Immunostimulatory agents in combination with angiogenesis inhibitors
Inventors
Lopes, Jared • LOSEY, HEATHER C. • Winquist, Raymond J.
Assignees
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Publication Number
US-11834483-B2
Publication Date
2023-12-05
Expiration Date
Abstract
The invention provides compositions and methods of treating cancer in a patient with a combination therapy comprising administering to the patient a fusion protein of SEQ ID NO: 1, in combination with an angiogenesis inhibitor (e.g., an anti-VEGF antibody or lenvatinib).
Core Innovation
Not explicitly described in patent.
Not explicitly described in patent.
Claims Coverage
The independent claim covers a cancer-treatment method in which a fusion protein of SEQ ID NO: 1 is administered together with lenvatinib, with step (i) carried out simultaneously with step (ii). Dependent claims further specify IL-2Rβγ activation by the fusion protein, receptor-kinase targets inhibited by lenvatinib, and comparison-based outcomes versus monotherapy.
Simultaneous administration of fusion protein and lenvatinib
A method of treating cancer in a patient comprising administering a therapeutically effective amount of a fusion protein of SEQ ID NO: 1 and administering a therapeutically effective amount of lenvatinib, wherein step (i) is carried out simultaneously with step (ii).
IL-2Rβγ activation by fusion protein
A method wherein the therapeutically effective amount of the fusion protein of SEQ ID NO: 1 is capable of activating the IL-2 intermediate receptor, IL-2Rβγ.
Lenvatinib inhibits VEGF, PDGF, and FGF receptor tyrosine kinases
A method wherein lenvatinib inhibits vascular endothelial growth factor receptor types 1, 2, and 3, platelet derived growth factor receptor types alpha and beta, and fibroblast growth factor receptor types 1, 2, and 3.
Progression-free survival increase versus monotherapy
A method wherein the increase in a patient’s progression-free survival is at least about 10% compared with fusion protein SEQ ID NO: 1 given as monotherapy or lenvatinib given as monotherapy.
CD8+ T cell increase at least 2-fold greater than monotherapy
A method wherein the increase in CD8+ T cells is at least 2-fold greater than the increase produced by administering the fusion protein of SEQ ID NO: 1 or lenvatinib alone as monotherapies.
Esm1 decrease and interferon-associated gene increase versus monotherapy
A method wherein steps (i) and (ii) produce decreased Esm1 expression and increased Type I interferon and Type II interferon-associated gene expression compared with monotherapy using the fusion protein of SEQ ID NO: 1 or monotherapy using lenvatinib at a therapeutically effective amount.
The claims are centered on simultaneous co-administration of the SEQ ID NO: 1 fusion protein with lenvatinib, with further definition by IL-2Rβγ activation, specified receptor-kinase inhibition by lenvatinib, and comparison-based outcomes versus monotherapy including progression-free survival, CD8+ T cell expansion, and Esm1 and interferon-associated gene-expression changes.
Stated Advantages
Increased progression-free survival by at least about 10% compared with fusion protein SEQ ID NO: 1 monotherapy or lenvatinib monotherapy.
CD8+ T cells increase at least 2-fold greater than the increase produced by fusion protein SEQ ID NO: 1 or lenvatinib alone as monotherapies.
Combination produces decreased Esm1 expression.
Combination produces increased Type I interferon and Type II interferon-associated gene expression compared with monotherapy.
Documented Applications
Treating cancer in a patient in need thereof using simultaneous administration of a fusion protein of SEQ ID NO: 1 and lenvatinib.
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