“First-in-human studies are scheduled to start in the fourth quarter of this year.”

In context

“statistics from the International Agency for Research on Cancer indicate there is more to do to help increase vaccination rates. The latest statistics from 2022 ranked cervical cancer as the fourth most common cancer globally in terms of incidents and mortality in women and the leading cause of cancer death in 37 countries, predominantly in sub-Saharan Africa, South America and Southeast Asia regions. At the Urogen Congress, last month, we disclosed plans to build on the development of GARDASIL with a new clinical program to identify a novel multivalent HPV vaccine candidate with the potential to extend protection against a broader array of HPV types. This includes several types known to disproportionately impact African and Asian populations and individuals of African and Asian descent. First-in-human studies are scheduled to start in the fourth quarter of this year. In addition, we announced plans to conduct 2 randomized, double-blind multiyear clinical trials in females and males ages 16 to 26 years to examine the short- and long-term efficacy and immunogenicity of a single dose of GARDASIL-9 versus the currently approved 3-dose regimen. The goal of these studies is to generate data that clearly demonstrates whether or not a single dose of GARDASIL-9 provides comparable long-term protection to the approved regimen, while also satisfying the high standards required by regulatory authorities. The clinical trials are anticipated to start enrolling in the fourth quarter. In oncology, we continue to focus on our 3-pillared strategy comprised of immuno-oncology, precision molecular targeting and tissue targeting agents. In immuno-oncology, September 202”