Monash spinout leads first worldwide in-human-trial of Extracellular Vesicle therapy for Crohn’s disease
Crohn's disease, a chronic inflammatory bowel condition, affects millions worldwide, causing debilitating symptoms and significantly impacting quality of life. While current treatments offer some relief, many patients still struggle to find lasting solutions. But now, a groundbreaking therapy is on the horizon, offering hope for those battling this challenging condition.
Exosome BioSciences, a dynamic spinout company from Monash University and Hudson Institute of Medical Research, is leading the charge with an innovative approach to treating Crohn's disease. They're pioneering the world's first, in-human trial of an extracellular vesicle (EV) therapy, a revolutionary treatment that harnesses the body's natural healing mechanisms.
During the clinical trial, hAEC-EVs will be administered via local injection to 15 participants with complex refractory Crohn’s perianal fistulas. So far, five patients have been recruited into the study and one patient has received hAEC-EV injection without any adverse events.
It is made possible by a $1.5 million grant awarded to Exosome BioSciences in 2023 by CUREator, an Australian biotech incubator delivered by Brandon BioCatalyst with funding from the Australian Federal Government's Medical Research Future Fund.
The novel treatment uses extracellular vesicles (EVs) derived from human amniotic epithelial cells (hAECs), to deliver the same benefits as stem cell treatments at a greatly reduced cost.
EVs are small, membrane-bound particles released by almost all cell types. They play a crucial role in intercellular communication by transporting proteins, lipids, and nucleic acids between cells.
IBD is the collective term for Crohn’s disease and Ulcerative Colitis – both inflammatory conditions of the digestive tract, often affecting the bowel. Complex fistulising perianal Crohn’s disease is a debilitating and incurable form of IBD in which abnormal connections form between the lumen of the bowel and other sections of bowel, vagina, uterus and skin, causing faecal incontinence, recurrent severe infections, chronic inflammation and tissue damage.
According to Global Data, Crohn’s Disease has a current total market size of $9.2 billion expected to grow to $13.4 billion by 2026. One third of Crohn’s patients will develop fistulas.
Exosome Bioscience’s new treatment offers several significant advantages:
- Cost-effective manufacturing at scale
- First-in-class regenerative medicine platform
- Higher exosome yield compared to MSCs
- Simplified logistics, storage, and handling
- Off-the-shelf, easy-to-use product for clinicians
Monash Innovation played a pivotal role in transforming this groundbreaking research into a commercial venture. They facilitated the creation of Exosome BioSciences P/L by leveraging collaborative intellectual property from Hudson Institute of Medical Research, Monash University, and Monash Health. This spinout now holds exclusive rights to key intellectual assets, positioning it for further development and potential market impact.
This trial is led by Dr Charlotte Keung, an IBD specialist gastroenterologist at Monash Health, early career researcher at Monash University, and member of the Amnion Cell Biology Research group at Hudson Institute, together with Associate Professor Rebecca Lim who pioneered the treatment and holds a joint appointment at Hudson Institute of Medical Research and the Department of Obstetrics and Gynaecology at Monash University.
Further research and clinical trials will be needed to fully evaluate the safety and efficacy of this innovative EV therapy. The therapy will also need to undergo rigorous regulatory review and approval processes before it can become widely available to patients.
If successful, this clinical trial marks a significant step in turning groundbreaking research into real-world treatments, highlighting the transformative power of innovation in biomedicine.