Patent application EP19167917A (EP), filed 2019-04-08
Publication number: EP3721899A1
Title: COMBINATION THERAPIES COMPRISING DENDRITIC CELLS-BASED VACCINE AND IMMUNE CHECKPOINT INHIBITOR
Abstract: [0001]    The present disclosure provides a method for treating HCC comprising co-administering to the patient, dendritic cells-based vaccine in combination with an immune checkpoint inhibitor. The treatment with DC vaccine in combination with immune checkpoint inhibitor has significantly improved overall survival in subjects.
IPC codes: A61K  39/    00            A I
A61P  35/    00            A I
C07K  16/    00            A I
Claims: number: 1
text: A method for treating a hepatocellular carcinoma (HCC) comprising co-administering to the patient, a dendritic cells-based vaccine in combination with an immune checkpoint inhibitor.
number: 2
text: The method of Claim 1, wherein the dendritic cells-based vaccine is administered at a dose ranging from about 1×10<5> cells/dose/day to about 1×10<8> cells/dose/day.
number: 3
text: The method of Claim 1, wherein the dendritic cells-based vaccine is administered at a dose of about 1×10<6> cells/dose/day.
number: 4
text: The method of Claim 1, wherein the dendritic cells-based vaccine is immature dendritic cell, mature dendritic cell, myeloid dendritic cells (cDCs), plasmacytoid dendritic cells (pDCs) or bone marrow-derived dendritic cell.
number: 5
text: The method of Claim 1, wherein the immune checkpoint inhibitor is an antibody directed against cytotoxic T-lymphocyte antigen 4 (CTLA-4 or CD152) or programmed cell death ligand-1 (PDL-1) or programmed cell death protein 1 (PD-1).
number: 6
text: The method of Claim 1, wherein the immune checkpoint inhibitor is administered at a dose ranging from about 50 µg/dose/day to about 400 µg/dose/day.
number: 7
text: The method of Claim 1, wherein the immune checkpoint inhibitor is administered at a dose of about 100 µg/dose/day or about 200 µg/dose/day.
number: 8
text: The method of Claim 1, wherein the dendritic cells-based vaccine in combination with an immune checkpoint inhibitor is administered by infusion or injection.
number: 9
text: The method of Claim 1, co-administration is through the route of intravenous, intraperitoneal, intramuscular, intrathecal or subcutaneous.
number: 10
text: The method of Claim 1, wherein the dendritic cells-based vaccine and the immune checkpoint inhibitor may be provided as separate medicaments for administration at the same time or at different times.
number: 11
text: The method of Claim 1, wherein the co-administration is repeated on a cyclic basis.
number: 12
text: The method of Claim 11, wherein an administration cycle comprises administering the dendritic cells-based vaccine and the immune checkpoint inhibitor every other day for three total doses.
number: 13
text: The method of Claim 11, wherein the co-administration comprises simultaneous administration or separate administration of the dendritic cells-based vaccine and the immune checkpoint inhibitor.
number: 14
text: The method of Claim 13, wherein the dendritic cells-based vaccine and the immune checkpoint inhibitor are formulated for separate administration and are administered concurrently or sequentially.
number: 15
text: The method of Claim 14, wherein the dendritic cells-based vaccine may be administered first, followed by the administration of the immune checkpoint inhibitor.
number: 16
text: A medical kit for administering dendritic cells-based vaccine in combination with immune checkpoint inhibitor, comprising a printed instruction for administering dendritic cells-based vaccine and immune checkpoint inhibitor, and a combination of dendritic cells-based vaccine and immune checkpoint inhibitor in dosage units for at least one cycle.
Office action: search_report, dated 2020-10-14
Rejection reasons: novelty_epc_54
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ref_id: - BUTTERFIELD LH; RIBAS A; POTTER DM; ECONOMOU JS: "Spontaneous and vaccine induced AFP-specific T cell phenotypes in subjects with AFP-positive hepatocellular cancer", CANCER IMMUNOL IMMUNOTHER, vol. 56, 2007, pages 1931 - 1943, XP019561043, DOI: doi:10.1007/s00262-007-0337-9
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Final disposition: pending (2020-10-14)