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NZ736820B2 - Combination of an anti-cd19 antibody and a bruton's tyrosine kinase inhibitor and uses thereof - Google Patents

Combination of an anti-cd19 antibody and a bruton's tyrosine kinase inhibitor and uses thereof

Info

Publication number
NZ736820B2
NZ736820B2 NZ736820A NZ73682016A NZ736820B2 NZ 736820 B2 NZ736820 B2 NZ 736820B2 NZ 736820 A NZ736820 A NZ 736820A NZ 73682016 A NZ73682016 A NZ 73682016A NZ 736820 B2 NZ736820 B2 NZ 736820B2
Authority
NZ
New Zealand
Prior art keywords
use according
lymphoma
seq
sequence
hodgkin
Prior art date
Application number
NZ736820A
Other versions
NZ736820A (en
Inventor
Rainer Boxhammer
Jan Endell
Mark Winderlich
Original Assignee
Incyte Corporation
Filing date
Publication date
Application filed by Incyte Corporation filed Critical Incyte Corporation
Priority claimed from PCT/EP2016/061744 external-priority patent/WO2016189014A1/en
Publication of NZ736820A publication Critical patent/NZ736820A/en
Publication of NZ736820B2 publication Critical patent/NZ736820B2/en

Links

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
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • 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
    • 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
    • A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • 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
    • A61P35/02—Antineoplastic agents specific for leukemia
    • 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
    • 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
    • C07K16/2896—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against molecules with a "CD"-designation, not provided for elsewhere
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • 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]

Abstract

The present disclosure describes a pharmaceutical combination of an anti-CD19 antibody and a Bruton's tyrosine kinase (BTK) inhibitor for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia and/or acute lymphoblastic leukemia.

Claims (18)

We Claim:
1. Use of an antibody specific for CD19 in the manufacture of a medicament for the treatment of non-Hodgkin's ma, chronic lymphocytic ia or acute lymphoblastic leukemia in ation with ibrutinib, wherein said antibody comprises an HCDR1 region of sequence SYVMH (SEQ ID NO: 1), an HCDR2 region of sequence NPYNDG (SEQ ID NO: 2), an HCDR3 region of sequence TRVFDY (SEQ ID NO: 3), an LCDR1 region of sequence RSSKSLQNVNGNTYLY (SEQ ID NO: 4), an LCDR2 region of sequence RMSNLNS (SEQ ID NO: 5), and an LCDR3 region of sequence MQHLEYPIT (SEQ ID NO: 6).
2. The use according to claim 1, wherein the antibody comprises a variable heavy chain of the sequence EVQLVESGGGLVKPGGSLKLSCAASGYTFTSYVMHWVRQAPGKGLEWIGYINPY NDGTKYNEKFQGRVTISSDKSISTAYMELSSLRSEDTAMYYCARGTYYYGTRVFDYWG VSS (SEQ ID NO: 10) and a variable light chain of the sequence DIVMTQSPATLSLSPGERATLSCRSSKSLQNVNGNTYLYWFQQKPGQSPQLLIYR MSNLNSGVPDRFSGSGSGTEFTLTISSLEPEDFAVYYCMQHLEYPITFGAGTKLEIK (SEQ ID NO:
3. The use according to claim 1 or claim 2, wherein the antibody comprises a heavy chain constant domain of the sequence ASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSL SSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPDVFLFPPKP KDTLMISRTPEVTCVVVDVSHEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTFRVVSVLTVVHQ DWLNGKEYKCKVSNKALPAPEEKTISKTKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSD IAVEWESNGQPENNYKTTPPMLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQK SLSLSPGK (SEQ ID NO: 12).
4. The use ing to any one of claims 1-3, wherein the antibody comprises a light chain constant domain of the sequence RTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDS TYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC (SEQ ID NO: 13).
5. The use according to any one of claims 1-4, wherein said antibody specific for CD19 and ibrutinib are to be administered separately.
6. The use ing to any one of claims 1-5, wherein ibrutinib is to be administered prior to administration of the antibody specific for CD19.
7. The use according to any one of claims 1-5, wherein said antibody ic for CD19 and nib are to be administered simultaneously.
8. The use according to any one of claims 1-7, wherein said antibody ic for CD19 and ibrutinib are to be administered at a time where both drugs are active in the patient at the same time.
9. The use according to any one of claims 1-8, in the manufacture of a medicament for the treatment of chronic lymphocytic leukemia.
10. The use according to any one of claims 1-8, in the manufacture of a medicament for the treatment of acute lymphoblastic ia.
11. The use according to any one of claims 1-8, in the manufacture of a medicament for the treatment of non-Hodgkin’s lymphoma.
12. The use according to claim 11, wherein the non-Hodgkin’s lymphoma is follicular lymphoma.
13. The use according to claim 11, wherein the dgkin’s lymphoma is small lymphocytic lymphoma.
14. The use according to claim 11, wherein the non-Hodgkin’s lymphoma is mucosaassociated lymphoid tissue lymphoma.
15. The use according to claim 11, wherein the non-Hodgkin’s ma is e large B cell lymphoma.
16. The use according to claim 11, wherein the non-Hodgkin’s lymphoma is Burkitt's lymphoma.
17. The use according to claim 11, wherein the non-Hodgkin’s lymphoma is mantle cell lymphoma.
18. The use according to claim 11, wherein the dgkin’s lymphoma is marginal zone lymphoma. 51 789 84 0 7 0 !"#$%"0&9 ' "()84* 8"49 *4+ 3919 %1#1", - !0 - . . / 0 / . .1 1 . . / - . .1 .1 2800' - '# 8,858*4 91231451 - 9&4 %1 85 5"49 #35 01# &# 5*4 !1 689 - '# 8,858*4 91231451 - 9&4 %1 85 5"49 #35 '94 #" &# '94 '9$ 4& - '# 8,858*4 91231451 - 9&4 %1 85 5"49 #35 01231451 789 84 ! ! ! ! ! "! #$ 1 "9% ! "! 8(858$ 91231451 9 4 1 85 5)49 !35 "! 01! 01! 7 9 01! 713 4 "94 #$ "94 "94 ! ! 713 ! "! 8(858$ 91231451 9 4 1 85 5)49 !35 "! *1 01! "94 713 "94 01! "! 8(858$ 51 9 4 1 85 5)49 !35 *1 4 ,89 713 3 ! !) - 1 ! ,).) 9$%8149 *1 !) !) !) "! 713 713 1 1 713 713 1 713 ! !) *1 51 789 84 3 3 3 713 7!9 3 3 ! 9" 94 713 4 !9 713 7!9 ! % 01 9" ! % 4 4 713 % " 01 3 01 713 7!9 %1 713 7!9 713 01 713 ! 713 ! 713 ! & 1 '89 (1 713 & 1 # # ) " 713 %1 & 1 %1 94 01 4 4 (1 ! ! %1 ! 713 )# * *# !9 4 ! 01 3 7!9 " 4 ! 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(% (% (9 #1 & 4 +89 * , , 713 & 3 (% %' 1 $% $1 & ( " & ( $% 7(9 713 & 3 1 7(9 % $% !" " " %' 01% !" $1 1 $1 %' %' 01% 9 & 3 & 4 713 7(9 01% & ( $% " 01% !" !" (9 713 713 94 94 $1 (% %' % & 3 " 7(9 !" & 4 % 7(9 !" 9 94 " 713 & 4 01% & ( 94 01% & 4 & 3 01% !" $% & 3 & 4 9 01% 7(9 9 01% $% (% 01% 713 01% 01% $% 713 $% 713 01% 7(9 " 9 (% & 3 * * , 7(9 +89 7(9 !" (% " (9 & 3 !" $% +89 & 4 & ( 713 01% 01% %' !" $% 7(9 01% $1 94 % & ( & 3 (9
NZ736820A 2016-05-25 Combination of an anti-cd19 antibody and a bruton's tyrosine kinase inhibitor and uses thereof NZ736820B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP15169124 2015-05-26
EP15196860 2015-11-27
PCT/EP2016/061744 WO2016189014A1 (en) 2015-05-26 2016-05-25 Combination of an anti-cd19 antibody and a bruton's tyrosine kinase inhibitor and uses thereof

Publications (2)

Publication Number Publication Date
NZ736820A NZ736820A (en) 2025-02-28
NZ736820B2 true NZ736820B2 (en) 2025-06-04

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