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公开(公告)号:US11918650B2
公开(公告)日:2024-03-05
申请号:US15972489
申请日:2018-05-07
Applicant: AMGEN INC.
Inventor: Jeff Abel , Lingwen Cui , Devrishi Goswami , Joon Huh , Bharadwaj Jagannathan , Sekhar Kanapuram , Arnold McAuley , Michael Schneider , Ananthakrishnan G. Sethuraman , Michael Treuheit , Jun Zhang
IPC: A61K39/395 , A61K9/00 , A61K9/08 , A61K9/19 , A61K47/10 , A61K47/12 , A61K47/14 , A61K47/18 , A61K47/24 , A61K47/26 , C07K16/28 , C07K16/46 , A61J1/05 , A61J1/10 , A61K39/00
CPC classification number: A61K39/39591 , A61K9/0019 , A61K9/08 , A61K9/19 , A61K39/3955 , A61K47/10 , A61K47/12 , A61K47/14 , A61K47/183 , A61K47/24 , A61K47/26 , C07K16/2803 , C07K16/2809 , C07K16/2863 , C07K16/468 , A61J1/05 , A61J1/10 , A61K2039/54 , A61K2039/545 , A61K2039/627 , C07K2317/24 , C07K2317/31 , C07K2317/41 , C07K2317/569
Abstract: 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.
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公开(公告)号:US20230406929A1
公开(公告)日:2023-12-21
申请号:US18251120
申请日:2021-11-08
Applicant: AMGEN INC. , AMGEN RESEARCH (MUNICH)
Inventor: Doris Rau , Tobias Raum , Partrick Hoffmann , Markus Muenz , Matthias Klinger , Virginie Naegele , Lisa Winkel , Pavan Ghattyvenkatakrishna , Joon Hoi Huh , Arnold McAuley , Sekhar Kanapuram
IPC: C07K16/28
CPC classification number: C07K16/2809 , C07K16/2875 , C07K2317/31 , C07K2317/622 , C07K2317/73 , C07K2317/94 , C07K2317/92
Abstract: 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 X1 is S or Q; and X2 is D, G, K, S, or E; and a CDR-H3 sequence of HX1NFGNSYX2SX3X4AY, where X1 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 X1 SSTGAVTX2X3X4YX5N, where X1 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 X1 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.
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公开(公告)号:US20230310324A1
公开(公告)日:2023-10-05
申请号:US18024893
申请日:2021-09-14
Applicant: AMGEN INC.
Inventor: Arnold McAuley , Michael J. Treuheit , Twinkle R. Christian , Bharadwaj Jagannathan
CPC classification number: A61K9/19 , A61K47/26 , A61K47/183 , C07K16/2863 , C07K2317/31
Abstract: Disclosed herein are methods of preparing lyophilized formulations comprising a protein, such as an antibody or a bispecific antibody construct, that exhibits improved storage stability.
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4.
公开(公告)号:US20190151448A1
公开(公告)日:2019-05-23
申请号:US15972489
申请日:2018-05-07
Applicant: AMGEN INC.
Inventor: Jeff Abel , Lingwen Cui , Devrishi Goswami , Joon Huh , Bharadwaj Jagannathan , Sekhar Kanapuram , Arnold McAuley , Michael Schneider , Ananthakrishnan G. Sethuraman , Michael Treuheit , Jun Zhang
IPC: A61K39/395 , C07K16/28 , A61K47/10 , A61K47/14 , A61K47/24 , A61K47/12 , A61K47/26 , A61K47/18 , C07K16/46
Abstract: 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.
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