Technical design, production, pricing and licensing strategies for T cell cancer therapy

Purpose and goal

Tcer AB has developed a new methodology for efficient identification and expansion of tumor selective T-cells for personal immunotherapy (NAGb). The purpose of the project has been to develop regulatory adapted processes for manufacturing, to expand the concept to several indications and to develop credible pricing strategies for NAGb. All three set goals have been achieved and the company is now better positioned for future clinical studies and related activities than was the case before the project was implemented.

Expected results and effects

The result of the project means that the company has now established an approved synthesis process for the production of NAGb as well as established production processes that facilitate future clinical studies and treatment of a number of different types of cancer. Furthermore, an economic base model adapted for ATMP has been developed which will be a very useful tool for future discussions with relevant authorities as well as potential partners.

Planned approach and implementation

The project has been structured into three different sub-projects, linked to each of the three main objectives described above. The implementation has since been carried out with the help of internal resources as well as external consultants where needs have existed. Regular reconciliations have been made during the course of the project and minor adjustments have been made in cases where it is deemed necessary, but in general the original project plan has been followed.