Working with Waisman Biomanufacturing, WHV is pleased to announce today the completion of testing and release of two clinical lots of a novel 4-valent gp120 protein vaccine.
Previously, the laboratory of Dr. Shan Lu at the University of Massachusetts Medical School (UMMS) developed the HIV vaccine candidate PDPHV including polyvalent DNA and protein components. In recently completed phase I clinical trial HVTN124 supported by US NIH/NIAID, four gp120 proteins from the four major clades of HIV-1 (A, B, C, and AE) were individually vialed. The proteins had to be mixed with each other and with the GLA-SE adjuvant at bedside prior to administration.
Over the past year, WHV has launched a major program to establish the production of a final drug product with four gp120 proteins mixed in the same vial. The four previously produced gp120 proteins were tested for stability and then mixed in equal amounts to produce and vial the 4-valent protein mixture.
Extensive pilot tests were conducted to ensure the proteins can be characterized using existing and new analytical assays. Now WHV and Waisman used these analytical approaches to characterize two lots of the vialed 4-protein mixture vaccine and released it for clinical use.
This novel 4-valent formulation will greatly simplify storage, transportation, and administration of the protein vaccine. Having both DNA and protein vaccine components positions WHV for rapid advancement toward the next stages of clinical testing of the PDPHV vaccine candidate.
