Be Prepared 25/07/2023

 hVIVO plc (AIM & Euronext: HVO), the world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces a £13.1m contract with an existing top five global pharmaceutical client to develop an Influenza B ("Flu B") human challenge model.

 

Highlights

·    Key prerequisite phase of manufacturing virus is complete

·    Characterisation trial due to commence in Q4 2023 following completion of manufacturing process

·    Supplementary fee to ensure expedited delivery and guaranteed availability of beds

·    Potential for a future challenge trial pending a successful characterisation study

 

The contract scope includes the manufacture of an influenza B challenge virus, a characterisation study, and a supplementary fee to ensure sufficient capacity is available to complete the characterisation trial in an expedited manner. The successful manufacturing of the challenge virus is a prerequisite for the characterisation trial revenue to be delivered, and with the Good Manufacturing Practice (GMP) challenge agent manufacture now in its final stages, the Company will be able to commence the characterisation study in Q4 2023.

 

The characterisation study aims to identify a dose of influenza B that elicits a safe and reproducible infection in healthy volunteers recruited through the FluCamp platform. Subject to the successful completion of the characterisation study and the receipt of relevant regulatory approvals, the Company expects to conduct an influenza B human challenge trial in H1 2024. Revenue from this human challenge model development contract will be recognised throughout 2023 and 2024.

 

hVIVO is proud to be the exclusive contract research organisation offering this bespoke human challenge model development services with unparalleled knowledge and expertise in this field spanning back as far as the UK Common Cold Unit. Testing medicines against specific virus strains offer numerous benefits to biopharma clients including the certainty of testing efficacy against specific and new strains of virus.

 

The Centers for Disease Control and Prevention reports that both influenza A and B can have equally severe symptoms,¹ although type B is less prevalent. Similar to type A, influenza B is also highly contagious and can cause life-threatening complications in severe cases. Unlike influenza A viruses, which are known to infect a variety of different species and, therefore, have pandemic potential, influenza B viruses typically only infect humans. Influenza B causes seasonal epidemics and gradually evolves to evade the immune system so, like influenza A viruses, the seasonal vaccine component against influenza B virus needs to be updated frequently to maximise protective efficacy.