US 12,077,820 B2
Biomarkers for assessing the response status for treatment of Inflammatory condition or disease affecting the digestive tract such as inflammatory bowel disease in human patients
Nicolas Poirier, Treillieres (FR); and Richard Danger, Reze (FR)
Assigned to OSE IMMUNOTHERAPEUTICS, Nantes (FR); and CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES, Nantes (FR)
Appl. No. 16/636,162
Filed by OSE IMMUNOTHERAPEUTICS, Nantes (FR); and CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES, Nantes (FR)
PCT Filed Aug. 3, 2018, PCT No. PCT/EP2018/071206
§ 371(c)(1), (2) Date Feb. 3, 2020,
PCT Pub. No. WO2019/025624, PCT Pub. Date Feb. 7, 2019.
Claims priority of application No. 17306039 (EP), filed on Aug. 3, 2017.
Prior Publication US 2020/0181706 A1, Jun. 11, 2020
Int. Cl. C12Q 1/68 (2018.01); C07K 16/24 (2006.01); C07K 16/28 (2006.01); C12P 19/34 (2006.01); C12Q 1/6883 (2018.01); G01N 33/543 (2006.01)
CPC C12Q 1/6883 (2013.01) [C07K 16/241 (2013.01); C07K 16/2839 (2013.01); C12Q 2600/106 (2013.01); C12Q 2600/158 (2013.01); G01N 33/543 (2013.01); G01N 2800/065 (2013.01)] 9 Claims
 
1. A method of in vitro assessing the response status of a human patient for treatment of inflammatory bowel disease (IBD) with an anti-TNFalpha agent and/or with an anti α4β7 agent, wherein the method comprises the steps of:
(a) obtaining a colon mucosal sample from said human patient, and in said sample detecting a sample expression profile of transcripts of a set of genes comprising the IL7R, STAT5A, JAK1 and JAK3 genes;
(b) comparing the detected sample expression profile to a reference expression profile of transcripts of a set of genes comprising the ILR7, STAT5A, JAK1 and JAK3 genes, wherein the expression reference profile is obtained from colon biopsies of non-IBD human control subjects;
(c) detecting:
expression of the set of genes in the sample profile that is overexpressed as compared to the expression of the set of genes in the reference expression profile, and predicting that the patient will be non-responsive to treatment with an anti-TNFalpha agent and/or with an anti-α4β7 agent; or
expression of the set of genes in the sample profile that is not overexpressed as compared to the expression of the set of genes in the reference expression profile, and predicting that the patient will be responsive to treatment with an anti-TNFalpha agent and/or with an anti-α4β7 agent; and
(d) administering to the subject a treatment for IBD, wherein: a predicted non-responsive patient is treated with anti-inflammatory agents, steroids, and/or immunosuppressive drugs; or a predicted responsive patient is treated with an anti-TNFalpha agent and/or with an anti-α4β7 agent.