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1. 发明申请

WO2018141910A1 LOW PH PHARMACEUTICAL COMPOSITION COMPRISING T CELL ENGAGING ANTIBODY CONSTRUCTS 审中-公开
公开(公告)号：WO2018141910A1
公开(公告)日：2018-08-09
申请号：PCT/EP2018/052665
申请日：2018-02-02
申请人： AMGEN RESEARCH (MUNICH) GMBH , AMGEN INC.
发明人： MCAULEY, Arnold , GHATTYVENKATAKRISHNA, Pavan , ABEL, Jeff , HUH, Joon , POMPE, Cornelius , KANAPURAM, Sekhar , TREUHEIT, Michael , JAGANNATHAN, Bharadwaj
IPC分类号： A61K39/395 , C07K16/28
摘要： The present disclosure provides a low pH pharmaceutical composition comprising (a) an antibody constructs comprising a first domain binding to a target cell surface antigen, a second domain binding to a second antigen and preferably a third domain, which is a specific Fc modality, (b) at least one buffer agent, (c) at least one saccharide, and (d) at least one surfactant; and wherein the pH of the pharmaceutical composition is in the range of 3.5 to 6.

2. 发明申请

WO2022096698A1 POLYPEPTIDE CONSTRUCTS BINDING TO CD3 审中-公开
公开(公告)号：WO2022096698A1
公开(公告)日：2022-05-12
申请号：PCT/EP2021/080859
申请日：2021-11-08
申请人： AMGEN INC. , AMGEN RESEARCH (MUNICH) GMBH
发明人： RAU, Doris , RAUM, Tobias , HOFFMANN, Patrick , MUENZ, Markus , KLINGER, Matthias , NAEGELE, Virgine , WINKEL, Lisa , GHATTYVENKATAKRISHNA, Pavan , HUH, Joon Hoi , MCAULEY, Arnold , KANAPURAM, Sekhar
IPC分类号： C07K16/28 , A61P35/00
摘要： The invention relates to a polypeptide or polypeptide construct comprising: a binding domain binding to an extracellular epitope of the human CD3s chain comprising or consisting of a VH region and a VL region, wherein i) the VH region comprises: a CDR- H1 sequence of X1YAX2N, where X1 is K, V, S, G, R, T, or I; and X2 is M or I; a CDR-H2 sequence of RIRSKYNNYATYYADX1VKX2, where Χ1 is S or Q; and X2 is D, G, K, S, or E; and a CDR-H3 sequence of HX1NFGNSYX2SX3X4AY, where ΧΊ is G, R, or A; X2 is I, L, V, or T; X3 is Y, W or F; and X4 is W, F or Y; and ii) wherein the VL region comprises: a CDR-L1 sequence of ΧΊ SSTGAVTX2X3X4YX5N, where ΧΊ is G, R, or A; X2 is S or T; X3 is G or S; X4 is N or Y; and X5 is P or A; a CDR-L2 sequence of X1TX2X3X4X5X6; where Χ1 is G or A; X2 is K, D, or N; X3 is F, M or K; X4 is L or R; X5 is A, P, or V; and X6 is P or S; and a CDR-L3 sequence of X1LWYSNX2VW, where X1 is V, A, or T; and X2 is R or L; and iii) wherein one or more of CDR sequences of the VH region of i) and/or of the VL region of ii) comprise one amino acid substitution or a combination thereof selected from X24V and X24F in CDR-H1; D15, and X116A in CDR-H2; H1, X12E, F4, and N6 in CDR-H3; and X11L and W3 in CDR-L3. The invention also relates to a polynucleotide encoding the polypeptide or polypeptide construct of the invention, a vector comprising said polynucleotide and a host cell transformed or transfected with said polynucleotide or with said vector. Moreover, the invention also provides for a process for the production of said polypeptide or polypeptide construct and a pharmaceutical composition comprising said polypeptide or polypeptide construct of the invention. Furthermore, the invention relates to medical uses of said polypeptide or polypeptide construct and kits comprising said polypeptide or polypeptide construct.

3. 发明申请

WO2017129585A1 PHARMACEUTICAL COMPOSITION COMPRISING BISPECIFIC ANTIBODY CONSTRUCTS 审中-公开
标题翻译：包含双特异性抗体构建体的药物组合物
公开(公告)号：WO2017129585A1
公开(公告)日：2017-08-03
申请号：PCT/EP2017/051486
申请日：2017-01-25
申请人： AMGEN RESEARCH (MUNICH) GMBH , AMGEN INC.
发明人： KANAPURAM, Sekhar , LATYPOV, Ramil , THANGARAJ, Balakumar , POMPE, Cornelius
IPC分类号： C07K16/28 , A61K39/395 , A61K47/00
CPC分类号： A61K39/3955 , A61K9/0019 , A61K9/1652 , A61K9/19 , A61K47/02 , A61K47/10 , A61K47/12 , A61K47/183 , A61K47/26 , A61K47/40 , A61K2039/505 , B01D61/145 , B01D2315/16 , C07K16/2803 , C07K16/2809 , C07K16/2878 , C07K2317/24 , C07K2317/31 , C07K2317/622 , C07K2317/94
摘要： The present invention provides novel and stable pharmaceutical compositions comprising bispecific single chain antibody constructs, cyclodextrins and a buffer.
摘要翻译：本发明提供了包含双特异性单链抗体构建体，环糊精和缓冲液的新颖且稳定的药物组合物。

4. 发明申请

WO2018156741A1 LOW-VISCOSITY, HIGH-CONCENTRATION EVOLOCUMAB FORMULATIONS AND METHODS OF MAKING THE SAME 审中-公开
公开(公告)号：WO2018156741A1
公开(公告)日：2018-08-30
申请号：PCT/US2018/019189
申请日：2018-02-22
申请人： AMGEN INC.
发明人： SLOEY, Christopher James , KANAPURAM, Sekhar , CUI, Huanchun , CHAN, Chio Mui , BINABAJI, Elaheh
IPC分类号： C07K16/40 , A61K39/395 , A61K47/18
摘要： Provided herein are formulations of PCSK9-binding polypeptides, such as those comprising evolocumab, that comprise N-acetyl arginine and have reduced viscosities when compared to formulations lacking N-acetyl arginine. Provided herein are also methods of formulating such compositions that are advantageous in that they conserve certain components. Such formulations comprising PCSK9-binding polypeptides can be administered to patients to treat and/or prevent PCSK9-related diseases, conditions, and disorders.

5. 发明申请

WO2021081326A1 COMPOSITIONS AND METHODS FOR MINIMIZING PROTEIN LOSS AT LOW PROTEIN CONCENTRATIONS 审中-公开
公开(公告)号：WO2021081326A1
公开(公告)日：2021-04-29
申请号：PCT/US2020/057065
申请日：2020-10-23
申请人： AMGEN INC.
发明人： ZHU, Chen , GREENE, Daniel Gerard , HAO, Qi , KANAPURAM, Sekhar , TREUHEIT, Michael John
IPC分类号： A61K39/395 , C07K16/28
摘要： The present invention relates to compositions and methods for minimizing protein loss (e.g., due to adsorption to solid surfaces) at low protein concentrations. Inventions disclosed herein generally relate to the field of compositions comprising proteins, in particular, pharmaceutical compositions comprising therapeutic proteins at low protein concentrations. Inventions disclosed herein also relate to methods of administering the composition to a subject in need thereof.

6. 发明申请

WO2016065181A1 REDUCING VISCOSITY OF PHARMACEUTICAL FORMULATIONS 审中-公开
标题翻译：降低制药配方的粘度
公开(公告)号：WO2016065181A1
公开(公告)日：2016-04-28
申请号：PCT/US2015/056972
申请日：2015-10-22
申请人： AMGEN INC.
发明人： SLOEY, Christopher James , KANAPURAM, Sekhar
IPC分类号： A61K47/18 , A61K39/395 , A61K9/19
CPC分类号： A61K39/39591 , A61K9/0019 , A61K9/19 , A61K39/3955 , A61K47/183 , C07K2317/90
摘要： A method for reducing the viscosity of a pharmaceutical formulation is provided that utilizes a viscosity-reducing concentration of an excipientselected from the group consisting of the n-acetyl arginine, n-acetyl lysine, n-acetyl proline and mixtures thereof in combination with a therapeutiv protein. A stable pharmaceutical formulation is also provided.
摘要翻译：提供了降低药物制剂粘度的方法，该方法利用选自正乙酰基精氨酸，正乙酰赖氨酸，正乙酰脯氨酸及其混合物的赋形剂的降粘浓度与治疗组合蛋白。还提供了稳定的药物制剂。

7. 发明申请

WO2019055902A1 VEGFR-FC FUSION PROTEIN FORMULATIONS 审中-公开
公开(公告)号：WO2019055902A1
公开(公告)日：2019-03-21
申请号：PCT/US2018/051311
申请日：2018-09-17
申请人： AMGEN INC.
发明人： WEXLER-COHEN, Yael , FESINMEYER, Robert Matthew , GOSS, Monica Michelle , KANAPURAM, Sekhar , KAUSHIK, Rahul Rajan , PADALA, Sai Chakradhar
IPC分类号： A61K9/00 , A61K47/10 , A61K47/12 , A61K47/18 , A61K47/26 , A61K38/17 , C07K14/71
CPC分类号： A61K9/0019 , A61K38/179 , A61K47/10 , A61K47/12 , A61K47/183 , A61K47/26 , C07K14/71
摘要： VEGFR-Fc fusion protein formulations and methods of making using such formulations are provided herein. In one embodiment, the formulation is an ophthalmic formulation, such as for intravitreal administration. In some embodiments, the VEGFR-Fc fusion protein is aflibercept.

8. 发明申请

WO2018204907A1 PHARMACEUTICAL COMPOSITION COMPRISING BISPECIFIC ANTIBODY CONSTRUCTS FOR IMPROVED STORAGE AND ADMINISTRATION 审中-公开
公开(公告)号：WO2018204907A1
公开(公告)日：2018-11-08
申请号：PCT/US2018/031347
申请日：2018-05-07
申请人： AMGEN INC.
发明人： ABEL, Jeff , CUI, Lingwen , GOSWAMI, Devrishi , HUH, Joon , JAGANNATHAN, Bharadwaj , KANAPURAM, Sekhar , MCAULEY, Arnold , SCHNEIDER, Michael , SETHURAMAN, Ananthakrishnan, G. , TREUHEIT, Michael , ZHANG, Jun
IPC分类号： A61K39/395 , C07K16/28 , A61K47/00
摘要： The present invention provides an improved pharmaceutical composition for storage and administration comprising (a) a bispecific antibody construct comprising a first domain binding to a target cell surface antigen and a second domain binding to a second antigen, wherein the bispecific antibody construct is present at a concentration in the range from about 0.5 μg/ml to 20 mg/ml, (b) a preservative at a concentration effective to inhibit the growth of microbes, and (c) a diluent wherein bispecific antibody construct is stable and recoverable.

9. 发明申请

WO2018201064A1 N-ACETYLATED AND NON-ACETYLATED DIPEPTIDES CONTAINING ARGININE TO REDUCE THE VISCOSITY OF VISCOUS COMPOSITIONS OF THERAPEUTIC POLYPEPTIDES 审中-公开
公开(公告)号：WO2018201064A1
公开(公告)日：2018-11-01
申请号：PCT/US2018/029981
申请日：2018-04-27
申请人： AMGEN INC.
发明人： AGRAWAL, Neeraj Jagdish , GHATTYVENKATAKRISHNA, Pavan , KANAPURAM, Sekhar , SLOEY, Christopher James
IPC分类号： A61K39/395 , A61K9/08 , A61K47/18 , A61K9/19
摘要： Provided herein are excipients capable of effectively reducing the viscosity of polypeptide (e.g., therapeutic polypeptide) formulations. The viscosity reducing excipients are dipeptides containing arginine at the carboxy terminus and N-acetylated serine or N-acetylated proline at the N-terminus. Glutamate-arginine is also disclosed as a viscosity-reducing dipeptide. Among the disclosed methods, methods of reducing the viscosities of such formulations are also provided.

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