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SpyBiotech Announces First Patient Dosed in Phase I Trial of SPYVLP01

SpyBiotech, a biotechnology company with a novel vaccine platform technology that can target infectious diseases, cancer, and chronic diseases, today announced that the first subject has been dosed with SPYVLP01, a candidate vaccine targeting human cytomegalovirus (HCMV) using its Hepatitis B virus-like-particle platform technology. There is currently no approved vaccine against HCMV.

The Phase I trial will be assessing safety and immunogenicity of the company's HCMV vaccine in two different doses in healthy adults aged 18-50. The study features a six-month dosing schedule and will be carried out in the UK. Target enrollment is approximately 120 participants and clinical data is expected in the first half of 2024.

"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," said Mark Leuchtenberger, Chief Executive Officer of SpyBiotech. "We see a great need for a vaccine against HCMV, as this virus causes thousands of permanent disabilities in newborns each year. We look forward to seeing clinical data in the first half of 2024."

SpyBiotech's novel SpyVLP vaccine platform is based on a proprietary protein "superglue" technology which binds antigens to vaccine delivery platforms in a way which minimizes delivery risk and enhances immunogenicity and efficacy. While the lead program is focused on HCMV, SpyBiotech's vaccine technology can be applied to generate vaccines against a wide range of pathogens and therapeutic indications and is currently utilized by the company for several product candidates in development.

About HCMV

Human cytomegalovirus (HCMV) is a betaherpesvirus that causes lifelong infection in humans. HCMV has a prevalence of 55-100% within the human population, depending on different socioeconomic and geographical factors1. Primary HCMV infection is generally asymptomatic in healthy hosts, but it can cause severe and sometimes fatal disease in immunocompromised individuals and neonates. HCMV is the leading infectious cause of congenital abnormalities in the Western world. HCMV intrauterine infection may cause significant morbidity, including low birth weight, hearing loss, visual impairment and microcephaly.

About SpyBiotech

SpyBiotech is a clinical stage biotechnology company with novel vaccine platform technologies to target infectious diseases, cancer and chronic diseases. The company was spun out of the University of Oxford in 2017 by Oxford Science Enterprises (OSE) and Google Ventures (GV). Based on science developed at the University of Oxford, SpyBiotech's novel vaccine platform is based on a proprietary protein "superglue" technology which binds antigens to vaccine delivery platforms in a way which minimizes delivery risk and enhances immunogenicity and efficacy. This makes it ideal for use against infectious diseases in challenging environments, such as in the developing world, but also with potential application in non-infectious disease settings such as cancer. SpyBiotech has the exclusive rights from the University of Oxford to apply, commercialize and sub-license the SpyTag/SpyCatcher and related "superglue" technologies in vaccine development. www.spybiotech.com

Gabrielle Stack, Maria Stacey, Cardiff University, UK, British Society for Immunology

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