller hyppighed, eller smerten forbundet med tilstanden eller sygdommen forebygges, bedres eller reduceres i sværhedsgrad eller hyppighed; hvor den GFRa3-relaterede tilstand eller sygdom er valgt fra gruppen bestående af akut smerte, kronisk smerte, neuropatisk smerte, inflammatorisk smerte, et funktionelt smertesyndrom, arthritis, pancreatitis, osteoarthritis, ledsmerte, klyngehovedpine, trigeminal neuralgi, herpetisk neuralgi, generelle neuralgier, neurodegenerative forstyrrelser, bevægelsesforstyrrelser, neuroendokrine forstyrrelser, ataksi, visceral smerte, gigt, post-herpetisk neuralgi, diabetisk neuropati, iskias, rygsmerte, hoved- eller halssmerte, svær smerte, eller smerte, der er vanskelig at behandle, gennembrydende smerte, postkirurgisk smerte, arvelig erythromelalgi, dental smerte, rhinitis, cancersmerte, komplekst regionalt smertesyndrom (CRPS), inflammatorisk tarmsygdom (f.eks. Crohns sygdom eller ulcerøs colitis) og blæreforstyrrelser.
13. Isoleret antistof, antigenbindingsfragment deraf eller farmaceutisk sammensætning til anvendelse ifølge krav 12, hvor det funktionelle smertesyndrom er valgt fra gruppen bestående af kronisk lændesmerte, irritabel tarmsyndrom (IBS), fibromyalgi (FM), kronisk træthedssyndrom, abdominal smerte, temporomandibulær ledforstyrrelse (TMJD), smertefuldt blæresyndrom (interstitiel cystitis), funktionelle gastrointestinale forstyrrelser/syndromer, funktionelt brystsmertesyndrom, migræne og hovedpine af spændingstypen, kronisk bækkensmertesyndrom, smertefuld prostatasyndrom (kronisk prostatitis), multipelt kemisk sensitivitetssyndrom og Golfkrigssyndrom; eller hvor cancersmerten er forbundet med en cancer valgt fra gruppen bestående af endometriecancer, prostatacancer, brystcancer, cervixcancer, levercancer, pankreascancer, coloncancer, mavecancer, uteruscancer, ovariecancer, nyrecancer, ikke-småcellet lungecancer, hjernecancer, en leukæmi, et lymfom, knoglecancer og smerte forbundet med cancermetastase.
14. Antistof, antigenbindingsfragment eller farmaceutisk sammensætning til anvendelse ifølge krav 12 eller 13, hvor antistoffet, antigenbindingsfragmentet eller den farmaceutiske sammensætning er til administration til en patient i kombination med et andet terapeutisk middel; hvor det andet terapeutiske middel eventuelt er som defineret i krav 11.
15. Isoleret antistof eller antigenbindingsfragment ifølge krav 1, der omfatter en HCDR1-aminosyresekvens ifølge SEQ ID NO: 148; en HCDR2-aminosyresekvens ifølge SEQ ID NO: 150; en HCDR3-aminosyresekvens ifølge SEQ ID NO: 152; en LCDR1 - aminosyresekvens ifølge SEQ ID NO: 156; en LCDR2-aminosyresekvens ifølge SEQ ID NO: 158 og en LCDR3-aminosyresekvens ifølge SEQ ID NO: 160.
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| JO3462B1 (ar) | 2012-08-22 | 2020-07-05 | Regeneron Pharma | أجسام مضادة بشرية تجاه gfr?3 وطرق لاستخدامها |
| ES2702315T3 (es) | 2012-08-24 | 2019-02-28 | Univ California | Anticuerpos y vacunas para su uso en tratar cánceres ROR1 e inhibir metástasis |
| WO2016025884A1 (en) * | 2014-08-14 | 2016-02-18 | The Trustees Of The University Of Pennsylvania | Glycosyl-phosphatidylinositol (gpi)-linked gdnf family alpha-receptor 4 (gfralpha4)-specific antibody and uses thereof |
| US10729771B2 (en) * | 2016-02-10 | 2020-08-04 | Rutgers, The State University Of New Jersey | Anti-LAM and anti-PIM6/LAM monoclonal antibodies for diagnosis and treatment of Mycobacterium tuberculosis infections |
| US20170281756A1 (en) * | 2016-02-25 | 2017-10-05 | University Of Southern California | Compositions and methods to selectively block pain induced by cold |
| CN108697795A (zh) * | 2016-02-29 | 2018-10-23 | 伊莱利利公司 | Gfral受体疗法 |
| MY194669A (en) | 2016-03-31 | 2022-12-12 | Ngm Biopharmaceuticals Inc | Binding Proteins and Methods of use Thereof |
| EP3454886A1 (en) | 2016-05-13 | 2019-03-20 | Instituto de Medicina Molecular | Methods of treating diseases associated with ilc3 cells |
| TWI767915B (zh) | 2016-06-27 | 2022-06-21 | 加州大學董事會 | Ror-1與btk拮抗劑的組合 |
| CN107827983B (zh) * | 2017-11-06 | 2020-09-25 | 中国药科大学 | 一种靶向artn的单链抗体、制备方法及应用 |
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| WO2019210144A1 (en) * | 2018-04-27 | 2019-10-31 | Vanderbilt University | Broadly neutralizing antibodies against hepatitis c virus |
| CN109265551B (zh) * | 2018-09-25 | 2020-09-15 | 华东师范大学 | Cd38抗体、嵌合抗原受体和药物 |
| SG11202108398YA (en) * | 2019-02-01 | 2021-08-30 | Novarock Biotherapeutics Ltd | Anti-claudin 18 antibodies and methods of use thereof |
| MX2021012335A (es) * | 2019-04-10 | 2021-11-12 | Regeneron Pharma | Anticuerpos humanos que se unen a ret y metodos de uso de los mismos. |
| EP4041404A4 (en) * | 2019-09-30 | 2023-10-25 | The Trustees of the University of Pennsylvania | HUMANIZED ANTI-ALPHA RECEPTOR 4 ANTIBODY (GRF-ALPHA-4) AND CHIMERIC ANTIGEN RECEPTOR (CAR) |
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