The UK-based Barinthus Biotherapeutics (formerly Vaccitech) has released topline data from its Phase Ib/II APOLLO trial for its human papillomavirus (HPV) treatment, VTP-200.
The randomised placebo-controlled APOLLO trial (NCT04607850) met its primary safety endpoint, showing that VTP-200 was generally well-tolerated. There were no grade III or higher treatment-related adverse effects (AEs).
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At 12 months, the highest high-risk HPV (hrHPV) clearance rate of 60% and highest cervical clearance rate of 67% was seen in the group that received the highest dose of chimpanzee adenovirus vector (ChAdOx) vector – a component of VTP-200 – compared to 33% and 39% clearance rate in the placebo group, respectively.
However, there was no statistically significant improvement observed between the placebo and active group for either hrHPV clearance or cervical lesion clearance rates when data from all active dose groups was pooled. The company was quick to add that “these differences compared to placebo were not statistically significant given that the trial was not powered for individual dose group comparisons.”
The APOLLO study recruited 108 women aged 25-55 years with persistent hrHPV infection and low-grade cervical lesions. The participants were divided into a placebo group and five active groups that received different doses of the two vaccine vector components, namely the ChAdOx vector and the modified vaccinia virus Ankara (MVA) vector.
Barinthus’ VTP-200 consists of an initial ChAdOx vector and a second dose using an MVA vector, both encoding the same HPV antigens which are designed to prompt an antigen-specific T-cell immune response.
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By GlobalDataAnother therapy in development for treating precancerous cervical lesions is Asieris Pharmaceuticals’ drug-device combination, Cevira (APL-1702). Last month, the company reported topline data from the Phase III trial of Cevira in participants with cervical high-grade squamous intraepithelial lesions (HSIL).
The study achieved its primary endpoint by showing an improved response rate of 89.4% at six months. The therapy also showed an improved clearance rate of high-risk HPV16 and/or HPV18, with a 103.9% increase in the Cevira group compared to placebo.
There is a US Food and Drug Administration (FDA) approved vaccine for preventing certain cancers, such as cervical, anal, oropharyngeal, and head and neck cancers, caused by nine different HPV types, Merch & Co’s Gardasil 9 (recombinant Human Papillomavirus 9-valent). However, the worldwide vaccine coverage remains low.
