# US 11,304,996 B2 · Yeast-based immunotherapy and type I interferon sensitivity > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,304,996 B2 - Document ID: US11304996B2 - Status: Granted - Kind: B2 - Application number: 17/007,908 - Filed: 2020-08-31 - Published: 2020-12-17 - Granted: 2022-04-19 - Earliest claimed: 2014-04-11 - Assignees: The Regents of the University of Colorado, a body corporate; GlobeImmune, Inc. - Applicants: Globeimmune, Inc.; THE REGENTS OF THE UNIVERSITY OF COLORADO, a body corporate - Inventors: Donald Bellgrau; Thomas H. King - Web page: https://patentgrep.com/patent/US11304996B2 ## CPC - A61K 39/0011: {Cancer antigens} - A61K 36/064: Saccharomycetales, e.g. baker's yeast - A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics - A61P 33/00: Antiparasitic agents - A61P 35/00: Antineoplastic agents - G01N 33/573: for enzymes or isoenzymes - A61K 2039/52: {Bacterial cells; Fungal cells; Protozoal cells} - A61K 2039/57: {characterised by the type of response, e.g. Th1, Th2} - G01N 2333/555: Interferons [IFN] - G01N 2333/914: Hydrolases (3) - G01N 2800/52: Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) ## Abstract Disclosed are methods of treating individuals with yeast-based immunotherapy who have been preselected as being sensitive to type I interferons, as well as methods for selecting individuals for treatment with yeast-based immunotherapeutic compositions and methods for enhancing or improving an individual's response to yeast-based immunotherapy, based on the individual's sensitivity to type 1 interferons (T1IFNs). ## Claims ### Claim 1 A method of preselecting a subject for treatment with yeast-based immunotherapy, comprising: a) measuring a baseline level of one or more Type 1 Interferon (T1IFN)-regulated biomarkers ex vivo or in vitro in a biological sample isolated from a subject who is a candidate for yeast-based immunotherapy; b) contacting the biological sample with T1IFN ex vivo or in vitro; c) measuring the level of the one or more T1IFN-regulated biomarkers after step (b) of contacting; and d) preselecting T1IFN-sensitive subjects for treatment with yeast-based immunotherapy whose level of the one or more T1IFN-regulated biomarker is up- or down-regulated as a result of contacting the biological sample with T1IFN. ### Claim 2 (depends on 1) The method of claim 1, wherein subjects are preselected whose level of the T1IFN-regulated biomarker measured after contact with the T1IFN as compared to the level of the T1IFN-regulated biomarker measured before contact with the T1IFN is statistically significantly different. ### Claim 3 (depends on 1) The method of claim 1, wherein subjects are preselected whose ratio between the level of the T1IFN-regulated biomarker measured after contact with the T1IFN and the level of the T1IFN-regulated biomarker measured before contact with the T1IFN is at least three. ### Claim 4 (depends on 1) The method of claim 1, wherein subjects are preselected whose ratio between the level of the T1IFN-regulated biomarker measured after contact with the T1IFN and the level of the T1IFN-regulated biomarker measured before contact with the T1IFN is at least five. ### Claim 5 (depends on 1) The method of claim 1, wherein the step (a) and/or (c) of measuring comprises using an assay selected from the group consisting of: enzyme-linked immunosorbant assay (ELISA), real-time polymerase chain reaction (PCR), flow cytometry, multiplex bead-based immunoassay, and quantitative selected reaction monitoring (SRM)-based mass spectrometry. ### Claim 6 (depends on 1) The method of claim 1, wherein the biological sample is peripheral blood mononuclear cells (PBMCs) isolated from the subject. ### Claim 7 (depends on 1) The method of claim 1, wherein the biological sample is a tissue biopsy from the subject. ### Claim 8 (depends on 1) The method of claim 1, wherein the method further comprises the steps of: further contacting the biological sample with Type 1 Interferon after step (c) and measuring the level of the one or more Type 1 Interferon-regulated biomarkers after contacting the biological sample with Type 1 Interferon after step (c); and preselecting Type 1 Interferon-sensitive subjects for treatment with yeast-based immunotherapy whose level of the one or more Type 1 Interferon-regulated biomarker was up- or down-regulated at least three fold as a result of contacting the biological sample with Type 1 Interferon in step (b), and whose level of the one or more Type 1 Interferon-regulated biomarker was not up- or down-regulated as a result of further contacting the biological sample with Type 1 Interferon. ### Claim 9 (depends on 1) The method of claim 1, wherein the biological sample has not been exposed to exogenous Type 1 Interferon prior to preselecting the subject. ### Claim 10 (depends on 1) The method of claim 1, wherein the subject has not received an exogenous source of Type 1 Interferon prior to step (a). ### Claim 11 (depends on 1) The method of claim 1, wherein cells in the biological sample upregulate one or more type 1 interferon-stimulated genes (ISGs) as a result of contact with Type 1 Interferon ex vivo or in vitro. ### Claim 12 (depends on 1) The method of claim 1, wherein a Type 1 Interferon-regulated biomarker in the biological sample has increased phosphorylation as a result of contact with Type 1 Interferon ex vivo or in vitro. ### Claim 13 (depends on 1) The method of claim 1, wherein cells in the biological sample produce a higher level of Type 1 Interferon-regulated protein as a result of contact with Type 1 Interferon ex vivo or in vitro. ### Claim 14 (depends on 1) The method of claim 1, wherein the Type 1 Interferon is interferon-α or interferon β. ### Claim 15 (depends on 1) The method of claim 1, wherein the subject has cancer or an infectious disease.