Merck Unveils Clinical Trial Strategy for New HPV Vaccine and GARDASIL®9 Single-Dose Regimen

Merck (NYSE: MRK), also known as MSD outside the United States and Canada, made a significant announcement today at the EUROGIN 2024 HPV Congress. The company revealed its intentions to commence clinical development of a groundbreaking investigational multi-valent HPV vaccine aimed at offering broader protection against various HPV types. Additionally, Merck outlined plans to conduct clinical trials in both females and males to assess the efficacy and safety of a single-dose regimen of GARDASIL®9 compared to the approved three-dose regimen.

Dr. Eliav Barr, Senior Vice President, Head of Global Clinical Development, and Chief Medical Officer at Merck Research Laboratories, emphasized the growing body of evidence highlighting the vital role of GARDASIL and GARDASIL 9 in public health. These strategic investments underscore Merck’s commitment to global health by potentially reducing the burden of HPV-related cancers and diseases.

In the United States, GARDASIL 9 is currently indicated for use in females aged 9 through 45 and males aged 9 through 45. It is aimed at preventing various cancers and precancerous lesions caused by specific HPV types. Notably, the oropharyngeal and head and neck cancer indication for GARDASIL 9 is approved under accelerated approval, with ongoing confirmatory trials.

Merck’s ongoing research endeavors in the HPV vaccine domain are focused on expanding protection against a wider range of HPV types. The company’s latest pipeline addition utilizes proprietary virus-like particle (VLP) technology to incorporate additional VLPs, particularly targeting HPV types with significant impact in African and Asian populations. Phase 1 trials for this new vaccine candidate are scheduled to commence in the fourth quarter of 2024.

Responding to scientific inquiries regarding alternative dosing regimens for GARDASIL 9, Merck plans to conduct prospective clinical trials in both females and males aged 16 to 26 years old. These trials will compare the short and long-term efficacy and immunogenicity of a single dose of GARDASIL 9 with the current three-dose regimen. The aim is to generate robust data to ascertain whether a single dose provides comparable long-term protection while meeting regulatory standards. Enrollment for these trials is expected to begin in the fourth quarter of 2024.

To meet the escalating global demand for HPV vaccines and ensure equitable access, Merck has significantly expanded its manufacturing capacity. This commitment has led to a substantial increase in supply between 2017 and 2024, with further expansions planned to meet anticipated demand for 2025 and beyond.

In conclusion, Merck’s initiatives underscore its dedication to advancing preventive measures against HPV-related diseases and cancers. As clinical trials progress and manufacturing capacities expand, these efforts hold promise for broader protection and improved public health outcomes.

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