Stable aqueous anti-TFPI antibody formulation
Inventors
Crowley, Thomas Joseph • Dufield, Robert Lee • Juneau, Jennifer
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-12708668-B2
Publication Date
2026-08-18
Expiration Date
Abstract
The present invention relates to the field of pharmaceutical formulations of antibodies. Specifically, the present invention relates to a stable liquid antibody formulation and its pharmaceutical preparation and use. This invention is exemplified by an aqueous formulation of an anti-Tissue Factor Pathway Inhibitor (TFPI) antibody.
Core Innovation
The disclosure describes a stable, high-concentration aqueous pharmaceutical formulation containing an antibody that specifically binds an epitope in Kunitz Domain 2 of Tissue Factor Pathway Inhibitor. The formulation combines the antibody with histidine buffer, sucrose, polysorbate 80, and disodium edetate dihydrate. Specific formulation quantities and conditions are [procedural detail omitted for safety].
The disclosure reports low degradation and retained potency during refrigerated storage, as well as lower aggregate formation under thermal stress than an anti-VEGF comparator. It identifies the antibody through specified CDR and antibody-chain sequences, which are [procedural detail omitted for safety]. The background section is not included in the provided content, so the problem being solved is not explicitly described in patent.
Claims Coverage
The provided claims identify four independent claims: claims 1, 6, 7, and 8. They cover four inventive features relating to stable anti-TFPI K2 antibody formulations; exact formulation quantities, conditions, and sequence data are [procedural detail omitted for safety].
Formulation with defined antibody CDRs
Claim 1 covers a stable pharmaceutical formulation containing an antibody that specifically binds an epitope in TFPI K2, with defined heavy- and light-chain CDRs, histidine buffer, sucrose, polysorbate 80, and disodium edetate dihydrate. Specific formulation quantities, pH, and sequence data are [procedural detail omitted for safety].
Formulation with defined variable regions
Claim 6 covers a stable pharmaceutical formulation containing a TFPI K2-binding antibody with defined heavy- and light-chain variable regions, together with histidine buffer, sucrose, polysorbate 80, and disodium edetate dihydrate. Specific formulation quantities, pH, and sequence data are [procedural detail omitted for safety].
Formulation with defined heavy and light chains
Claim 7 covers a stable pharmaceutical formulation containing a TFPI K2-binding antibody with defined heavy and light chains, together with histidine buffer, sucrose, polysorbate 80, and disodium edetate dihydrate. Specific formulation quantities, pH, and sequence data are [procedural detail omitted for safety].
Formulation with an alternative defined heavy chain
Claim 8 covers a stable pharmaceutical formulation containing a TFPI K2-binding antibody with a defined heavy chain and light chain, together with histidine buffer, sucrose, polysorbate 80, and disodium edetate dihydrate. Specific formulation quantities, pH, and sequence data are [procedural detail omitted for safety].
The independent claims cover stable anti-TFPI K2 antibody formulations distinguished by antibody CDR, variable-region, or chain definitions and a specified set of formulation components. The quantitative and sequence-specific claim elements are [procedural detail omitted for safety].
Stated Advantages
The formulation shows low degradation and retained potency during refrigerated storage; specific storage duration and conditions are [procedural detail omitted for safety].
The formulation shows lower aggregate formation under thermal stress than an anti-VEGF comparator.
Documented Applications
The formulation is described for treatment of bleeding disorders, including hemophilia A, hemophilia B, and hemophilia C.
The claims describe use of the formulation in a method for shortening bleeding time.
Interested in licensing this patent?