SpyBiotech Completes Phase I Enrollment for HCMV Vaccine SPYVLP01

SpyBiotech, a biotechnology company known for its innovative vaccine platform, has announced the successful completion of participant enrollment for its Phase I clinical trial of SPYVLP01, a vaccine candidate aimed at combating human cytomegalovirus (HCMV). The company utilizes Hepatitis B virus-like-particle technology for this purpose.

The Phase I trial is designed to evaluate the safety and immune response efficacy of the HCMV vaccine in two different dosages. A total of 120 healthy individuals between the ages of 18 and 50 are participating in this study, conducted over a six-month period in the United Kingdom. As of now, there is no approved vaccine available for HCMV.

Sumi Biswas, President, Co-founder, and Chief Scientific Officer of SpyBiotech, expressed optimism about the initial findings from the Phase I trial. “The preliminary results are very promising,” said Biswas. “This represents a significant milestone as we further analyze the vaccine's safety and immune response against HCMV, a major infectious contributor to congenital abnormalities.”

Mark Leuchtenberger, the Chief Executive Officer, also sees the trial's milestones as pivotal for the company's future. “The completion of enrollment and the encouraging initial results are propelling us into the next phase of our development,” said Leuchtenberger. “Our focus will continue to be on advancing our leading candidate and our collaboration with the University of Oxford on Epstein-Barr Virus (EBV) focused projects.”

Human cytomegalovirus (HCMV) is a betaherpesvirus that establishes lifelong infections in humans. The virus affects 55-100% of the global population, varying based on socioeconomic and geographic factors. Although primary HCMV infections are usually asymptomatic in healthy individuals, the virus can cause severe or even fatal conditions in immunocompromised individuals and newborns. HCMV is notably the leading infectious cause of congenital abnormalities in the Western world, potentially resulting in significant complications such as low birth weight, hearing loss, vision impairment, and microcephaly in newborns.

SpyBiotech, established in 2017 as a spin-out from the University of Oxford, focuses on developing vaccines for infectious diseases, cancer, and chronic conditions. The company was co-founded by Oxford Science Enterprises (OSE) and Google Ventures (GV). In 2021, SpyBiotech raised $32.5 million through a Series A equity financing round.

The company’s innovative vaccine platform is built upon a proprietary protein “superglue” technology, which effectively binds antigens to vaccine delivery systems. This technique minimizes delivery risks while enhancing both immunogenicity and efficacy, making it particularly suited for use in challenging environments such as those found in developing countries. The technology also shows promise for applications beyond infectious diseases, including cancer treatment.

SpyBiotech holds exclusive rights from the University of Oxford to commercialize and sub-license the SpyTag/SpyCatcher and related “superglue” technologies for vaccine development. The company's ongoing efforts aim to address significant public health needs, leveraging cutting-edge science to deliver impactful healthcare solutions.