Shrinking time to market with a Fast Track and Special Protocol Assessment for the Phase IIIB trial.

After the Phase IIIA trial, Vaccinogen began the process of developing the Phase IIIB protocol using the new manufacturing procedures recommended by the FDA and the results indicated from the bioequivalency study.  We sent a letter to the FDA to clarify questions we needed the FDA to answer to complete design of the protocol.   The primary endpoint requested was 3-year Disease-Free Survival (DFS), based on enrollment of 560 patients randomized 1:1, including an interim analysis 1 year after the enrollment of the last patient.  We also requested and were granted Fast Track designation and Special Protocol Assessment. 

The FDA approved the Phase IIIB Protocol in September of 2015.  As stated in the FDA’s Special Protocol Assessment, the primary endpoint is Disease-Free Survival (DFS) with the final primary analysis expected three years after the last patient is enrolled.  An interim analysis will be performed one year after the enrollment of the last patient.  The statistician approved by the FDA for this study, analyzed the Phase IIIB study, together with the actual results of the 8701 study, 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.  This consortium consists of a globally recognized CDMO that will be manufacturing OncoVAX®, and a world-class CRO that will be managing and performing the Phase IIIB trial.  The worldwide footprint and facilities eliminates of our partners will speed up the process for the Trial's execution, and limit the need for any capital investment in developing a standalone vaccine processing facility.  Both partners bring world-class trial management and personnel significantly reducing the overall cost to run and complete the Phase IIIB Trial.