The assessment of several formulations of the firm’s HCMV vaccine is the primary objective of the Phase I clinical study. Credit: catshila / Shutterstock.

SpyBiotech has submitted a clinical trial application (CTA) to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the assessment of the SPYVLP01 vaccine targeting human cytomegalovirus (HCMV).

SPYVLP01 is designed to combat HCMV by leveraging the Hepatitis B virus-like-particle platform technology.

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The assessment of various formulations of SpyBiotech’s HCMV vaccine is the primary objective of the Phase I clinical study.

The trial intends to enrol around 120 participants.

The first participant is set to receive the first dose later this year and clinical data is anticipated to be revealed in the first half of next year.

SpyBiotech president and chief scientific officer Sumi Biswas said: “Submission of our clinical trial application to evaluate SPYVLP01 marks important progress in the fight against the HCMV virus, a leading infectious cause of congenital abnormalities.

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“We believe in the potential of the SpyVLP vaccine platform technology. While our lead program is focused on HCMV, our vaccine technology can be applied to generate vaccines against a wide range of pathogens and therapeutic indications.”

The company’s new SpyVLP vaccine platform is based on a protein ‘superglue’ technology that binds antigens to vaccine delivery platforms for reducing delivery risk and improving efficacy and immunogenicity.

SpyBiotech CEO Mark Leuchtenberger said: “The MHRA trial application is a strong next step in the development of our cost-effective and highly scalable vaccine technology.

“There is a great need for medical progress against HCMV. There is no currently approved vaccine against this betaherpesvirus that can cause lifelong infection in humans.”