LOI signed for Phase 3 Whooping Cough trial

LOI signed with ILiAD Biotechnologies for Pivotal Phase 3 Human Challenge Trial to Assess BPZE1, ILiAD's Whooping Cough Vaccine Candidate

Highlights

• hVIVO has been selected to conduct a large-scale Phase 3 human challenge trial ("HCT") for ILiAD Biotechnologies' lead Bordetella pertussis (whooping cough) vaccine candidate, BPZE1
• World's first pivotal Phase 3 human challenge trial in Bordetella pertussis
• Expanding hVIVO's human challenge model portfolio
• Expected to be Company's largest HCT to date
• Trial expected to commence H2 2025

hVIVO plc (AIM: HVO), a fast-growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that it has signed a letter of intent (LOI) with ILiAD Biotechnologies, LLC (ILiAD), to conduct a pivotal Phase 3 human challenge trial for its lead Bordetella pertussis vaccine candidate, BPZE1. ILiAD is a late-stage biotech development company, which has raised over $100m to date, and is dedicated to the prevention of whooping cough, a life-threatening disease caused by Bordetella pertussis. hVIVO and ILiAD are currently working to finalise the definitive agreement, a further announcement will be made in due course.

This landmark study would be the first-ever pivotal Phase 3 study to be conducted using a human challenge trial for Bordetella Pertussis, a highly contagious respiratory bacterium which causes whooping cough. A human challenge trial overcomes the difficulties associated with conducting traditional Phase 3 field studies for whooping cough due to the unpredictability of Bordetella pertussis outbreaks. The study is expected to commence in H2 2025.

Whooping cough, caused by the highly contagious respiratory bacterium Bordetella pertussis, is particularly dangerous for babies under six months of age, causing serious and sometimes life-threatening complications. Pertussis outbreaks are cyclical, and there is currently a large increase in cases globally; according to the CDC cases in the US rose by six times in 2024 versus 2023. Bordetella pertussis affected approximately 16 million people globally, accounting for nearly 200,000 deaths in 2008. Although estimated global vaccination coverage is 84%, current vaccines have failed to control Bordetella pertussis epidemics.

BPZE1 is the leading next-generation Bordetella pertussis vaccine designed to induce comprehensive and durable protection against Bordetella pertussis infection (colonisation) and disease (whooping cough). BPZE1 is being developed to block Bordetella pertussis from colonising the nasal passages of adults and children, to protect them from whooping cough, and to potentially prevent transmission, including transmission to infants. While ILiAD is currently focused on developing a vaccine to directly protect adults and children and to indirectly protect vulnerable infants, future development aims to immunise neonates directly.

Yamin 'Mo' Khan, Chief Executive Officer of hVIVO, said: "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."

Dr. Keith Rubin, Chief Executive Officer of ILiAD Biotechnologies, said: "We look forward to working with hVIVO on our expected pivotal Phase 3 human challenge trial for BPZE1, ILiAD's leading next generation intranasal pertussis vaccine candidate. The limitations of current pertussis vaccines are evident, with cases reaching 10-year highs in both the US and Europe in 2024. By leveraging hVIVO's extensive experience and expertise in human challenge trials, we plan to generate robust pivotal clinical data to support global marketing authorisation applications for BPZE1, a vaccine with the potential to address a major unmet medical need."

About ILiAD Biotechnologies, LLC

ILiAD Biotechnologies is a privately held, clinical stage biotechnology company dedicated to the prevention and treatment of human disease caused by Bordetella pertussis. The company is developing and acquiring key technologies, working with leading scientists to overcome the limitations of current vaccines, investigating the impact of B. pertussis in a range of human disease, and is focused on validating its proprietary vaccines in human clinical trials.