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AssigneesGlycode, Universite Francois Rabelais
InventorsGilles Thibault, Hervé Watier, Sebastien Dall'Ozzo
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The invention relates to steps for the development or the quality control of recombinant monoclonal antibodies (MoAbr) used as medicaments, and also to the selection of the patients liable to effectively respond to a treatment with a given monoclonal antibody. More specifically, the invention relates to a method for evaluating, in vitro, the effector functions of NK cells in response to a test monoclonal antibody, comprising at least the following steps: (i) the NK cells are brought into contact with said monoclonal antibody, which is fixed on a support, in the presence of an agent for inhibiting the secretion of cytokines by said cells; (ii) by way of positive control for the activation of the NK cells, the same experiment is carried out using, in place of the test monoclonal antibody, a monoclonal antibody directed against the Fc RIIIa receptor; (iii) after an incubation period of at least 1 hour, the response of the NK cells is observed by measuring the presence of the CD107 marker at the cell surface, and also the presence of intracellular IFN and/or of intracellular TNF.
A method for evaluating, in vitro, the effector functions of cells expressing FcγRIIIa in response to a test monoclonal antibody, comprising:
A method for predicting the response of a patient to a treatment with a given monoclonal antibody comprising quantifying the effector functions of cells expressing FcγRIIIa in the patient in response to the given monoclonal antibody by measuring the presence of the CD107 marker at the cell surface of cells expressing FcγRIIIa, and also the presence of intracellular interferon gamma (IFNγ) and/or of intracellular tumor necrosis factor alpha (TNFα).
A method, for comparing the ability of different recombinant monoclonal antibodies to induce antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cytokine production (ADCP) by cells expressing FcγRIIIa comprising comparing the presence of the CD107 marker at the cell surface of cells expressing FcγRIIIa, and also the presence of intracellular interferon gamma (IFNγ) and/or of intracellular tumor necrosis factor alpha (TNFα).
A method for improving the effectiveness of recombinant monoclonal antibodies for therapeutic purposes comprising determining the presence of the CD107 marker at the cell surface of cells expressing FcγRIIIa, and also the presence of intracellular interferon gamma (IFNγ) and/or of intracellular tumor necrosis factor alpha (TNFα).
A method for carrying out a quality control of a sample of recombinant monoclonal antibodies comprising determining the presence of the CD107 marker at the cell surface of cells expressing FcγRIIIa, and also the presence of intracellular interferon gamma (IFNγ) and/or of intracellular tumor necrosis factor alpha (TNFα).
Dependencies are inferred from the claim text.