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AG019

Development stage: Phase 2
Lead developer: Precigen ActoBio
Modality: Frozen FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Recombinant Proteins and Enzymes, Microbial Metabolites → Microbiome-Derived Products → Microbiome Therapeutics, Synthetic Biology Platforms → Engineered Microbial Therapeutics → Microbiome Therapeutics, Genetically Modified Bacteria → Engineered Microbial Therapeutics → Microbiome Therapeutics, Microbial Proteins → Microbiome-Derived Products → Microbiome Therapeutics, Peptides, Gene Silencing → Gene Therapies, Fresh FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Complex Communities → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Gene Editing → Gene Therapies, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Gene Addition/Replacement → Gene Therapies
Administration: Oral

Overview

AG019 is an investigational oral capsule therapy consisting of genetically modified *Lactococcus lactis* bacteria engineered to deliver human proinsulin (hPINS) and the tolerance-enhancing cytokine human interleukin-10 (hIL-10) directly to the mucosal lining of the gastrointestinal tract. The goal is to induce antigen-specific immune tolerance in patients with type 1 diabetes mellitus (T1D), potentially preserving endogenous insulin production by modulating immune responses against pancreatic beta cells. The drug acts as a microbiome-based gene therapy, combining features of immunotherapy, gene transfer, and bacterial delivery systems. It has been developed primarily for newly diagnosed T1D and has shown safety and tolerability in early-phase clinical trials, both as monotherapy and in combination with teplizumab[2][3][4][5][6][7].

Targets

IL10RA (Interleukin-10 Receptor)Major histocompatibility complex class II-proinsulin peptide complex

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