Drug intelligence / Profile preview

LGNA-100

Development stage
Phase 1
Lead developer
Laguna Biotherapeutics
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
Administration
Intravenous
01

Overview

LGNA-100 (also known as QUAIL-100) is a first-in-class, attenuated live bacterial immunotherapy being developed by Laguna Biotherapeutics. Derived from *Listeria monocytogenes*, the drug is designed to harness the immune system's evolved response to the bacterium to robustly and durably expand and activate endogenous gamma delta (γδ) T cells. These activated γδ T cells can directly kill cancer cells and potentially enhance the efficacy of other immunotherapies. LGNA-100 is primarily being developed for the treatment of high-risk pediatric leukemias and myelodysplastic syndromes (MDS), particularly in patients following hematopoietic stem cell transplantation (HSCT). The FDA cleared the Investigational New Drug (IND) application for LGNA-100 in April 2026 for a Phase 1 study.

02

Targets

γδ TCR (T-cell receptor)

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