IL-4-fusion formulations for treatment of central nervous system (CNS) tumors
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Publication Number
US-12274735-B2
Publication Date
2025-04-15
Expiration Date
Abstract
The present invention provides methods for the treatment of a central nervous system (CNS) tumor in a subject comprising administering and IL-4 targeted cargo protein formulated in an artificial cerebral spinal fluid formulation. The present invention also provides formulations and methods for administration along with a surrogate tracer for monitoring.
Core Innovation
The invention provides a method of treating a central nervous system (CNS) tumor in a subject by intratumorally administering a formulation that includes an IL-4 targeted cargo protein in an artificial cerebral spinal fluid (CSF) solution with 0.02% human serum albumin. The formulation is optionally co-administered with a surrogate tracer to a subject in need thereof.
The disclosed approach is grounded in targeting IL-4 receptor (IL-4R) and associated tumor features, including embodiments involving IL-4R-positive status. The document describes the IL-4 targeted cargo protein as including an IL-4 targeting moiety and a cargo moiety, with examples including PRX 321 (cpIL-4 fused to truncated Pseudomonas exotoxin A).
The invention also includes embodiments for monitoring delivery distribution by optionally co-administering a surrogate tracer, including magnetic resonance imaging (MRI) contrast agent examples. Tracer imaging is used to assess intratumoral and peritumoral delivery during convection-enhanced delivery (CED), and the disclosed treatment indication includes recurrent or refractory glioblastoma.
Claims Coverage
The independent claim coverage is centered on one independent claim, which contains a formulation-based treatment method for a CNS tumor using an IL-4 targeted cargo protein in artificial CSF with 0.02% human serum albumin, optionally co-administered with a surrogate tracer. The dependents refine the core claim by adding inventive features related to the cargo composition, targeting moiety, tracer, delivery mode, and specific tumor indications.
Intratumoral administration of an IL-4 targeted cargo protein formulation in artificial CSF
Intratumorally administering to the subject a formulation comprising an IL-4 targeted cargo protein in an artificial cerebral spinal fluid (CSF) solution.
0.02% human serum albumin in the artificial CSF formulation
Including 0.02% human serum albumin in the formulation administered intratumorally.
Optional co-administration with a surrogate tracer
Optionally co-administering the formulation with a surrogate tracer to a subject in need thereof.
IL-4-targeted cargo protein with one or more cargo moieties and optionally a toxin
Using an IL-4-targeted cargo protein that includes one or more cargo moieties and optionally includes a toxin.
IL-4R antibody targeting moiety
Having the targeting moiety of the IL-4 targeted cargo protein be an IL-4R antibody.
Recurrent or refractory glioblastoma indication
Using the method for treating a recurrent or refractory glioblastoma in the central nervous system (CNS).
Overall, the independent-claim concept is a CNS intratumoral treatment formulation in artificial CSF containing an IL-4 targeted cargo protein and 0.02% human serum albumin, with optional surrogate tracer co-administration. The principal claim refinements specify cargo/toxin composition options, an IL-4R antibody targeting moiety, and narrowed treatment to recurrent or refractory glioblastoma.
Stated Advantages
Pro-apoptotic effects and target-associated selectivity are described in connection with the IL-4 targeted cargo protein.
The use of a surrogate tracer supports monitoring of intratumoral and peritumoral delivery during convection-enhanced delivery (CED).
Documented Applications
Treatment of a central nervous system (CNS) tumor.
Treatment of recurrent or refractory glioblastoma.
Imaging assessment of intratumoral and peritumoral delivery during convection-enhanced delivery (CED).
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