hVIVO #HVO – Influenza HCT contract signed with Traws Pharma & launch of unified brand identity April 14, 2026 – Posted in: Blog, hVIVO (HVO) – Tags: , , , , , , ,

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, 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 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.”

 

hVIVO plc also today announces the launch of a new brand identity, reflecting the Group’s strategic transformation from specialist provider to a differentiated end-to-end drug development partner.

The rebrand follows the successful integration of Venn Life Sciences, CRS and Cryostore and marks the completion of the Group’s transition from a specialist services provider to a fully integrated platform supporting clients from preclinical strategy through to Phase II and selected Phase III programmes. All operating companies will now trade under the hVIVO brand, simplifying the Group’s structure and re-enforcing its single partner model. This provides clients with one integrated team, clear continuity across the development pathway. 

The Group now operates through four integrated service lines, forming a purpose-built platform designed to generate faster, more decisive, high-quality human data, reducing complexity, minimising handoffs and enabling novel, more efficient trial designs:

·      Consulting: provides early stage scientific, regulatory and development strategy support across the drug development lifecycle, enabling clients to design robust programmes and generate decision ready data from the outset. Drawing on deep expertise in early drug development, clinical pharmacology and biostatistics, teams support sponsors from pre-clinical planning through to clinical proof-of-concept, including study design, dose rationale and regulatory strategy;

·      Clinical Trials: provides specialist early phase clinical trial services through owned and controlled clinical research sites, supporting studies from First-in-Human through to Phase II and selected Phase III programmes. It includes full Phase I and II CRO services, complemented by Phase II and III site services delivered within hVIVO’s facilities. This model enables greater operational control, accelerates timelines and ensures reliable recruitment across healthy volunteers, patient populations and specialist cohorts;

·      Human Challenge Trials: enables rapid and controlled evaluation of vaccines and therapeutics by exposing healthy volunteers to well characterised pathogens under carefully controlled conditions. These studies allow earlier assessment of efficacy, biological response and dose selection compared to traditional field-based studies;

·      Laboratories: provide specialist virology, immunology and biomarker analysis to support early phase clinical development, human challenge trials and standalone laboratory programmes. Closely integrated with clinical operations, services include assay development, sample analysis and data interpretation and biobanking with long-term storage capabilities.

Yamin ‘Mo’ Khan, Chief Executive Officer of hVIVO, said: “This rebrand reflects our strategic transformation into a purpose-built, full-service international clinical development partner, addressing the industry’s need for faster, high-quality data that can de-risk drug development.

“By bringing together consulting, clinical trials, human challenge trials and laboratories into a single, unified platform, we offer clients a seamless pathway from pre-clinical strategy to clinical proof-of-concept, delivered by one expert partner. Our unified brand reinforces the strength of our integrated model, proprietary infrastructure and deep scientific expertise, and our ability to ultimately help pharmaceutical and biotech companies bring important medicines to patients faster.”