SpyBiotech Announces the Completion of Enrollment in Phase I Trial of SPYVLP01 Targeting Human Cytomegalovirus (HCMV)

Oxford, UK and Cambridge, MA - (July 23, 2024) --- SpyBiotech, a biotechnology company with a novel vaccine platform technology that can target infectious diseases, cancer, and chronic diseases, announced today the completion of enrollment in its Phase I trial of SPYVLP01, a vaccine candidate targeting human cytomegalovirus (HCMV) using its Hepatitis B virus-like-particle platform technology.

The Phase I clinical trial is assessing safety and immunogenicity of the company’s HCMV vaccine in two different doses in 120 healthy adults aged 18-50. The study features a six-month dosing schedule and is being carried out in the UK. There is currently no approved vaccine against HCMV.

“The initial results of our Phase I study are very encouraging,” said Sumi Biswas, President, Co-founder and Chief Scientific Officer of SpyBiotech. “This is an important step forward as we further evaluate the safety and immunogenicity of our vaccine targeting HCMV, a leading infectious cause of congenital abnormalities.”

“The end of enrollment in our Phase I trial of SPYVLP01 and the initial promising results both serve as a springboard as we move into the next phase of company development,” said Mark Leuchtenberger, Chief Executive Officer. “We will continue to progress our scientific pipeline with a focus on our lead candidate and on our EBV-focused collaboration with the University of Oxford.”

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). The company raised $32.5 million in a Series A equity financing in 2021. 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.

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