B7-H4 antibodies and methods and use thereof
Inventors
Kaplan, Charles • PALUMBO, ALESSANDRO • Miller, Kathy • Park, Hangil • MENDOZA, NERISSA • Ghoddusi, Majid
Assignees
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Publication Number
US-11939383-B2
Publication Date
2024-03-26
Expiration Date
Abstract
The present disclosure provides antibodies and antigen-binding fragments thereof that specifically bind to human B7-H4. The anti-B7-H4 antibodies or antigen-binding fragments thereof are useful, for example in detecting B7-H4. Immunohistochemistry (IHC) can be used to detect B7-H4. The present disclosure also provides methods for treating cancer wherein increased B7-H4 has been detected, by administering a therapeutic anti-B7-H4 antibody or antigen-binding fragment thereof.
Core Innovation
The disclosure provides isolated antibodies and antigen-binding fragments that specifically bind to human B7-H4. The antibodies are defined by sequence-specific heavy chain variable region complementarity determining regions, including VH CDR1, VH CDR2, and VH CDR3, together with sequence-specific light chain variable region CDRs, including VL CDR1, VL CDR2, and VL CDR3.
The disclosed antibody binding specificity is further characterized by defined combinations of heavy chain variable region and light chain variable region amino acid sequences. The patent provides explicit pairing options that specify which SEQ ID NOs correspond to the heavy chain and which correspond to the light chain, and together these variable-region and CDR sequence constraints specify antibodies that specifically bind human B7-H4.
The disclosure further characterizes nucleic acids encoding the variable domains and recombinant expression elements, together with diagnostic and therapeutic use concepts directed to B7-H4. Binding characterization is described through competitive binding assay concepts, and use of the antibodies for diagnostic detection modalities including ELISA, FACS, and IHC on cancer-related samples is described, alongside therapeutic use in B7-H4-expressing cancers.
Claims Coverage
The independent claims are directed to isolated antibodies or antigen-binding fragments that specifically bind human B7-H4, defined by fixed VH/VL CDR sequences and by specified heavy-chain/light-chain variable-region sequence pairings. Across the independent claims, there are two core inventive feature sets.
Cdr-defined isolated anti-human B7-H4 antibody or antigen-binding fragment
An isolated antibody or antigen-binding fragment thereof that specifically binds to human B7-H4, comprising a heavy chain variable region (VH) CDR1 comprising the amino acid sequence of SEQ ID NO:22, a VH CDR2 comprising the amino acid sequence of SEQ ID NO:23, a VH CDR3 comprising the amino acid sequence of SEQ ID NO:24, a light chain variable region (VL) CDR1 comprising the amino acid sequence of SEQ ID NO:25, a VL CDR2 comprising the amino acid sequence of SEQ ID NO:26, 27, or 28, and a VL CDR3 sequence comprising the amino acid sequence of SEQ ID NO:29.
Variable-region-pair isolated anti-human B7-H4 antibody or antigen-binding fragment
An isolated antibody or antigen-binding fragment thereof that specifically binds to human B7-H4, comprising a heavy chain variable region and a light chain variable region comprising the amino acid sequences of: (a) SEQ ID NOs:6 and 9, respectively; (b) SEQ ID NOs:6 and 10, respectively; (c) SEQ ID NOs:6 and 11, respectively; (d) SEQ ID NOs:7 and 9, respectively; (e) SEQ ID NOs:7 and 10, respectively; (f) SEQ ID NOs:7 and 11, respectively; (g) SEQ ID NOs:8 and 9, respectively; (h) SEQ ID NOs:8 and 10, respectively; or (i) SEQ ID NOs:8 and 11, respectively.
The claim set defines isolated antibodies or antigen-binding fragments that specifically bind human B7-H4 by fixing either specific VH and VL CDR amino acid sequences or specific heavy-chain/light-chain variable-region sequence pair combinations.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Diagnostic detection of B7-H4 in a sample by contacting the sample with an antibody or an antigen-binding fragment thereof.
Diagnostic detection in cancer selected from breast cancer, ductal carcinoma, endometrial carcinoma, ovarian cancer, non-small cell lung cancer, pancreatic cancer, thyroid cancer, kidney cancer, or bladder cancer.
Diagnostic and detection use of the B7-H4 binding antibodies or antigen-binding fragments, including ELISA, FACS, immunohistochemistry (IHC), immunoprecipitation, and Western blot with labeled conjugates and secondary-antibody formats.
Therapeutic use for B7-H4-expressing cancers, including breast cancer, endometrial cancer, ovarian cancer, non-small cell lung cancer, pancreatic cancer, thyroid cancer, kidney cancer, and bladder cancer.
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