Liège, Belgium, December 2, 2024 – EXO Biologics and its CDMO subsidiary, ExoXpert, leading innovators in exosome-based therapeutics and drug delivery solutions, today announce ExoXpert is the first European CDMO specializing in exosomes to receive Good Manufacturing Practice (GMP) certification for its state of the art manufacturing plant. In addition, EXO Biologics has managed to achieve the loading of GMP-grade exosomes with mRNA and DNA payloads, a major milestone for the development of exosome-based therapies. These achievements are two significant milestones that will further solidify EXO Biologics position at the forefront of the maturing exosome field.

GMP Certification of Clean Rooms in Liège, Belgium

ExoXpert is the first European exosome specialist CDMO to receive Good Manufacturing Practice (GMP) certification. The certification is for its exosome manufacturing plant in Liège, Belgium and has been awarded by the Belgian federal agency for medicines and health products. The growth of Exo Biologics and ExoXpert has been strongly supported by BioWin (the health cluster of Wallonia) and SPW (Wallonia Public Service). This certification results in official clarification of ExoXpert’s ability to produce exosomes with the highest industry standards. The GMP-certified facilities will enable EXO Biologics to internalize the production of EXOB-001, its lead asset currently in clinical phase I and the first global EMA-approved MSC-based exosome therapeutic clinical trial. ExoXpert will also be able to be the first CDMO internationally to offer exosome specialized GMP capabilities to its current client portfolio in both US and EU markets as well as future partners. ExoXpert can activate additional clean room on demand.

The GMP certification to be awarded to a specialist exosome CDMO is a significant international achievement. It allows EXO Biologics & ExoXpert to support across the industry clinical trials and regulatory submissions for the growing number of exosome-based products and services internationally. Currently, the greatest demand is for the use of exosome as safe and non-viral drug delivery system for cell & gene therapy applications.

Successful Loading of mRNA and DNA Payloads into GMP-Grade Exosomes

In addition to the production site certification, Exo Biologics and ExoXpert have successfully completed loading a number of chemical molecules and nucleic acids into exosomes from various cell sources. This breakthrough represents a critical step toward developing safe, efficient, and scalable exosome-based therapies for genetic material delivery.

Small molecules and short nucleic acids (siRNA and miRNA) have already been validated in an end-to-end GMP-like setting. Now Exo Biologics has made significant progress in loading larger molecules, such as mRNA and DNA, into GMP-grade exosomes for third-party non-viral drug delivery applications. Preliminary data from EXO Biologics’ trials show a retention rate up to 80% of the loaded DNA cargo upon exosome loading.

EXO Biologics and ExoXpert are now working together on optimization and GMP translation of this new unit operation to provide a seamless platform toward clinical application. The loading step is to be incorporated in ExoXpert’s cutting edge ExoPulse™ exosome manufacturing GMP platform. ExoPulse is currently being used by several partners to develop exosome-based product with a derisked path to clinical.

Exosomes, as naturally occurring extracellular vesicles, are increasingly recognized for their ability to transport biologically active cargo, such as mRNA and DNA, with reduced immunogenicity and enhanced cellular uptake. EXO Biologics’ novel approach to loading genetic payloads into exosomes is opening new avenues for the development of non-viral gene therapies such as cancer immunotherapies, vaccines, and gene editing, offering a safer alternative to traditional viral-based delivery systems.

Advancing the Future of Exosome-Based Therapies

“We have now achieved two critical strategic milestones by the end of 2024, which extends our continued progress in developing scalable, GMP-compliant solutions for exosome as therapeutic and drug delivery system. This extends our market leading position in the development of exosome-based technologies, unlocking new possibilities for drug delivery, gene therapy, and immunotherapy,” said Hugues Wallemacq, CEO of EXO Biologics. “The GMP certification of ExoXpert’s Liège manufacturing facility and the successful loading by EXO Biologics of mRNA and DNA into exosomes are major steps in bringing safe and effective exosome-based therapies to patients worldwide. We are now working on optimizing the loading technology to further reduce the manufacturing cost and strengthen the attractiveness of exosome therapeutics and manufacturing compared to alternative classical technologies. This will revolutionize the treatment of complex diseases, including cancer, genetic disorders, and viral infections.”