Pharmaceutical composition for enhancing radiotherapy comprising fusion protein containing IL-2 protein and CD80 protein
Inventors
Jang, Myung Ho • Nam, Su Youn • Koh, Young Jun
Assignees
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Publication Number
US-12478675-B2
Publication Date
2025-11-25
Expiration Date
Abstract
A pharmaceutical composition for enhancing radiation therapy, containing a fusion protein dimer is disclosed. The fusion protein dimer includes an IL-2 protein and a CD80 protein. A method of radiation therapy for cancer, using the composition is also disclosed. The composition for enhancing radiation therapy may increase the effect of radiation therapy in cancer treatment.
Core Innovation
The invention relates to a cancer radiotherapy-enhancing pharmaceutical composition comprising a fusion protein dimer containing an IL-2 protein and a CD80 protein (B7-1). The fusion protein dimer is described as a structured fusion including defined IL-2 and CD80 components, and it is intended to enhance radiation therapy for cancer. The disclosed fusion protein architecture is supported by structural definitions, including linker/Fc/cysteine hinge architecture and structural formulas (I) and (II).
The described approach focuses on radiation therapy enhancement through a synergistic effect between the fusion protein dimer and radiation. The patent content indicates that the combination increases local tumor inhibition and also produces a distal abscopal effect. This radiotherapy-enhancing activity is framed as a functional outcome of administering the IL-2/CD80 fusion protein dimer in the context of radiation therapy.
Preclinical mouse data are described using mGI-101, defined as a mouse CD80-Fc-IL-2 variant (2M) with R38A and F42A. The data are summarized in a B16F10 melanoma model in C57BL/6 mice, including results described in terms of tumor growth inhibition (TGI). The content additionally describes an administration timing relationship relative to irradiation, and it provides a dosing context and radiation dose ranges used in combination with the composition.
Claims Coverage
The relevant independent claim identifies one core claim scope: a pharmaceutical composition for enhancing radiation therapy for cancer comprising a fusion protein dimer of IL-2 and CD80. Dependent claim refinements explicitly cover fusion protein structural/formula constraints, IL-2/CD80 component definitions and sequence/identity constraints, and method-related constraints tied to radiation dose and administration timing.
Fusion protein dimer comprising IL-2 and CD80
A pharmaceutical composition for enhancing radiation therapy for cancer, comprising a fusion protein dimer comprising an IL-2 protein and a CD80 protein.
Fusion protein architecture defined by structural formulas
A pharmaceutical composition in which the fusion protein has a structure either formula (I) or formula (II), wherein CD80 (X) and IL-2 (Y) are linked to an Fc domain via peptide linkers with n and m each independently 0 or 1.
Sequence identity relative to specified reference sequences
A pharmaceutical composition in which the fusion protein has a sequence identity of 85% or higher to the amino acid sequence of SEQ ID NO: 9, 26, 28, or 30.
CD80 fragment defined by amino-acid range
A pharmaceutical composition in which the CD80 fragment comprises amino acids 35 through 242 of SEQ ID NO: 11.
Radiation dose amount for the therapy method
A method in which the irradiating radiation amount ranges from 0.1 Gy to 100 Gy.
Administration timing window relative to irradiation
A method in which the pharmaceutical composition is administered before or after 6 to 48 hours based on the time of radiation irradiation.
Across the independent claim and its refinements, the inventive scope centers on a fusion protein dimer combining IL-2 and CD80 to enhance radiation therapy for cancer, with additional claim coverage defining the fusion architecture, sequence/identity constraints, and method parameters such as radiation dose and administration timing.
Stated Advantages
Enhances radiation therapy for cancer.
Increases local tumor inhibition.
Provides a distal abscopal effect.
Documented Applications
Radiation therapy for cancer using a pharmaceutical composition administered to a non-human mammal receiving radiation, including preclinical use in a B16F10 melanoma model in C57BL/6 mice (tumor growth inhibition and distal abscopal effect described).
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