Methods and Compositions for Clinical Evaluation of Therapeutic Agents
AssigneeJanssen Biotech, Inc.
InventorsEsi Sama Natya Lamouse-Smith, Nina Sabins
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Abstract
Methods and kits are described for clinical evaluation of a therapeutic agent. In particular, an immune perturbation reflecting an immune response signature of a disease is induced in a healthy subject, and a therapeutic agent of interest is clinically evaluated in the healthy subject with the immune perturbation.
Claims20
A method of identifying an antigen that elicits an immune perturbation in a healthy subject reflecting an immune response signature of a disease, the method comprising:
- (1) administering to the healthy subject an effective amount of a composition comprising an antigen;
- (2) collecting a biological sample from the healthy subject before and at multiple time points after the administering of step (1);
- (3) measuring longitudinal changes from baseline in immune cell populations and/or inflammatory mediators in the biological sample;
- (4) comparing the measured longitudinal changes with the immune response signature of the disease to detect an effect of an immune perturbation induced by the antigen in the healthy subject;
- and
- (5) identifying the antigen that elicits the immune perturbation in the healthy subject reflecting the immune response signature of the disease.
A method of predicting an effect of a therapeutic agent, the method comprising:
- (1) administering to a healthy subject an effective amount of a composition comprising an antigen known to elicit an immune perturbation in the healthy subject reflecting an immune response signature of a disease;
- (2) administering a pharmaceutical composition comprising the therapeutic agent to the healthy subject having the immune perturbation;
- (3) measuring an impact of the therapeutic agent on the immune perturbation in the healthy subject;
- and
- (4) predicting the effect of the therapeutic agent in a subject in need of a treatment of the disease based on the impact measured in (3).
A method of predicting an effect of a therapeutic agent, the method comprising:
- (1) administering to a subject in need of a treatment of a disease an effective amount of a composition comprising an antigen known to elicit an immune perturbation in a healthy subject reflecting an immune response signature of the disease;
- (2) collecting a biological sample from the subject in need of the treatment before and at multiple time points after the administering of step (1);
- (3) measuring longitudinal changes from baseline in immune cell populations and/or inflammatory mediators in the biological sample;
- (4) comparing the measured longitudinal changes with the immune response signature of the disease to detect an effect of an immune perturbation induced by the antigen in the subject in need of the treatment;
- and
- (5) predicting the effect of the therapeutic agent in the subject in need of the treatment based on the immune perturbation induced by the antigen.
A kit for clinical evaluation of a therapeutic agent, comprising:
- a. a composition comprising an antigen for use in inducing an immune perturbation comprising an immune response signature of a disease in a healthy subject;
- and
- b. a pharmaceutical composition comprising a therapeutic agent.
Dependencies are inferred from the claim text.