Idiopathic Pulmonary Fibrosis (IPF) is an incurable, fatal lung disease. It affects ~5 million people worldwide and existing medications are very costly. Researchers at Monash University and the Hudson Institute have developed an exosome therapy to treat IPF and formed the spinout company Regenasome.
Exosomes are nano-vesicles that are released by all cell types. They contain proteins, RNA and cytokines that reflect the cellular contents of their donor cell and have the potential to be curative. Regenasome has derived exosomes from a proprietary bank of stem cells that exhibit potent immune-modulatory, anti-fibrotic and pro-regenerative effects. These exosomes enhance epithelial repair in the lung and are effective in preclinical models of inflammation-induced pulmonary fibrosis.
The Regenasome exosomes have unique production advantages and handled like any standard drug product. An inhaled delivery system is being developed for treatment.
The company is seeking US$10m Series A funding to achieve production and manufacturing milestones and a Phase 1b/2a clinical trial.
Amniotic exosomes reverse established lung inflammation and fibrosis in a mouse model of bleomycin-induced lung fibrosis, demonstrated by a reduction in activated myofibroblasts (αSMA positive) and reduction in collagen deposition in the lungs (Sirius Red).
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