CYP1A1-targeted monoclonal antibody with reactivity across vertebrate taxa

Patent metadata

Field	Value
Publication number	US-12534540-B2
Application number	US-202418420450-A
Country	US
Kind code	B2
Filing date	Jan 23, 2024
Priority date	Jan 23, 2023
Publication date	Jan 27, 2026
Grant date	Jan 27, 2026

Abstract

This invention is directed to a monoclonal antibody or an antigen binding fragment thereof targeting the expression and function of CYP1A1 with cross reactivity across the vertebrate taxa. This invention is also directed to nucleic acid molecules, vectors, host cells and compositions comprising the same, as well as methods for use of the same and for producing the same.

First claim

What is claimed is:

1 . A monoclonal antibody or an antigen binding fragment thereof that specifically binds cytochrome P450 1A1 (CYP1A1) protein conserved sequence SEQ ID NO: 15, SEQ ID NO:34 and/or SEQ ID NO:35, wherein the antibody or antigen binding fragment thereof comprises the CDR-H1, CDR-H2, CDR-H3, CDR-L1, CDR-L2, and CDR-L3 sequences of SEQ ID NO: 28-33, respectively.

2 . The monoclonal antibody or antigen binding fragment thereof of claim 1 , comprising a primary heavy chain and light chain variable sequence of SEQ ID NOs: 17 and 20.

3 . The monoclonal antibody or antigen binding fragment thereof of claim 1 , comprising a heavy chain and light chain constant sequence of SEQ ID NOs: 18 and 21.

4 . The monoclonal antibody or antigen binding fragment thereof of claim 1 , comprising a signal peptide comprising an amino acid selected from SEQ ID NOs: 16 and 19.

5 . The monoclonal antibody or antigen binding fragment thereof of claim 2 , wherein the primary heavy chain and light chain variable sequence is encoded by a nucleic acid sequence comprising a nucleic acid sequence selected from any one of SEQ ID NOs: 23 and 26.

6 . The monoclonal antibody or antigen binding fragment thereof of claim 3 , wherein the heavy chain and light chain constant sequence is encoded by a nucleic acid sequence comprising a nucleic acid sequence selected from any one of SEQ ID NOs: 24 and 27.

7 . The monoclonal antibody or antigen binding fragment thereof of claim 4 , wherein the signal peptide sequence is encoded by a nucleic acid sequence comprising a nucleic acid sequence selected from any one of SEQ ID NOs: 22 and 25.

8 . The monoclonal antibody or antigen binding fragment thereof of claim 1 , being humanized and/or chimeric.

9 . An isolated nucleic acid molecule comprising a sequence encoding the monoclonal antibody or an antigen binding fragment thereof of claim 1 .

10 . A vector comprising the nucleic acid molecule of claim 9 .

11 . A host cell comprising the nucleic acid molecule of claim 9 .

12 . A composition comprising the monoclonal antibody or antigen binding fragment thereof of claim 1 and further a suitable carrier, diluent, or excipient.

13 . A method of producing the monoclonal antibody or antigen binding fragment thereof of claim 1 , the method comprising:
cultivating the host cell of claim 12 thereby allowing the monoclonal antibody or antigen binding fragment thereof to be expressed; recovering the monoclonal antibody or antigen binding fragment thereof; and optionally purifying the monoclonal antibody or antigen binding fragment thereof.

14 . A method of producing the monoclonal antibody or antigen binding fragment thereof of claim 1 , the method comprising:
(a) contacting a cell-free expression system with a nucleic acid product template, the nucleic acid product template encoding the monoclonal antibody or antigen binding fragment thereof according to claim 1 ; (b) allowing transcription and translation of the nucleic acid product template to occur, thereby allowing a reaction mixture to be formed; (c) recovering the monoclonal antibody or antigen binding fragment thereof from the reaction mixture; and (d) optionally purifying the monoclonal antibody or antigen binding fragment thereof.

15 . A method of diagnosing a disease or disorder associated with activated CYP1A in a subject, the method comprising:
(i) contacting a biological sample from the subject with the monoclonal antibody or antigen binding fragment thereof of claim 1 under conditions permissive for specific binding of the monoclonal antibody or antigen binding fragment thereof to CYP1A, and (ii) detecting whether a complex between the monoclonal antibody or antigen binding fragment thereof and CYP1A is formed; wherein detection of the complex indicates the presence of activated CYP1A in the subject.

16 . A kit comprising the monoclonal antibody or antigen binding fragment thereof of claim 1 together with a packaged combination of reagents with instructions.

Assignees

• Univ Clemson Res Foundation

Inventors

• Rice Charles David

Classifications

• C12N15/00

  Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor (mutants or genetically engineered microorganisms, per se C12N1/00, C12N5/00, C12N7/00; new plants per se A01H; plant reproduction by tissue culture techniques A01H4/00; new animals per se A01K67/00; use of medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases, gene therapy A61K48/00) · CPC title

• C07K2317/565

  Complementarity determining region [CDR] · CPC title

• C07K2317/33

  Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity · CPC title

• C07K2317/14

  Specific host cells or culture conditions, e.g. components, pH or temperature · CPC title

• C07K16/46

  Hybrid immunoglobulins (hybrids of an immunoglobulin with a peptide not being an immunoglobulin C07K19/00) · CPC title