The ExoCyte dendritic cancer cell vaccine (ET-08) will be commercialized through a network of franchised cell therapy centers established in partnership with leading medical institutions worldwide. Our initial commercialization plan is to engage the European marketplace with a dendritic cell vaccine through a “named patient program” that enables the early use of experimental therapeutics. Clinical trials for the exosome-electroporated dendritic cell vaccine (ET-08) will be conducted in both Europe and Asia. The Asian marketplace enables product launching in countries such as Japan where the regulatory framework for cell based immunotherapies allows for an expedited path to market.
ExoCyte will provide franchisees with standardized protocols (for cell and exosome harvest, processing and vaccination), equipment specifications, and comprehensive training, as new centers are established. Thereafter, Exocyte will provide regular oversight and quality assurance to ensure compliance to GMP (Good Manufacturing Process) and ExoCyte SOPs (Standard Operating Procedures). Franchisees will pay royalties to ExoCyte on a per patient basis. Each cell therapy center may support a number of peripheral oncology clinics for the recruitment of patients and administration of vaccine prepared at the regional cell therapy center.
This model of commercialization will allow the ExoCyte vaccine to be made available at a wide number of locations, reducing the burden of travel on patients. It also allows early establishment of treatment centers in countries with accommodating regulatory pathways while experience, data and early revenues are generated to support regulatory activities and corporate growth in more highly regulated markets such as the US.