hVIVO unveils key Covid-19 biomarker insights from human challenge study
() , a contract research organisation specialising in human challenge trials, announced a new peer-reviewed paper from its Covid-19 characterisation trial that has been published in Nature Communications. The publication builds on insights from the world's first Covid-19 characterisation study, which hVIVO conducted in 2021.
The title of the paper is "SARS-CoV-2 human challenge reveals single-gene blood transcriptional biomarkers that discriminate early and late phases of acute respiratory viral infections" by Rosenheim, J. et al. and it is available on Nature Communications' website here.
As the title suggests, the paper explores the study's successful identification of key blood-based biomarkers, not only in SARS-CoV-2 infection (the original Covid-19 strain), but also in other respiratory viruses, that can identify and distinguish between early and late phases of infection.
This is significant, as these biomarkers could provide the basis for advancements in diagnosis and management in both early and late-stage infections.
Dr Andrew Catchpole, CSO of hVIVO, commenting: "Human challenge trials allow researchers to observe in detail infection progression, particularly in the early stages, that would not be possible with a traditional field study. It is fantastic to see that our original COVID-19 viral characterisation study is continuing to enhance understanding of the immune response to SARS-CoV-2 infection and other respiratory viruses, and to see the findings published in a prestigious journal such as Nature Communications."
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hVIVO notes another published peer-reviewed paper, based on its Covid-19 characterisation trial conducted in 2021. The trial was the world's first SARS-CoV-2 characterisation study, using the original Covid-19 strain, with data showing that Covid-19 human challenge studies were safe in healthy young adults. The study also bolstered understanding of the immune system's response to Covid-19 and other respiratory viruses.
Additionally, 's study provided insights into the course of Covid-19 infection, with multiple public health implications. The clinical results were initially published in Nature Medicine in March 2022. Today's announcement further highlights the value of the study in enabling material advancements in diagnosis in both early and late-stage infections of Covid-19 and other respiratory viruses.
also noted that the referenced early-stage biomarker was observable sometimes even before PCR testing confirmed the presence of the virus - suggesting future clinical utility in discovering the infection early, as well as helping to stratify patients for antiviral therapy.
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.
Put simply, hVIVO's trials are in high demand as they offer time-efficient and cost-effective ways to generate early human efficacy data and inform later-stage trial design, accelerating the path to market for new drugs. In the case of Covid-19 and other respiratory viruses, early-stage infection progression could not be studied effectively using traditional methods, necessitating the use of human challenge trials that and other biotechs provide.
There is strong and growing interest in Covid-19 and other respiratory indications, as pharmas continue development of effective treatments for Omicron and related 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, today's announcement and 's work in the space are significant in advancing the next generation of treatments.
In June 2024, won a major £2.5m contract for a Covid-19 Omicron challenge study. The study will characterise 's Omicron challenge agent, developed last year at its state-of-the-art CL3 facilities in Canary Wharf. The 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 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 £2.5m contract, significant developments are expected in 2025.
hVIVO maintained a strong orderbook of £71m at the end of H1 2024, with full visibility for the remainder of FY24 as well as excellent visibility for FY25, bolstered by its recently won £11.5m RSV contract. also this week reaffirmed its full-year revenue guidance of £62m, with management projecting full-year EBITDA margins to be at the upper end of market expectations.
hVIVO has a significant pipeline that is continuing to grow, including new challenge models and new revenue streams (eg clinical site studies, standalone lab services, and volunteer/patient recruitment). aims for £100m of revenues by FY28, which is highly achievable given its strong sales momentum and US$37m cash position.
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