Variants of Coagulation Factor VIII and Uses Thereof
Summary
USPTO published patent application US20260091138A1 by Seattle Children's Hospital covering FVIII (coagulation factor VIII) protein variants with an N2118Q mutation for hemophilia A treatment. The application claims variants with reduced immunogenicity, higher gene expression, increased stability, and enhanced functional activity suitable for protein replacement therapy and gene therapy applications.
What changed
Seattle Children's Hospital (d/b/a Seattle Children's Research Institute) filed patent application US20260091138A1 for coagulation factor VIII (FVIII) protein variants. The core innovation involves an N2118Q mutation that can be combined with other mutations including BDD-FVIII, N6, V3, RH, furin-cleavage site deletion, X10, K12, and F309S to produce FVIII variants with reduced immunogenicity, higher gene expression, increased secretion and stability, and greater functional activity. The variants are directed toward protein replacement therapy and gene therapy for hemophilia A.
This is a patent publication notice, not a regulatory requirement. Entities developing hemophilia A therapeutics—including biotechnology companies, gene therapy developers, and research institutions—should review the application claims to assess potential freedom-to-operate implications for their own FVIII-related programs. No compliance action is required; this is an informational publication of pending patent claims. The patent, if granted, would provide Seattle Children's Hospital with exclusionary rights covering these specific FVIII variant compositions and their therapeutic uses.
Archived snapshot
Apr 2, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
VARIANTS OF COAGULATION FACTOR VIII AND USES THEREOF
Application US20260091138A1 Kind: A1 Apr 02, 2026
Assignee
Seattle Children’s Hospital d/b/a Seattle Children’s Research Institute
Inventors
Carol Hsing Miao
Abstract
Variants of coagulation factor VIII (FVIII) and expression cassettes encoding the FVIII variants thereof are described. A variant FVIII includes a glycoepitope of the FVIII protein including an N2118Q mutation. The N2118Q mutation can be combined with other mutations including a BDD-FVIII, N6, V3, RH, furin-cleavage site deletion. X10, K12, and/or F309S mutation to form additional FVIII variants. The FVIII variants with the N2118Q mutation and expression cassettes thereof can result in reduced immunogenicity of the resulting protein. When combined with other FVIII mutations, higher gene expression, increased secretion, increased stability, and higher FVIII functional activity can be achieved by the expressed FVIII variants. The variant FVIII and expression cassettes described here can be useful in protein replacement therapy and/or gene therapy for the treatment of hemophilia A.
CPC Classifications
A61K 48/0058 A61K 38/37 A61P 7/04 C07K 14/755 C12N 15/86 C12N 2740/15043 C12N 2740/15045
Filing Date
2023-09-20
Application No.
19113657
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