A NOVEL ANTIBODY BINDING SPECIFICALLY TO HUMAN CEACAM1/3/5 AND USE THEREOF

Abstract

The present invention is directed to an isolated antibody or antigen binding fragment thereof that binds within huCEA-CAMl/3/5 specifically to the amino acid epitope sequence PQQLFGYSWY (SEQ ID NO: 11), wherein the isolated antibody or antigen binding fragment preferably comprises three heavy chain complementarity determining regions (HCDR1, HCDR2, and HCDR3), and three light chain complementarity determining regions (LCDR1, LCDR2, and LCDR3), wherein HCDR1 comprises the amino acid sequence of SEQ ID NO:1; HCDR2 comprises the amino acid sequence of SEQ ID NO:2; and HCDR3 comprises the amino acid sequence of SEQ ID NO:3; and wherein LCDR1 comprises the amino acid sequence of SEQ ID NO:4; LCDR2 comprises the amino acid sequence of GAT or GATX as in SEQ ID NO:5; and LCDR3 comprises the amino acid sequence of SEQ ID NO:6.

Description

Claims

1. An isolated antibody or antigen binding fragment thereof binding specifically to an epitope on huCEACAM1/3/5 consisting of the amino acid sequence of SEQ ID NO:11.

2. The isolated antibody or antigen binding fragment thereof of claim 1, wherein the isolated antibody or antigen binding fragment comprises three heavy chain complementarity determining regions (HCDR1, HCDR2, and HCDR3), and three light chain complementarity determining regions (LCDR1, LCDR2, and LCDR3), wherein HCDR1 comprises the amino acid sequence of SEQ ID NO:1;HCDR2 comprises the amino acid sequence of SEQ ID NO:2; andHCDR3 comprises the amino acid sequence of SEQ ID NO:3; and whereinLCDR1 comprises the amino acid sequence of SEQ ID NO:4;LCDR2 comprises the amino acid sequence of GAT or GATX as in SEQ ID NO:5; andLCDR3 comprises the amino acid sequence of SEQ ID NO:6.

3. The isolated antibody or antigen binding fragment thereof ofclaim 1, wherein the antibody or antigen binding fragment comprises a heavy chain comprising the amino acid sequence of SEQ ID NO:7, and a light chain comprising the amino acid sequence of SEQ ID NO:8.

4. The isolated antibody or antigen binding fragment thereof ofclaim 1, wherein the antibody is monoclonal.

5. The isolated antibody or antigen binding fragment thereof of claim 1, wherein the antibody is recombinant; or wherein the antibody is an IgG, IgM, IgA or an antigen binding fragment thereof; or wherein the antibody is a Fab fragment, a Fab′ fragment, a F(ab′)2 fragment, a F(ab′)3 fragment, a Fd fragment, a Fd′ fragment, a Fv fragment, a scFv, a bivalent scFv, a diabody, a linear antibody, or a monovalent.

6. The isolated antibody or antigen binding fragment thereof of claim 1, wherein the antibody is a humanized antibody or de-immunized antibody.

7. The isolated antibody or antigen binding fragment thereof of claim 1, wherein the antibody is conjugated to an active agent, preferably to an imaging agent, a therapeutic agent, a toxin or a radionuclide.

8. A pharmaceutical composition comprising the isolated antibody or antigen binding fragment thereof of claim 1 and a pharmaceutically or physiologically acceptable carrier or excipient.

9. The pharmaceutical composition of claim 8, further comprising a second active ingredient, preferably said second active ingredient comprises or consists of an isolated antibody or antigen binding fragment thereof binding specifically to CEACAM1, more preferably said second active ingredient comprises or consists of an isolated antibody or antigen binding fragment thereof binding specifically to CEACAM1 lacking the N-domain.

10. A polynucleotide molecule comprising a nucleic acid sequence encoding an isolated antibody or antigen binding fragment thereof of claim 1.

11. A host cell comprising one or more polynucleotide molecule(s) encoding an isolated antibody or antigen binding fragment thereof of claim 1, optionally wherein the host cell is a mammalian cell, a yeast cell, a bacterial cell, a ciliate cell or an insect cell.

12. A method of manufacturing an antibody comprising: (a) expressing one or more polynucleotide molecule(s) encoding an isolated antibody or antigen binding fragment thereof of claim 1 in a cell; and(b) purifying the antibody from the cell.

13. A kit comprising an isolated antibody or antigen binding fragment of claim 1, and instructions for use of the antibody, optionally further wherein the antibody is lyophilized.

14. An isolated antibody or antigen binding fragment of claim 1, for use in a diagnostic method of a disease or medical condition.

15. An isolated antibody or antigen binding fragment of claim 1, for use in treating or preventing a disease or medical condition.

16. An antibody or antigen binding fragment for use or a pharmaceutical composition for use according to claim 13, wherein the disease or medical condition is selected from infection, acute and chronic inflammatory diseases, immunodeficiencies or immunocompromises, vaccinations, leukocyte expansion and differentiation, maturation of antigen presenting cells, transplantation, cancer/cancer metastasis, photothermal therapy, adopted T cell transfer, wound healing, leukocyte expansion and differentiation, diseases associated with T-cell and/or B-cell response, immune diseases, autoimmune diseases, restoration and/or improvement of immune response, adoptive immune therapy, e.g. CAR-T cell therapy, photodynamic therapy (PDT), photo-thermal therapy (PTT).

17. The pharmaceutical composition of claim 8, for use in a diagnostic method of a disease or medical condition.

18. The pharmaceutical composition of claim 8, for use in treating or preventing a disease or medical condition.