EXO Biologics has launched ExoXpert, a contract development and manufacturing organisation (CDMO) specialising in exosomes which offers a mesenchymal stem cells (MSC)-based exosome manufacturing platform used in European clinical trials.
During the development of its lead exosome candidate, EXOB-001, Exo Biologics developed ExoPulse, an industrial exosome manufacturing platform designed for GMP production of exosomes. In July 2023 the European Medicines Agency (EMA) authorised the EVENEW study, a Phase I/II European clinical trial using EXOB-001. This is EXO Biologics’ lead MSC-based exosome candidate for prevention of Bronchopulmonary Dysplasia (BPD) in preterm newborns.
“The potential of exosomes continues to be demonstrated across the cell and gene therapy sector. As a result, exosome-based clinical trials have the potential to significantly increase in number, if industrial supply of exosomes can be met. Currently there is a lack of exosome production, manufacturing specialists and facilities to supply exosomes for both R&D and clinical trials,” said Romain de Rauville, Chief Business Officer, EXO Biologics. “ExoXpert has been launched using our expertise in the development of exosome-based therapeutics to offer GMP-compliant specialist exosome manufacturing capabilities to the market. This will make a significant contribution to the industry’s efforts to develop exosome-based products.”
“Challenges around producing and characterising exosomes remain a significant barrier to the development of exosome-based therapeutics and their delivery to patients. In addition, navigating the regulatory pathways to their production is a major hinderance across the market,” said Hugues Wallemacq, CEO, EXO Biologics. “EXO Biologics has now developed a regulatory-compliant GMP manufacturing platform and facility that provides a solution to biotech companies developing exosome-based therapeutics. ExoXpert is already supporting the development of products for two biotech companies and is at the center of ExoFasttrack, a major Biowin project, to create an industrial exosome ecosystem. EXO Biologics has launched ExoXpert to be a major division of the company with the aim of contributing to the global development of exosomes.”