EXO Biologics and ExoXpert Reach Two Critical Milestones that Advance Exosomes
EXO Biologics and its subsidiary, ExoXpert, have received GMP certification of a European exosomes manufacturing facility and have successfully loaded mRNA and DNA payloads into GMP-grade exosomes for drug delivery.
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On Dec. 2, 2024, Belgium-based EXO Biologics and its contract development and manufacturing organization (CDMO) subsidiary, ExoXpert, both innovators in exosome-based therapeutics and drug delivery solutions, announced that ExoXpert has received good manufacturing practice (GMP) certification for its state-of-the-art manufacturing facility in Liège, Belgium. At the same time, EXO Biologics has achieved the loading of GMP-grade exosomes with messenger RNA (mRNA) and DNA payloads. Both achievements mark significant milestones for the development of exosome-based therapeutics (1).
According to a company press release, ExoXpert is the first European CDMO specializing in exosomes that has received GMP certification (1). The certification was awarded by the Belgian Federal Agency for Medicines and Health Products. Both BioWin, the Health Cluster of Wallonia, Belgium, and the Public Service of Wallonia have been strong supporters of EXO Biologics’ and ExoXpert’s growth, according to the press release.
“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, in the press release.
The importance of the GMP certification lays in the official status it gives to ExoXpert’s ability to produce exosomes according to the highest industry standards. The GMP-certified facilities enable EXO Biologics to internalize production of EXOB-001, currently in Phase I clinical development and the first global European Medicines Agency-approved mesenchymal stem cell-based exosome therapeutic in clinical trials. The certification also enables ExoXpert to offer exosome-specialized GMP capabilities internationally, including to current clients in the United States and European Union markets as well as future partners. ExoXpert also has the ability to activate additional cleanroom on demand. The greatest demand for exosomes currently is their use as a safe and non-viral drug delivery system for cell and gene therapy applications, according to the company press release (1).
The second achievement, the successful loading of mRNA and DNA payloads into GMP-grade exosomes, represents a critical step toward developing safe, efficient, and scalable exosome-based therapies for genetic material delivery. While small molecules and short nucleic acids (e.g., small interfering RNA and microRNA) have already been validated in an end-to-end GMP-like setting (2), EXO Biologics’ achievement demonstrates significant progress in the loading of larger molecules (i.e., mRNA and DNA) into GMP-grade exosomes that can then be used for third-party non-viral drug delivery applications. The company’s preliminary trials data have shown a retention rate up to 80% of the loaded DNA cargo upon exosome loading (1).
“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,” Wallemacq said in the release (1).
References
1. EXO Biologics. EXO Biologics & ExoXpert Achieve Two Critical Industry-First Milestones for the Exosome Field. Press Release. Dec. 2, 2024.
2. Bhome, R.; Del Vecchio, F.; Lee, G-H.; et al. Exosomal MicroRNAs (exomiRs): Small Molecules with a Big Role in Cancer. Cancer Letters 2018, 420, 228–235. DOI: 10.1016/j.canlet.2018.02.002
