Our Pipeline

Our lead vaccine candidate answers a huge and urgent unmet medical need

SpyBiotech is currently recruiting healthy adult participants in its UK-based Phase 1 clinical trial testing a novel vaccine candidate against Human Cytomegalovirus (HCMV). The primary aim of the clinical trial, which tests different doses and formulations, is to determine whether our vaccine candidate against HCMV is safe. Additionally, we will also assess the immunogenicity to guide selection of a preferred dose and formulation for further development of this candidate vaccine.

HCMV is a disease with life-threatening implications, particularly for babies and children. There is currently a lack of effective treatment or prevention for HCMV.

We chose this candidate for four reasons:

There is a huge and urgent unmet medical need for an effective vaccine.

It is commercially appealing given the size of the target population and pricing potential.

The immunology is well understood, allowing us to demonstrate proof of concept with a very high degree of confidence.

Progress to develop a vaccine for this disease has in the past lacked the technology that we have at our disposal and want to showcase.

HCMV or Human Cytomegalovirus

Our HCMV vaccine candidate targets a key unmet need worldwide. HCMV is the most common virus that most people have never heard of, even though it has now been identified as a high priority for vaccines development by key authorities such as the FDA and Institute of Medicine.

In the developed world, HCMV infects 50-80% of adults before they reach their fortieth birthday and around 30% of children under five years old. It is even more widespread in developing countries. Infection is typically asymptomatic and not harmful to healthy individuals. However, the virus can cause serious complications in groups with weak immune systems such as elderly people, transplant recipients and infants infected in utero. In these patients, infection can cause severe and life-threatening complications including birth defects and organ failure.

Congenital HCMV occurs when HCMV is transferred from a pregnant woman to her fetus in utero and has a very high disease burden. In many parts of the world it is second only to cerebral palsy as a cause of serious infant malformation. In the United States 5,000 infants each year develop permanent conditions including deafness, blindness and neurologic disorders from HCMV. Overall, it affects more live births in the US than Fetal Alcohol Syndrome or Down’s and is estimated to generate over $2 billion in healthcare costs annually.

It is estimated that the HCMV vaccine market could exceed $1 billion of sales annually.

A final vaccine candidate has been selected from the lab and both the virus-like particle (VLP) and the HCMV antigen have been manufactured to Good Manufacturing Practice (GMP) with plans to initiate Phase 1 clinical trials in 2023.