Four years ago, WHV was established as its founder Mr. Weibo Li signed a licensing agreement with the University of Massachusetts Chan Medical School (UMMS) to advance the development of PDPHV, a heterologous DNA/Protein HIV vaccine candidate that was created in the laboratory of Dr. Shan Lu. Soon after WHV was founded in early 2018, the phase 1a trial HVTN124 was launched in collaboration with the HIV Vaccine Trial Network (HVTN), testing the safety and immunogenicity of PDPHV. This six-site, randomized, placebo-controlled trial was completed early 2021 and showed excellent safety results and robust immunogenicity data which will soon be published. The 5-plasmid DNA – quadrivalent gp120 protein vaccine has since been advanced to the currently recruiting phase 1b trial WHV138, a single site trial testing various optimized vaccination schedules and anticipated to be completed in 2023.
Over the last four years, WHV established a dynamic and highly functional management system successfully running phase 2 grade vaccine products through CMOs, establishing a full quality control program, and submitting US FDA INDs leading to rapid progress of their clinical research program.
This second generation PDPHV is currently the only HIV vaccine candidate tested in humans that not only covers the four major circulating subtypes of HIV strains, but also includes matched immunogens for the DNA and Protein vaccine components. All four Env antigens in PDPHV are from authentic viral sequences – a method that had never been done before in the history of HIV vaccine development. WHV is proud of their product development program holding significant promise for the HIV vaccine field, accelerating the development of a safe and effective preventative HIV vaccine with the possibility of global application.
This quickly advancing product development program is a testament of a major achievement for such a young biotech company.