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pp-204

Solution for infusion

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Comments
Indication: Celiac disease — antigen-specific immune tolerance induction for gluten sensitivity Clinical stage: Phase 2b Modality: Biological (antigen-coupled biodegradable PLGA nanoparticle — novel NBE/nanoparticle platform) Mechanism / Target: Gliadin peptide-coupled PLGA (poly lactic-co-glycolic acid) biodegradable nanoparticles; induces antigen-specific immune tolerance to gluten by targeting tolerogenic antigen-presenting cells (APCs) in spleen; reprograms T-cell response to gluten without systemic immunosuppression Route / form: IV infusion Differentiation: First-in-class antigen-specific tolerance induction therapy for celiac disease; only disease-modifying approach (vs. strict gluten-free diet as sole current option); FDA Fast Track Designation; no systemic immunosuppression;
Manufacturer #39341
Europe-based clinical-stage biotech developing Rx nanoparticle-based immune-tolerance therapies using a proprietary platform for antigen-specific tolerance. Injectable pipeline targets autoimmune diseases, allergies, and unwanted immune responses.

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