Patent application EP15198715A (EP), filed 2015-12-09
Publication number: EP3178848A1
Title: TYPE II ANTI-CD20 ANTIBODY FOR REDUCING FORMATION OF ANTI-DRUG ANTIBODIES
Abstract: [0001]    The present invention relates to methods of treating a disease, and methods for reduction of the formation of anti-drug antibodies (ADAs) in response to the administration of a therapeutic agent comprising administration of a Type II anti-CD20 antibody, e.g. obinutuzumab, to the subject prior to administration of the therapeutic agent.
IPC codes: A61K  39/   395            A I
C07K  16/    28            A I
C07K  16/    30            A I
Claims: number: 1
text: A Type II anti-CD20 antibody for use in a method of treating a disease in a subject, the method comprising a treatment regimen comprising
number: 2
text: The Type II anti-CD20 antibody of claim 1, wherein the treatment regimen effectively reduces the formation of anti-drug antibodies (ADAs) in the subject in response to the administration of the therapeutic agent as compared to a corresponding treatment regimen without the administration of the anti-CD20 antibody.
number: 3
text: A Type II anti-CD20 antibody for use in a method for reducing the formation of anti-drug antibodies (ADAs) against a therapeutic agent in a subject, comprising administration of the anti-CD20 antibody to the subject prior to administration of the therapeutic agent.
number: 4
text: The Type II anti-CD20 antibody of claim 3, wherein the period of time between the administration of the anti-CD20 antibody and administration of the therapeutic agent is sufficient for reduction of the number of B-cells in the subject in response to the administration of the CD20 antibody.
number: 5
text: The Type II anti-CD20 antibody of any one of the preceding claims, wherein the anti-CD20 antibody comprises a heavy chain variable region comprising the heavy chain CDR (HCDR) 1 of SEQ ID NO: 4, the HCDR2 of SEQ ID NO: 5, and the HCDR3 of SEQ ID NO: 6; and a light chain variable region comprising the light chain CDR (LCDR) 1 of SEQ ID NO: 7, the LCDR2 of SEQ ID NO: 8 and the LCDR3 of SEQ ID NO: 9.
number: 6
text: The Type II anti-CD20 antibody of any one of the preceding claims, wherein the anti-CD20 antibody comprises the heavy chain variable region sequence of SEQ ID NO: 10 and the light chain variable region sequence of SEQ ID NO: 11.
number: 7
text: The Type II anti-CD20 antibody of any one of the preceding claims, wherein the anti-CD20 antibody is an IgG antibody, particularly an IgG<1> antibody, and wherein at least about 40% of the N-linked oligosaccharides in the Fc region of the anti-CD20 antibody are non-fucosylated.
number: 8
text: The Type II anti-CD20 antibody of any one of the preceding claims, wherein the anti-CD20 antibody is obinutuzumab.
number: 9
text: The Type II anti-CD20 antibody of any one of the preceding claims, wherein the therapeutic agent comprises a polypeptide.
number: 10
text: The Type II anti-CD20 antibody of any one of the preceding claims, wherein the therapeutic agent comprises an antibody.
number: 11
text: The Type II anti-CD20 antibody of claim 10, wherein the antibody specifically binds to carcinoembryonic antigen (CEA).
number: 12
text: The Type II anti-CD20 antibody of claim 11, wherein the antibody comprises
number: 13
text: The Type II anti-CD20 antibody of any one of the preceding claims, wherein the therapeutic agent comprises a cytokine, particularly interleukin-2.
number: 14
text: The Type II anti-CD20 antibody of claim 13, wherein the cytokine is a mutant human IL-2 polypeptide comprising the amino acid substitutions F42A, Y45A and L72G (numbering relative to the human IL-2 sequence SEQ ID NO: 12).
number: 15
text: The Type II anti-CD20 antibody of any one of the preceding claims, wherein the therapeutic agent comprises an immunoconjugate comprising an antibody as defined in claim 12, and a cytokine as defined in claim 14.
Office action: search_report, dated 2017-06-14
Rejection reasons: novelty_epc_54
inventive_step_epc_56
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Final disposition: pending (2017-06-14)