GCIhVIVO wins £2.5m contract for Covid-19 Omicron challenge study
() , a contract research organisation specialising in human challenge trials, announced a £2.5m contract with an undisclosed mid-sized pharma client for a Covid-19 Omicron characterisation study. The study aims to establish the world's first Omicron BA.5 challenge model.
The study aims to identify a dose of 's Omicron BA.5 agent that establishes a safe and reproducible disease in healthy volunteers aged 18-30, with a sufficient infection rate to use the model to develop antivirals and vaccines. Recruitment will be handled by 's dedicated recruitment arm FluCamp to pick volunteers of the correct age who have previously received a full course of a licensed Covid-19 vaccine.
The study will commence in Q4 2024 at 's new CL3 quarantine facility in Canary Wharf. This is the first Covid-related human challenge study that is undertaking since the first Omicron contract was signed in June 2022. The majority of revenue from the study is expected to be recognised in FY25.
Yamin 'Mo' Khan, CEO of hVIVO, commenting: "One of our key goals at hVIVO is to further diversify our challenge trial offerings. The establishment of a COVID challenge model is a key step to penetrating a new and expanding market, especially with regards to mucosal and multi-valent COVID vaccine development. This study will take place at our new CL3 quarantine facility in Canary Wharf, which will open shortly. The new site, which was largely funded by a number of key clients, is the largest human challenge trial quarantine clinic in the world and is highly specialised in its design to facilitate the safe conduct of challenge studies. Securing this contract further validates the move to our new facilities and the new opportunities it brings for CL3 category projects"
View from Vox
hVIVO adds a large £2.5m contract to its pipeline, materially bolstering revenue visibility for FY25. The study will characterise 's Omicron challenge agent, developed last year at its brand new CL3 facilities in Canary Wharf. hVIVO previously conducted the world's first SARS-CoV-2 characterisation study, using the original Covid-19 strain in 2021, with data showing that Covid-19 human challenge studies are safe in healthy young adults.
hVIVO's characterisation studies offer numerous benefits to its biopharma clients, including insights into specific pathogens that are more precise, actionable, and relevant to support and refine vaccine or antiviral development. They also provide the necessary data from which to design subsequent antiviral or vaccine efficacy testing studies.
There is strong and growing interest in Covid-19 indications as evidenced by today's announcement, as pharma companies continue development of effective treatments for Omicron and other variants, which remain threats to global health. New developments, including mucosal and multivalent vaccines, are underway to improve upon the limitations of the initial vaccines, such as their inability to prevent transmission. In this context, the announced contract and 's work in the space are significant in advancing the next generation of Covid-19 vaccines.
The £2.5m contract is a precursor to a more extensive suite of human challenge trials expects to undertake in 2025 and 2026, contingent on the success of the initial study and receipt of relevant regulatory approvals. We do not foresee any hurdles along the way and anticipate more Omicron trials to test medical products from mid-2025, further adding to 's Covid-19 pipeline. For the current £2.5m contract, significant developments are expected in 2025 after commencement of the study in Q4 2024.
The new study is made possible by hVIVO's new state-of-the-art C3L quarantine unit in Canary Wharf. When fully online, it will be the world's largest commercial human challenge trial unit, and should significantly diversify 's pipeline and boost the group's EBITDA and margins. hVIVO recently issued revenue guidance of £62m for FY24, being H1-weighted. 90% of this revenue guidance is already contracted, and there is excellent visibility into FY25. aims for £100m of revenues by FY28, which is highly achievable given its momentum and US$37m cash position. Q1 2024 trading has been in line with expectations as heads for another year of significant growth.
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