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Publication Number
US-12668616-B2
Publication Date
2026-06-30
Expiration Date
Abstract
Disclosed herein are nucleic acid molecules comprising one or more nucleic acid sequences that encode a mutated WT1 antigen. Vectors, compositions and vaccines comprising one or more nucleic acid sequences that encode a mutated WT1 antigen are disclosed. Methods of treating an individual who has a WT1-expressing tumor and methods of preventing a WT1-expressing tumor are disclosed. Mutated WT1 antigen is disclosed.
Core Innovation
The invention relates to nucleic-acid vaccines for targeting Wilm’s tumor suppressor gene 1 (WT1) using nucleic acids encoding mutated/consensus WT1 antigens. The described nucleic acids include sequences identified as SEQ ID NO:1 and SEQ ID NO:3, with versions without the leader sequence, and the encoded products are proteins identified as SEQ ID NO:2 and SEQ ID NO:4, with versions without the leader sequence. Vaccine components include nucleic acid molecule(s), including vectors such as plasmids or viral vectors, together with vaccine formulation elements such as peptides and excipients/adjuvants.
A key aspect of the invention is the design of consensus WT1 antigens (ConWT1), including ConWT1-L and ConWT1-S variants. The described approach involves zinc finger disruption or complete zinc finger removal, using modified CCHH motifs and an IgE leader placement for ConWT1-L, and removal of zinc fingers for ConWT1-S. The patent further frames sequence scope using stated sequence-identity and fragment concepts, including defined coverage of the entire length and identity percentages over that length.
The disclosed vaccines are used for prophylactic or therapeutic treatment, including treating or preventing WT1-expressing tumors by administering an effective amount of the vaccine. The document reports enhanced immune responses in mouse immunogenicity studies, including enhanced T-cell responses measured by IFN-γ ELISpot and humoral responses. Expression confirmation is also described using staining/immunoblot for ConWT1-L and ConWT1-S.
Claims Coverage
The partial content identifies three independent claims, covering an isolated nucleic acid molecule, a nucleic-acid vaccine method, and a protein vaccine method, all directed to WT1-expressing tumors and defined by named SEQ ID NOs and sequence-identity/fragment constraints.
Isolated nucleic acid with leader-free SEQ ID NO:1/SEQ ID NO:3 variants and defined fragment/identity thresholds
An isolated nucleic acid molecule comprising one or more nucleic acid sequences selected from SEQ ID NO:1 without the leader sequence; a fragment comprising at least 90% of the entire length of SEQ ID NO:1 without the leader sequence; a nucleic acid sequence at least 98% identical to SEQ ID NO:1 over the entire length of SEQ ID NO:1 without the leader sequence; and corresponding fragment and identity variants for SEQ ID NO:3 without the leader sequence.
Administering a nucleic-acid vaccine encoding WT1-related proteins from SEQ ID NO:2/SEQ ID NO:4 without the leader sequence
A method of treating an individual with a WT1-expressing tumor or preventing development of a WT1-expressing tumor, comprising administering an amount of a vaccine effective to slow growth of, reduce, or eliminate WT1-expressing tumors, wherein the vaccine comprises a nucleic acid molecule comprising one or more nucleic acid sequences encoding a protein or a fragment thereof, the protein comprising an amino acid sequence selected from SEQ ID NO:2 without the leader sequence; fragments with at least 90% entire length; amino acid sequences at least 98% identical over the entire length; and corresponding fragment and identity variants for SEQ ID NO:4 without the leader sequence.
Administering a vaccine protein with SEQ ID NO:2/SEQ ID NO:4 amino-acid variants without the leader sequence
A method of treating an individual with a WT1-expressing tumor or preventing development of a WT1-expressing tumor, comprising administering an amount of a vaccine effective to slow growth of, reduce, or eliminate WT1-expressing tumors, wherein the vaccine comprises a protein comprising an amino acid sequence selected from SEQ ID NO:2 without the leader sequence; fragments with at least 90% entire length; amino acid sequences at least 98% identical over the entire length; and corresponding fragment and identity variants for SEQ ID NO:4 without the leader sequence.
Coverage centers on WT1-targeting vaccine antigens defined by named SEQ ID NO:1/SEQ ID NO:3 nucleic-acid sequences and SEQ ID NO:2/SEQ ID NO:4 amino-acid sequences, each constrained to leader-free forms with specified entire-length fragment coverage and sequence identity.
Stated Advantages
Enhanced immune responses in mouse immunogenicity studies, including enhanced T-cell responses measured by IFN-γ ELISpot and humoral responses.
Documented Applications
Treating or preventing WT1-expressing tumors.
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