Patent application EP17158038A (EP), filed 2017-02-27
Publication number: EP3213768A1
Title: COMBINATION OF LOW DOSE IMMUNE CHECKPOINT BLOCKADE WITH HIGH DOSE IL-2 FOR TREATING METASTATIC CANCER
Abstract: The invention provides methods for low dose immune checkpoint (IC) treatment of metastatic cancer by delivering anti-CTLA-4 and anti-PD-1 antibodies to cancer patients. Methods also provide for IL-2 stimulation for the activation of T cells against tumor cells. The invention further provides methods for daily cyclic high fever response (hyperthermia) during IL-2 therapy. The methods provide treatment of metastatic cancer without unacceptable autoimmune side effects.
IPC codes: A61K  39/   395            A I
C07K  16/    28            A I
Claims: number: 1
text: A combination of an anti-PD-1 antibody and an anti-CTLA-4 antibody for use in the treatment of cancer, wherein the administration of the combination of the anti-PD-1 antibody and the anti-CTLA-4 antibody to a patient in a need thereof results in a lower level of autoimmunity as compared to the administration of either the anti-CTLA-4 or the anti-PD-1 antibody alone.
number: 2
text: A combination of an anti-PD-1 antibody and an anti-CTLA-4 antibody for use in enhancing cancer immunity, wherein the administration of the combination of the anti-PD-1 antibody and the anti-CTLA-4 antibody to a patient in a need thereof results in a lower level of autoimmunity as compared to the administration of either the anti-CTLA-4 or the anti-PD-1 antibody alone.
number: 3
text: The combination for use according to claims 1 or 2, wherein the administration of the combination includes the co-administration of Taurolidine with high dose (HD) IL-2.
number: 4
text: The combination for use according to any one of claims 1 to 3, wherein the administration of the combination is used in conjunction with hyperthermia.
number: 5
text: The combination for use according to any one of claims 1 to 4, wherein the administration of the combination includes 0.5 mg/kg or lower dose of anti-PD-1 antibody with co-administration of 0.3 mg/kg or lower dose of anti-CTLA-4 antibody.
number: 6
text: The combination for use according to any one of claims 1 to 5, wherein the administration of the combination includes 300 mg/m2 or lower dose of cyclophosphamide.
number: 7
text: The combination for use according to any one of claims 1 to 6, wherein the administration of the combination includes 0.5 mg/kg or lower dose of anti-PD-1 antibody with co-administration of 0.3 mg/kg or lower dose of anti-CTLA-4 antibody.
number: 8
text: The method according to any of claims 1 to 7, wherein the administration of the combination results in an anti-cancer effect selected from the group consisting of decreased tumor burden, decreased metastasis, decreased tumor growth, and reduction in new tumor formation.
number: 9
text: The combination for use according to any one of claims 1 to 8, wherein the anti-PD-1 antibody and the anti-CTLA-4 antibody are administered simultaneously.
number: 10
text: The combination for use according to any one of claims 1 to 8, wherein the anti-PD-1 antibody and the anti-CTLA-4 antibody are administered at different times.
number: 11
text: A composition for treating cancer comprising effective amounts of an anti-PD-1 antibody, an anti-CTLA-4 antibody, and at least one pharmaceutically acceptable excipient, wherein the amount of the antibodies in the composition is sufficient to produce a lower level of autoimmunity as compared to a composition of either antibody alone.
Office action: search_report, dated 2017-09-06
Rejection reasons: novelty_epc_54
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ref_type: patent
severity: novelty_destroying
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ref_type: npl
severity: background
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ref_type: npl
severity: background
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ref_type: npl
severity: background
ref_id: - JULIE R BRAHMER ET AL, "Safety and activity of anti-PD-L1 antibody in patients with advanced cancer", NEW ENGLAND JOURNAL OF MEDICINE, THE - NEJM, MASSACHUSETTS MEDICAL SOCIETY, US, (20120628), vol. 366, no. 26, doi:10.1056/NEJMOA1200694, ISSN 1533-4406, pages 2455 - 2465, XP002685330 [A] 1-11 * the whole document *
ref_type: npl
severity: background
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ref_type: npl
severity: background
Final disposition: pending (2017-09-06)