Combination immune therapy and cytokine control therapy for cancer treatment
Inventors
Assignees
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Publication Number
US-11318163-B2
Publication Date
2022-05-03
Expiration Date
Abstract
Compositions disclosed herein, and methods of use thereof included those for treating or preventing sepsis in a subject in need, including methods of extending of the survival of a subject suffering from sepsis, and reduction of organ dysfunction or failure due to sepsis. Methods of treating or preventing sepsis in a subject in need includes administering compositions comprising early apoptotic cells or early apoptotic cell supernatants. Compositions and methods of use thereof may reduce the negative proinflammatory effect accompanying sepsis. Further, anti-inflammatory cytokine release may be reduced. In certain instances, compositions may include additional agents.
Core Innovation
The disclosed technology provides methods for treating, preventing, inhibiting, reducing the incidence of, ameliorating, or alleviating sepsis in a human subject in need by administering a composition that comprises an early apoptotic cell population. The early apoptotic cell population comprises a mononuclear enriched cell population having at least 60% AnnexinV+ and at least 15% propidium iodide+ cells.
The source of sepsis is selected from pneumonia, endovascular infection, methicillin-resistant Staphylococcus aureus (MRSA) infection, a urinary tract infection (UTI), or a biliary tract infection. In the recited method, the administration treats, prevents, inhibits, reduces the incidence of, ameliorates, or alleviates sepsis in the subject.
The disclosure further states that administration variations include delivering the composition as a single composition or as multiple separate compositions, and that timing strategies are described for when apoptotic cells or apoptotic supernatants are provided relative to other administered immune-related agents. The disclosure also states that immune-modulating and efficacy effects are achieved, including reduced pro-inflammatory cytokines and cytokine release syndrome (CRS) with IL-6 reduction, while maintaining comparable or improved cytotoxic activity of genetically modified immune cells against tumors.
Claims Coverage
The document excerpt identifies one independent claim. The claim contains three main inventive requirements: use of an early apoptotic cell population, defined mononuclear-enriched AnnexinV+/propidium iodide+ thresholds, and a sepsis indication with explicitly listed source types.
Early apoptotic mononuclear-enriched cell composition for sepsis
Administering a composition comprising an early apoptotic cell population to a human subject in need, wherein the administration treats, prevents, inhibits, reduces the incidence of, ameliorates, or alleviates sepsis.
AnnexinV and propidium iodide thresholds in mononuclear enriched cells
The early apoptotic cell population comprises a mononuclear enriched cell population comprising at least 60% AnnexinV+ and at least 15% propidium iodide+ cells.
Sepsis sources selected from specified infection types
The source of sepsis is selected from pneumonia, endovascular methicillin-resistant Staphylococcus aureus (MRSA) infection, a urinary tract infection (UTI), or a biliary tract infection.
Across the identified independent claim, the coverage is anchored on administering an early apoptotic, mononuclear-enriched cell composition meeting AnnexinV+ and propidium iodide+ threshold criteria, for sepsis treatment with sepsis source selected from pneumonia, endovascular MRSA infection, UTI, or biliary tract infection.
Stated Advantages
Treats, prevents, inhibits, reduces the incidence of, ameliorates, or alleviates sepsis in the subject.
Rebalances the immune response.
Reduces the secretion of one or more proinflammatory cytokine/chemokines.
Decreases toxic cytokine production associated with cytokine release syndrome/cytokine storm.
Aims to preserve anti-tumor CAR-T efficacy while addressing cytokine storm.
Reduced pro-inflammatory cytokines and cytokine release syndrome (CRS), including IL-6 reduction, while maintaining comparable or improved cytotoxicity against tumors.
Broad therapeutic goals including tumor burden reduction, delayed progression, and increased survival.
Documented Applications
Treating, preventing, inhibiting, reducing the incidence of, ameliorating, or alleviating sepsis, where the source of sepsis is selected from pneumonia, endovascular infection, MRSA infection, UTI, or biliary tract infection.
Controlling cytokine release syndrome/cytokine storm associated with immune therapies such as CAR T-cell therapy by decreasing toxic cytokine production while aiming to preserve anti-tumor CAR-T efficacy.
Immune-modulating applications associated with reduced pro-inflammatory cytokines and cytokine release syndrome (CRS), including IL-6 reduction, in the context described in the provided summary.
Cancer treatment goals including tumor burden reduction, delayed progression, and increased survival in the context described in the provided summary.
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