The Next Five Years In EV Therapeutics

In this segment of Cell & Gene Live, Redefining CGTs with Exosomes and EVs, Aegle Therapeutics’ Dr. Gloria Matthews underscores that success for extracellular vesicle (EV)-based therapeutics over the next three to five years will hinge on advancements in manufacturing and securing initial regulatory approvals, particularly in the U.S. and Europe. Once a few EV products are approved, the regulatory path will likely become clearer for others. Compared to viral gene therapies and lipid nanoparticles (LNPs), EVs enjoy a smoother regulatory journey with fewer safety concerns, given their natural cell-based origins. Dr. Matthews notes that while viral and LNP-based platforms have their strengths, they often require rigorous post-market monitoring and safety protocols, which EVs currently avoid. This comparatively low regulatory friction could accelerate adoption and innovation in the EV space.