REG - hVIVO PLC - HCT contract signed with ILiAD Biotechnologies

hVIVOAnnouncement

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RNS Number : 3809B  hVIVO PLC  22 April 2026

 

hVIVO plc

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

 

hVIVO to conduct world's first pivotal Phase III human challenge

whooping cough vaccine trial for ILiAD Biotechnologies

 

·    World's first pivotal Phase III human challenge trial ("HCT") in
Bordetella pertussis (the bacteria that causes whooping cough) for ILiAD
Biotechnologies vaccine candidate, BPZE1

·    hVIVO's largest HCT to date, with over 500 participants anticipated,
with revenue recognition expected from H1 2026

·    Trial expected to be hVIVO's largest value HCT to date; making a
strong contribution to near and mid‑term revenues with the majority expected
to be recognised during 2026 and 2027

 

London, UK - 22 April 2026, hVIVO plc (AIM: HVO), a purpose-built,
full-service international clinical development partner and the world leader
in human challenge trials, announces that it has signed a contract to conduct
a pivotal Phase III human challenge trial for ILiAD Biotechnologies,
Inc. ("ILiAD") to test its Bordetella pertussis ("B pertussis") vaccine
candidate, BPZE1.

 

The study will be the first ever pivotal B pertussis Phase III human challenge
trial assessing BPZE1's efficacy in preventing infection (colonization) by B
pertussis, a respiratory bacterium which causes whooping cough. The trial is
anticipated to include over 500 healthy volunteers recruited through the
Company's participant recruitment arm, FluCamp (http://www.flucamp.com) . This
represents hVIVO's largest HCT to date, with BPZE1's efficacy being measured
against the current standard of care Tdap combination vaccine.

 

HVIVO is expected to recognise revenue from H1 2026, with the majority of
revenue recognised during 2026 and 2027. This multi-year contract will make a
strong contribution to near- and mid‑term revenues. The Company has worked
closely with ILiAD over the past year to develop the bacterial assays for this
study, and hVIVO's bacterial laboratory in Canary Wharf will conduct the
microbiology assay for the primary and key secondary endpoints of the trial.
Given baseline pertussis vaccination rates and the unpredictability of B
pertussis outbreaks, conventional pertussis vaccine field studies are
unfeasible. HCTs offer a faster and more efficient pathway to pivotal efficacy
data with fewer participants.

 

Whooping cough poses a significant risk, particularly for infants under six
months of age, causing serious and sometimes life-threatening complications -
outbreaks are cyclical but unpredictable and do not follow a seasonal pattern.
In the UK, cases rose in 2024 by 17x versus 2023.(1) A study in 2017
estimated the global burden of B pertussis to be 24 million cases per year,
with 160,000 deaths among young children.(2) Despite 85% vaccination coverage
worldwide,(3) the efficacy of current vaccines is known to be relatively
short-lived and as such the level of community protection is waning.

 

BPZE1 is a next-generation live attenuated needleless intranasal B
pertussis vaccine designed to provide comprehensive and durable protection
against B pertussis infection (colonisation) and disease (whooping cough).
BPZE1 is being developed to block B pertussis from colonising the nasal
passages of adults and children, to protect them from whooping cough, and
potentially to prevent transmission, including transmission to vulnerable
infants.

 

Yamin 'Mo' Khan, Chief Executive Officer of hVIVO, said: "This study
represents a landmark moment for human challenge trials which can help to
bring vital medicines to market faster. We are pleased that data generated
from this trial will be used in ILiAD's future marketing applications for
BPZE1 to the US FDA, UK MHRA, EMA and other global regulatory agencies,
underlining the growing recognition that HCTs can deliver rapid and
high-quality data supporting global licensures. This approach has the
potential to accelerate the development of future vaccines and antiviral
therapies, in other indications with unpredictable seasonality, ultimately,
bringing important medicines to patients faster."

 

Dr. Keith Rubin, Chief Executive Officer of ILiAD Biotechnologies,
said: "We greatly appreciate the partnership with hVIVO to initiate our
pivotal Phase III human challenge trial for BPZE1, a vaccine with the
potential to address a major global unmet medical need. This is a highly
innovative, world-first Phase III human challenge trial, and we're confident
that hVIVO has the experience and expertise to deliver a rigorous and
well-executed study. We expect this trial to generate important pivotal data
to form a core part of our global marketing authorisation applications for
BPZE1 and to accelerate access to this urgently needed vaccine."

 

(https://url.uk.m.mimecastprotect.com/s/7AhfCYyY0U3JENNu0fYTx9fpW?domain=investormeetcompany.com)

(1) UKHSA, Confirmed cases of pertussis in England by month, 2024.

(2) Yeung KH, Duclos P, Nelson EA, Hutubessy RC (September 2017). "An update
of the global burden of pertussis in children younger than 5 years: a
modelling study". The Lancet. Infectious Diseases. 17 (9): 974-980.
doi:10.1016/S1473-3099(17)30390-0. ISSN 1474-4457. PMID 28623146

(3) Childhood vaccination rates lag in Europe - fueling further resurgence of
measles and whooping cough. Available at:
https://www.unicef.org/moldova/en/press-releases/childhood-vaccination-rates-lag-europe-fueling-further-resurgence-measles-and
(https://www.unicef.org/moldova/en/press-releases/childhood-vaccination-rates-lag-europe-fueling-further-resurgence-measles-and)
 

 

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, Callum Davidson

Trisyia Jamaludin, 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

 ICR Healthcare (Financial PR & IR)                                                  hVIVO@icrhealthcare.com

 Mary-Jane Elliott / Stephanie Cuthbert / Phillip Marriage / Louis Ashe-Jepson

 

Notes to Editors

 

hVIVO plc (https://hvivo.com/) (AIM: HVO) is a purpose-built, full-service
international clinical development partner and the global leader in human
challenge trials, serving seven of the world's ten largest biopharma
companies.

 

The Company has an end-to-end platform designed to bring important medicines
to patients faster: spanning preclinical strategy, first‑in‑human studies,
Phase II patient trials and specialist laboratory services, delivered through
a large participant database, wholly owned sites and laboratories across the
UK and Germany.

 

With a combined Group heritage of more than 100 years, hVIVO delivers an
accelerated pathway to clinical proof-of-concept through four integrated
service lines: Consulting, Clinical Trials, Human Challenge Trials, and
Laboratories.

 

·    Consulting
(https://www.hvivo.com/solutions/drug-development-consulting) provides
expert-led preclinical and clinical strategy, encompassing non-clinical,
clinical, CMC, pharmacokinetics, data management, biostatistics, and
regulatory support to guide trial design, execution, and interpretation.

·    Clinical Trials (https://www.hvivo.com/solutions/clinical/) offers
Phase I/II CRO services, Phase II/III site services across the UK and Germany,
and specialist recruitment through FluCamp (http://www.flucamp.com/) ,
Europe's largest recruitment database.

·    Human Challenge Trials
(https://www.hvivo.com/solutions/human-challenge) leverages hVIVO's
state-of-the-art quarantine facility in London - the largest of its kind
worldwide - to deliver fast, controlled, high-quality efficacy data through
guaranteed viral exposure.

·    Laboratories (https://www.hvivo.com/solutions/laboratory) provides
cutting-edge virology and immunology laboratory services, including biobanking
and sample storage, supporting both challenge trials and standalone client
studies.

 

About ILiAD Biotechnologies, LLC

 

ILiAD Biotechnologies (http://www.iliadbio.com
(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fprotect.checkpoint.com%2Fv2%2Fr06%2F___http%3A%2Fwww.iliadbio.com%2F___.ZXV3Mjp1bml2ZXJzaXR5aG9zcGl0YWxzb3V0aGFtcHRvbjpjOm86YjM0M2MxOTFjM2JmNDk5ZmMxZDJhZDIzNjU3ZGFhNjE6NzplOWIwOjE1N2JjNWE3ZGViYzkxNWU5ZDdlODRkNjQ2YWZmZDBhMjQ4ZWEwMzhjNzIzM2JjYmY2MzM3MzJmZGEzNDM2Yjk6cDpUOk4&esheet=54364492&newsitemid=20251201920333&lan=en-US&anchor=http%3A%2F%2Fwww.iliadbio.com&index=3&md5=b656731bc9d1e0c727806f417ffa4b1a)
) is a privately held, late 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.

 

 

 

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