Compositions and methods for treatment of cancer
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Publication Number
US-11807691-B2
Publication Date
2023-11-07
Expiration Date
Abstract
Compositions, e.g., compositions comprising cellular therapeutics and/or protein therapeutics, and methods of using such compositions for treating cancer are described.
Core Innovation
The invention relates to a fusion protein that combines an antibody or antigen-binding fragment that binds a tumor antigen with an extracellular domain of CD19, or a fragment thereof, wherein the extracellular domain or fragment includes an epitope recognized by anti-CD19 antibody FMC63. The subject matter includes recombinant therapeutic fusion protein formats and antibody formats used in the CD19 extracellular-domain/FMC63 epitope fusion context.
A treatment method is described for a subject having a tumor, where the fusion protein is administered together with a cellular therapeutic or an antibody-drug conjugate. The cellular therapeutic or antibody-drug conjugate binds the extracellular domain of CD19 or the fragment thereof that is included in the fusion protein, establishing a defined binding relationship between the administered fusion protein and an additional therapeutic component.
The subject matter also includes related constructs in which tumor-associated features enable inducible targeting and conditional protein behavior, including inducible or cleavable fusion proteins via linkers released by tumor-associated proteases and Fc-based CD19 fusion constructs and masked constructs using masking moieties and cleavable linkers. The background and description indicate a problem of achieving tumor-selective activity and safety in cellular therapeutics or protein therapeutics, including cell-killing associated with induced toxin expression and a safety framework using kill switches.
Claims Coverage
The claim set covers a tumor-treatment method with a CD19 extracellular-domain-containing fusion protein and a cellular therapeutic or antibody-drug conjugate that binds the same CD19 extracellular domain or fragment. The independent claim structure includes two main inventive features, with dependent refinements directed to antibody formats, tumor antigen choices, a CD19 extracellular-domain absence condition in the tumor, post-administration binding, and a tumor-killing outcome tied to the binding interaction.
Fusion protein with tumor-antigen antibody binding and FMC63-recognized CD19 extracellular epitope
Administering a fusion protein comprising an antibody or antigen-binding fragment that binds a tumor antigen, and an extracellular domain of CD19, or a fragment thereof, that includes an epitope recognized by anti-CD19 antibody FMC63.
Second therapeutic component binds the CD19 extracellular domain or fragment
Administering a cellular therapeutic or antibody-drug conjugate to the subject, wherein the cellular therapeutic or antibody-drug conjugate binds the extracellular domain or fragment thereof.
Antibody component defined as an antigen-binding fragment format
The antibody or antigen-binding fragment is an antigen-binding fragment that is an Fab, scFv, Fv, or VHH.
Tumor antigen selected from a defined set
The tumor antigen is selected from HER-2/neu, c-met, EGFR, Ga733/EpCAM, CD20, ROR1, CLL-1/CLECK12A, or BCMA.
Tumor does not express the CD19 extracellular domain or fragment
The tumor does not express the extracellular domain or a fragment of it.
Post-administration binding of fusion protein to tumor antigen
After administration, the fusion protein binds to a tumor antigen.
Binding of second therapeutic component triggers tumor killing
Binding of a cellular therapeutic or an antibody-drug conjugate to an extracellular domain or a fragment of it triggers killing of the tumor.
Overall, the claim set centers on a coordinated method in which a fusion protein carrying an FMC63-recognized CD19 extracellular domain or fragment targets a tumor antigen, followed by a cellular therapeutic or antibody-drug conjugate that binds that CD19 extracellular domain or fragment.
Stated Advantages
Documented Applications
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