hVIVO turns it up to 11 with Omicron human challenge model
( ), a specialist contract research organisation, announced that its Omicron human challenge agent has been successfully manufactured.
This expands hVIVO's portfolio to 11 human challenge models, testing a wide range of infectious and respiratory disease products. hVIVO actively offers Omicron human challenge trials as part of its service offering, and says it is currently in discussions with existing and potential customers.
The model was developed in partnership with Vaxart with the intent to conduct a subsequent Omicron human challenge study to test the efficacy of Vaxart's oral vaccine candidate. On March 15, Vaxart announced its decision to postpone clinical trials in its Covid-19 programme, including the challenge study, in order to focus on an oral pan-betacoronavirus vaccine.
hVIVO clarified that Vaxart's challenge study was not included in hVIVO's orderbook and its postponement will have no impact on hVIVO's 2023 financial guidance.
View from Vox
Another milestone for hVIVO, adding Omicron to its portfolio of human challenge study models. hVIVO now boasts 11 human challenge study models and has become a go-to partner for big pharma and biotech clients. The company's orderbook continues to grow, standing at £76m on 31 December 2022, up 60% year-on-year. hVIVO's recent stock performance reflects this momentum, with up 45% year-to-date.
In 2023 so far, hVIVO has won a £5.2m contract to test an RSV vaccine, a €3.2m consultancy contract, and a £6.8m RSV contract with an APAC client - the second APAC contract for the company. hVIVO now has 95% of forecast revenue for 2023 with strong visibility into 2024.
More and more pharma and biotech companies are trusting hVIVO's model as they learn about the benefits of human challenge trials. Four of the top ten global biopharma companies are now regular clients of hVIVO.
This growth is being driven by increasing demand for human challenge services in a rapidly expanding infectious and respiratory disease clinical trials market. Since the Covid-19 pandemic, there has been a marked increase in the number of companies looking to test vaccines and antivirals against specific subtypes of viruses that have the potential to be widely spread. APAC is an exceptionally fast-growing market for clinical trials, with over 8,000 started in the region in 2021.
Human challenge studies provide great value for biopharma companies as they offer access to fast and cost-effective data that enables easy decisions ahead of larger Phase 2 studies. This gives companies the best possible chance of quickly advancing their candidates through the development pathway.
We expect hVIVO to meet or exceed FY23 market forecasts, with today's announcement further strengthening its revenue visibility into 2024.
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