Patent classifications
A61K39/39591
LOW-VISCOSITY, HIGH CONCENTRATION EVOLOCUMAB FORMULATIONS AND METHODS OF MAKING THE SAME
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.
EXCIPIENT COMPOUNDS FOR BIOPOLYMER FORMULATIONS
Disclosed herein are reduced viscosity liquid formulations comprising a protein and an excipient compounds. Further disclosed are methods of reducing the viscosity of a liquid formulation comprising a protein, methods of treatment, and methods of improving protein processing.
Formulation for anti-α4β7 antibody
Antibody formulations are described comprising a mixture of an anti-α4β7 antibody, an antioxidant or chelator, and at least one free amino acid. The disclosed formulations may have improved stability, reduced aggregate formation, or both. The present invention further provides a safe dosing regimen of these antibody formulations that is easy to follow, and which results in a therapeutically effective amount of the anti-α4β7 antibody in vivo.
Viscosity-reducing compounds for protein formulations
The invention encompasses formulations and methods for the production thereof that permit the delivery of concentrated protein solutions. The inventive methods can yield a lower viscosity liquid protein formulation or a higher concentration of therapeutic or nontherapeutic proteins in the liquid formulation, as compared to traditional protein solutions. The inventive methods can also yield a higher stability of a liquid protein formulation.
Anti-IL31 antibodies for veterinary use
Provided are various embodiments relating to anti-IL31 antibodies binding to canine IL31. Such antibodies can be used in methods to treat IL31-induced conditions in companion animals, such as canines, felines, and equines.
Methods for purifying antibodies having reduced high molecular weight aggregates
Provided herein, in some embodiments, are methods and compositions for purifying antibodies from cellular cultures using one or more thiol containing additives during a purification process, for example in a chromatographic purification process.
ADOPTIVE IMMUNOTHERAPY
Disclosed herein is the use of a first population of allogeneic T-cells recognizing a first EBV epitope, and a second allogeneic population recognizing a second EBV epitope in the treatment of EBV-associated disorders. Also disclosed is the use of a population of allogeneic T-cells recognizing an EBV antigen in combination with a further therapeutic agent such as an immunotherapeutic agent, a MAPK, BET or MEK. pathway inhibitor for treating EBV-associated disease.
ADOPTIVE IMMUNOTHERAPY
Disclosed herein is the use of a first population of allogeneic T-cells recognizing a first EBV epitope, and a second allogeneic population recognizing a second EBV epitope in the treatment of EBV-associated disorders. Also disclosed is the use of a population of allogeneic T-cells recognizing an EBV antigen in combination with a further therapeutic agent such as an immunotherapeutic agent, a MAPK, BET or MEK. pathway inhibitor for treating EBV-associated disease.
ANTIBODY-CONTAINING FORMULATION
In one non-limiting embodiment, the present disclosure is an antibody-containing formulation comprising an anti-IL-6 receptor antibody as an active ingredient, and contains histidine-aspartate buffer or histidine-glutamate buffer, Poloxamer 188, and arginine, and has a pH of 5.5 to 6.6. In one non-limiting embodiment, the present disclosure is a method of stabilizing an antibody-containing solution, a method of suppressing antibody association (e.g., dimerization), and a method of suppressing the generation of insoluble particles, wherein L-aspartic acid or L-glutamic acid, and optionally, Poloxamer 188 are added.
FGF21 mimetic antibodies and uses thereof
The present disclosure relates to monoclonal antibodies and antigen-binding fragments thereof that bind to human β-klotho, and pharmaceutical compositions and methods of treatment comprising the same.