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MRx0518

Development stage: Phase 2
Lead developer: 4D pharma
Modality: Genetically Modified Bacteria → Engineered Microbial Therapeutics → Microbiome Therapeutics, Frozen 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, Fresh FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Synthetic Biology Platforms → Engineered Microbial Therapeutics → Microbiome Therapeutics, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Microbial Metabolites → Microbiome-Derived Products → Microbiome Therapeutics, Microbial Proteins → Microbiome-Derived Products → Microbiome Therapeutics
Administration: Oral

Overview

MRx0518 is an oral live biotherapeutic product derived from the gut microbiome and developed by 4D pharma for cancer immunotherapy. Public descriptions identify it as a microbiome-based, immunostimulatory bacterial therapy, with published work linking its activity to **Enterococcus gallinarum MRx0518** and especially its flagellin-mediated innate immune activation. Clinically, MRx0518 has been studied as monotherapy in a neoadjuvant pre-surgical setting in treatment-naive patients with solid tumors and in combination with immune checkpoint inhibitors such as pembrolizumab and avelumab to enhance anti-tumor immune responses and potentially overcome resistance to prior PD-1 blockade. Development has focused on solid tumors including urothelial carcinoma, pancreatic cancer, melanoma, renal cell carcinoma, bladder cancer, non-small cell lung cancer, and other surgically resectable malignancies.

Targets

TLR5

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