Combination of an IL-2RBETA-selective agonist and a long-acting IL-15 agonist
Inventors
Charych, Deborah H. • Kirk, Peter Benedict
Assignees
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Publication Number
US-12233104-B2
Publication Date
2025-02-25
Expiration Date
Abstract
In one or more embodiments of the invention, a method is provided, the method comprising the steps of administering to a cancer patient: (a) an IL-2Rβ-activating amount of a long-acting, IL-2Rβ-selective agonist; and (b) an IL-15R-activating amount of a long-acting, IL-15 moiety. In one or more embodiments of the invention, a composition is provided, the composition comprising: an IL-2Rβ-activating amount of a long-acting, IL-2Rβ-selective agonist; and an IL-15R-activating amount of a long-acting, IL-15 moiety. In one or more embodiments of the invention, a kit is provided, the kit comprising: an IL-2Rβ-activating amount of a long-acting, IL-2Rβ-selective agonist; an IL-15R-activating amount of a long-acting, IL-15 moiety; and instructions for use of the IL-2Rβ-selective agonist and the long-acting, IL-15 moiety.
Core Innovation
The invention relates to treating a patient suffering from cancer by administering an IL-2Rβ-activating amount of a long-acting, IL-2Rβ-selective agonist. The long-acting IL-2Rβ-selective agonist includes an IL-2 moiety covalently attached to a water-soluble polymer having n that is an integer from 3 to 4000, or pharmaceutically acceptable salts thereof.
The invention further provides co-administration of a long-acting IL-15 agonist. The long-acting IL-15 agonist includes an IL-15 receptor-activating amount and an IL-15 protein covalently attached to at least one water-soluble polymer having an n that is an integer from 3 to 4000, or pharmaceutically acceptable salts thereof.
The disclosed approach is directed to improved antitumor efficacy in combination treatment, with documented in vivo mouse tumor studies including CT26 colon carcinoma and B16F10 metastatic melanoma. The combination of the long-acting IL-2Rβ-selective agonist with the long-acting IL-15 agonist is described as significantly prolonging median survival compared to either long-acting single agent, and compared to RSLAIL-2 with native IL-15 in the reported study.
Claims Coverage
The independent claim covers a method of treating a patient suffering from cancer using co-administration of a long-acting IL-2Rβ-selective agonist and a long-acting IL-15 agonist, each comprised of a cytokine covalently attached to a water-soluble polymer with n from 3 to 4000. The independent claim includes two core inventive administration elements and the polymer attachment framework.
Treating a cancer patient with a long-acting IL-2Rβ-selective agonist
Administering to the patient an IL-2Rβ-activating amount of a long-acting, IL-2Rβ-selective agonist comprised of an IL-2 moiety covalently attached to a water-soluble polymer having n as an integer from 3 to 4000, or pharmaceutically acceptable salts thereof.
Co-administering a long-acting IL-15 receptor-activating agonist
Administering an IL-15 receptor-activating amount of a long-acting IL-15 agonist comprised of an IL-15 protein covalently attached to at least one water-soluble polymer having n as an integer from 3 to 4000, or pharmaceutically acceptable salts thereof.
Overall, the claim coverage centers on administering both a long-acting IL-2Rβ-selective IL-2 polymer agonist and a long-acting IL-15 receptor-activating IL-15 polymer agonist to treat a cancer patient, using water-soluble polymer embodiments with n from 3 to 4000 and the covalent cytokine-polymer architecture.
Stated Advantages
Significantly prolonged median survival in the reported study compared to either long-acting single agent.
Significantly prolonged median survival compared to RSLAIL-2 with native IL-15 in the reported study.
Increased CD8 T cells.
Increased CD8:regulatory T-cell ratio.
Reported tolerability in the described in vivo study context.
Documented Applications
Antitumor efficacy studies in mouse tumor models including CT26 colon carcinoma and B16F10 metastatic melanoma using combination treatment of the long-acting IL-2Rβ-selective agonist with the long-acting IL-15 agonist.
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