REG - hVIVO PLC - RSV contract signed with Inhalon Biopharma

hVIVOAnnouncement

03/02/2025 07:15

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20250203:nRSC6128Va&default-theme=true

RNS Number : 6128V  hVIVO PLC  03 February 2025

hVIVO plc

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

 

RSV human challenge trial contract signed with new client, Inhalon Biopharma

 

Highlights

·    hVIVO RSV human challenge trial to test IN-002, an inhaled (mucosal)
antiviral candidate to treat RSV infection

·    FluCamp to recruit healthy volunteers to test IN-002 efficacy across
three dosing levels

·    Trial expected to commence in H2 2026 with the majority of revenue
recognised in 2026

 

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 contract
with Inhalon Biopharma, Inc. ("Inhalon"), a clinical-stage company advancing a
first-in-class inhaled antibody platform for treating acute respiratory
infections, to assess its inhaled IN-002 antiviral candidate ("IN-002") using
the hVIVO Respiratory Syncytial Virus (RSV) Human Challenge Model.

 

The Phase 2a randomised, double-blinded placebo-controlled human challenge
trial will evaluate the safety, pharmacokinetics and antiviral activity of
inhaled IN-002 following RSV infection, at three dose levels. hVIVO will
leverage its in-house volunteer recruitment arm, FluCamp, to enrol healthy
volunteers into the study. The study is expected to commence in H2 2026 at
hVIVO's state-of-the-art quarantine facilities in Canary Wharf, with the
majority of revenue expected to be recognised in 2026.

 

IN-002 uses Inhalon's patented drug delivery platform, with its direct inhaled
delivery into the lung showing potential to be significantly more effective
for combating RSV infections. Early data from human clinical studies with
other Inhalon candidates indicates patients may benefit from swift recovery of
symptoms with rapid control of inflammation. For infants and young children
suffering from RSV, IN-002's inhaled dosing offers greater comfort and ease of
delivery, with the potential to shift treatment of respiratory infections to
an at home "test-and-treat" approach.

 

Yamin 'Mo' Khan, Chief Executive Officer of hVIVO, said: "We previously
identified the next generation of vaccines and antivirals, including
mucosal-based delivery systems, as being a key growth driver for our challenge
trial business. The contract win strengthens our longer term orderbook, adding
to visibility into 2026. Inhalon's IN-002 and its innovative delivery platform
could provide a novel way to combat RSV infections. The study is also notable
for including three dosing arms - further supporting the trend of biopharma
companies looking to obtain greater actionable insights into their candidates
earlier to help inform later-stage field trials."

 

John Whelan, President and Chief Executive Officer of Inhalon, said: "We look
forward to working with hVIVO on this Phase 2a study of our inhaled IN-002
antiviral candidate for RSV. Because preventive vaccines are underutilized,
RSV and other respiratory infections continue to pose a significant risk to
public health. There remains an unmet need for novel therapeutics that can
treat underlying respiratory diseases counteracting severe illness,
particularly in vulnerable populations such as infants, toddlers, and the
elderly. Inhalon's inhaled antibody treatment approach not only targets the
underlying pathophysiology of RSV and other respiratory infections, it also
provides painless, self-administration by patients in their own homes,
potentially reducing hospitalizations."

 

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

 

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.

 

 

Notes to Editors

 

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 Inhalon Biopharma

Inhalon Biopharma, Inc., is a private, clinical-stage company advancing a
proprietary inhaled antibody platform for treating a variety of acute
respiratory infections. Inhalon Biopharma's intellectual property includes
approved U.S. and EU patents covering the composition and use of aerosolized
muco-trapping antibodies. Inhalon Biopharma is supported by the Thiel
Foundation's Breakout Labs, Cambrian Growth Partners, Berkeley Catalyst Fund,
JSR Life Sciences and Life Science Angels, as well as several federal grants
from the NIH and USAMRDC.

 

About RSV

RSV remains a leading cause of childhood lower respiratory infections and is
responsible for a significant burden of disease in the elderly and in adults
with chronic medical problems. Globally RSV affects an estimated 33 million
people annually, leading to approximately 4 million hospitalisations and
approximately 101,000 RSV-attributable deaths in children under five years.(1)
Even with a number of RSV vaccines approved in recent years, there remains a
considerable unmet need for effective antivirals that address acute disease
which continues to have a major impact on vulnerable populations worldwide.

 

1 Li Y et al. Global, regional, and national disease burden estimates of acute
lower respiratory infections due to respiratory syncytial virus in children
younger than 5 years in 2019: a systematic analysis. Lancet. 2022 May
28;399(10340):2047-2064. doi: 10.1016/S0140-6736(22)00478-0. Epub 2022 May 19.
PMID: 35598608; PMCID: PMC7613574.

 

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  MSCUUOWRVKUURAR