Fusion protein comprising IL-2 protein and CD80 protein, and use thereof
Inventors
Assignees
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Publication Number
US-12291555-B2
Publication Date
2025-05-06
Expiration Date
Abstract
Provided is a fusion protein comprising IL-2 protein and CD80 protein. A fusion protein containing CD80 fragment, immunoglobulin Fc, and an IL-2 variant can activate immune cells, such as natural killer cells, and at the same time, can control immune cell regulatory activity of regulatory T cells. Therefore, a pharmaceutical composition containing the fusion protein as an active ingredient is very industrially useful in that such pharmaceutical composition can increase immune activity in the body, and thus can be effectively used against infectious diseases as well as cancer.
Core Innovation
The invention relates to a polynucleotide encoding a fusion protein having a structural formula (I) or (II). In the structural formulas, the fusion protein includes a CD80 protein, an Fc domain, and an IL-2 protein connected by peptide linkers, with both orientations covered in which CD80 protein and IL-2 protein appear at opposite ends of the fusion protein.
In structural formula (I), the arrangement is N′-X-[linker (1)]-Fc domain-[linker (2)]-Y—C′, while in structural formula (II) the arrangement is N′-Y-[linker (1)]-Fc domain-[linker (2)]-X—C′. The peptide linkers (1) and (2) are peptide linkers, and n and m are each independently 0 or 1.
Dependent refinements specify particular IL-2 variants, particular CD80 forms, and specific Fc-domain variants, and constrain the encoded sequences using defined sequence identity thresholds and reference sequences. The fusion proteins are framed as immunopotentiating constructs intended to activate immune cells and regulate immune activity, including effects on Treg activity and modulation of NK and CD8 T cells.
Functional rationale presented in the document includes reducing IL-2-associated toxicity, including capillary leak, while maintaining immune activity. Therapeutic use is described for cancers and infectious diseases, supported by functional readouts and assessment of immune activation and toxicity in relevant models.
Claims Coverage
The independent claim identified in the provided portion is polynucleotide-level coverage for encoding a fusion protein with structural formula (I) or (II), including orientation, CD80/IL-2 placement, peptide linkers, and optional terminal additions represented by n and m. The main inventive features are expressed as construction constraints of the fusion-protein architecture encoded by the polynucleotide.
Fusion protein with structural formula (I) or (II) using CD80 and IL-2 with Fc and peptide linkers
A polynucleotide encoding a fusion protein of structural formula (I) or (II) having N′-X-[linker (1)]-Fc domain-[linker (2)]-Y—C′ or N′-Y-[linker (1)]-Fc domain-[linker (2)]-X—C′, where X is a CD80 protein and Y is an IL-2 protein; linkers (1) and (2) are peptide linkers; n and m are each independently 0 or 1.
Coverage centers on polynucleotide encoding of an Fc-based IL-2–CD80 fusion protein with peptide linkers, covering both swapping orientations of the IL-2 and CD80 portions and allowing n and m to be 0 or 1. Dependent claims refine the specific IL-2 variants, CD80 fragments, Fc-domain variants, and sequence-identity constraints, and also include vectors and transformed cells containing the polynucleotide.
Stated Advantages
Reduces IL-2-associated toxicity, including capillary leak.
Activates immune cells, including NK and CD8 T cells.
Regulates Treg activity.
Provides therapeutic use against cancers and infectious diseases.
Documented Applications
Therapeutic use against cancers.
Therapeutic use against infectious diseases.
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