hVIVO, a subsidiary of the specialist contract research organisation Open Orphan (ORPH ), has signed a $13.4m contract with an unnamed US-based biotechnology company which will test its novel antiviral candidate using the hVIVO Influenza Human Challenge Study Model.  

The study is expected to commence in H2 2022 and will be conducted at hVIVO’s quarantine facilities in London, with the majority of these revenues expected to be recognised in 2022.

The Company acknowledged that the ongoing coronavirus pandemic has highlighted the increased investment needed from governments and Big Pharma to develop effective, novel treatments for a range of infectious diseases that have potential to cause the next pandemic. 

As a result, hVIVO said it expects to sign an increasing number of contracts in this area.

‘Influenza is one such disease, with emergencies of flu pandemics impossible to predict,’ the company stated. It outlined that ‘symptoms of influenza may be mild or cause severe disease, or in certain cases, death. Influenza is a serious global health threat with an estimated 1 billion cases per year, 3-5 million severe cases and 290,000 – 650,000 deaths per year.’

hVIVO has two decades of experience and expertise in safely conducting challenge studies across a range of respiratory viruses, including RSV, various strains of Influenza, human Rhinovirus HRV, malaria, and asthma. In 2020, this expanded to include SARS-CoV-2.

Cathal Friel, Open Orphan’s Executive Chairman, said the contract reflected the company’s continued ability to convert its portfolio of challenge study models into substantial contracts.

He said this is demonstrated through the several contracts that it has signed across a number of its challenge study models including RSV, asthma, hRV, and flu in the clinic next year. 

Addressing shareholders, he stated: “This underlines our market position as the world leader in the testing of vaccines, antivirals and respiratory products using human challenge trials.”

Commenting on the current situation, he outlined that “the recent emergence of the Omicron variant has illustrated the threat of pandemic infectious diseases, and as a result, pharma companies globally are looking to address the next cohort of infectious diseases which have potential to reach pandemic level, and are developing new therapeutics to help tackle them. 

He added that the infectious disease market is expected to be worth $250 billion by 2025.

Earlier this week, Open Orphan acknowledged positive results from a recent human challenge study testing SAB-176, an investigational therapeutic aimed at treating seasonal influenza.

hVIVO, a subsidiary of London-listed Open Orphan, conducted the Phase 2a randomised, double-blinded, placebo-controlled study using its Influenza Human Challenge Study Model.

The trial evaluated the safety and treatment efficacy of SAB-176 in 60 healthy adults challenged with a pandemic influenza strain (pH1N1). Participants were intranasally inoculated with the virus and then randomised to receive either SAB-176 or placebo.

SAB-176, SAB Biotherapeutic’s investigational therapeutic which is being developed for the treatment of seasonal influenza, achieved statistically significant (p = 0.026) reductions in viral load and clinical signs and symptoms compared to placebo in a Phase 2a challenge study.

Additionally, no serious adverse events were reported and SAB-176 appeared to be safe and well tolerated. Based on the positive results from this study, SAB Biotherapeutic has informed investors that it plans to further evaluate SAB-176 in a further Phase 2 influenza clinical trial.

There are four types of seasonal influenza viruses, types A, B, C and D. Influenza A and B viruses circulate and cause seasonal epidemics of disease. According to the World Health

Organisation (WHO), worldwide, these annual epidemics are estimated to result in about three to five million cases of severe illness, and about 290 000 to 650 000 respiratory deaths.

hVIVO said it expects to see a rise in the number of human challenge studies taking place across multiple infectious diseases, “as interest in these disease areas continues to grow.”

Last month, hVIVO announced that it had signed a £5.1m contract to test its Investigational Medicinal Product using its respiratory syncytial virus (RSV) Human Challenge Study Model. 

The medical lab division is to conduct the study on behalf of its biopharmaceutical client to demonstrate the efficacy of its IMP against RSV infection. The study is due to commence in 2H22, with the revenue from the contract being recognised across 2021 and 2022, it noted.

RSV is a contagious virus that affects the respiratory tract of children and at-risk older adults; in severe cases, it can cause pneumonia and other life-threatening breathing difficulties. 

RSV is a significant public health threat and is one of the leading causes of hospitalisation to at-risk older adults. Among the elderly (aged 65+), RSV causes as many hospitalisations and deaths as influenza, according to The Centers for Disease Control and Prevention (CDC).

Open Orphan said RSV may lower immunity and increase the risk of developing COVID-19, and where these infections occur together, it can worsen the severity of COVID-19 illness. 

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