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1. 发明申请

WO2018204343A1 STABLE FORMULATIONS OF ANTI-CTLA4 ANTIBODIES ALONE AND IN COMBINATION WITH PROGRAMMED DEATH RECEPTOR 1 (PD-1) ANTIBODIES AND METHODS OF USE THEREOF 审中-公开
公开(公告)号：WO2018204343A1
公开(公告)日：2018-11-08
申请号：PCT/US2018/030420
申请日：2018-05-01
申请人： MERCK SHARP & DOHME CORP. , BHATTACHARYA, Soumendu , DE, Arnab , NARASIMHAN, Chakravarthy Nachu , SHARMA, Manoj, K. , YANG, Xiaoyu
发明人： BHATTACHARYA, Soumendu , DE, Arnab , NARASIMHAN, Chakravarthy Nachu , SHARMA, Manoj, K. , YANG, Xiaoyu
IPC分类号： A61K39/395 , C07K16/28 , C07K16/30
摘要： The invention relates to stable formulations comprising antibodies or antigen binding fragments thereof that bind to cytotoxic T lymphocyte associated antigen 4 (CTLA4), optionally further containing an anti-human programmed death receptor 1 (PD-1) antibody or antigen binding fragment thereof. Also provided are methods of treating various cancers and chronic infections with the formulations of the invention.

2. 发明申请

WO2018204405A1 STABLE FORMULATIONS OF ANTI-TIGIT ANTIBODIES ALONE AND IN COMBINATION WITH PROGRAMMED DEATH RECEPTOR 1 (PD-1) ANTIBODIES AND METHODS OF USE THEREOF 审中-公开
公开(公告)号：WO2018204405A1
公开(公告)日：2018-11-08
申请号：PCT/US2018/030516
申请日：2018-05-01
申请人： MERCK SHARP & DOHME CORP. , DE, Arnab , NARASIMHAN, Chakravarthy Nachu
发明人： DE, Arnab , NARASIMHAN, Chakravarthy Nachu
IPC分类号： A61K39/00 , A61K39/395 , A61P31/12 , A61P35/00
摘要： The present invention relates to stable formulations of antibodies against T cell immunoreceptor with Ig and ITIM domains (TIGIT), optionally further containing an anti-human programmed death receptor 1 (PD-1) antibody or antigen binding fragment thereof. Also provided are methods of treating various cancers and chronic infections with the formulations of the invention.

3. 发明申请

WO2014004436A3 CRYSTALLINE ANTI-HUMAN IL-23 ANTIBODIES 审中-公开
标题翻译：结晶抗人IL-23抗体
公开(公告)号：WO2014004436A3
公开(公告)日：2014-12-04
申请号：PCT/US2013047500
申请日：2013-06-25
申请人： MERCK SHARP & DOHME , REICHERT PAUL , PROSISE WINIFRED W , ORTH PETER , NARASIMHAN CHAKRAVARTHY NACHU , KASHI RAMESH S
发明人： REICHERT PAUL , PROSISE WINIFRED W , ORTH PETER , NARASIMHAN CHAKRAVARTHY NACHU , KASHI RAMESH S
IPC分类号： A61K39/395
CPC分类号： C07K16/244 , A61K39/39591 , C07K2299/00 , C07K2317/565 , C07K2317/76 , C07K2317/92
摘要： Crystalline forms of antibodies to human IL-23, such as antibodies to human IL-23p19, are provided, as well as methods of producing such crystalline forms, and uses of such crystalline forms, e.g. in treatment of inflammatory, autoimmune, and proliferative disorders. In various embodiments, the anti-hulL-23 antibody crystals, such as anti-hulL-23p19 antibody crystals of the present invention are obtainable by batch crystallization methods, vapor diffusion methods, liquid-liquid diffusion methods, and dialysis. In other aspects, the invention relates to suspensions of the crystalline anti-hulL- 23 antibodies of the present invention, including those at higher concentrations and lower viscosities than would be possible with a corresponding non-crystalline solution at the same concentration of antibody. In other embodiments, the anti-huiL-23 antibody crystals of the present invention have increased stability, i.e. they maintain biological activity of the anti-huiL-23 antibody, such as anti-huiL-23p 19 antibody, longer than corresponding solution formulations.
摘要翻译：提供了对人IL-23的抗体的结晶形式，例如针对人IL-23p19的抗体，以及产生此类结晶形式的方法，以及使用这种结晶形式，例如，治疗炎症，自身免疫和增殖性疾病。在各种实施方案中，本发明的抗hulL-23p19抗体晶体可以通过分批结晶法，蒸气扩散法，液 - 液扩散法和透析法获得。在其它方面，本发明涉及本发明的结晶抗hulL-23抗体的悬浮液，包括在相同抗体浓度下与相应的非结晶溶液相比可能的浓度和粘度更低的那些。在其它实施方案中，本发明的抗-HLL-23抗体晶体具有提高的稳定性，即它们比抗相对应的溶液制剂更长时间保持抗-HuiL-23抗体（例如抗-HLL-23p19抗体）的生物学活性。

4. 发明申请

WO2020092233A1 ANTI-HUMAN PD-1 ANTIBODY CRYSTALS AND METHODS OF USE THEREOF 审中-公开
公开(公告)号：WO2020092233A1
公开(公告)日：2020-05-07
申请号：PCT/US2019/058339
申请日：2019-10-28
申请人： MERCK SHARP & DOHME CORP. , REICHERT, Paul , PROSISE, Winifred, W. , YANG, Xiaoyu , STRICKLAND, Corey , NARASIMHAN, Chakravarthy Nachu , FISCHMANN, Thierry, O. , WALSH, Erika, R. , SU, Yongchao
发明人： REICHERT, Paul , PROSISE, Winifred, W. , YANG, Xiaoyu , STRICKLAND, Corey , NARASIMHAN, Chakravarthy Nachu , FISCHMANN, Thierry, O. , WALSH, Erika, R. , SU, Yongchao
IPC分类号： C07K16/28
摘要： The invention provides methods for producing crystalline an anti- PD-1 monoclonal antibody (mAb), wherein the mAb is pembrolizumab or a pembrolizumab variant, comprising (1) mixing a solution comprising (a) the mAb, (b) polyethylene glycol (PEG), and (c) an additive selected from the group consisting of: caffeine, theophylline, 2' deoxyguanosine-5'-monophosphate, a bioactive gibberellin, and a pharmaceutically acceptable salt of said bioactive gibberellin, to form a crystallization solution, (2) incubating the crystallization solution for a period of time sufficient for crystal formation; and (3) optionally harvesting the crystalline anti-PD-1 mAb from the solution. In specific embodiments, the PEG is PEG 3350 and the additive is caffeine. The invention also relates to the novel anti-human PD-1 mAb crystals produced by the methods described herein. Characterization of re-dissolved crystalline suspensions using several biochemical methods showed the bio-physical properties of the re-dissolved mAb crystals were consistent with the intact antibody starting sample. The crystals and methods of the invention are amenable to multiple pharmaceutical applications such as purification, storage, formulation, and drug delivery.

5. 发明申请

WO2014004436A2 CRYSTALLINE ANTI-HUMAN IL-23 ANTIBODIES 审中-公开
标题翻译：结晶抗人IL-23抗体
公开(公告)号：WO2014004436A2
公开(公告)日：2014-01-03
申请号：PCT/US2013/047500
申请日：2013-06-25
申请人： MERCK SHARP & DOHME CORP. , REICHERT, Paul , PROSISE, Winifred, W. , ORTH, Peter , NARASIMHAN, Chakravarthy Nachu , KASHI, Ramesh, S.
发明人： REICHERT, Paul , PROSISE, Winifred, W. , ORTH, Peter , NARASIMHAN, Chakravarthy Nachu , KASHI, Ramesh, S.
IPC分类号： A61K39/395
CPC分类号： C07K16/244 , A61K39/39591 , C07K2299/00 , C07K2317/565 , C07K2317/76 , C07K2317/92
摘要： Crystalline forms of antibodies to human IL-23, such as antibodies to human IL- 23p19, are provided, as well as methods of producing such crystalline forms, and uses of such crystalline forms, e.g . in treatment of inflammatory, autoimmune, and proliferative disorders.
摘要翻译：提供了对人IL-23的抗体的结晶形式，例如人IL-23p19的抗体，以及产生此类结晶形式的方法，以及使用这种结晶形式，例如，治疗炎症，自身免疫和增殖性疾病。

6. 发明申请

WO2020097141A1 STABLE FORMULATIONS OF PROGRAMMED DEATH RECEPTOR 1 (PD-1) ANTIBODIES AND METHODS OF USE THEREOF 审中-公开
公开(公告)号：WO2020097141A1
公开(公告)日：2020-05-14
申请号：PCT/US2019/059957
申请日：2019-11-06
申请人： MERCK SHARP & DOHME CORP. , FORREST, William, P., Jr. , NARASIMHAN, Chakravarthy Nachu , KRISHNAMACHARI, Yogita
发明人： FORREST, William, P., Jr. , NARASIMHAN, Chakravarthy Nachu , KRISHNAMACHARI, Yogita
IPC分类号： A61K39/00 , A61K47/02 , A61K47/12 , A61K47/14 , A61K9/08
摘要： The invention relates to stable formulations of antibodies against human programmed death receptor PD-1, or antigen binding fragments thereof. In some embodiments the formulations of the invention comprise between 5-250 mg/mL anti- PD-1 antibody, or antigen binding fragment thereof, a buffer, a stabilizer, a surfactant, and an antioxidant in the amounts specified herein. In particular embodiments, the anti-PD-1 antibody is pembrolizumab. The invention further provides methods for treating various cancers with stable formulations of the invention. In some embodiments of the methods of the invention, the formulations are administered to a subject by intravenous or subcutaneous administration.

7. 发明申请

WO2020081408A1 FORMULATIONS OF ANTI-RSV ANTIBODIES AND METHODS OF USE THEREOF 审中-公开
公开(公告)号：WO2020081408A1
公开(公告)日：2020-04-23
申请号：PCT/US2019/056027
申请日：2019-10-14
申请人： MERCK SHARP & DOHME CORP. , HASHEMI, Venus , DE, Arnab , NARASIMHAN, Chakravarthy Nachu
发明人： HASHEMI, Venus , DE, Arnab , NARASIMHAN, Chakravarthy Nachu
IPC分类号： C07K16/24 , A61K9/19 , A61K47/12 , A61K47/18 , A61K47/36 , A61P35/00
摘要： The present invention relates to stable formulations comprising antibodies or antigen-binding fragments thereof that bind to respiratory syncytial virus (RSV). Also provided are methods of preventing and/or treating RSV-related diseases with the formulations of the invention.

8. 发明申请

WO2018204368A1 STABLE FORMULATIONS OF PROGRAMMED DEATH RECEPTOR 1 (PD-1) ANTIBODIES AND METHODS OF USE THEREOF 审中-公开
公开(公告)号：WO2018204368A1
公开(公告)日：2018-11-08
申请号：PCT/US2018/030459
申请日：2018-05-01
申请人： MERCK SHARP & DOHME CORP. , SHARMA, Manoj, K. , BENJAMIN, Wendy , MITTAL, Sarita , BASARKAR, Ashwin , NARASIMHAN, Chakravarthy Nachu , KASHI, Ramesh, K. , SHAMEEM, Mohammed , BHATTACHARYA, Soumendu , FORREST, William, P, Jr.
发明人： SHARMA, Manoj, K. , BENJAMIN, Wendy , MITTAL, Sarita , BASARKAR, Ashwin , NARASIMHAN, Chakravarthy Nachu , KASHI, Ramesh, K. , SHAMEEM, Mohammed , BHATTACHARYA, Soumendu , FORREST, William, P, Jr.
IPC分类号： A61K9/00 , A61K9/08 , A61K9/19 , A61K39/00 , A61K39/395 , A61K47/26 , C07K16/18
摘要： The invention relates to stable formulations of antibodies against human programmed death receptor PD-1, or antigen binding fragments thereof. In some embodiments the formulations of the invention comprise between 5-200 mg/mL anti- PD-1 antibody, or antigen binding fragment thereof. The invention further provides methods for treating various cancers with stable formulations of the invention. In some embodiments of the methods of the invention, the formulations are administered to a subject by intravenous or subcutaneous administration.

9. 发明申请

WO2019217252A1 RAPID METHOD TO PREDICT STABILITIES OF PHARMACEUTICAL COMPOSITIONS CONTAINING PROTEIN THERAPEUTICS AND NON-REDUCING SUGARS 审中-公开
公开(公告)号：WO2019217252A1
公开(公告)日：2019-11-14
申请号：PCT/US2019/030802
申请日：2019-05-06
申请人： MERCK SHARP & DOHME CORP. , DE, Arnab , NARASIMHAN, Chakravarthy Nachu
发明人： DE, Arnab , NARASIMHAN, Chakravarthy Nachu
IPC分类号： A61K9/08 , A61K39/395 , A61K47/12 , A61K47/18 , A61K47/26 , A61K47/34
摘要： Provided is a method of determining the stability increase provided by a non-reducing sugar in a pharmaceutical composition containing a protein therapeutic, the method comprising: (i) providing: a first pharmaceutical composition comprising an aqueous solution of the protein therapeutic in the substantial absence of a non-reducing sugar, wherein the first pharmaceutical composition has a first B22 value and a second pharmaceutical composition comprising an aqueous solution of the protein therapeutic and the non-reducing sugar, wherein the second pharmaceutical composition has a second B22 value; (ii) determining the difference between the first and second B22 values; and (iii) predicting the stability increase provided by the non-reducing sugar based on the difference in B22 values.

10. 发明申请

WO2017112621A1 FORMULATIONS OF ENGINEERED ANTI-IL-10 ANTIBODIES 审中-公开
标题翻译：工程抗IL-10抗体的制剂
公开(公告)号：WO2017112621A1
公开(公告)日：2017-06-29
申请号：PCT/US2016/067658
申请日：2016-12-20
申请人： MERCK SHARP & DOHME CORP. , NARASIMHAN, Chakravarthy Nachu , BASARKAR, Ashwin , BHATTACHARYA, Soumendu , BENJAMIN, Wendy , SHAMEEM, Mohammed
发明人： NARASIMHAN, Chakravarthy Nachu , BASARKAR, Ashwin , BHATTACHARYA, Soumendu , BENJAMIN, Wendy , SHAMEEM, Mohammed
IPC分类号： C07K16/18 , C07K16/24
CPC分类号： C07K16/244 , C07K2317/94
摘要： The present invention provides formulations of anti-IL-10 hum12G8, and their use in treating various disorders.
摘要翻译：本发明提供了抗IL-10 hum12G8的制剂及其在治疗各种疾病中的用途。

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