Immunomodulatory IL-2 agents in combination with immune checkpoint inhibitors
Inventors
LOSEY, HEATHER C. • Lopes, Jared • Winquist, Raymond J.
Assignees
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Publication Number
US-11248050-B2
Publication Date
2022-02-15
Expiration Date
Abstract
The invention provides compositions and methods of treating cancer in a patient with a combination therapy comprising a fusion protein of SEQ ID NO: 1 in combination with an immune checkpoint inhibitor. Preferably the patient has failed to achieve complete or partial response with prior or ongoing treatment with an immune checkpoint inhibitor.
Core Innovation
The invention provides a method of treating cancer in a patient in need thereof by administering a therapeutically effective amount of a fusion protein of SEQ ID NO: 1, or a variant thereof, together with an immune checkpoint inhibitor. The method is defined to reduce CD4+ regulatory T cells and increase CD8+ memory T cells, and the combination is framed around modulating the patient immune cell populations relevant to anti-tumor immunity.
A key aspect of the method is the temporal relationship between the fusion protein administration and the immune checkpoint inhibitor administration. Step (i) is carried out before, after or simultaneously with step (ii), and the patient previously fails to achieve complete or partial response to prior treatment or to ongoing treatment with an immune checkpoint inhibitor.
The fusion protein used in the method includes variant fusion proteins that are at least 80% identical to full length SEQ ID NO: 1. The combination is administered as a therapeutically effective amount of the fusion protein and a therapeutically effective amount of an immune checkpoint inhibitor, with patient selection based on prior lack of complete or partial response to checkpoint inhibitor therapy.
Claims Coverage
The relevant claim set includes two independent claims: a method claim and a kit claim. The method claim includes four inventive features: the specified fusion protein or an at least 80% identical variant, administration with an immune checkpoint inhibitor, before/after/simultaneous sequencing, and patient selection based on prior failure to achieve complete or partial response to immune checkpoint inhibitor treatment. The kit claim covers the fusion protein and an immune checkpoint inhibitor in sterile containers.
Reducing CD4+ regulatory T cells and increasing CD8+ memory T cells for cancer treatment
A method of reducing CD4+ regulatory T cells and increasing CD8+ memory T cells for treating cancer in a patient in need thereof by administering a therapeutically effective amount of the fusion protein of SEQ ID NO: 1, or a variant thereof, together with an immune checkpoint inhibitor.
Fusion protein combined with immune checkpoint inhibitor dosing sequence
The method comprising administering the therapeutically effective amount of the fusion protein in step (i), wherein step (i) is carried out before, after or simultaneously with step (ii), the administration of the therapeutically effective amount of an immune checkpoint inhibitor.
Patient selection based on prior failure to achieve complete or partial response to checkpoint inhibitor therapy
The method wherein the patient has previously failed to achieve complete or partial response to prior treatment or to ongoing treatment with an immune checkpoint inhibitor, as part of treating cancer.
At least 80% identical variant fusion proteins
The method wherein the variant fusion protein is at least 80% identical to full length SEQ ID NO: 1.
Kit with sterile fusion protein and immune checkpoint inhibitor
A kit comprising the fusion protein of SEQ ID NO: 1 or variant thereof provided in a sterile container, and an immune checkpoint inhibitor provided in a separate sterile container or in the same sterile container, with the fusion protein optionally in the form of a pharmaceutical composition suitable for administration to a subject.
Overall, the independent claims cover a cancer treatment method that combines an SEQ ID NO: 1 fusion protein or at least 80% identical variant with an immune checkpoint inhibitor, includes specified before/after/simultaneous administration timing and prior failure to achieve complete or partial response to checkpoint inhibitor therapy, and a kit supplying the fusion protein and immune checkpoint inhibitor in sterile containers.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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