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NZ729270B2 - Combination therapies with anti cd40 antibodies - Google Patents

Combination therapies with anti cd40 antibodies Download PDF

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Publication number
NZ729270B2
NZ729270B2 NZ729270A NZ72927015A NZ729270B2 NZ 729270 B2 NZ729270 B2 NZ 729270B2 NZ 729270 A NZ729270 A NZ 729270A NZ 72927015 A NZ72927015 A NZ 72927015A NZ 729270 B2 NZ729270 B2 NZ 729270B2
Authority
NZ
New Zealand
Prior art keywords
antibody
seq
specifically binds
antigen
binding portion
Prior art date
Application number
NZ729270A
Other versions
NZ729270A (en
Inventor
Peter Ellmark
Per Norlen
Niina Veitonmaki
Original Assignee
Alligator Bioscience Ab
Filing date
Publication date
Priority claimed from GBGB1414270.7A external-priority patent/GB201414270D0/en
Priority claimed from GBGB1507541.9A external-priority patent/GB201507541D0/en
Application filed by Alligator Bioscience Ab filed Critical Alligator Bioscience Ab
Priority claimed from PCT/EP2015/068598 external-priority patent/WO2016023960A1/en
Publication of NZ729270A publication Critical patent/NZ729270A/en
Publication of NZ729270B2 publication Critical patent/NZ729270B2/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A61K2039/507—Comprising a combination of two or more separate antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7088—Compounds having three or more nucleosides or nucleotides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/04—Antineoplastic agents specific for metastasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2818—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against CD28 or CD152
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2878—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/732—Antibody-dependent cellular cytotoxicity [ADCC]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/75—Agonist effect on antigen
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin

Abstract

The present invention relates to combination therapies for treating a solid tumour in a subject. The combination therapies comprise (a) an antibody, or antigen-binding portion thereof, that specifically binds to CD40, and (b) a further immunotherapeutic agent, other than an anti-CD40 antibody or antigen-binding fragment, with efficacy in the treatment of cancer. The said antibody or antigen-binding portion thereof that specifically binds to CD40 comprises light chain CDR sequences of SEQ ID NOs: 1, 2 and 3 and heavy chain CDR sequences of SEQ ID NOs: 4, 5 and 6 and wherein the further immunotherapeutic agent is an anti-PD-1 antibody or an anti-PD-L1 antibody which blocks the interaction between PD1 and PD-L1. The invention also relates to pharmaceutical compositions and kits comprising said therapies.

Claims (35)

1. Use of (a) an antibody, or antigen-binding portion thereof, that ically binds to CD40, in the manufacture of a medicament for treating a solid tumour in a subject in combination with (b) a r immunotherapeutic agent with efficacy in the treatment of cancer, wherein the antibody or n-binding portion thereof that specifically binds to CD40 ses light chain CDR sequences of SEQ ID NOs: 1, 2 and 3 and heavy chain CDR sequences of SEQ ID NOs: 4, 5 and 6 and wherein the further immunotherapeutic agent is an anti-PD-1 antibody or an anti-PD-L1 dy which blocks the interaction between PD1 and PD-L1.
2. The use according to Claim 1 wherein the combination of (a) the antibody, or antigenbinding portion f, that specifically binds to CD40 and (b) the further immunotherapeutic agent, es a synergistic benefit in the treatment of a solid tumour in a subject.
3. The use according to Claim 1 or 2 wherein the solid tumour is selected from the groups consisting of an adenoma, a blastoma, a carcinoma, a d tumour, a desmopolastic small round cell tumour, an endocrine tumour, a germ cell tumour, a lymphoma, a sarcoma, a Wilms tumour, a lung tumour, a colon tumour, a lymph tumour, a breast tumour and a melanoma.
4. The use according to any one of the preceding claims wherein the solid tumour is a melanoma.
5. A use ing to any one of the preceding claims wherein the antibody or nbinding portion thereof that specifically binds to CD40 comprises or consists of an intact
6. A use according to any one of Claims 1 to 4 wherein the antibody or antigen-binding portion thereof that specifically binds to CD40 comprises or consists of an antigen-binding fragment selected from the group consisting of: an Fv fragment and a Fab-like fragment.
7. A use according to any one of the preceding claims wherein the antibody or antigenbinding portion thereof is human or humanised. 20328668_1 (GHMatters) P105227.NZ
8. A use ing to any one of the preceding claims, wherein the antibody or antigenbinding portion thereof that specifically binds to CD40 comprises the light chain variable region of SEQ ID NO: 7 and/or the heavy chain variable region of SEQ ID NO: 8.
9. A use according to any one of the preceding claims, wherein the antibody or antigenbinding portion thereof that specifically binds to CD40 comprises the light chain constant region of SEQ ID NO: 11 and/or the heavy chain constant region of SEQ ID NO: 12.
10. A use according to any one of the ing claims, wherein the antibody or antigenbinding portion thereof that specifically binds to CD40 ses or consists of the light chain of SEQ ID NO: 7 plus SEQ ID NO:11, and/or the heavy chain of SEQ ID NO: 8 plus SEQ ID NO:12.
11. A use according to any one of the preceding claims wherein the anti-PD-1 antibody is selected from the group consisting of Nivolumab, Pembrolizumab, Lambrolizumab, Pidilzumab, and AMP-224.
12. Use of an therapeutic agent with efficacy in the treatment of cancer in the manufacture of a medicament for treating a solid tumour in a subject in combination with an antibody, or antigen-binding portion thereof, that specifically binds to CD40, wherein the antibody or antigen-binding portion thereof that ically binds to CD40 comprises light chain CDR sequences of SEQ ID NOs: 1, 2 and 3 and heavy chain CDR sequences of SEQ ID NOs: 4, 5 and 6 and n the immunotherapeutic agent with efficacy in the treatment of cancer is an anti- PD-1 antibody or anti-PD-L1 antibody which blocks the interaction between PD1 and PD-L1.
13. The use according to claim 12, wherein the antibody or antigen-binding portion thereof that specifically binds to CD40 comprises or consists of an intact dy.
14. The use ing to Claim 12 or 13, wherein the antibody or antigen-binding portion f that specifically binds to CD40 comprises or consists of an antigen-binding fragment selected from the group consisting of: an Fv fragment and a Fab-like fragment.
15. The use according to any one of claims 12 to 14, wherein the antibody or nbinding portion thereof is human or humanised. 20328668_1 (GHMatters) P105227.NZ
16. The use according to any one of claims 12 to 15, wherein the antibody or antigenbinding portion thereof that specifically binds to CD40 comprises the light chain variable region of SEQ ID NO: 7 and/or the heavy chain le region of SEQ ID NO: 8.
17. The use according to any one of claims 12 to 16, wherein the antibody or antigenbinding portion thereof that specifically binds to CD40 comprises the light chain constant region of SEQ ID NO: 11 and/or the heavy chain constant region of SEQ ID NO: 12.
18. The use according to any one of claims 12 to 17, wherein the dy or antigenbinding portion thereof that specifically binds to CD40 comprises or ts of the light chain of SEQ ID NO: 7 plus SEQ ID NO:11, and/or the heavy chain of SEQ ID NO: 8 plus SEQ ID NO:12.
19. The use according to any one of claims 12 to 18 wherein the further immunotherapeutic agent with efficacy in the treatment of cancer is an anti-PD-1 antibody ed from the group consisting of Nivolumab, Pembrolizumab, Lambrolizumab, Pidilzumab, and 4.
20. A ceutical composition sing (a) an antibody, or antigen-binding portion thereof, that specifically binds to CD40, and (b) a further immunotherapeutic agent with cy in the treatment of cancer, which agent is an anti-PD-1 antibody or anti-PD-L1 antibody which blocks the interaction between PD1 and PD-L1, wherein the antibody or antigen-binding portion thereof that specifically binds to CD40 comprises light chain CDR sequences of SEQ ID NOs: 1, 2 and 3 and heavy chain CDR sequences of SEQ ID NOs: 4, 5 and 6.
21. The pharmaceutical composition according to claim 20, wherein the antibody or antigen-binding portion thereof that specifically binds to CD40 comprises or consists of an intact antibody.
22. The pharmaceutical composition according to Claim 20 or 21, wherein the antibody or antigen-binding n thereof that specifically binds to CD40 comprises or ts of an n-binding fragment selected from the group consisting of: an Fv fragment and a Fab-like fragment.
23. The pharmaceutical composition according to any one of claims 20 to 22, wherein the antibody or antigen-binding portion thereof is human or humanised. 20328668_1 (GHMatters) P105227.NZ
24. The pharmaceutical composition according to any one of claims 20 to 23, n the antibody or antigen-binding n thereof that specifically binds to CD40 comprises the light chain le region of SEQ ID NO: 7 and/or the heavy chain variable region of SEQ ID NO: 8.
25. The pharmaceutical composition according to any one of claims 20 to 24, wherein the dy or antigen-binding portion thereof that specifically binds to CD40 comprises the light chain nt region of SEQ ID NO: 11 and/or the heavy chain constant region of SEQ ID NO: 12.
26. The pharmaceutical composition according to any one of claims 20 to 25, wherein the antibody or n-binding portion f that specifically binds to CD40 comprises or ts of the light chain of SEQ ID NO: 7 plus SEQ ID NO:11, and/or the heavy chain of SEQ ID NO: 8 plus SEQ ID NO:12.
27. The pharmaceutical composition according to any one of claims 20 to 26 wherein the further immunotherapeutic agent with efficacy in the treatment of cancer is an anti-PD-1 antibody selected from the group consisting of Nivolumab, Pembrolizumab, Lambrolizumab, Pidilzumab, and AMP-224.
28. A kit for treating a solid tumour comprising (a) an antibody, or n-binding portion thereof, that specifically binds to CD40, and (b) a further immunotherapeutic agent with efficacy in the treatment of cancer, which agent is an anti-PD-1 antibody or anti-PD-L1 antibody which blocks the interaction between PD1 and PD-L1, wherein the antibody or antigen-binding portion thereof that specifically binds to CD40 comprises light chain CDR sequences of SEQ ID NOs: 1, 2 and 3 and heavy chain CDR sequences of SEQ ID NOs: 4, 5 and 6.
29. The kit according to claim 28, wherein the antibody or antigen-binding portion thereof that specifically binds to CD40 comprises or consists of an intact dy.
30. The kit according to Claim 28 or 29, wherein the antibody or antigen-binding n thereof that specifically binds to CD40 comprises or consists of an antigen-binding fragment selected from the group consisting of: an Fv fragment and a Fab-like fragment.
31. The kit according to any one of claims 28 to 30, wherein the antibody or antigen-binding portion thereof is human or humanised. 20328668_1 (GHMatters) P105227.NZ
32. The kit according to any one of claims 28 to 31, wherein the antibody or n-binding portion thereof that specifically binds to CD40 comprises the light chain variable region of SEQ ID NO: 7 and/or the heavy chain variable region of SEQ ID NO: 8.
33. The kit according to any one of claims 28 to 32, wherein the antibody or antigen-binding portion f that specifically binds to CD40 comprises the light chain constant region of SEQ ID NO: 11 and/or the heavy chain constant region of SEQ ID NO: 12.
34. The kit according to any one of claims 28 to 33, wherein the antibody or n-binding portion thereof that specifically binds to CD40 comprises or consists of the light chain of SEQ ID NO: 7 plus SEQ ID NO:11, and/or the heavy chain of SEQ ID NO: 8 plus SEQ ID NO:12.
35. The kit according to any one of claims 28 to 34 wherein the further immunotherapeutic agent with efficacy in the treatment of cancer is an anti-PD-1 antibody selected from the group consisting of Nivolumab, Pembrolizumab, Lambrolizumab, Pidilzumab, and AMP-224. 20328668_1 ters) P105227.NZ a a 60 b A E E av *2? § 5 Jun-l +5 E G} "J a E 0 Cl 0 Q g Pemumorat 39332ng. . . . 5 injectinn mm the area surrmmding {he tumor ‘45 iii?IEQEUCBQLMLBCLO” E éniecfion Ento the tumor U 4 8 12 15 2E] 24 Timem)
NZ729270A 2015-08-12 Combination therapies with anti cd40 antibodies NZ729270B2 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
GBGB1414270.7A GB201414270D0 (en) 2014-08-12 2014-08-12 Antibodies
GB201422614 2014-12-18
GBGB1507541.9A GB201507541D0 (en) 2015-05-01 2015-05-01 Antibodies
PCT/EP2015/068598 WO2016023960A1 (en) 2014-08-12 2015-08-12 Combination therapies with anti cd40 antibodies

Publications (2)

Publication Number Publication Date
NZ729270A NZ729270A (en) 2024-03-22
NZ729270B2 true NZ729270B2 (en) 2024-06-25

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