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公开(公告)号:US10772942B2
公开(公告)日:2020-09-15
申请号:US15128951
申请日:2015-03-24
Applicant: Bioverativ Therapeutics Inc.
Inventor: Brian M. Thome , Cherie Parkhurst-Lang , Brandon W. Leveille
Abstract: The present invention provides, among other things, pre-lyophilization formulations, reconstituted formulations, and lyophilate powder compositions comprising a Factor IX (FIX) polypeptide. The present invention also provides lyophilization methods for producing lyophilate powder comprising a FIX polypeptide. The present invention is directed to a pre-lyophilization formulation comprising: (a) a Factor IX (FIX) polypeptide having FIX coagulation activity; (b) a buffering agent; (c) a stabilizing agent; (d) a bulking agent; and (e) a surfactant, wherein the formulation has a fill volume of less than about 5 mL, and wherein each of (a)-(e) are at an amount per vial (mg/vial) sufficient to allow (1) improved stability of the FIX polypeptide when lyophilized.
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公开(公告)号:US20200283474A1
公开(公告)日:2020-09-10
申请号:US16793676
申请日:2020-02-18
Applicant: BIOVERATIV THERAPEUTICS INC.
Inventor: Glen BOLTON , Keith SELVITELLI
IPC: C07K1/22 , A61L2/00 , C07K16/06 , C07K1/16 , C07K14/755
Abstract: The present invention is directed to a method of inactivating virus that is present during production of a polypeptide of interest. In particular, the present invention is directed to a method of on-column virus inactivation using a low pH and high salt wash solution that effectively inactivates viruses with minimum recovery loss of the polypeptide.
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公开(公告)号:US10584147B2
公开(公告)日:2020-03-10
申请号:US15035145
申请日:2014-11-07
Applicant: Bioverativ Therapeutics Inc.
Inventor: Karina Thorn
IPC: C07K14/745 , C07K14/00 , A61K38/00
Abstract: The present invention provides a fusion compound comprising a procoagulant compound and an immunoglobulin constant region or a portion thereof and methods of making and using the fusion compound. The fusion compounds of the present disclosure are useful for the treatment of coagulation disorders, such as hemophilia. In some aspects, the invention includes a method of reducing or preventing aggregates which comprise a procoagulant compound comprising fusing the procoagulant compound to an immunoglobulin constant region or a portion thereof wherein the procoagulant compound comprises an amino acid sequence. In another embodiment, the fusion compound forms less aggregates compared to a compound consisting of the procoagulant compound.
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公开(公告)号:US20200069817A1
公开(公告)日:2020-03-05
申请号:US16537192
申请日:2019-08-09
Applicant: BIOVERATIV THERAPEUTICS INC.
Inventor: Tongyao LIU , Alexey SEREGIN , Robert T. PETERS , Jiayun LIU , Philip ZAKAS , Douglas DRAGER , Susannah PATARROYO-WHITE
Abstract: The present disclosure provides nucleic acid molecules comprising a first inverted terminal repeat (ITR), a second ITR, and a genetic cassette encoding a target sequence. In some embodiments, the target sequence encodes a miRNA and/or a therapeutic protein. In certain embodiments, the therapeutic protein comprises a clotting factor, a growth factor, a hormone, a cytokine, an antibody, a fragment thereof, and a combination thereof. In some embodiments, the first ITR and/or the second ITR is an ITR of a non-adeno-associated virus (AAV). The present disclosure also provides methods of treating a metabolic disorder of the liver in a subject comprising administering to the subject the nucleic acid molecule or a polypeptide encoded thereby.
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公开(公告)号:US20190241960A1
公开(公告)日:2019-08-08
申请号:US16246225
申请日:2019-01-11
Applicant: Bioverativ Therapeutics Inc. , Puget Sound Blood Center
Inventor: Haiyan Jiang , Tongyao Liu , Sriram Krishnamoorthy , Neil Josephson , Glenn Pierce
IPC: C12Q1/6883 , C07K14/755 , A61K47/68 , A61K39/00 , A61K38/21 , A61K38/37
CPC classification number: C12Q1/6883 , A61K38/21 , A61K38/37 , A61K39/0008 , A61K47/6811 , A61K47/6815 , A61K2039/6031 , A61K2039/6056 , C07K14/755 , C07K2319/30 , C12Q2600/156 , A61K2300/00
Abstract: The present disclosure provides methods of administering chimeric and hybrid Factor VIII (FVIII) polypeptides comprising FVIII and Fc to subjects at risk of developing inhibitory FVIII immune responses, including anti-FVIII antibodies and/or cell-mediated immunity. The administration is sufficient to promote coagulation and to induce immune tolerance to FVIII. The chimeric polypeptide can comprise full-length FVIII or a FVIII polypeptide containing a deletion, e.g., a full or partial deletion of the B domain.
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公开(公告)号:US20190192641A1
公开(公告)日:2019-06-27
申请号:US16271689
申请日:2019-02-08
Applicant: BIOVERATIV THERAPEUTICS INC.
Inventor: Glenn Pierce , Samantha Truex , Robert T. Peters , Haiyan Jiang
Abstract: The present invention provides methods of administering Factor IX; methods of administering chimeric and hybrid polypeptides comprising Factor IX; polynucleotides encoding such chimeric and hybrid polypeptides; cells comprising such polynucleotides; and methods of producing such chimeric and hybrid polypeptides using such cells.
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公开(公告)号:US10138291B2
公开(公告)日:2018-11-27
申请号:US14413765
申请日:2013-07-10
Applicant: Bioverativ Therapeutics Inc.
Inventor: Ekta Seth Chhabra , Tongyao Liu , Pei-yun Chang , Robert T. Peters , John Kulman
Abstract: The present invention provides a chimeric protein comprising a VWF protein comprising the D′ domain and D3 domain of VWF, one or more XTEN sequence, and a FVIII protein, wherein the VWF fragment, the XTEN sequence, or the FVIII protein are linked to or associated with each other. The chimeric protein can further comprise one or more Ig constant region or a portion thereof (e.g., an Fc region). A polypeptide chain comprising a VWF fragment of the invention binds to or is associated with a polypeptide chain comprising a FVIII protein linked to an XTEN sequence and the polypeptide chain comprising the VWF fragment can prevent or inhibit binding of endogenous VWF to the FVIII protein linked to the XTEN sequence. By preventing or inhibiting binding of endogenous VWF to the FVIII protein, which is a half-life limiting factor for FVIII, the VWF fragment can induce extension of half-life of the chimeric protein comprising a FVIII protein. The invention also includes nucleotides, vectors, host cells, methods of using the VWF fragment, or the chimeric proteins.
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公开(公告)号:US20180207244A1
公开(公告)日:2018-07-26
申请号:US15820080
申请日:2017-11-21
Applicant: Bioverativ Therapeutics Inc.
Inventor: Glenn PIERCE , Samantha Truex , Robert T. Peters , Haiyan Jiang
IPC: A61K38/48 , A61K47/64 , C12N9/64 , C12N9/96 , A61K9/00 , A61K38/38 , A61K39/395 , C07K16/18 , C07K14/76
Abstract: The present invention provides methods of administering Factor IX; methods of administering chimeric and hybrid polypeptides comprising Factor IX; polynucleotides encoding such chimeric and hybrid polypeptides; cells comprising such polynucleotides; and methods of producing such chimeric and hybrid polypeptides using such cells.
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公开(公告)号:US09636416B2
公开(公告)日:2017-05-02
申请号:US14530256
申请日:2014-10-31
Applicant: Bioverativ Therapeutics Inc.
Inventor: Robert T. Peters , Adam R. Mezo , Daniel S. Rivera , Alan J. Bitoni , Susan C. Low
IPC: C07K14/475 , A61K47/48 , C07K14/505 , C07K14/555 , C07K14/56 , C07K14/565 , C07K14/745 , C07K16/00 , C12N9/64 , C12N9/96
CPC classification number: C07K14/755 , A61K38/00 , A61K47/60 , A61K47/642 , A61K47/68 , A61K47/6803 , A61K47/6811 , A61K47/6813 , A61K47/6835 , C07K14/475 , C07K14/505 , C07K14/555 , C07K14/56 , C07K14/565 , C07K14/59 , C07K14/61 , C07K14/70503 , C07K14/745 , C07K16/00 , C07K2317/52 , C07K2319/00 , C07K2319/30 , C12N9/6437 , C12N9/644 , C12N9/647 , C12N9/96 , C12Y304/21021 , C12Y304/21022
Abstract: The invention relates to a chimeric monomer-dimer hybrid protein wherein the protein comprises a first and a second polypeptide chain, the first polypeptide chain comprising at least a portion of an immunoglobulin constant region and a biologically active molecule, and the second polypeptide chain comprising at least a portion of an immunoglobulin constant region without the biologically active molecule of the first chain. The invention also relates to methods of using and methods of making the chimeric monomer-dimer hybrid protein of the invention.
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公开(公告)号:US20250092117A1
公开(公告)日:2025-03-20
申请号:US18819571
申请日:2024-08-29
Applicant: BIOVERATIV THERAPEUTICS INC.
Inventor: Craig BENSON , Pronabesh DASMAHAPATRA , Suresh KATRAGADDA , Yunzhi LIN , Annemieke WILLEMZE , Amanda WILSON
Abstract: The present disclosure provides a method of treating hemophilia A in a human subject in need thereof comprising administering to the subject a chimeric protein comprising (i) a factor VIII (FVIII) protein and (ii) a von Willebrand factor (VWF) fragment comprising a D′ domain of VWF and a D3 domain of VWF.
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