SG11201908540PA - Stable antibody formulation - Google Patents
Stable antibody formulationInfo
- Publication number
- SG11201908540PA SG11201908540PA SG11201908540PA SG11201908540PA SG 11201908540P A SG11201908540P A SG 11201908540PA SG 11201908540P A SG11201908540P A SG 11201908540PA SG 11201908540P A SG11201908540P A SG 11201908540PA
- Authority
- SG
- Singapore
- Prior art keywords
- international
- rule
- antibody
- tarrytown
- applicant
- Prior art date
Links
- 238000009472 formulation Methods 0.000 title abstract 3
- 239000000203 mixture Substances 0.000 title abstract 3
- 239000003795 chemical substances by application Substances 0.000 abstract 2
- 239000008194 pharmaceutical composition Substances 0.000 abstract 2
- 101100519207 Mus musculus Pdcd1 gene Proteins 0.000 abstract 1
- 150000001413 amino acids Chemical class 0.000 abstract 1
- 239000003814 drug Substances 0.000 abstract 1
- 239000002736 nonionic surfactant Substances 0.000 abstract 1
- 230000008520 organization Effects 0.000 abstract 1
Classifications
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- 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
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39591—Stabilisation, fragmentation
-
- 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
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
-
- 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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
- A61K9/08—Solutions
-
- 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
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
- C07K16/2818—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against CD28 or CD152
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- Immunology (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- General Chemical & Material Sciences (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Dermatology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
Abstract
INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date 11 October 2018 (11.10.2018) WIPO I PCT omit IIl °nolo mo 110n rum° oimIE (10) International Publication Number WO 2018/187057 Al (51) International Patent Classification: A61K 9/00 (2006.01) A61K 47/26 (2006.01) A61K 39/00 (2006.01) C07K 16/28 (2006.01) A61K 47/18 (2017.01) (21) International Application Number: PCT/US2018/024032 (22) International Filing Date: 23 March 2018 (23.03.2018) (25) Filing Language: English (26) Publication Language: English (30) Priority Data: 62/482,270 06 April 2017 (06.04.2017) US (71) Applicant: REGENERON PHARMACEUTICALS, INC. [US/US]; 777 Old Saw Mill River Road, Tarrytown, New York 10591-6707 (US). (72) Inventors: HU, Qingyan; 777 Old Saw Mill River Road, Tarrytown, New York 10591 (US). LIU, Dingjiang; 777 Old Saw Mill River Road, Tarrytown, New York 10591 (US). (74) Agent: EL HIOUM, Dianna G.; Fox Rothschild LLP, 997 Lenox Drive, Lawrenceville, NJ 08648-2311 (US). (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). Declarations under Rule 4.17: as to applicant's entitlement to apply for and be granted a patent (Rule 4.17(ii)) as to the applicant's entitlement to claim the priority of the earlier application (Rule 4.17(iii)) Published: — with international search report (Art. 21(3)) with sequence listing part of description (Rule 5.2(a)) 1-1 1-1 N O N 00 1-1 00 O N O (54) Title: STABLE ANTIBODY FORMULATION (57) : The present invention provides stable pharmaceutical formulations comprising a human antibody that specifically binds to human programmed death -1 protein (PD-1). In certain embodiments, the formulations contain, in addition to an anti-PD-1 antibody, a buffer, an amino acid, a non-ionic surfactant, and a sugar. The pharmaceutical formulations of the present invention exhibit a substantial degree of antibody stability upon stress and storage.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201762482270P | 2017-04-06 | 2017-04-06 | |
| PCT/US2018/024032 WO2018187057A1 (en) | 2017-04-06 | 2018-03-23 | Stable antibody formulation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| SG11201908540PA true SG11201908540PA (en) | 2019-10-30 |
Family
ID=62028099
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SG11201908540P SG11201908540PA (en) | 2017-04-06 | 2018-03-23 | Stable antibody formulation |
| SG10202111008QA SG10202111008QA (en) | 2017-04-06 | 2018-03-23 | Stable antibody formulation |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SG10202111008QA SG10202111008QA (en) | 2017-04-06 | 2018-03-23 | Stable antibody formulation |
Country Status (29)
| Country | Link |
|---|---|
| US (2) | US11603407B2 (en) |
| EP (2) | EP4249512A3 (en) |
| JP (1) | JP7229171B2 (en) |
| KR (1) | KR102667484B1 (en) |
| CN (1) | CN110709062B (en) |
| AR (1) | AR111455A1 (en) |
| AU (1) | AU2018247501A1 (en) |
| BR (1) | BR112019020246A2 (en) |
| CA (1) | CA3059087A1 (en) |
| CL (1) | CL2019002828A1 (en) |
| CO (1) | CO2019011021A2 (en) |
| DK (1) | DK3606504T5 (en) |
| EA (1) | EA201992377A1 (en) |
| ES (1) | ES2955062T3 (en) |
| FI (1) | FI3606504T3 (en) |
| HR (1) | HRP20231282T1 (en) |
| HU (1) | HUE063509T2 (en) |
| IL (1) | IL269499B1 (en) |
| LT (1) | LT3606504T (en) |
| MA (1) | MA49043B1 (en) |
| MX (1) | MX2019011207A (en) |
| PH (1) | PH12019502123A1 (en) |
| PL (1) | PL3606504T3 (en) |
| PT (1) | PT3606504T (en) |
| RS (1) | RS64680B1 (en) |
| SG (2) | SG11201908540PA (en) |
| SI (1) | SI3606504T1 (en) |
| TW (1) | TWI795396B (en) |
| WO (1) | WO2018187057A1 (en) |
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| JOP20190260A1 (en) | 2017-05-02 | 2019-10-31 | Merck Sharp & Dohme | Stable formulations of programmed death receptor 1 (pd-1) antibodies and methods of use thereof |
| WO2018204374A1 (en) | 2017-05-02 | 2018-11-08 | Merck Sharp & Dohme Corp. | Formulations of anti-lag3 antibodies and co-formulations of anti-lag3 antibodies and anti-pd-1 antibodies |
| EP3876978A4 (en) | 2018-11-07 | 2022-09-28 | Merck Sharp & Dohme Corp. | Stable formulations of programmed death receptor 1 (pd-1) antibodies and methods of use thereof |
| SI3880186T1 (en) | 2018-11-14 | 2024-07-31 | Regeneron Pharmaceuticals, Inc., | Intralesional administration of pd-1 inhibitors for treating skin cancer |
| MA55033A (en) | 2019-02-18 | 2021-12-29 | Lilly Co Eli | THERAPEUTIC ANTIBODY FORMULATION |
| CA3137361A1 (en) | 2019-02-28 | 2020-09-03 | Regeneron Pharmaceuticals, Inc. | Administration of pd-1 inhibitors for treating skin cancer |
| SG11202109003QA (en) | 2019-03-06 | 2021-09-29 | Regeneron Pharma | Il-4/il-13 pathway inhibitors for enhanced efficacy in treating cancer |
| US20200369760A1 (en) * | 2019-05-24 | 2020-11-26 | Regeneron Pharmaceuticals, Inc. | Stabilized formulations containing anti-angptl3 antibodies |
| US20210101974A1 (en) * | 2019-10-02 | 2021-04-08 | Alamab Therapeutics, Inc. | Anti-connexin antibody formulations |
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