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GUT-115

Development stage: Preclinical
Lead developer: Gusto Giusto
Modality: Synthetic Biology Platforms → Engineered Microbial Therapeutics → Microbiome Therapeutics, Fresh FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Frozen FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Genetically Modified Bacteria → Engineered Microbial Therapeutics → Microbiome Therapeutics, Microbial Metabolites → Microbiome-Derived Products → Microbiome Therapeutics, Microbial Proteins → Microbiome-Derived Products → Microbiome Therapeutics, Complex Communities → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics

Overview

GUT-115 is a preclinical-stage live biotherapeutic product (LBP) developed by Gusto Global for use in immuno-oncology. It consists of a rationally engineered bacterial consortium designed to modulate the gut microbiome, serving as an adjuvant to immune checkpoint inhibitors like pembrolizumab (Keytruda). The therapeutic is specifically aimed at patients who are non-responsive to checkpoint inhibitors, with the goal of converting them into responders by awakening the host immune system and increasing the density of tumor-infiltrating immune cells. GUT-115 was developed using Gusto's proprietary Tapestry platform, which integrates mechanistic data on microbe-host interactions to design therapeutic consortia that target the gut microbiome-immune checkpoint pathway.

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