Abstract

The EVENEW Study - From the Production Process Development to the Clinic

Marcin Jurga, Chief Scientific Officer, Exo Biologics

EXO Biologics received approval from the EMA for the EVENEW study, an adaptive, seamless Phase 1/2 trial assessing the safety and efficacy of intratracheal administration of EXOB-001 in preventing Bronchopulmonary Dysplasia (BPD) in preterm newborns. The EVENEW study is the first mesenchymal stromal cell-derived extracellular vesicles (EVs) trial approved by the EMA.

The production platform and the manufacturing process developed by EXO Biologics were crucial in clinical translation of EXOB-001. The platform was designed to achieve a reproducible and efficient production of the EVs. The platform is broadly scalable maintaining the drug product’s identity.

The production process is essential in the Company’s development strategy focused on novel drug candidates for therapeutic applications in Respiratory Diseases, Gastroenterology, Neurology, and drug delivery.