REG - hVIVO PLC - Influenza HCT contract signed with Traws Pharma

hVIVOAnnouncement

Today 07:02

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20260414:nRSN2814Aa&default-theme=true

RNS Number : 2814A  hVIVO PLC  14 April 2026

 

hVIVO plc

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

 

Influenza HCT contract signed with Traws Pharma

 

London, UK - 14 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 Clinical Trial
Agreement ("CTA") to conduct a human challenge (HCT) trial on behalf of Traws
Pharma (NASDAQ: TRAW), a clinical-stage biopharmaceutical company developing
novel therapies for respiratory viral diseases.  The trial will test Traws'
prophylactic antiviral candidate, tivoxavir marboxil ("TXM"), using the hVIVO
Influenza Human Challenge Study Model. TXM is an investigational oral, small
molecule CAP-dependent endonuclease inhibitor designed to be administered as a
single-dose for the treatment of seasonal influenza and bird flu.

 

The Phase 2a, randomised, double-blinded placebo-controlled trial is planned
to take place at the Company's specialist state-of-the-art quarantine
facilities in Canary Wharf. The study will evaluate TXM's safety,
tolerability, and effectiveness in reducing the incidence and severity of
influenza-induced illness in healthy adult participants.

The study is expected to commence in H1 2026, with the majority of the revenue
recognised in 2026. Approximately 150 healthy participants will be recruited
through the Company's participant recruitment arm, FluCamp
(http://www.flucamp.com/) , and all lab work associated with the study will be
conducted by hVIVO's own specialist virology laboratory in Canary Wharf.

 

Seasonal influenza causes significant morbidity and mortality each year, with
an estimated 1 billion cases per year, 3-5 million severe cases and 290,000 -
650,000 deaths per year. To date, hVIVO has inoculated >5,000 healthy
participants across 2,477 influenza, RSV and other viral HCTs, and has also
helped accelerate the development of several antiviral and vaccine candidates
for both Big Pharma and biotechnology clients through its consulting,
laboratory and clinical trial services. This includes Cidara Therapeutics,
Inc, which was acquired by Merck Sharp & Dohme LLC
(https://www.londonstockexchange.com/news-article/HVO/msd-to-acquire-cidara/17346675)
in January 2026, following a longstanding clinical development partnership
across hVIVO's fully integrated early phase service offering.

 

Yamin 'Mo' Khan, Chief Executive Officer of hVIVO, said: "Through our
Influenza Human Challenge Trial Model, we will be able to deliver fast,
controlled, high-quality efficacy data for Traws Pharma that would not be
achievable in traditional field studies, reducing development risk for TXM and
improving capital efficiency. By leveraging key synergies across our
integrated clinical development services and conducting participant
recruitment all under one roof, this trial illustrates our unique value
proposition as a true full-service clinical development partner."

 

Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, added: "Influenza
causes significant strain on global healthcare infrastructure each year and a
new influenza pandemic continues to pose a worldwide threat, underlining the
critical need for effective prophylactic antivirals. Our Influenza Human
Challenge Study Model has been optimised by our expert team over decades, and
our purpose-built, full-service offering is well placed to deliver an
accelerated path to clinical proof-of-concept for TXM, and ultimately bring
this and other important medicines to patients, faster."

 

Iain D. Dukes, Chief Executive Officer of Traws Pharma, commented: "This
agreement represents an important step forward for Traws as we advance our
programme and seek to generate high‑quality, efficacy clinical data
efficiently. Partnering with hVIVO enables us to leverage a proven human
challenge platform to support our development strategy and accelerate progress
towards our next value‑inflection point."

 

Forward-Looking Statements:

 

Certain statements in this press release which are not historical facts are
forward- looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the Securities Exchange
Act of 1934, as amended, and are provided pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995. Any
statements in this press release that are not statements of historical fact
may be deemed forward-looking statements. Words such as "continue," "will,"
"may," "could," "should," "expect," "expected," "plans," "intend,"
"anticipate," "believe," "estimate," "predict," "potential," and similar
expressions are intended to identify such forward-looking statements. These
forward-looking statements include, but are not limited to, statements
concerning whether this CTA and/or the HCT trial represents an important step
forward for Traws Pharma in advancing its programme, whether this CTA  and/or
the HCT trial will generate high‑quality, efficacy clinical data
efficiently, whether Traws Pharma's partnering with hVIVO will enable Traws
Pharma to leverage human challenge platform to support Traws Pharma's
development strategy and whether this CTA and/or the HCT trial will accelerate
progress towards Traws Pharma's next value‑inflection point. All
forward-looking statements involve significant risks and uncertainties that
could cause actual results to differ materially from those expressed or
implied in the forward-looking statements, many of which are generally outside
the control of Traws Pharma and/or hVIVO and are difficult to predict. Factors
other than those referred to above could also cause Traws Pharma's and/or
hVIVO's results to differ materially from expected results. Additional factors
that could cause actual results to differ materially from those expressed or
implied in the forward-looking statements can be found in Traws Pharma's
filings with the Securities and Exchange Commission (the "SEC"), including its
Annual Report on Form 10-K for the fiscal year ended December 31, 2024, its
Quarterly Reports on Form 10-Q filed with the SEC during 2025 and 2026, as
well as in its subsequent filings with the SEC. Traws Pharma anticipates that
subsequent events and developments may cause its plans, intentions and
expectations to change. Traws Pharma assumes no obligation, and it
specifically disclaims any intention or obligation, to update any
forward-looking statements, whether as a result of new information, future
events or otherwise, except as expressly required by law. Forward-looking
statements speak only as of the date they are made and should not be relied
upon as representing Traws Pharma's plans and expectations as of any
subsequent date. Additionally, the business and financial materials and any
other statement or disclosure on, or made available through, Traws Pharma's
website or other websites referenced or linked to this press release shall not
be incorporated by reference into this press release.

 

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
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 pillars: Consulting, Clinical Trials, Human Challenge Trials, and
Laboratories.

 

·    Consulting provides expert-led pre-clinical and clinical strategy,
encompassing non-clinical, clinical, CMC, pharmacokinetics, data management,
biostatistics, and regulatory support to guide trial design, execution, and
interpretation.

·    Clinical Trials offers Phase I/II CRO services, Phase II/III site
services across the UK and Germany, and specialist recruitment through
FluCamp, Europe's largest recruitment database.

·    Human Challenge Trials 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 provides cutting-edge virology and immunology
laboratory services, including biobanking and sample storage, supporting both
challenge trials and standalone client studies.

 

 

 

 

 

 

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  CNTBCGDSCUBDGLX



            Copyright 2019 Regulatory News Service, all rights reserved