Targeted alpha therapy in the treatment of ovarian cancer

Purpose and goal

The idea of this project has been to develop a targeted alpha particle radioimmunotherapy based on 211-astatin conjugated with a monoclonal antibody as a new drug for the treatment of ovarian cancer. We planned to conduct a ´First-in-Man´ clinical study to address: Pharmacokinetics, biodistribution as well as safety and toxicity. During the project, we were forced to change the carrier of the radionuclide (the antibody), which delayed the project. The goal of commercializing the results was therefore not reached. The project parties will continue the collaboration.

Expected results and effects

The project did not complete the intended phase-1 study therefore commercial plans was not achieved. All documentation was prepared for the application of a Manufacturing permit for investigational medicinal products using the alpha-radiating nuclide 211-astat, and approved by Swedish MPA. Necessary documentation to obtain trial authorization for the phase-1 study has been produced, including additional preclinical investigations. A joint venture company, Aprit AB, is formed by the researchers and Smerud, a pitching presentation is prepared and a business plan is drafted.

Planned approach and implementation

The project has worked according to 6 work packages, the relevant parts of which have been processed as planned. The project has shown good cooperation between the project parties. Miscalculation that the intended vector (ie the antibody that will carry the nuclide to the tumor cells) became unavailable for the project was beyond our control. The project is therefore delayed, but is proceeding as intended, now with a commercially available antibody. Obtaining a manufacturing permit for the study drug turned out to be more extensive than imagined at the start of the project.