Method Useful in Tolerance Induction Therapy and Kits Therefore

Simple SummaryContent extracted from patent full text and abstract with AI.

This patent describes a method and associated kits for guiding and monitoring treatment strategies for patients with immune antibody-mediated diseases, such as hemophilia A. The approach involves measuring the expression level of PD-1 on specific B-cells that produce antibodies against therapeutic compounds (e.g., Factor VIII). The measured PD-1 levels serve as a marker for immune tolerance, enabling personalized adjustment of treatment regimens and prediction of treatment success or failure. The kit allows for this measurement using flow cytometry and specific antibody markers.

Use CasesContent extracted from patent full text and abstract with AI.

• Personalized monitoring of immune tolerance induction therapy (ITI) in hemophilia A patients receiving Factor VIII replacement.
• Stratification and adjustment of treatments in patients with other antibody-mediated diseases undergoing replacement therapies (e.g., lysosomal storage disorders like Fabry's disease, Pompe's disease).
• Early identification of likely ITI treatment failure, allowing timely switching to alternative therapies.
• Research into mechanisms of immune tolerance in autoimmune and alloimmune settings.
• Development of companion diagnostics for immune therapies targeting B-cell mediated antibody responses.

BenefitsContent extracted from patent full text and abstract with AI.

• Enables real-time, patient-specific adjustment of immune tolerance therapies for improved efficacy.
• Predicts which patients are likely to respond to ITI, thus avoiding unnecessary or ineffective treatments.
• Reduces treatment costs and burdens by allowing discontinuation or tailoring of expensive therapies when indicated.
• Provides a diagnostic tool for monitoring immune tolerance status objectively, rather than relying solely on clinical/laboratory endpoints.
• Supports development and implementation of precision medicine in antibody-mediated conditions.
• May reduce complications from inhibitor formation in diseases such as hemophilia A, improving clinical outcomes.

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Inventors & Applicants

Patent Abstract

The present invention relates in a first aspect to a method for the stratification of a therapeutic regimen of a subject afflicted or suspected to be afflicted with an immune regulatory antibody-mediated disease based on the immune status of said subject, the method is based on determining the level or amount of expression of PD-1 in a predetermined subset of B-cells, thus, reflecting the immune tolerance status against an immune tolerance inducing compound of said subject. In addition, a method for monitoring of the development or progress of a treatment in a subject based on an administration of immune-tolerance-inducing compound containing antigenic epitopes recognized by the B-cells producing these antibodies. Further, a method for determining the risk of developing antibody-producing B-cells based failure of immune tolerance induction (ITI) treatment in a subject is provided. Moreover, the use of PD-1 expression as a marker in antibody-mediated disease based on B-cell tolerance status is described. Finally, a kit for use in determining antibody-producing B-cells for determining B-cell tolerance status in a predetermined set of B-cells is described.