Monoclonal antibody and a method thereof
AssigneeBiocon Limited & Centro de Immunologia Molecular
InventorsRamakrishnan Melarkode, Pradip Nair, Sundaraj David Rajkumar, Kedarnath Nanjund Sastry, Monalisa Chatterji, Laxmi Adhikary, Hema Balasubramanian, Jose Enrique Montero Casimiro, Josefa Lombardero Valladares, Rolando Perez Rodriguez
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Abstract
The present invention relates to a humanized IgG1 isotype anti-CD6 antibody (T1h) that binds to the Scavenger receptor cysteine-rich (SRCR) domain 1 (D1) of CD6 present on the surface of thymic epithelial cells, monocytes, activated T cells and a variety of other cells types.
Claims6
A monoclonal anti-CD6 antibody that binds to domain 1 (D1) of CD6 and inhibits T cell proliferation without interfering with ALCAM binding, wherein the monoclonal antibody comprises heavy and light chain variable regions comprising amino acid sequences as set forth in Sequence ID No. 1 and 2, respectively, encoded by nucleotide sequences as set forth in Sequence ID Nos. 3 and 4 respectively, and effectively treats a disorder selected from a group consisting of multiple sclerosis, transplant rejection, rheumatoid arthritis, and psoriasis.
A monoclonal anti-CD6 antibody comprising heavy and light chain variable regions as set forth in Sequence ID No 1 and 2, respectively, wherein the monoclonal antibody treats a disorder selected from a group consisting of multiple sclerosis, transplant rejection, rheumatoid arthritis, and psoriasis and exhibits at least one of the following functions:
- inhibits proliferation of naïve PBMCs induced by tethered anti-CD3;
- inhibits one way MLR where Raji cells are Antigen Presenting Cells and PBMCs proliferate;
- inhibits one way autologous MLR mediated by PBMCs;
- inhibits T cell proliferation by mediating suppression of IL2;
- and
- inhibits naive T cell proliferation by reducing CD25 and CD4 counts.
A monoclonal anti-CD6 antibody comprising heavy and light chain variable regions as set forth in Sequence ID No 1 and 2, respectively and encoded by nucleotide sequences as set forth in Sequence ID Nos. 3 and 4, respectively and used for treatment of a disorder selected from a group consisting of multiple sclerosis, transplant rejection, rheumatoid arthritis, and psoriasis.
A therapeutically effective composition comprising a monoclonal anti-CD6 antibody, wherein the monoclonal antibody comprises heavy and light chain variable regions as set forth in Sequence ID No. 1 and 2, respectively, and in an amount to deliver a dose of 0.1-25 mg/Kg/week to a subject in need thereof, wherein the monoclonal antibody treats an auto-immune disorder in the subject selected from a group consisting of multiple sclerosis, transplant rejection, rheumatoid arthritis, and psoriasis and exhibits at least one of the following characteristics selected form the group consisting of:
- i does not induce complement dependent cytotoxicity (CDC), antibody dependent cytotoxicity or apoptosis in-vitro;
- ii inhibits naive T-cell proliferation by decreasing pro-inflammatory cytokines;
- and
- iii does not inhibit Memory-T-cell proliferation.
Dependencies are inferred from the claim text.