SpyBiotech, a leading biotechnology company known for its groundbreaking vaccine platform technology targeting infectious diseases, cancer, and chronic conditions, has marked a significant achievement by initiating the dosing of the first subject in the Phase I trial of SPYVLP01. This candidate vaccine, designed to combat human cytomegalovirus (HCMV) using the Hepatitis B virus-like-particle platform technology, is a pioneering effort in the absence of an approved HCMV vaccine.

The Phase I trial aims to evaluate the safety and immunogenicity of SpyBiotech's HCMV vaccine in two distinct doses among healthy adults aged 18-50. Conducted in the UK, the study will follow a six-month dosing schedule, with an approximate enrollment target of 120 participants. Anticipated in the first half of 2024, clinical data from this pivotal trial is eagerly awaited.

Mark Leuchtenberger, Chief Executive Officer of SpyBiotech, highlighted the significance of this development, stating, "This is a crucial step forward in our evaluation of the safety and efficacy of SPYVLP01, a vaccine targeting HCMV, a leading infectious cause of congenital abnormalities." He emphasized the pressing need for an HCMV vaccine, given the virus's role in causing numerous permanent disabilities in newborns each year.

SpyBiotech's SpyVLP vaccine platform, known for its proprietary protein "superglue" technology, enables the binding of antigens to vaccine delivery platforms. This approach minimizes delivery risk while enhancing immunogenicity and efficacy. While the current focus is on HCMV, SpyBiotech's versatile vaccine technology can be applied to generate vaccines targeting a broad spectrum of pathogens and therapeutic indications, with several product candidates in development.

Human cytomegalovirus (HCMV), a betaherpesvirus causing lifelong infection in humans, is prevalent in 55-100% of the global population. While primary HCMV infection is typically asymptomatic in healthy individuals, it can lead to severe and potentially fatal disease in immunocompromised individuals and neonates. HCMV stands as the primary infectious cause of congenital abnormalities in the Western world, contributing to significant morbidity such as low birth weight, hearing loss, visual impairment, and microcephaly.

 

Source: businesswire.com

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