Patent application EP17174320A (EP), filed 2017-06-02
Publication number: EP3252078A1
Title: TYPE II ANTI-CD20 ANTIBODY AND ANTI-CD20/CD3 BISPECIFIC ANTIBODY FOR TREATMENT OF CANCER
Abstract: [0001]    The present invention relates to combination treatment methods of treating a disease comprising a type II anti-CD20 antibody and an anti-CD20/anti-CD3 bispecific antibody. The present invention further relates to methods for reduction of cytokine release associated with the administration of a T-cell activating 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 the use in a method for treating or delaying progression of cancer of an individual, wherein the Type II anti-CD20 antibody is used in combination with an anti-CD20/anti-CD3 bispecific antibody.
number: 2
text: The Type II anti-CD20 antibody for the use in a method according to claim 1, wherein the anti-CD20/anti-CD3 bispecific antibody and the Type II anti-CD20 antibody are administered together in a single composition or administered separately in two or more different compositions.
number: 3
text: The Type II anti-CD20 antibody for the use in a method according to claim 1 or 2, wherein the anti-CD20/anti-CD3 bispecific antibody and the Type II anti-CD20 antibody are administered in two or more different composition, wherein the two or more different compositions are administered at different points in time.
number: 4
text: The Type II anti-CD20 antibody for the use in a method according to any of claims 1 to 3, wherein the Type II 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 IDNO: 7, the LCDR2 of SEQ ID NO: 8 and the LCDR3 of SEQ ID NO: 9.
number: 5
text: The Type II anti-CD20 antibody for the use in a method according to any of claims 1 to 4, wherein the Type II 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: 6
text: The Type II anti-CD20 antibody the use in a method according to any of claims 1 to 5, wherein the Type II anti-CD20 antibody is an IgG antibody, particularly an IgG1 antibody, and wherein at least about 40% of the N-linked oligosaccharides in the Fc region of the anti-CD20 antibody are nonfucosylated.
number: 7
text: The Type II anti-CD20 antibody for the use in a method according to any of claims 1 to 6, wherein the Type II anti-CD20 antibody is Obinutuzumab.
number: 8
text: The Type II anti-CD20 antibody for the use in a method according to any of claims 1 to 7, wherein the Type II anti-CD20 antibody is administered concurrently with, prior to, or subsequently to the anti-CD20/anti-CD3 bispecific antibody.
number: 9
text: The Type II anti-CD20 antibody for the use in a method according to any of claims 1 to 8, wherein furthermore an anti-PD-L1 antibody, preferably Atezolizumab, is administered.
number: 10
text: The Type II anti-CD20 antibody for the use in a method according to claim 9, wherein the anti-PD-L1 antibody is administered separately or in combination with at least one of the anti-CD20/anti-CD3 bispecific antibody and the Type II anti-CD20 antibody.
number: 11
text: The Type II anti-CD20 antibody for the use in a method of any one of the preceding claims, wherein the anti-CD20/anti-CD3 bispecific antibody comprises a first antigen binding domain that binds to CD3, and a second antigen binding domain that binds to CD20.
number: 12
text: The Type II anti-CD20 antibody for use in a method according to claim 11, wherein the anti-CD20/anti-CD3 bispecific antibody comprises a first antigen binding domain comprising a heavy chain variable region (VHCD3) and a light chain variable region (VLCD3), and a second antigen binding domain comprising a heavy chain variable region (VHCD20) and a light chain variable region (VLCD20).
number: 13
text: The Type II anti-CD20 antibody for use in a method of any one of claims 11 to 12, wherein the first antigen binding domain of the anti-CD20/anti-CD3 bispecific antibody comprises a heavy chain variable region (VHCD3) comprising CDR-H1 sequence of SEQ ID NO: 97, CDR-H2 sequence of SEQ ID NO: 98, and CDR-H3 sequence of SEQ ID NO: 99; and/or a light chain variable region (VLCD3) comprising CDR-L1 sequence of SEQ ID NO: 100, CDR-L2 sequence of SEQ ID NO: 101, and CDR-L3 sequence of SEQ ID NO: 102.
number: 14
text: The Type II anti-CD20 antibody for use in a method of any one of claims 11 to 12, wherein the first antigen binding domain of the anti-CD20/anti-CD3 bispecific antibody comprises a heavy chain variable region (VHCD3) comprising the amino acid sequence of SEQ ID NO: 103 and/or a light chain variable region (VLCD3) comprising the amino acid sequence of SEQ ID NO: 104.
number: 15
text: The Type II anti-CD20 antibody for use in a method of any one of claims 11 to 14, wherein the second antigen binding domain of the anti-CD20/anti-CD3 bispecific antibody comprises a heavy chain variable region (VHCD20) comprising CDR-H1 sequence of SEQ ID NO: 4, CDR-H2 sequence of SEQ ID NO: 5, and CDR-H3 sequence of SEQ ID NO: 6, and/or a light chain variable region (VLCD20) comprising CDR-L1 sequence of SEQ ID NO: 7, CDR-L2 sequence of SEQ ID NO: 8, and CDR-L3 sequence of SEQ ID NO: 9.
number: 16
text: The Type II anti-CD20 antibody for use in a method of any of claims 11 to 14, wherein the second antigen binding domain of the anti-CD20/anti-CD3 bispecific antibody comprises a heavy chain variable region (VHCD20) comprising the amino acid sequence of SEQ ID NO: 10 and/or a light chain variable region (VLCD20) comprising the amino acid sequence of SEQ ID NO: 11.
number: 17
text: The Type II anti-CD20 antibody for use in a method of any of claims 11 to 16, wherein the anti-CD20/anti-CD3 bispecific antibody comprises a third antigen binding domain that binds to CD20.
number: 18
text: The Type II anti-CD20 antibody for use in a method of claim 17, wherein the third antigen binding domain of the anti-CD20/anti-CD3 bispecific antibody comprises a heavy chain variable region (VHCD20) comprising CDR-H1 sequence of SEQ ID NO: 4, CDR-H2 sequence of SEQ ID NO: 5, and CDR-H3 sequence of SEQ ID NO: 6; and/or a light chain variable region (VLCD20) comprising CDR-L1 sequence of SEQ ID NO: 7, CDR-L2 sequence of SEQ ID NO: 8, and CDR-L3 sequence of SEQ ID NO: 9.
number: 19
text: The Type II anti-CD20 antibody for use in a method of claim 17 or 18, wherein the third antigen binding domain of the anti-CD20/anti-CD3 bispecific antibody comprises a heavy chain variable region (VHCD20) comprising the amino acid sequence of SEQ ID NO: 10 and/or a light chain variable region (VLCD20) comprising the amino acid sequence of SEQ ID NO: 11.
number: 20
text: The Type II anti-CD20 antibody for use in a method of any of claims 11 to 19, wherein the first antigen binding domain of the anti-CD20/anti-CD3 bispecific antibody is a cross-Fab molecule wherein the variable domains or the constant domains of the Fab heavy and light chain are exchanged, and the second and third, if present, antigen binding domain is a conventional Fab molecule.
number: 21
text: The Type II anti-CD20 antibody for use in a method of claim 20, wherein the anti-CD20/anti-CD3 bispecific antibody comprises an IgG1 Fc domain.
number: 22
text: The Type II anti-CD20 antibody for use in a method of claim 21, wherein the IgG1 Fc domain of the anti-CD20/anti-CD3 bispecific antibody comprises one or more amino acid substitutions that reduce binding to an Fc receptor and/or effector function.
number: 23
text: The Type II anti-CD20 antibody for use in a method of claims 21 or 22, wherein the IgG1 Fc domain of the anti-CD20/anti-CD3 bispecific antibody comprises the amino acid substitutions L234A, L235A and P329G (numbering according to Kabat EU index).
number: 24
text: The Type II anti-CD20 antibody for use in a method of any of claims 21 to 23, wherein the anti-CD20/anti-CD3 bispecific antibody comprises a third antigen binding domain,
wherein (i) the second antigen binding domain of the anti-CD20/anti-CD3 bispecific antibody is fused at the C-terminus of the Fab heavy chain to the N-terminus of the Fab heavy chain of the first antigen binding domain, the first antigen binding domain of the anti-CD20/anti-CD3 bispecific antibody is fused at the C-terminus of the Fab heavy chain to the N-terminus of the first subunit of the Fc domain, and the third antigen binding domain of the anti-CD20/anti-CD3 bispecific antibody is fused at the C-terminus of the Fab heavy chain to the N-terminus of the second subunit of the Fc domain, or (ii) the first antigen binding domain of the anti-CD20/anti-CD3 bispecific antibody is fused at the C-terminus of the Fab heavy chain to the N-terminus of the Fab heavy chain of the second antigen binding domain, the second antigen binding domain of the anti-CD20/anti-CD3 bispecific antibody is fused at the C-terminus of the Fab heavy chain to the N-terminus of the first subunit of the Fc domain, and the third antigen binding domain of the anti-CD20/anti-CD3 bispecific antibody is fused at the C-terminus of the Fab heavy chain to the N-terminus of the second subunit of the Fc domain.
number: 25
text: The Type II anti-CD20 antibody for use in a method of any one of the preceding claims, wherein the combination is administered at intervals from about one week to three weeks.
number: 26
text: The Type II anti-CD20 antibody for the use in a method according to any of claims 1 to 25, wherein a pretreatment with a Type II anti-CD20 antibody, preferably Obinutuzumab, is performed prior to the combination treatment, wherein the period of time between the pretreatment and the combination treatment is sufficient for the reduction of B-cells in the individual in response to the Type II anti-CD20 antibody, preferably Obinutuzumab.
number: 27
text: A method for treating or delaying progression of a proliferative disease, particularly cancer, in an individual comprising administering an Type II anti-CD20 antibody and an anti-CD20/anti-CD3 bispecific antibody, wherein the Type II anti-CD20 antibody and the anti-CD20/anti-CD3 bispecific antibody are administered in a single composition or in two or more compositions.
number: 28
text: A pharmaceutical composition comprising a Type II anti-CD20 antibody for the use in a combination treatment and an optional pharmaceutically acceptable carrier, and a second medicament comprising an anti-CD20/anti-CD3 bispecific antibody and an optional pharmaceutically acceptable carrier, and optionally a third medicament comprising an anti-PD-L1 antibody and an optional pharmaceutically acceptable carrier, for the use in the combined treatment of a disease, in particular cancer.
number: 29
text: A kit comprising a first medicament comprising a Type II anti-CD20 antibody and an optional pharmaceutically acceptable carrier, and a second medicament comprising an anti-CD20/anti-CD3 bispecific antibody and an optional pharmaceutically acceptable carrier, and optionally a third medicament comprising an anti-PD-L1 antibody and an optional pharmaceutically acceptable carrier, for the use in the combined treatment of a disease, in particular cancer.
number: 30
text: The kit according to claim 29, wherein the kit comprises instructions for use of the first medicament and the second medicament and optionally the third medicament for treating or delaying the progression of cancer in an individual.
number: 31
text: Use of a combination of a Type II anti-CD20 antibody and an anti-CD20/anti-CD3 bispecific antibody in the manufacture of a medicament for therapeutic application, preferably for treating or delaying the progression of a proliferative disease, particularly cancer, in an individual.
number: 32
text: Use of a Type II anti-CD20 antibody in the manufacture of a medicament for treating or delaying progression of cancer in an individual, wherein the medicament comprises the Type II anti-CD20 antibody and an optional pharmaceutically acceptable carrier, and wherein the treatment comprises administration of the medicament in combination with a composition comprising an anti-CD20/anti-CD3 bispecific antibody and an optional pharmaceutically acceptable carrier.
number: 33
text: Use of an anti-CD20/anti-CD3 bispecific antibody in the manufacture of a medicament for treating or delaying progression of cancer in an individual, wherein the medicament comprises the anti-CD20/anti-CD3 bispecific antibody and an optional pharmaceutically acceptable carrier, and wherein the treatment comprises administration of the medicament in combination with a composition comprising an anti-CD20 antibody and an optional pharmaceutically acceptable carrier.
number: 34
text: 36. A method for treating or delaying progression of cancer in an individual comprising administering a Type II anti-CD20 antibody and of an anti-CD20/anti-CD3 antibody to the individual.
number: 35
text: 37. The method according to clam 36, wherein furthermore an anti-PD-L1 antibody is administered to the individual.
number: 36
text: 39. An anti-CD20/anti-CD3 bispecific antibody for the use in a method for treating or delaying progression of cancer of an individual, wherein the anti-CD20/anti-CD3 bispecific antibody is used in combination with a Type II anti-CD20 antibody.
number: 37
text: 40. The anti-CD20/anti-CD3 bispecific antibody for the use in a method according to claim 39, wherein the anti-CD20/anti-CD3 bispecific antibody and the Type II anti-CD20 antibody are administered together in a single composition or administered separately in two or more different compositions.
number: 38
text: 41. The anti-CD20/anti-CD3 bispecific antibody for the use in a method according to claim 39 or 40, wherein the anti-CD20/anti-CD3 bispecific antibody and the Type II anti-CD20 antibody are administered in two or more different composition, wherein the two or more different compositions are administered at different points in time.
number: 39
text: 42. The anti-CD20/anti-CD3 bispecific antibody for the use in a method according to any of claims 39 to 41, wherein the Type II 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 IDNO: 7, the LCDR2 of SEQ ID NO: 8 and the LCDR3 of SEQ ID NO: 9.
number: 40
text: 43. The anti-CD20/anti-CD3 bispecific antibody for the use in a method according to any of claims 39 to 42, wherein the Type II 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: 41
text: 44. The anti-CD20/anti-CD3 bispecific antibody the use in a method according to any of claims 39 to 42, wherein the Type II anti-CD20 antibody is an IgG antibody, particularly an IgG1 antibody, and wherein at least about 40% of the N-linked oligosaccharides in the Fc region of the anti-CD20 antibody are nonfucosylated.
number: 42
text: 45. The anti-CD20/anti-CD3 bispecific antibody for the use in a method according to any of claims 39 to 44, wherein the Type II anti-CD20 antibody is Obinutuzumab.
number: 43
text: 46. The anti-CD20/anti-CD3 bispecific antibody for the use in a method according to any of claims 39 to 45, wherein the Type II anti-CD20 antibody is administered concurrently with, prior to, or subsequently to the anti-CD20/anti-CD3 bispecific antibody.
number: 44
text: 47. The anti-CD20/anti-CD3 bispecific antibody for the use in a method according to any of claims 39 to 46, wherein furthermore an anti-PD-L1 antibody, preferably Atezolizumab, is administered.
number: 45
text: 48. The anti-CD20/anti-CD3 bispecific antibody for the use in a method according to claim 47, wherein the anti-PD-L1 antibody is administered separately or in combination with at least one of the anti-CD20/anti-CD3 bispecific antibody and the Type II anti-CD20 antibody.
number: 46
text: 49. The anti-CD20/anti-CD3 bispecific antibody for use in a method of any one of claims 39 to 48, wherein the anti-CD20/anti-CD3 bispecific antibody comprises a first antigen binding domain that binds to CD3, and a second antigen binding domain that binds to CD20.
number: 47
text: 50. The anti-CD20/anti-CD3 bispecific antibody for use in a method according to claim 49, wherein the anti-CD20/anti-CD3 bispecific antibody comprises a first antigen binding domain comprising a heavy chain variable region (VHCD3) and a light chain variable region (VLCD3), and a second antigen binding domain comprising a heavy chain variable region (VHCD20) and a light chain variable region (VLCD20).
number: 48
text: 51. The anti-CD20/anti-CD3 bispecific antibody for use in a method of any one of claims 48 to 50, wherein the first antigen binding domain of the anti-CD20/anti-CD3 bispecific antibody comprises a heavy chain variable region (VHCD3) comprising CDR-H1 sequence of SEQ ID NO: 97, CDR-H2 sequence of SEQ ID NO: 98, and CDR-H3 sequence of SEQ ID NO: 99; and/or a light chain variable region (VLCD3) comprising CDR-L1 sequence of SEQ ID NO: 100, CDR-L2 sequence of SEQ ID NO: 101, and CDR-L3 sequence of SEQ ID NO: 102.
number: 49
text: 52. The anti-CD20/anti-CD3 bispecific antibody for use in a method of any one of claims 48 to 51, wherein the first antigen binding domain of the anti-CD20/anti-CD3 bispecific antibody comprises a heavy chain variable region (VHCD3) comprising the amino acid sequence of SEQ ID NO: 103 and/or a light chain variable region (VLCD3) comprising the amino acid sequence of SEQ ID NO: 104.
number: 50
text: 53. The anti-CD20/anti-CD3 bispecific antibody for use in a method of any one of claims 48 to 52, wherein the second antigen binding domain of the anti-CD20/anti-CD3 bispecific antibody comprises a heavy chain variable region (VHCD20) comprising CDR-H1 sequence of SEQ ID NO: 4, CDR-H2 sequence of SEQ ID NO: 5, and CDR-H3 sequence of SEQ ID NO: 6, and/or a light chain variable region (VLCD20) comprising CDR-L1 sequence of SEQ ID NO: 7, CDR-L2 sequence of SEQ ID NO: 8, and CDR-L3 sequence of SEQ ID NO: 9.
number: 51
text: 54. The anti-CD20/anti-CD3 bispecific antibody for use in a method of any of claims 48 to 52, wherein the second antigen binding domain of the anti-CD20/anti-CD3 bispecific antibody comprises a heavy chain variable region (VHCD20) comprising the amino acid sequence of SEQ ID NO: 10 and/or a light chain variable region (VLCD20) comprising the amino acid sequence of SEQ ID NO: 11.
number: 52
text: 55. The anti-CD20/anti-CD3 bispecific antibody for use in a method of any of claims 48 to 54, wherein the anti-CD20/anti-CD3 bispecific antibody comprises a third antigen binding domain that binds to CD20.
number: 53
text: 56. The anti-CD20/anti-CD3 bispecific antibody for use in a method of claim 55, wherein the third antigen binding domain of the anti-CD20/anti-CD3 bispecific antibody comprises a heavy chain variable region (VHCD20) comprising CDR-H1 sequence of SEQ ID NO: 4, CDR-H2 sequence of SEQ ID NO: 5, and CDR-H3 sequence of SEQ ID NO: 6; and/or a light chain variable region (VLCD20) comprising CDR-L1 sequence of SEQ ID NO: 7, CDR-L2 sequence of SEQ ID NO: 8, and CDR-L3 sequence of SEQ ID NO: 9.
number: 54
text: 57. The anti-CD20/anti-CD3 bispecific antibody for use in a method of claim 55 or 56, wherein the third antigen binding domain of the anti-CD20/anti-CD3 bispecific antibody comprises a heavy chain variable region (VHCD20) comprising the amino acid sequence of SEQ ID NO: 10 and/or a light chain variable region (VLCD20) comprising the amino acid sequence of SEQ ID NO: 11.
number: 55
text: 58. The anti-CD20/anti-CD3 bispecific antibody for use in a method of any of claims 48 to 57, wherein the first antigen binding domain of the anti-CD20/anti-CD3 bispecific antibody is a cross-Fab molecule wherein the variable domains or the constant domains of the Fab heavy and light chain are exchanged, and the second and third, if present, antigen binding domain is a conventional Fab molecule.
number: 56
text: 59. The anti-CD20/anti-CD3 bispecific antibody for use in a method of claim 58, wherein the anti-CD20/anti-CD3 bispecific antibody comprises an IgG1 Fc domain.
number: 57
text: 60. The anti-CD20/anti-CD3 bispecific antibody for use in a method of claim 59, wherein the IgG1 Fc domain of the anti-CD20/anti-CD3 bispecific antibody comprises one or more amino acid substitutions that reduce binding to an Fc receptor and/or effector function.
number: 58
text: 61. The anti-CD20/anti-CD3 bispecific antibody for use in a method of claims 59 or 60, wherein the IgG1 Fc domain of the anti-CD20/anti-CD3 bispecific antibody comprises the amino acid substitutions L234A, L235A and P329G (numbering according to Kabat EU index).
number: 59
text: 62. The anti-CD20/anti-CD3 bispecific antibody for use in a method of any of claims 59 to 61, wherein the anti-CD20/anti-CD3 bispecific antibody comprises a third antigen binding domain,
wherein (i) the second antigen binding domain of the anti-CD20/anti-CD3 bispecific antibody is fused at the C-terminus of the Fab heavy chain to the N-terminus of the Fab heavy chain of the first antigen binding domain, the first antigen binding domain of the anti-CD20/anti-CD3 bispecific antibody is fused at the C-terminus of the Fab heavy chain to the N-terminus of the first subunit of the Fc domain, and the third antigen binding domain of the anti-CD20/anti-CD3 bispecific antibody is fused at the C-terminus of the Fab heavy chain to the N-terminus of the second subunit of the Fc domain, or (ii) the first antigen binding domain of the anti-CD20/anti-CD3 bispecific antibody is fused at the C-terminus of the Fab heavy chain to the N-terminus of the Fab heavy chain of the second antigen binding domain, the second antigen binding domain of the anti-CD20/anti-CD3 bispecific antibody is fused at the C-terminus of the Fab heavy chain to the N-terminus of the first subunit of the Fc domain, and the third antigen binding domain of the anti-CD20/anti-CD3 bispecific antibody is fused at the C-terminus of the Fab heavy chain to the N-terminus of the second subunit of the Fc domain.
number: 60
text: 63. The anti-CD20/anti-CD3 bispecific antibody for use in a method of claims 39 to 62, wherein the combination is administered at intervals from about one week to three weeks.
number: 61
text: 64. The anti-CD20/anti-CD3 bispecific antibody for the use in a method according to any of claims 39 to 63, wherein a pretreatment with an Type II anti-CD20 antibody, preferably Obinutuzumab, is performed prior to the combination treatment, wherein the period of time between the pretreatment and the combination treatment is sufficient for the reduction of B-cells in the individual in response to the Type II anti-CD20 antibody, preferably Obinutuzumab.
number: 62
text: 65. A pharmaceutical composition comprising an anti-CD20/anti-CD3 bispecific antibody for the use in a combination treatment and an optional pharmaceutically acceptable carrier, and a second medicament comprising an Type II anti-CD20 antibody and an optional pharmaceutically acceptable carrier, and optionally a third medicament comprising an anti-PD-L1 antibody and an optional pharmaceutically acceptable carrier, for the use in the combined treatment of a disease, in particular cancer.
number: 63
text: 66. The invention as described hereinbefore.
Office action: search_report, dated 2017-12-06
Rejection reasons: novelty_epc_54
inventive_step_epc_56
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ref_id: - L. L. SUN ET AL, "Anti-CD20/CD3 T cell-dependent bispecific antibody for the treatment of B cell malignancies", SCIENCE TRANSLATIONAL MEDICINE, (20150513), vol. 7, no. 287, doi:10.1126/scitranslmed.aaa4802, ISSN 1946-6234, pages 287ra70 - 287ra70, XP055241859 [A] 1-33,36-66 * abstract, figures *
ref_type: npl
severity: background
ref_id: - SEUNG Y CHU ET AL, "Immunotherapy with Long-Lived Anti-CD20 x Anti-CD3 Bispecific Antibodies Stimulates Potent T Cell-Mediated Killing of Human B Cell Lines and of Circulating and Lymphoid B Cells in Monkeys: A Potential Therapy for B Cell Lymphomas and Leukemias", BLOOD, (20141206), vol. 124, page 3111, XP055390512 [A] 1-33,36-66 * abstract *
ref_type: npl
severity: background
Final disposition: pending (2017-12-06)