Methods of reducing immunogenicity against factor viii in individuals undergoing factor viii therapy
AssigneesBioverativ Therapeutics Inc., Puget Sound Blood Center
InventorsHaiyan Jiang, Tongyao Liu, Sriram Krishnamoorthy, Neil Josephson, Glenn Pierce
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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.
Claims86
A method of administering Factor VIII (FVIII) to a subject at risk of developing an inhibitory FVIII immune response comprising administering to the subject a chimeric polypeptide comprising a FVIII portion and an Fc portion.
A method of inducing immune tolerance to FVIII in a subject, wherein the subject is a fetus, the method comprising administering to the mother of the fetus a polypeptide comprising a chimeric polypeptide comprising a FVIII portion and an Fc portion.
A method of administering a clotting factor to a subject at risk of developing an inhibitory immune response to the clotting factor comprising administering to the subject a chimeric polypeptide comprising a clotting factor portion and an Fc portion.
A method of inducing immune tolerance to a clotting factor in a subject, wherein the subject is a fetus, the method comprising administering to the mother of the fetus a polypeptide comprising a chimeric polypeptide comprising a clotting factor portion and an Fc portion.
A method of inducing immune tolerance to FVIII in a subject in need thereof, comprising administering to the subject a chimeric polypeptide comprising a FVIII portion and an Fc portion.
A method of preventing or inhibiting development of an inhibitor to FVIII, the method comprising administering to a subject in need of immune tolerance a chimeric polypeptide comprising FVIII portion and an Fc portion.
A method of inducing immune tolerance to a clotting factor in a subject in need thereof, comprising administering to the subject a chimeric polypeptide comprising a clotting factor portion and an Fc portion.
A method of preventing or inhibiting development of an inhibitor to a clotting factor comprising administering to a subject in need thereof a chimeric polypeptide comprising a clotting factor portion and an Fc portion.
A kit comprising:
- (a) a pharmaceutical composition comprising a chimeric polypeptide which comprises a clotting factor portion and an Fc portion or an FcRn binding partner portion and a pharmaceutically acceptable carrier, and
- (b) instructions to administer to the composition to a subject in need of immune tolerance to the clotting factor.
The kit of method 77, wherein the chimeric polypeptide comprises a FVIII portion, a FVII portion, or a FIX portion.
Dependencies are inferred from the claim text.