Patents Assigned to Baxalta GmbH
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Publication number: 20220175939Abstract: The present disclosure relates to materials and methods of conjugating a water soluble polymer to a therapeutic protein.Type: ApplicationFiled: February 22, 2022Publication date: June 9, 2022Applicants: Baxalta Incorporated, Baxalta GmbHInventors: Juergen Siekmann, Alfred Weber, Hanspeter Rottensteiner, Peter Turecek
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Patent number: 11305000Abstract: The invention relates to the development of chimeric OspA molecules for use in a new Lyme vaccine. More specifically, the chimeric OspA molecules comprise the proximal portion from one OspA serotype, together with the distal portion from another OspA serotype, while retaining antigenic properties of both of the parent polypeptides. The chimeric OspA molecules are delivered alone or in combination to provide protection against a variety of Borrelia genospecies. The invention also provides methods for administering the chimeric OspA molecules to a subject in the prevention and treatment of Lyme disease or borreliosis.Type: GrantFiled: January 19, 2018Date of Patent: April 19, 2022Assignees: Brookhaven Science Associates, LLC, The Research Foundation of State University of New York, Baxalta Incorporated, Baxalta GmbHInventors: Brian A. Crowe, Ian Livey, Maria O'Rourke, Michael Schwendinger, John J. Dunn, Benjamin J. Luft
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Publication number: 20210290486Abstract: The invention is directed to a female-female syringe adapter, related systems, and methods of using the female-female adapter. The female-female syringe adapter may be used with male nozzles of syringes and reconstitution devices when reconstituting a lyophilized powder. The female-female adapter also may be used to combine doses in a common syringe from mixed reconstitution products in a multi-chambered syringe.Type: ApplicationFiled: July 11, 2019Publication date: September 23, 2021Applicants: BAXALTA INCORPORATED, BAXALTA GMBHInventors: Scott Richard ARIAGNO, Mark SCHILLING, Amey MATHAKARI, Dan SANCHEZ, Chris BLACKLEDGE
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Patent number: 11081211Abstract: Systems and methods providing a clotting factor VIII dosing regimen are disclosed. The systems and methods include determining an estimated pharmacokinetic profile of a patient using a Bayesian model of pharmacokinetic profiles of sampled patients. The systems and methods can determine a first dosing regimen for a first dosing interval including (i) a first dosage and (ii) a first therapeutic plasma protein level in the patient varying over time based at least upon the estimated pharmacokinetic profile. The systems and methods can determine a second dosing regimen for a second dosing interval including (i) a second dosage and (ii) a second therapeutic plasma protein level in the patient varying over time. The estimated pharmacokinetic profile can be adjusted based on previous patient treatments. Further, a user can select which days a dosage is to be applied such that the protein level does not fall below a target trough.Type: GrantFiled: October 14, 2020Date of Patent: August 3, 2021Assignees: BAXALTA INCORPORATED, BAXALTA GMBHInventors: Kameswara Rao Kuchimanchi, Alexandra Loew-Baselli, Gerald Spotts, Myungshin Oh, Michael Don Hale, Martin Wolfsegger
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Publication number: 20210163990Abstract: The AAV compositions comprising an AAV and a buffer. These AAV compositions are appropriate for us in intracerebroventricular (ICV) and intraparenchymal (IPA) administration, as well as other routes of administration and can be provided in frozen, liquid or potentially freeze dried (lyophilized) state.Type: ApplicationFiled: July 11, 2019Publication date: June 3, 2021Applicants: BAXALTA INCORPORATED, BAXALTA GMBHInventors: Eva FRITSCHER, Christian FIEDLER, Tanvir TABISH, Dominik MITTERGRADNEGGER, Stefan REUBERGER
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Patent number: 11020459Abstract: A Factor VIII (FVIII) composition formulated such that NaCl is not present in the final formulation or is present in trace amounts, which allows for a concomitant reduction in the lyophilization cycle time and increased stability of the lyophilized FVIII.Type: GrantFiled: August 21, 2019Date of Patent: June 1, 2021Assignees: Baxalta Incorporated, Baxalta GmbH, University of ConnecticutInventors: Michael Pikal, Serguei Tchessalov, Erik Bjornson, Feroz Jameel, Marc Besman
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Publication number: 20210128701Abstract: Provided herein are methods for recanalization of occluded blood vessels in a subject having an infarction. The method includes a step of administering to the subject a therapeutically effective amount of isolated ADAMTS13 protein at particular dosages and ranges of times after detection of the infarction. As described herein, ADAMTS13 advantageously recanalizes occluded blood vessels and reduces infarction size, even when administered a prolonged period after stable occlusion. Accordingly, such methods and compositions are useful for the treatment of infractions caused by blood vessel occlusion.Type: ApplicationFiled: October 3, 2019Publication date: May 6, 2021Applicants: Baxalta Incorporated, Baxalta GmbH, Katholieke Universiteit LeuvenInventors: Barbara PLAIMAUER, Hanspeter Rottensteiner, Friedrich Scheiflinger, Simon De Meyer, Frederik Denorme
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Patent number: 10934340Abstract: The present invention relates to a method for separating a mature von Willebrand Factor (mat-VWF) from von Willebrand Factor pro-peptide (VWF-PP) by incubating a composition comprising inducing dissociation of mat-VWF and VWF-PP by disruption of the non-covalently associated mat-VWF and VWF-PP, wherein said dissociation is induced by: (i) addition of at least one chelating agent, or (ii) increasing the pH to a pH of at least 7, and then collecting said mat-VWF to obtain a high purity, propeptide depleted mature VWF (mat-VWF).Type: GrantFiled: March 20, 2019Date of Patent: March 2, 2021Assignees: Baxalta Incorporated, Baxalta GmbHInventors: Christian Fiedler, Meinhard Hasslacher, Christa Mayer
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Publication number: 20210032567Abstract: The present invention relates to methods for inactivating a lipid-enveloped virus using environmentally compatible detergents, and to methods for preparing a biopharmaceutical drug using environmentally compatible detergents. The invention also provides environmentally compatible detergents.Type: ApplicationFiled: October 30, 2018Publication date: February 4, 2021Applicants: Baxalta Incorporated, Baxalta GmbHInventors: Jean-Baptiste FARCET, Johanna KINDERMANN, Björn TILLE, Thomas R. KERIL
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Patent number: 10905746Abstract: The present invention relates to a method for treating gastrointestinal bleeding in a subject with severe von Willebrand Disease comprising administering to the subject at least one dose of recombinant von Willebrand Factor (rVWF) ranging from about 40 IU/kg to about 100 IU/kg, wherein the first dose further comprises recombinant Factor VIII (rFVIII).Type: GrantFiled: February 26, 2020Date of Patent: February 2, 2021Assignees: Baxalta GmbH, Baxalta IncorporatedInventors: Miranda Chapman, Bruce Ewenstein, Bettina Ploder
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Publication number: 20210027876Abstract: Systems and methods providing a clotting factor VIII dosing regimen are disclosed. The systems and methods include determining an estimated pharmacokinetic profile of a patient using a Bayesian model of pharmacokinetic profiles of sampled patients. The systems and methods can determine a first dosing regimen for a first dosing interval including (i) a first dosage and (ii) a first therapeutic plasma protein level in the patient varying over time based at least upon the estimated pharmacokinetic profile. The systems and methods can determine a second dosing regimen for a second dosing interval including (i) a second dosage and (ii) a second therapeutic plasma protein level in the patient varying over time. The estimated pharmacokinetic profile can be adjusted based on previous patient treatments. Further, a user can select which days a dosage is to be applied such that the protein level does not fall below a target trough.Type: ApplicationFiled: October 14, 2020Publication date: January 28, 2021Applicants: BAXALTA INCORPORATED, BAXALTA GMBHInventors: Kameswara Rao Kuchimanchi, Alexandra Loew-Baselli, Gerald Spotts, Myungshin Oh, Michael Don Hale, Martin Wolfsegger
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Patent number: 10900979Abstract: The invention generally relates to methods of testing the effectiveness of a von Willebrand factor (VWF) in treating von Willebrand disease (VWD) in a subject comprising measuring VWF cleavage fragments in a blood sample from the subject before and after treatment. In particular, the invention relates to methods of measuring VWF cleavage fragments, wherein an increase in VWF cleavage fragments after the treatment indicates that endogenous a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13 (ADAMTS13) in the subject is cleaving the VWF and wherein a decrease or absence of VWF cleavage fragments after the treatment indicates that endogenous ADAMTS13 in the subject is not cleaving the VWF.Type: GrantFiled: January 16, 2019Date of Patent: January 26, 2021Assignees: Baxalta Incorporated, Baxalta GmbHInventors: Katalin Varadi, Hanspeter Rottensteiner, Peter Turecek, Hans-Peter Schwarz, Jutta Schreiner
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Patent number: 10875906Abstract: The present invention provides novel methods for reducing the serine protease and/or serine protease zymogen content of a plasma-derived protein composition. Also provided are methods for manufacturing plasma-derived protein compositions having reduced serine protease and\or serine protease zymogen content. Among yet other aspects, the present invention provides aqueous and lyophilized compositions of plasma-derived proteins having reduced serine protease and/or serine protease zymogen content. Yet other aspects include methods for treating, managing, and/or preventing a disease comprising the administration of a plasma-derived protein composition having a reduced serine protease or serine protease zymogen content.Type: GrantFiled: January 7, 2019Date of Patent: December 29, 2020Assignees: Baxalta Incorporated, Baxalta GmbHInventors: Wolfgang Teschner, Hans-Peter Schwarz, Ruth Madlener, Sonja Svatos, Azra Pljevljakovic, Alfred Weber
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Publication number: 20200376098Abstract: The present invention relates to formulations of ADAMTS13 with enhanced or desirable properties. As such, the invention provides liquid and lyophilized formulations of ADAMTS13 that are suitable for pharmaceutical administration. Among other aspects, the present invention also provides methods of treating various diseases and conditions related to VWF and/or ADAMTS13 dysfunction in a subject. Also provided herein are kits comprising ADAMTS13 formulations useful for the treatment of various diseases and conditions.Type: ApplicationFiled: July 21, 2020Publication date: December 3, 2020Applicants: BAXALTA INCORPORATED, BAXALTA GMBHInventors: Peter MATTHIESSEN, Peter L. TURECEK, Hans-Peter Schwarz
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Patent number: 10822376Abstract: A peptide or peptide derivative comprising: (i) WDLYFEIVW (SEQ ID NO:1); or (ii) a variant amino acid sequence comprising one, two, three or four L-amino acid substitutions in WDLYFEIVW (SEQ ID NO: 1); or (iii) the retro-inverso variant of the peptide or peptide derivative of either one of parts (i) and (ii), wherein said peptide or peptide derivative has procoagulant activity. A peptide or peptide derivative comprising: (i) an amino acid sequence comprising imfwydcye; or (ii) a variant amino acid sequence comprising one, two, three, four, five or six amino acid substitutions in imfwydcye, wherein said peptide or peptide derivative has procoagulant activity.Type: GrantFiled: March 20, 2019Date of Patent: November 3, 2020Assignees: Baxalta GmbH, Baxalta IncorporatedInventors: Friedrich Scheiflinger, Michael Dockal
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Patent number: 10822394Abstract: Among other aspects, the present invention relates to cell culture conditions for producing high molecular weight vWF, in particular, highly multimericWF with a high specific activity and ADAMTS13 with a high specific activity. The cell culture conditions of the present invention can include, for example, a cell culture medium with an increased copper concentration and/or cell culture supernatant with a low ammonium (NH4+) concentration. The present invention also provides methods for cultivating cells in the cell culture conditions to express high molecular weight vWF and rA13 having high specific activities.Type: GrantFiled: September 7, 2018Date of Patent: November 3, 2020Assignees: Baxalta GmbH, Baxalta IncorporatedInventors: Leopold Grillberger, Manfred Reiter, Wolfgang Mundt
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Publication number: 20200332266Abstract: Provided herein are methods of producing an adeno-associated virus (AAV) product and methods of purifying adeno-associated virus. AAV is loaded onto an affinity resin, wash steps are undertaken, and AAV is eluted from the affinity resin. Various buffers are disclosed for use in the wash steps and elution.Type: ApplicationFiled: December 27, 2018Publication date: October 22, 2020Applicants: BAXALTA INCORPORATED, BAXALTA GMBHInventors: Christian FIEDLER, Meinhard HASSLACHER, Jadranka KOEHN
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Patent number: 10800816Abstract: The invention provides peptides that bind Tissue Factor Pathway Inhibitor (TFPI), including TFPI-inhibitory peptides, and compositions thereof. Peptide complexes also are provided. The peptides may be used to inhibit a TFPI, enhance thrombin formation in a clotting factor-deficient subject, increase blood clot formation in a subject, treat a blood coagulation disorder in a subject, purify TFPI, and identify a TFPI-binding compound.Type: GrantFiled: November 16, 2017Date of Patent: October 13, 2020Assignees: Baxalta GmbH, Baxalta IncorporatedInventors: Michael Dockal, Rudolf Hartmann, Friedrich Scheiflinger, Frank Osterkamp, Thomas Polakowski, Ulrich Reineke
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Patent number: 10772968Abstract: A water soluble polymer, in particular polysialic acid (PSA) or a modified PSA (mPSA), is conjugated to an oxidized carbohydrate moiety of a glycoprotein other than a blood coagulation protein or to a ganglioside or drug delivery system by contacting the oxidized carbohydrate moiety with the water soluble polymer, wherein said water soluble polymer contains an aminooxy group and an oxime linkage is formed between the oxidized carbohydrate moiety and the aminooxy group on the water soluble polymer or wherein said water soluble polymer contains a hydrazide group and a hydrazone linkage is formed between the oxidized carbohydrate moiety and the hydrazide group on the water soluble polymer. Conjugates of aminooxy- or hydrazide-water soluble polymer, such as PSA and mPSA, are thus obtained in which the PSA or mPSA is attached via a carbohydrate moiety.Type: GrantFiled: September 18, 2017Date of Patent: September 15, 2020Assignees: Lipoxen Technologies Limited, Baxalta Incorporated, Baxalta GmbHInventors: Sanjay Jain, Gregory Gregoriadis, Archana Dwivedi, Srijit Nath, Juergen Siekmann, Stefan Haider, Hanspeter Rottensteiner, Peter Turecek
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Patent number: D898342Type: GrantFiled: October 3, 2018Date of Patent: October 13, 2020Assignees: Baxalta GmbH, Baxalta IncorporatedInventors: Madeleine Clare Gibson, Seth Dale Jones, Daniel Edward Roush, Nicholas John Schill, Ron Theis, Denise A. Alexander