PrimeVax has partnered with several leading companies to manufacture our therapy to strict GMP standards. We are also in the process of securing a license for use of our strain of the dengue virus from the CDC.
At this stage of our clinical development phase, we believe that an outsourced model for manufacturing will maximize the speed with which we can push our clinical development forward.
The Gates Center for Regenerative Medicine (Gates) at the University of Colorado is PrimeVax’s dendritic cell manufacturer of choice. We have chosen to partner with Gates because of their technical quality and standards in producing GMP autologous dendritic cells at scalable costs. Gates has worked with PrimeVax to establish a one time, 2 week turnaround protocol for PrimeVax's proprietary SmartDC technology.
ViGene Biosciences will manufacture PrimeVax’s dengue-2 #1710 virus to GMP specifications for PrimeVax’s human clinical trial needs. ViGene has
a track record of producing genetically-modified and unmodified
therapeutic virus strains for human clinical trials.
The U.S. Army Medical Materiel Development Activity (USAMMDA) has awarded PrimeVax with the exclusive use rights of the wild type strain of dengue virus used in the PV-001 therapy. Our dengue strain is unique in that its history shows zero confirmed dengue deaths and has an existing safety package on file with FDA. This strain was isolated by Dr. Leon Rosen of the Pacific Biomedical Research Center on the Island of Nauru in 1974.