ExoXpert exosome CDMO and ExoPulse GMP manufacturing platform
undisclosedplatform · high · Wed Jan 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
Provide GMP exosome manufacturing and development services for research and clinical exosome-based products, including large-molecule loading into exosomes.
Contract development and manufacturing organization using EXO Biologics' ExoPulse exosome manufacturing GMP platform and an exosome loading unit operation.
ExoXpert was launched worldwide on January 31, 2024; supplied records also state GMP certification for an EU exosome manufacturing facility and incorporation of large-molecule loading into ExoPulse.
The platform is described as being used by several partners to develop exosome-based products with a derisked path to clinical application.
EXOB-001 for prevention of bronchopulmonary dysplasia
phase 1drug program · high · Thu Dec 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Prevent bronchopulmonary dysplasia in extremely premature neonates using extracellular vesicles derived from umbilical cord mesenchymal stromal cells.
Phase 1/2 clinical trial of endotracheally administered EXOB-001 versus placebo; phase 1 evaluates one or three administrations across three dose levels, with phase 2 planned to randomize 203 subjects to selected doses or saline placebo.
First cohort dosing in EVENEW was completed; the trial is designed to follow infants up to 2 years corrected age.
Preclinical rat BPD work reported that intratracheal clinical/GMP-grade MSC-EVs protected against oxidative stress, improved pulmonary epithelial function, and reduced fibrosis markers. No clinical efficacy results are supplied.
Drug loading and delivery extracellular vesicle platform
exploratoryplatform · medium
Use extracellular vesicles and exosomes as a drug loading and delivery technology.
Extracellular vesicle/exosome engineering or loading approach; implementation details are not disclosed in the supplied material.
Identified in the company strategy as a focus area for drug loading and delivery.
Extracellular vesicles for inflammatory bowel disease model research
exploratoryresearch program · medium
Evaluate the anti-inflammatory potential of extracellular vesicles in a 3D intestinal mucosa-like model relevant to inflammatory bowel disease.
Three-dimensional multilayer structure model built with Caco-2 cells and BJ fibroblasts, stimulated with pro-inflammatory cytokines, then treated with EVs and assessed by RT-qPCR.
A 2025 Scientific Reports publication described the model and EV anti-inflammatory findings.
EV treatment increased IL-10 anti-inflammatory gene expression and LGR5+ stemness gene expression, suggesting possible regulation of inflammation and epithelial repair biology in the model.
GMP extracellular vesicle manufacturing platform
undisclosedplatform · medium
Provide GMP-grade extracellular vesicle manufacturing capabilities for research and clinical use.
GMP manufacturing platform for extracellular vesicles/exosomes, including clinical-grade MSC-EV production referenced in supplied publications.
GMP-grade EVs used in preclinical BPD and regeneration studies; company site describes a GMP manufacturing platform for research and clinical use.
GMP-grade EV preparations were used in studies reporting protection against oxidative stress/fibrosis in BPD models and TNF-alpha modulation in muscle-neural regeneration models.
Inflammatory bowel disease 3D multilayer EV testing model
preclinicalresearch program · medium
Develop a 3D intestinal mucosa-like model to study inflammatory bowel disease biology and test the anti-inflammatory potential of extracellular vesicles.
Three-dimensional multilayer structure built with Caco-2 cells and BJ fibroblasts, stimulated with pro-inflammatory cytokines, then treated with extracellular vesicles for gene-expression analysis.
2025 Scientific Reports publication describing the model and EV testing results.
EV treatment increased IL-10 anti-inflammatory gene expression and LGR5+ stemness gene expression, suggesting a regulatory role in inflammation and epithelial/stromal response.
MSC-EV muscle and neuronal regeneration research program
preclinicalresearch program · high
Investigate whether mesenchymal stromal cell-derived extracellular vesicles promote muscle and neuronal regeneration and define the mechanism of action.
GMP-grade EVs tested in human decellularized muscle tissue models with human muscle precursor cells and macrophages, rat fetal organotypic spinal cord models, and LPS-stimulated primary microglia neuroinflammation assays.
A 2026 Journal of Extracellular Vesicles publication reported mechanistic findings for TNFα modulation in muscle-neural regeneration models.
EVs reduced cell death after damage, stimulated proliferation, downregulated TNFα, regulated neuroinflammation, and promoted neural axon sprouting in supplied preclinical models.
Rare inflammatory diseases extracellular vesicle therapeutics program
undiscloseddrug program · medium
Develop extracellular vesicle and exosome-based biopharmaceuticals for rare inflammatory diseases with unmet medical need.
MSC-derived extracellular vesicle/exosome therapeutic approach; specific indications beyond bronchopulmonary dysplasia are not disclosed in the supplied material.
Listed by the company as a pipeline focus area.
