公开(公告)号：US20200071385A1

公开(公告)日：2020-03-05

申请号：US16518642

申请日：2019-07-22

Applicant: BIOVERATIV THERAPEUTICS INC.

Inventor： Robert T. Peters ,  Adam R. Mezo ,  Daniel S. Rivera ,  Alan J. Bitonti ,  Susan C. Low

IPC: C07K14/755 ,  A61K47/68 ,  C07K14/475 ,  C07K14/505 ,  C07K14/555 ,  C07K14/56 ,  C07K14/745 ,  C07K16/00 ,  C12N9/64 ,  C07K14/565 ,  C12N9/96 ,  A61K47/60 ,  C07K14/59 ,  C07K14/61 ,  C07K14/705 ,  A61K47/64

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.

公开(公告)号：US20190309280A1

公开(公告)日：2019-10-10

申请号：US16357153

申请日：2019-03-18

Applicant: Bioverativ Therapeutics Inc.

Inventor： Vu Phong HONG ,  Adam R. MEZO ,  Joe SALAS ,  Robert PETERS

IPC: C12N9/64 ,  A61K38/02 ,  A61K38/36 ,  A61K38/48

Abstract: The present disclosure provides protease-activatable procoagulant compounds comprising a procoagulant polypeptide, e.g., a procoagulant peptide and/or clotting factor, and a linker comprising a protease-cleavable substrate (e.g., a synthetic thrombin substrate) and a self-immolative spacer (e.g., p-amino benzyl carbamate). Upon cleavage of the protease-cleavable substrate by a protease (e.g., thrombin), the self-immolative spacer cleaves itself from the procoagulant polypeptide such that the polypeptide is in an underivatized and active form. Also provided are pharmaceutical compositions, methods for treating bleeding disefficacy orders using the disclosed compounds, methods of enhancing in vivo of procoagulant polypeptides, methods of increasing the efficacy of proteolytic cleavage of compounds comprising procoagulant polypeptides, methods of activating procoagulant polypeptides, and methods of releasing a procoagulant polypeptide from a heterologous moiety such as PEG.

公开(公告)号：US10325687B2

公开(公告)日：2019-06-18

申请号：US15101756

申请日：2014-12-06

Applicant: Bioverativ Therapeutics Inc.

Inventor： Haiyan Jiang

IPC: G16H50/50 ,  A61K38/37 ,  A61K38/48 ,  G06N7/00 ,  G06F19/00 ,  C07K14/755 ,  C12N9/64

Abstract: The present invention is directed to computer based pharmacokinetics systems, such as. web-based pharmacokinetics systems, and their use to predict a dose and a dosing interval for a patient in need of a clotting factor therapy.

公开(公告)号：US10317376B2

公开(公告)日：2019-06-11

申请号：US14391775

申请日：2013-04-11

Applicant: Bioverativ Therapeutics Inc.

Inventor： Zoran Sosic ,  Andrew Blum ,  Bing Guan ,  Boris Boumajny

IPC: G01N30/60 ,  C08B37/00 ,  C08B37/02 ,  G01N30/02 ,  G01N33/68

Abstract: In one aspect, the disclosure provides methods of distinguishing a glycosaminoglycan from one or more other components in a sample by subjecting the sample to size-exclusion chromatography using a mobile phase having a pH of 6.8 or lower. A mobile phase having a pH of 6.8 or lower is found to improve the separation of glycosaminoglycans from proteins during size exclusion chromatography. In some embodiments, improved separation is due to the low pH of the mobile phase causing elution of less dispersed fractions of the protein and/or glycosaminoglycan. In some embodiments, the overlap between protein and/or glycosaminoglycan fractions is reduced.

公开(公告)号：US20190010212A1

公开(公告)日：2019-01-10

申请号：US16006594

申请日：2018-06-12

Applicant: Bioverativ Therapeutics Inc.

Inventor： Susan Low ,  Jennifer A. Dumont ,  Alan J. Bitonti

IPC: C07K14/755 ,  A61K35/00 ,  A61K38/00

Abstract: The present invention provides cell lines for producing single chain FVIII polypeptides, e.g., chimeric single chain FVIII polypeptides, methods of producing single chain FVIII polypeptides, single chain FVIII polypeptides, and methods of treating Hemophilia A with a single chain Factor VIII polypeptide.

公开(公告)号：US20180360982A1

公开(公告)日：2018-12-20

申请号：US15991629

申请日：2018-05-29

Applicant: Bioverativ Therapeutics Inc.

Inventor： Jennifer A. DUMONT ,  Susan LOW ,  Alan J. BITONTI ,  Glenn PIERCE ,  Alvin LUK ,  Haiyan JIANG ,  Byron MCKINNEY ,  Matt OTTMER ,  Jurg SOMMER ,  Karen NUGENT ,  Lian LI ,  Robert T. PETERS

IPC: A61K47/68 ,  A61K47/60 ,  G01N33/86 ,  A61K38/37 ,  C07K14/755

Abstract: The present invention provides methods of administering Factor VIII (processed FVIII, single chain FVIII, or a combination thereof); methods of administering chimeric and hybrid polypeptides comprising Factor VIII; chimeric and hybrid polypeptides comprising Factor VIII; polynucleotides encoding such chimeric and hybrid polypeptides; cells comprising such polynucleotides; and methods of producing such chimeric and hybrid polypeptides using such cells.

公开(公告)号：US10058480B2

公开(公告)日：2018-08-28

申请号：US14411739

申请日：2013-07-03

Applicant: Bioverativ Therapeutics Inc.

Inventor： Christine P. Janson ,  Ethan B. Jacoby ,  Frederick Carel Steinmann ,  Nikhil Gandhi ,  Chad Presher

IPC: A61J1/05 ,  B65D21/02 ,  B65D25/10 ,  B65D43/16 ,  A61M5/00 ,  A61J1/20

CPC classification number: A61J1/05 ,  A61J1/2096 ,  A61M5/002 ,  A61M5/008 ,  B65D21/0223 ,  B65D25/10 ,  B65D43/16 ,  B65D43/162 ,  B65D2543/00166 ,  B65D2543/00296 ,  B65D2543/00527 ,  B65D2543/00537 ,  B65D2543/00574 ,  B65D2543/00648 ,  B65D2543/00694 ,  B65D2543/00731 ,  B65D2543/00805 ,  B65D2543/00944

Abstract: Device containers, such as therapeutic kit containers, are disclosed. In one embodiment, a device container includes a first member configured to releasably hold a syringe barrel, a second member configured to releasably hold a vial, wherein the second member is coupled to the first member by a first hinge, and a third member configured to releasably hold a vial adapter, wherein the third member is coupled to the second member by a second hinge.

公开(公告)号：US10001495B2

公开(公告)日：2018-06-19

申请号：US14416214

申请日：2013-07-25

Applicant: Bioverativ Therapeutics Inc.

Inventor： Jurg Sommer

IPC: G01N33/86 ,  G01N33/92

CPC classification number: G01N33/86 ,  A61K38/4846 ,  C12Y304/21022 ,  G01N33/92 ,  G01N2333/755 ,  G01N2333/9645 ,  G01N2500/00 ,  G01N2800/224

Abstract: The present disclosure provides methods and compositions for diagnosing and treating subject having a bleeding disorder. The disclosed methods comprise contacting a sample, e.g., a blood or plasma sample obtained from the patient, with an activation mixture comprising an activated coagulation factor and a phospholipid mixture, wherein the activation mixture is dried onto a solid substrate. Also provided is a global hemostasis test based on the integration of clotting time (Ct) and pharmacokinetics data. The methods and compositions presented can be applied to point-of-care diagnostic systems.

公开(公告)号：US20170281734A1

公开(公告)日：2017-10-05

申请号：US15455043

申请日：2017-03-09

Applicant: Bioverativ Therapeutics Inc.

Inventor： Kevin MALONEY ,  Daniel Gage ,  Ahmad Abdul-Fattah

IPC: A61K38/37 ,  C07K14/755 ,  C07K16/28

Abstract: The present invention provides a formulation of a Factor VIII polypeptide, e.g., FVIII-Fc, and methods of using the same. The FVIII polypeptide can be a recombinant FVIII protein, a short-acting FVIII protein, or a long-acting FVIII protein. The pharmaceutical formulation comprising a FVIII polypeptide can be used for individual prophylaxis, weekly prophylaxis, episodic (on-demand) treatment, or perioperative management of hemophilia.

公开(公告)号：US09629903B2

公开(公告)日：2017-04-25

申请号：US15043457

申请日：2016-02-12

Applicant: Bioverativ Therapeutics Inc.

Inventor： Glenn Pierce ,  Samantha Truex ,  Robert T. Peters ,  Haiyan Jiang

IPC: A61K38/37 ,  A61K38/48 ,  A61K39/395 ,  C12N9/96 ,  A61K38/38 ,  C07K16/18 ,  C12N9/64 ,  C07K14/76 ,  A61K9/00 ,  A61K47/48

CPC classification number: A61K38/4846 ,  A61K9/0019 ,  A61K38/38 ,  A61K39/395 ,  A61K39/39533 ,  A61K39/3955 ,  A61K47/643 ,  C07K14/76 ,  C07K16/18 ,  C07K2317/21 ,  C07K2317/90 ,  C07K2317/94 ,  C07K2319/30 ,  C07K2319/31 ,  C07K2319/33 ,  C12N9/644 ,  C12N9/96 ,  C12Y304/21022

Abstract: The present invention provides methods of administering Factor IX; methods of administering chimeric and hybrid polypeptides comprising Factor IX; 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.