The Cell Factory and the University of Padova, Italy have confirmed, preclinically, the long-term therapeutic effect of the CF-MEV-132 extracellular vesicles drug candidate for the treatment of bronchopulmonary dysplasia (BPD). The results demonstrate a full regeneration of animal lungs affected by BPD using the CF-MEV-132 drug and the effect is stable until adulthood. The company is expecting to receive the clinical authorization (CTA) in the 2nd half of the year, so it can start clinical trials by the end of 2019. The scientific results will be presented during the annual meeting of Gruppo Italiano Staminali Mesenchimali in Genova, Italy on April 4-5, 2019.
The Cell Factory, founded in 2007 near Antwerp, Belgium, is a subsidiary of the Esperite group, developing the highest quality therapeutic tools for affordable regenerative medicine. The Cell Factory is focused on development, clinical translation and commercialization of advanced extracellular vesicles (EVs) biologic drugs and autologous stem cell therapies.
The goal of The Cell Factory is to become a leader in the development and production of extracellular vesicles drugs in treatment of different indications; inflammatory diseases, graft versus host disease (GvHD) after solid organ and cell transplantations, arthritis, multiple sclerosis, cystic fibrosis, stroke, traumatic brain and spinal cord injury, newborn encephalopathy, and type 1 diabetes among others.
The Cell Factory has developed a proprietary technology of large-scale production of ultra-pure EVs according to GMP guidelines, using fully defined, serum-free, xeno-free defined media with no use of animal-derived components and human platelet lysates at any stage of the production process. Production is performed in a closed and scalable stirring bioreactor including downstream processing based on the integrated sequential filtration system.
The EVs are continuously secreted by expanded mesenchymal stem cells (MSCs) allowing multiple harvests during one production cycle. This approach significantly reduces the contamination risk, production time, staff, GMP labs use and the cost of goods. Effectively a production of a single EVs dose is now up to 10 times cheaper when comparing to the allogenic MSCs dose equivalent, and these costs will be further reduced in the future.
Closed and semi-automated production system, fully defined culture media and ISO/GLP based quality assurance systems can facilitate technology transfer. EVs are expected to be a viable alternative to many allogenic stem cell therapies and will be able to target niche indications beyond the scope of current cell therapies, i.e., immediate anti-inflammatory interventions in neurology.
The Cell Factory is looking for investors and research collaboration opportunities to continue the development of the EVs drug candidates and the manufacturing technology.