Glycan therapeutic compositions and related methods thereof
Inventors
VON MALTZAHN, GEOFFREY A. • Yamanaka, Yvonne J. • Silverman, Jared • Milwid, John Miles • Rubens, Jacob Rosenblum • GEREMIA, John M.
Assignees
DSM Nutritional Products LLC • Flagship Pioneering Inc • Hercules Capital Inc
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Publication Number
US-12377113-B2
Publication Date
2025-08-05
Expiration Date
Abstract
Preparations of glycan therapeutics, pharmaceutical compositions, dietary supplements and medical foods thereof are provided, and methods of using said gycan therapeutics, e.g. in cancer therapy.
Core Innovation
The invention concerns a method for treating dysbiosis of the gastrointestinal microbiota in a subject having cancer by administering a composition comprising a glycan therapeutic preparation. The glycan therapeutic preparation comprises branched glycans comprising glucose, galactose, arabinose, mannose, fructose, xylose, fucose, or rhamnose glycan units, together with an average degree of branching (DB) of at least 0.01.
The glycan therapeutic preparation is further defined by a degree of polymerization (DP) distribution, where at least 50% of the glycans have a DP of at least 3 and less than 30 glycan units, and by a ratio of alpha to beta-glycosidic bonds present in the glycans between about 1:1 to about 5:1. In the disclosed embodiments, administering the glycan therapeutic preparation treats dysbiosis in the cancer subject.
The disclosed content describes biological outcomes associated with the approach, including immunologic and microbiome-mediated anti-tumor activity, modulation of microbial taxa and microbial metabolite effects on cancer, and effects related to short-chain fatty acids (SCFAs) and bile acids. It also describes evaluation of responders and non-responders using gastrointestinal microbiota, biomarkers, and functional or metabolite shifts, and discusses combination therapy with immune checkpoint modulators.
Claims Coverage
The document provides one independent claim directed to treating dysbiosis in a subject having cancer using a glycan therapeutic preparation with defined branched-glycan structural parameters. The claim is refined by dependent claim content describing downstream biological effects, symptom reduction, and optional checkpoint-inhibitor combination choices.
Treating dysbiosis in cancer subjects with a structured branched glycan therapeutic preparation
Administering to a subject having cancer an effective amount of a composition comprising a glycan therapeutic preparation, wherein the glycan therapeutic preparation comprises branched glycans comprising glucose, galactose, arabinose, mannose, fructose, xylose, fucose, or rhamnose glycan units; an average degree of branching (DB) of at least 0.01; at least 50% of glycans having a degree of polymerization (DP) of at least 3 and less than 30 glycan units; and a ratio of alpha to beta-glycosidic bonds between about 1:1 to about 5:1, thereby treating dysbiosis.
Overall, claim coverage centers on a single method claim defined by a branched glycan therapeutic preparation with specified monosaccharide units, DB, DP distribution, and alpha:beta glycosidic bond ratio, applied to dysbiosis treatment in a cancer subject. The broader claim content also describes SCFA-related effects, stimulation of specified gut bacteria taxa, reduction of treatment-induced symptoms such as diarrhea, and optional combination therapy with checkpoint inhibitors.
Stated Advantages
Enhanced tumor surveillance and anti-tumor activity in the context of glycan therapeutics in cancer/dysbiosis.
Modulation of beneficial gut microbial taxa and increased tumor-infiltrating bacteria.
Immune modulation characterized by increased Th1/Th17 and stimulation of cytotoxic T and NK cells.
Microbial metabolite effects on cancer, including effects related to toxic metabolites and repression of oncogenic pathways, and altered SCFAs and bile acids.
Ability to identify responders and non-responders via gastrointestinal microbiota, biomarkers, and functional/metabolite shifts.
Reduction of drug- or treatment-induced gastrointestinal toxicities/symptoms, including diarrhea and dysbiosis-related conditions.
Increases the level of a short-chain fatty acid (SCFA) after administering the composition.
Stimulates growth or activity of specified gut bacteria taxa.
Enables combination therapy using a checkpoint inhibitor selected from anti-PD-1, anti-PD-L1, anti-CTLA4, anti-TIM-3, or anti-LAG-3.
Documented Applications
Treating dysbiosis of the gastrointestinal microbiota in a subject having cancer.
Combination therapy context with immune checkpoint modulators, including checkpoint inhibitors such as anti-PD-1, anti-PD-L1, anti-CTLA4, anti-TIM-3, or anti-LAG-3, and other anticancer agents, in the setting of cancer and dysbiosis.
Management of drug- or treatment-induced gastrointestinal toxicities and dysbiosis, including diarrhea and constipation, in the context of cancer treatment.
Immune- and microbiome-mediated therapeutic outcomes in cancer/dysbiosis contexts, including modulation of microbial taxa and microbial metabolite effects involving SCFAs and bile acids.
As an adjunct approach to cancer therapy where checkpoint inhibitor treatment is used.
Reducing drug- or treatment-induced symptoms, including digestive abnormalities such as diarrhea, in the context of cancer treatment.
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