SpyBiotech Appoints Seasoned Biotech Executive Mark Leuchtenberger as Chief Executive Officer

Our pipeline

Our vaccine candidate answers a huge and urgent unmet medical need

Commercial opportunities in the vaccines industry fall into two broad categories – expanding and improving existing vaccines, or creating completely new ones. It is in this second, higher risk for higher return, category that we are concentrating our efforts for now.

We’re developing a vaccine candidate to combat human cytomegalovirus (HCMV). This is a disease with life-threatening implications, particularly for babies and children, that currently lacks effective treatment or prevention.

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

Disease Profile

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.

Market Opportunity

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

Our Progress

We have reached the pre-clinical process development stage in under two years. A final vaccine candidate has been selected from the lab and both the virus-like particle (VLP) and the HCMV antigen are currently being manufactured to Good Manufacturing Practice (GMP) to initiate Phase 1 clinical trials in 2023.

Meet our dynamic and dedicated team

Our Team