WHV cleared the path toward filing its own IND and hired Target Health to assist with preparing and filing the necessary documents with US FDA.
WHV is preparing to file a new IND for PDPHV, its investigational DNA-prime/protein-boost vaccine. PDPHV is comprised of five DNA plasmids and four gp120 recombinant proteins and is being tested in a Phase I clinical trial (HVTN 124) as a prime-boost regimen or co-administered in repeated doses, in healthy adult volunteers. Results of the HVTN 124 trial are expected in the next several months.
The Division of AIDS (DAIDS) of the National Institutes of Allergy and Infectious Diseases (NIAID) holds the current IND for the vaccine candidate and NIAID-supported HVTN is running the Phase I HVTN 124 trial. DAIDS expressed support for WHV’s plans to file its own IND and will facilitate the process by transferring several key documents to WHV.
Target Health, LLC, a New York-based CRO with many years of regulatory experience, joined the WHV team and will assist in preparing and filing the IND with the US FDA.
