Working with Waisman Biomanufacturing, WHV demonstrated that protein bulk drug substances manufactured in 2015 remain stable and will advance to formulating them into a 4-valent drug product for the first time.
Recombinant gp120 proteins from HIV-1 clades A, B, C, and AE were manufactured in 2015 at Waisman Biomanufacturing in Madison, WI with support from NIAID’s Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) program. At the time, some of the proteins were vialed individually as Final Drug Product for use in the Phase clinical trial HVTN 124. The trial completed vaccinations in October of 2019 and demonstrated good safety profile (the immunogenicity data are expected in early 2021).
The remaining bulk drug substances have been stored at -70C degree. Now, WHV and Waisman Biomanufacturing tested the proteins and found them to be stable and potent, supporting the decision to formulate the proteins into a Final Drug Product to be used in the planned Phase 2a clinical trial.
For the first time, the proteins will be formulated as a 4-valent mixture, greatly simplifying storage and administration of the vaccine. WHV and Waisman Biomanufacturing already defined release and stability assays to be used to characterize and monitor the 4-valent mixture. The US Food and Drug Administration (FDA) was consulted regarding the proposed plans and provided positive feedback for WHV’s plans.
