Okairos today announced the initiation of a Phase I clinical trial evaluating a vaccine against respiratory syncytial virus (RSV), a leading cause of hospital admissions in infants and children. This clinical trial will enroll 40 healthy adult volunteers in the UK, with endpoints measuring the vaccine’s safety and immunogenicity.
RSV is responsible for up to 126,000 infant hospitalizations for pneumonia or bronchiolitis every year in the US alone, according to the World Health Organization.1 There are currently no vaccines that protect children against RSV infections, and treatment options are limited.
Dr Riccardo Cortese, Chief Executive Officer of Okairos, said: “RSV is an area of significant unmet medical need and represents a major cause of illness in young children. We believe there will be great demand for a prophylactic vaccine that could help to reduce the burden RSV places on families and healthcare systems. We’re very excited to be advancing our vaccine into first-in-man studies.”
Okairos has evaluated its RSV vaccine candidate in well-established preclinical models and found that it stimulates both a strong neutralizing antibody and a robust T-cell response. Okairos’ vaccine candidate has also been shown to provide complete protection against RSV infection in challenge experiments in both cotton rats and neonatal calves, as well as an excellent safety profile, both before and after challenge.
About respiratory syncytial virus (RSV)
Respiratory syncytial virus (RSV) is the most important cause of viral lower respiratory tract infection in infants and children worldwide. The global disease burden of RSV is estimated at 64 million cases and 160,000 deaths every year. RSV is the most common cause of bronchiolitis and pneumonia in children under the age of one year in the US. RSV is responsible for 70,000 to 126,000 infant hospitalizations for pneumonia or bronchiolitis every year in the US alone. Almost all children in the US have been infected at least once with RSV by the age of two years. When infants and children are exposed to RSV for the first time, 25-40% of them have signs or symptoms of bronchiolitis or pneumonia, and 0.5-2% will require hospitalization. Most children hospitalized for RSV infection are under six months of age. Wheezing illnesses caused by RSV, particularly those severe enough to lead to hospitalization, are associated with an increased risk of asthma at school age.
Okairos is a clinical-stage biopharmaceutical company, developing genetic vaccines for major infectious diseases – including malaria, hepatitis C, HIV, respiratory syncytial virus and cancer – using a novel proprietary technology. The company is headquartered in Basel, Switzerland and has laboratories in Rome and Naples, Italy.
Okairos’ technology platform is centered on the development of new, potent adenovirus vectors to generate a pipeline of T-cell vaccines against a range of infectious diseases for which there is currently no effective vaccine. Okairos and its collaborators have vaccinated over 700 subjects with Okairos’ proprietary vectors, and in all cases have seen a strong immune response and excellent safety profile. The company is also pursuing therapeutic vaccines to treat cancer.
The company’s investors include BioMedInvest, Boehringer Ingelheim Venture Fund, LSP, Novartis Venture Funds and Versant Ventures.