REG - hVIVO PLC - LOI signed for Phase 3 Whooping Cough trial

hVIVOAnnouncement

27/01/2025 07:00

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20250127:nRSa6975Ua&default-theme=true

RNS Number : 6975U  hVIVO PLC  27 January 2025

hVIVO plc

("hVIVO", the "Company" or the "Group")

 

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."

 

The information contained within this announcement is deemed by the Company to
constitute inside information as stipulated under the Market Abuse Regulation
("MAR") EU no.596/2014. Upon the publication of this announcement
via Regulatory Information Service ("RIS"), this inside information is now
considered to be in the public domain.

 

For further information please contact:

 

 hVIVO plc                                       +44 (0) 20 7756 1300
 Yamin 'Mo' Khan, Chief Executive Officer

 Stephen Pinkerton, Chief Financial Officer

 Cavendish Capital Markets Limited (Nominated Adviser and Joint Broker)                  +44 (0) 20 7220 0500
 Geoff Nash, Camilla Hume, Harriet Ward

 Nigel Birks - Life Science Specialist Sales

 Louise Talbot - Sales

 Peel Hunt LLP (Joint Broker)                                        +44 (0)20 7418 8900
 James Steel, Dr Christopher Golden

 Davy (Joint Broker)                                                 +353 (0) 1 679 6363
 Anthony Farrell, Niall Gilchrist

 Walbrook PR (Financial PR & IR)                 +44 (0)20 7933 8780 or hvivo@walbrookpr.com

 Paul McManus / Phillip Marriage /               +44 (0)7980 541 893 / +44 (0)7867 984 082 /

Louis Ashe-Jepson
+44 (0)7747 515 393

 

 

Notes to Editors

 

About hVIVO

 

hVIVO plc (http://www.hvivo.com/)  (ticker: HVO) is a fast-growing specialist
contract research organisation (CRO) and the world leader in testing
infectious and respiratory disease vaccines and therapeutics using human
challenge clinical trials. The Group provides end-to-end early clinical
development services to its large, established and growing repeat client base,
which includes four of the top 10 largest global biopharma companies.

The Group's fast-growing services business includes a unique portfolio of 11
human challenge models, with a number of new models under development, to test
a broad range of infectious and respiratory disease products. The Group has
world class challenge agent manufacturing capabilities, specialist drug
development and clinical consultancy services via its Venn Life Sciences
(https://www.vennlifesciences.com/) brand, and a lab offering via its hLAB
(https://hlabservices.com/)  brand, which includes virology, immunology
biomarker and molecular testing. The Group also offers additional clinical
field trial services such as patient recruitment and clinical trial site
services

hVIVO runs challenge trials in London - its new state-of-the-art facilities
in Canary Wharf opened in 2024 and is the world's largest commercial human
challenge trial unit, with highly specialised on-site virology and immunology
laboratories, and an outpatient unit. To recruit volunteers / patients for its
studies, the Group leverages its unique clinical trial recruitment capability
via its FluCamp (http://www.flucamp.com/)  volunteer screening facilities
in London and Manchester.

About ILiAD Biotechnologies, LLC

ILiAD Biotechnologies (http://www.iliadbio.com) 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.

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  LOIPKABNCBKKNDB