HUMAN ANTIBODY SPECIFIC TO TOXIN PRODUCED FROM CLOSTRIDIUM DIFFICILE, OR ANTIGEN-BINDING FRAGMENT THEREOF

摘要

The present invention provides novel human-derived monoclonal antibodies specifically binding to toxins produced by Clostridium difficile (toxin A and toxin B), respectively, and having excellent neutralizing activity, and antigen-binding fragments thereof. The present invention also provides a pharmaceutical composition for the treatment of Clostridium difficile infection comprising any of the antibodies or antigen-binding fragments thereof.

主权项

1. An antibody capable of specifically binding to Clostridium difficile toxin A protein and neutralizing its biological activity, or an antigen-binding fragment thereof, comprising:
(i) (a) heavy chain CDR1 comprising the amino acid sequence of SEQ ID NO: 4 or an amino acid sequence deviated from the amino acid sequence of SEQ ID NO: 4 by deletion, substitution, insertion, and/or addition mutations of one to several amino acid residues, (b) heavy chain CDR2 comprising the amino acid sequence of SEQ ID NO: 5 or an amino acid sequence deviated from the amino acid sequence of SEQ ID NO: 5 by deletion, substitution, insertion, and/or addition mutations of one to several amino acid residues, and (c) heavy chain CDR3 comprising the amino acid sequence of SEQ ID NO: 6 or an amino acid sequence deviated from the amino acid sequence of SEQ ID NO: 6 by deletion, substitution, insertion, and/or addition mutations of one to several amino acid residues; and (ii) (a) light chain CDR1 comprising the amino acid sequence of SEQ ID NO: 10 or an amino acid sequence deviated from the amino acid sequence of SEQ ID NO: 10 by deletion, substitution, insertion, and/or addition mutations of one to several amino acid residues, (b) light chain CDR2 comprising the amino acid sequence of SEQ ID NO: 11 or an amino acid sequence deviated from the amino acid sequence of SEQ ID NO: 11 by deletion, substitution, insertion, and/or addition mutations of one to several amino acid residues, and (c) light chain CDR3 comprising the amino acid sequence of SEQ ID NO: 12 or an amino acid sequence deviated from the amino acid sequence of SEQ ID NO: 12 by deletion, substitution, insertion, and/or addition mutations of one to several amino acid residues.