After the positive results of our Phase IIIA trial, Vaccinogen began the process of developing the Phase IIIB protocol using new manufacturing procedures recommended by the FDA and the resulting from a bioequivalency study. The primary endpoint for the protocol granted by the FDA is 3-year Disease-Free Survival (DFS), and will be based on enrollment of 560 patients randomized 1:1, including an interim analysis 1 year after the enrollment of the last patient. We were granted a Fast Track designation and Special Protocol Assessment for this trial. The FDA approved this Phase IIIB Protocol in September of 2015. The statistician approved by the FDA for this study, analyzed the Phase IIIB protocol, together with the actual results of the 8701 study (Phase IIIA), and concluded that similar results would make for a 95% likelihood of success.
Since 2020, Vaccinogen has been building a consortium to conduct the Phase IIIB trial and then manufacture the vaccine in volume once FDA approval is achieved. The consortium includes a globally recognized CDMO to produce OncoVAX® and a world-class CRO to manage the trial. The global reach and facilities of these partners streamline the trial’s execution, eliminating the need for significant capital investment in standalone processing facilities. Their expertise in trial management and operations ensures efficiency and cost-effectiveness in completing the Phase IIIB trial.