hVIVO to lead landmark Phase 3 trial for ILiAD's BPZE1 whooping cough vaccine
( ) , a contract research organisation specialising in human challenge trials, has signed a letter of intent with ILiAD Biotechnologies to conduct a large-scale Phase 3 human challenge trial for ILiAD's Bordetella pertussis vaccine candidate, BPZE1. The two companies are working to finalise the definitive agreement, with a further announcement expected soon.
The landmark study will be the first ever Phase 3 trial to be conducted using a human challenge model for Bordetella pertussis, a highly contagious respiratory bacterium which causes whooping cough. The study is expected to commence in H2 2025.
Bordetella pertussis infections pose severe risks to infants under 6 months, and have seen a sharp global resurgence with US cases rising sixfold in 2024 over 2023. Despite 84% global vaccination coverage, current vaccines have been unable to effectively control outbreaks.
ILiAD's BPZE1 is a next-generation Bordetella pertussis vaccine designed to induce comprehensive and durable protection, targeting both infection (colonisation) and the resulting disease. The vaccine is being developed to block the bacteria from colonising the nasal passages of adults and children, to protect them from whooping cough and prevent transmission, including to infants.
Yamin 'Mo' Khan, CEO of hVIVO, commenting: "We are pleased to have been selected by ILiAD to conduct the world's first Phase 3 human challenge trial for a leading whooping cough vaccine candidate. At hVIVO we have a long history of successfully conducting human challenge trials for our clients, which has supported our clients to bring lifesaving medicine and vaccines to the global population. Conducting this large-scale Phase 3 human challenge trial offers the potential to bring this leading vaccine to patients faster than would otherwise be possible."
View from Vox
hVIVO has been selected to conduct a large-scale Phase 3 human challenge trial for ILiAD's flagship BPZE1 vaccine for Bordetella pertussis (whooping cough). The pivotal study will be the world's first Phase 3 human challenge trial targeting the disease, and is expected to be significantly more effective than a traditional Phase 3 field study due to the unpredictability of Bordetella pertussis outbreaks. The trial thus has the potential to produce a vaccine significantly more effective than existing treatments, as cases in the US and Europe reach 10-year highs.
The study is expected to commence in H2 2025 and will be hVIVO's largest human challenge trial to date, significantly enhancing its human challenge model portfolio. Customer ILiAD is a late-stage biotech development company dedicated to the prevention of whooping cough, having raised over US$100m to date. While the current vaccine is being developed to protect adults and children and indirectly safeguard infants, future development will focus on directly immunising neonates.
hVIVO has a strong track record of supporting the development of vaccine and antiviral candidates using its signature human challenge models. Most recently,
won an £11.5m contract with an existing top-tier pharma client to test its RSV candidate using 's RSV model. '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.hVIVO maintained a strong orderbook of £71m at the end of H1 2024, with excellent visibility into FY25, bolstered by the aforementioned £11.5m RSV contract. In December 2024,
reaffirmed its FY24 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.shares rose 9% on today's announcement.
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