HRP20220979T1 - Sastavi za liječenje amiloidoze - Google Patents
Sastavi za liječenje amiloidoze Download PDFInfo
- Publication number
- HRP20220979T1 HRP20220979T1 HRP20220979TT HRP20220979T HRP20220979T1 HR P20220979 T1 HRP20220979 T1 HR P20220979T1 HR P20220979T T HRP20220979T T HR P20220979TT HR P20220979 T HRP20220979 T HR P20220979T HR P20220979 T1 HRP20220979 T1 HR P20220979T1
- Authority
- HR
- Croatia
- Prior art keywords
- antibody
- patient
- duration
- use according
- effective
- Prior art date
Links
- 206010002022 amyloidosis Diseases 0.000 title 1
- 239000000203 mixture Substances 0.000 title 1
- 208000033808 peripheral neuropathy Diseases 0.000 claims 9
- 150000001413 amino acids Chemical class 0.000 claims 4
- GXJABQQUPOEUTA-RDJZCZTQSA-N bortezomib Chemical compound C([C@@H](C(=O)N[C@@H](CC(C)C)B(O)O)NC(=O)C=1N=CC=NC=1)C1=CC=CC=C1 GXJABQQUPOEUTA-RDJZCZTQSA-N 0.000 claims 3
- 229960001467 bortezomib Drugs 0.000 claims 3
- 239000003795 chemical substances by application Substances 0.000 claims 3
- 208000024891 symptom Diseases 0.000 claims 3
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 claims 2
- 208000023761 AL amyloidosis Diseases 0.000 claims 2
- 108010047041 Complementarity Determining Regions Proteins 0.000 claims 2
- AOJJSUZBOXZQNB-TZSSRYMLSA-N Doxorubicin Chemical compound O([C@H]1C[C@@](O)(CC=2C(O)=C3C(=O)C=4C=CC=C(C=4C(=O)C3=C(O)C=21)OC)C(=O)CO)[C@H]1C[C@H](N)[C@H](O)[C@H](C)O1 AOJJSUZBOXZQNB-TZSSRYMLSA-N 0.000 claims 2
- 208000005531 Immunoglobulin Light-chain Amyloidosis Diseases 0.000 claims 2
- 229920001213 Polysorbate 20 Polymers 0.000 claims 2
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 claims 2
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 claims 2
- 230000000747 cardiac effect Effects 0.000 claims 2
- 229960003957 dexamethasone Drugs 0.000 claims 2
- UREBDLICKHMUKA-CXSFZGCWSA-N dexamethasone Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@@H](C)[C@@](C(=O)CO)(O)[C@@]1(C)C[C@@H]2O UREBDLICKHMUKA-CXSFZGCWSA-N 0.000 claims 2
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 2
- GOTYRUGSSMKFNF-UHFFFAOYSA-N lenalidomide Chemical compound C1C=2C(N)=CC=CC=2C(=O)N1C1CCC(=O)NC1=O GOTYRUGSSMKFNF-UHFFFAOYSA-N 0.000 claims 2
- 229960004942 lenalidomide Drugs 0.000 claims 2
- 229960001924 melphalan Drugs 0.000 claims 2
- SGDBTWWWUNNDEQ-LBPRGKRZSA-N melphalan Chemical compound OC(=O)[C@@H](N)CC1=CC=C(N(CCCl)CCCl)C=C1 SGDBTWWWUNNDEQ-LBPRGKRZSA-N 0.000 claims 2
- 239000008194 pharmaceutical composition Substances 0.000 claims 2
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims 2
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims 2
- 229940068977 polysorbate 20 Drugs 0.000 claims 2
- 229960004618 prednisone Drugs 0.000 claims 2
- XOFYZVNMUHMLCC-ZPOLXVRWSA-N prednisone Chemical compound O=C1C=C[C@]2(C)[C@H]3C(=O)C[C@](C)([C@@](CC4)(O)C(=O)CO)[C@@H]4[C@@H]3CCC2=C1 XOFYZVNMUHMLCC-ZPOLXVRWSA-N 0.000 claims 2
- CMSMOCZEIVJLDB-UHFFFAOYSA-N Cyclophosphamide Chemical compound ClCCN(CCCl)P1(=O)NCCCO1 CMSMOCZEIVJLDB-UHFFFAOYSA-N 0.000 claims 1
- 102400001263 NT-proBNP Human genes 0.000 claims 1
- 229960004397 cyclophosphamide Drugs 0.000 claims 1
- 229960004679 doxorubicin Drugs 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 108010008064 pro-brain natriuretic peptide (1-76) Proteins 0.000 claims 1
- 230000003442 weekly effect Effects 0.000 claims 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
- C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
- C07K2317/565—Complementarity determining region [CDR]
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
- C07K2317/569—Single domain, e.g. dAb, sdAb, VHH, VNAR or nanobody®
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Biochemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Immunology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Epidemiology (AREA)
- Dermatology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Claims (13)
1. Antitijelo koje se sastoji od varijabilne regije lakog lanca koja sadrži tri regije koje određuju komplementarnost, a zadane su kao SEQ ID NO: 6, 7 i 8, i varijabilne regije teškog lanca koja obuhvaća tri regije koje određuju komplementarnost zadane kao SEQ ID NO: 9, 10 i 11 za upotrebu u postupku:
(A) liječenja periferne neuropatije kod pacijenta sa perifernom neuropatijom povezanom s AL amiloidozom; ili
(B) neovisnog liječenja periferne neuropatije kod pacijenta s AL amiloidozom, gdje:
(a) pacijent pokazuje simptome periferne neuropatije;
(b) pacijent nije pokazao nikakav srčani odgovor na djelotvornu dozu antitijela kada je prethodno davana;
(c) pacijent nije pokazao nikakav bubrežni odgovor na djelotvornu dozu antitijela kada je prethodno davna;
(d) pacijent je prethodno primio liječenje drugačijim sredstvom koje nije uticalo na pacijentovu perifernu neuropatiju; i/ili
(e) pacijent prima liječenje drugačijim sredstvom koje ne djeluje na pacijentovu perifernu neuropatiju;
i još gdje SEQ ID NO: 6, 7, 8, 9, 10 i 11 imaju sljedeće sekvence (upotrebljavajući jednoslovne kodove za aminokiseline): RSSQSLVHSTGNTYLH, KVSNRFS, GFTFNTYAMY, RIRSKSNNYAIYYADSVKD i PYSDSFAY, redom.
2. Antitijelo za upotrebu prema patentnom zahtjevu 1(A), gdje je:
(i) progresija periferne neuropatije preokrenuta; ili
(ii) trajanje liječenja je djelotvorno da se postigne ili održi povećanje od manje od 2 boda povećanja u NIS-LL od osnovne vrijednosti.
3. Antitijelo za upotrebu prema patentnom zahtjevu 1(A), gdje je Antitijelo humanizirano.
4. Antitijelo za upotrebu prema patentnom zahtjevu 1, gdje varijabilna regija lakog lanca obuhvaća sekvencu aminokiseline zadane kao SEQ ID NO: 4 i varijabilna regija teškog lanca obuhvaća sekvencu aminokiseline zadane kao SEQ ID NO: 5; i dalje gdje SEQ ID NO: 4 i 5 imaju sljedeće sekvence (upotrebljavajući jednoslovne kodove za aminokiseline):
DVVMTQSPLSLPVTPGEPASISCRSSQSLVHSTGNTYLHWYLQKPGQSP QLLIYKVSNRFSGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCSQSTHVPFTFG GGTKVEIK i EVQLVESGGGLVQPGGSLRLSCAASGFTFNTYAMYWIRQAPGKGLEW VARIRSKSNNYAIYYADSVKDRFTISRDDSKNSLYLQMNSLKTEDTAVYYCARP YSDSFAYWGQGTLVTVSS, redom.
5. Antitijelo za upotrebu prema patentnom zahtjevu 4, gdje je pacijent prethodno primio liječenje melfalanom, prednizonom, deksametazonom, bortezomibom, ciklofosfamidom, lenalidomidom, doksorubicinom, autolognim transplantom ili kombinacijom navedenog.
6. Antitijelo za upotrebu prema patentnom zahtjevu 1(B), gdje:
(i) drugačije sredstvo je melfalan, prednizon, deksametazon, bortezomib, cikloforfamid, lenalidomid ili kombinacija navedenog, ili
(ii) pacijent pokazuje simptom drugačiji od periferne neuropatije; i/ili
(iii) pacijent pokazuje simptome periferne neuropatije; i/ili
(iv) pacijent nije pokazao nikakav srčani ili bubrežni odgovor na prethodno davanje antitijela.
7. Antitijelo za upotrebu prema patentnom zahtjevu 1, formulirano kao farmaceutska formulacija koja obuhvaća:
(a) antitijelo u koncentraciji u okviru opsega od oko 1mg/mL do oko 100 mg/mL;
(b) histidinski pufer u koncentraciji u okviru opsega od oko 20mM do oko 30 mM;
(c) trehalozu u koncentraciji u okviru opsega od oko 210 mM do oko 250 mM; i
(d) polisorbat 20 u koncentraciji u okviru opsega od oko 0,005% do oko 0,05% po masi; i gdje je farmaceutska formulacija karakterizirana pH vrijednošću u okviru opsega od oko 6 do oko 7.
8. Antitijelo za upotrebu prema patentnom zahtjevu 7, koje obuhvaća dozu od oko 0,5 mg/kg do oko 30 mg/kg i gdje se antitijelo daje intravenozno ili supkutano u učestalosti od oko tjedno do oko kvartalno.
9. Antitijelo za upotrebu prema patentnom zahtjevu 8, gdje:
a) antitijelo je prisutno u koncentraciji od oko 50 mg/mL;
b) histidinski pufer je prisutan u koncentraciji od oko 25 mM;
c) trehaloza je prisutna u koncentraciji od oko 230 mM;
d) polisorbat 20 je prisutan u koncentraciji od oko 0,2 g/L; i
gdje je pH oko 6,5. F
10. Antitijelo za upotrebu prema patentnom zahtjevu 8, gdje je doziranje oko 24 mg/kg i antitijelo se daje intravenozno svakih 28 dana.
11. Antitijelo za upotrebu prema patentnom zahtjevu 10, gdje:
(i) trajanje liječenja je barem 9 mjeseci; ili
(ii) trajanje liječenja je barem 12 mjeseci; ili
(iii) trajanje liječenja je djelotvorno da se postigne ili održi povećanje manje od 2 boda na NIS-LL od osnovne vrijednosti; ili
(iv) trajanje je djelotvorno da se postigne ili održi umanjenje od barem 10% u NIS-LL od osnovne vrijednosti; ili
(v) trajanje je djelotvorno da se postigne ili održi umanjenje od barem 23% u NIS-LL od osnovne vrijednosti; ili
(vi) trajanje je djelotvorno da se postigne ili održi umanjenje od barem 35% u NIS-LL od osnovne vrijednosti; ili
(vii) trajanje je djelotvorno da se postigne ili održi umanjenje od barem 50% u NIS-LL od osnovne vrijednosti; ili
(vii) trajanje je djelotvorno da se postigne ili održi umanjenje od barem 70% u NIS-LL od osnovne vrijednosti; ili
(viii) trajanje je djelotvorno da se postigne ili održi umanjenje od barem 75% u NIS-LL od osnovne vrijednosti; ili
(ix) trajanje je djelotvorno da se postigne ili održi umanjenje od barem 75% u NIS-LL od osnovne vrijednosti i trajanje je djelotvorno da se postigne ili održi umanjenje od barem 30% i 300 pg/mL u NT-proBNP.
12. Antitijelo za upotrebu prema patentnom zahtjevu 5, 6(i) ili 10, gdje je pacijent prethodno primio liječenje CRD-om, PomDex-om, CyBorD-om, BMDex-om, MDex-om, LDex-om, CLD-om ili bortezomibom.
13. Antitijelo za upotrebu prema patentnom zahtjevu 1, gdje je antitijelo Fab, Fab’, F(ab’)₂, F(ab)c, ili Fv.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201662357151P | 2016-06-30 | 2016-06-30 | |
| PCT/US2017/040289 WO2018005967A1 (en) | 2016-06-30 | 2017-06-30 | Compositions for treating amyloidosis |
| EP17740200.5A EP3478713B1 (en) | 2016-06-30 | 2017-06-30 | Compositions for treating amyloidosis |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| HRP20220979T1 true HRP20220979T1 (hr) | 2022-11-11 |
| HRP20220979T8 HRP20220979T8 (hr) | 2023-02-03 |
Family
ID=59351103
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20220979TT HRP20220979T8 (hr) | 2016-06-30 | 2017-06-30 | Sastavi za liječenje amiloidoze |
Country Status (14)
| Country | Link |
|---|---|
| US (2) | US20190169280A1 (hr) |
| EP (1) | EP3478713B1 (hr) |
| JP (2) | JP2019519584A (hr) |
| DK (1) | DK3478713T3 (hr) |
| ES (1) | ES2914781T3 (hr) |
| HR (1) | HRP20220979T8 (hr) |
| HU (1) | HUE059400T2 (hr) |
| LT (1) | LT3478713T (hr) |
| MA (1) | MA45552A (hr) |
| PL (1) | PL3478713T3 (hr) |
| PT (1) | PT3478713T (hr) |
| RS (1) | RS63446B1 (hr) |
| SI (1) | SI3478713T1 (hr) |
| WO (1) | WO2018005967A1 (hr) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SG11202009295YA (en) * | 2018-03-23 | 2020-10-29 | Prothena Biosciences Ltd | Treatment and prophylaxis of amyloidosis |
| MA54923A (fr) * | 2019-02-12 | 2021-12-22 | Prothena Biosciences Ltd | Traitement de l'amylose al avec la combinaison d'anticorps monoclonaux dirigés contre des chaînes légères d'immunoglobuline et de la molécule de membrane cellulaire cd38 sur des cellules productrices d'anticorps et d'autres cellules immunitaires |
| MA55209A (fr) | 2019-03-05 | 2022-01-12 | Prothena Biosciences Ltd | Procédés de traitement de l'amylose al |
| EP4022062A1 (en) * | 2019-08-30 | 2022-07-06 | Alnylam Pharmaceuticals, Inc. | Neurofilament light chain (nfl) as a biomarker for transthyretin amyloidosis polyneuropathy |
| CN116813777A (zh) * | 2020-06-22 | 2023-09-29 | 恩格姆生物制药公司 | Lair-1结合剂及其使用方法 |
| TW202332465A (zh) * | 2021-01-29 | 2023-08-16 | 愛爾蘭商普羅希那生物科學有限公司 | 治療al類澱粉變性症之方法 |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2649037T3 (es) | 2000-12-12 | 2018-01-09 | Medimmune, Llc | Moléculas con semividas prolongadas, composiciones y usos de las mismas |
| KR101603076B1 (ko) | 2007-12-28 | 2016-03-14 | 프로테나 바이오사이언시즈 리미티드 | 아밀로이드증의 치료 및 예방 |
| SG11201401360XA (en) * | 2011-10-25 | 2014-05-29 | Onclave Therapeutics Ltd | Antibody formulations and methods |
-
2017
- 2017-06-30 PT PT177402005T patent/PT3478713T/pt unknown
- 2017-06-30 HR HRP20220979TT patent/HRP20220979T8/hr unknown
- 2017-06-30 RS RS20220716A patent/RS63446B1/sr unknown
- 2017-06-30 SI SI201731146T patent/SI3478713T1/sl unknown
- 2017-06-30 MA MA045552A patent/MA45552A/fr unknown
- 2017-06-30 JP JP2018568771A patent/JP2019519584A/ja not_active Withdrawn
- 2017-06-30 DK DK17740200.5T patent/DK3478713T3/da active
- 2017-06-30 PL PL17740200.5T patent/PL3478713T3/pl unknown
- 2017-06-30 ES ES17740200T patent/ES2914781T3/es active Active
- 2017-06-30 WO PCT/US2017/040289 patent/WO2018005967A1/en active Search and Examination
- 2017-06-30 HU HUE17740200A patent/HUE059400T2/hu unknown
- 2017-06-30 LT LTEPPCT/US2017/040289T patent/LT3478713T/lt unknown
- 2017-06-30 EP EP17740200.5A patent/EP3478713B1/en active Active
- 2017-06-30 US US16/314,143 patent/US20190169280A1/en not_active Abandoned
-
2020
- 2020-09-25 US US17/032,884 patent/US20210079078A1/en not_active Abandoned
-
2022
- 2022-07-01 JP JP2022106974A patent/JP2022121658A/ja active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| JP2019519584A (ja) | 2019-07-11 |
| US20210079078A1 (en) | 2021-03-18 |
| EP3478713B1 (en) | 2022-05-11 |
| RS63446B1 (sr) | 2022-08-31 |
| JP2022121658A (ja) | 2022-08-19 |
| LT3478713T (lt) | 2022-06-10 |
| HUE059400T2 (hu) | 2022-11-28 |
| PT3478713T (pt) | 2022-05-27 |
| HRP20220979T8 (hr) | 2023-02-03 |
| DK3478713T3 (da) | 2022-06-20 |
| MA45552A (fr) | 2019-05-08 |
| US20190169280A1 (en) | 2019-06-06 |
| SI3478713T1 (sl) | 2022-06-30 |
| ES2914781T3 (es) | 2022-06-16 |
| WO2018005967A1 (en) | 2018-01-04 |
| EP3478713A1 (en) | 2019-05-08 |
| PL3478713T3 (pl) | 2022-10-10 |
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