SpyBiotech Announces MHRA Clinical Trial Application Filing for SPYVLP01

2023-09-20

疫苗临床研究临床1期引进/卖出

SpyBiotech’s lead program to target HCMV OXFORD, England & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- SpyBiotech, a biotechnology company with a novel vaccine platform technology that can target infectious diseases, cancer, and chronic diseases, announced that the company has filed a clinical trial application (CTA) with the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to evaluate SPYVLP01, a vaccine targeting human cytomegalovirus (HCMV) using its Hepatitis B virus-like-particle platform technology. There is currently no approved vaccine against HCMV. “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,” said Sumi Biswas, Ph.D., President and Chief Scientific Officer of SpyBiotech. “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 MHRA trial application is a strong next step in the development of our cost-effective and highly scalable vaccine technology,” said Mark Leuchtenberger, Chief Executive Officer of SpyBiotech. “There is great need for medical progress against HCMV. There is no currently approved vaccine against this betaherpesvirus that can cause lifelong infection in humans.” The phase 1 clinical trial’s primary objective is to evaluate several formulations of the company’s HCMV vaccine, with a target enrollment of approximately 120 participants. The first participant is expected to be dosed later this year with clinical data emerging 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. 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 a novel vaccine platform technology 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 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 technology in vaccine development. 1 Gabrielle Stack, Maria Stacey, Cardiff University, UK, British Society for Immunology View source version on businesswire.com: Contacts US Media: Karen Sharma MacDougall Advisors ksharma@macdougall.bio +1 781-235-3060 UK Media: Sarah MacLeod, Adam Michael, Ibrahim Khalil Powerscourt Group spybiotech@powerscourt-group.com +44 (0)20 7250 1446 Source: SpyBiotech View this news release online at:

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