VirTus Respiratory Research Supports Development of Apollo Therapeutics’ APL-10456 from Preclinical Proof of Concept to Positive Phase 1 Data

VirTus Respiratory Research Ltd, a specialist respiratory contract research organisation (CRO), founded by Imperial College London investigators Professor Sebastian Johnston and Dr Michael Edwards, today highlighted its role in the preclinical development of Apollo Therapeutics’ and Imperial’s APL-10456, following the announcement of positive initial data from the vaccine’s Phase 1 clinical trial.

VirTus has worked on the APL-10456 programme for more than five years, conducting more than 20 preclinical studies to support the selection, development and progression of the candidate, testing the cross-species immunogenicity and efficacy. This work included evaluating the efficacy of several vaccine candidates in mouse models of rhinovirus infection, helping to select APL-10456 and establish early proof of concept and generating preclinical evidence that informed its progression into first-in-human clinical development.

APL-10456 is a first-in-class, adjuvanted recombinant protein subunit vaccine designed to prevent rhinovirus-driven exacerbations of chronic obstructive pulmonary disease (COPD) and asthma. Developing a broadly protective rhinovirus vaccine has historically been challenging because of the approximately 180 genetically distinct rhinovirus strains across three species – RV-A, RV-B and RV-C.

Apollo has announced that enrolment and dosing in the randomised, double-blind, placebo-controlled Phase 1 study of APL-10456, involving 144 healthy participants, has completed. Initial data from Part A of the study showed that a single dose was well tolerated and highly immunogenic, inducing seroconversion and Th1-polarised, cross-reactive cellular immune responses against all three rhinovirus species.

These first-in-human findings are consistent with previously reported preclinical data demonstrating broad cross-strain immunity and rapid clearance of heterotypic rhinovirus, and represent an important milestone in the translation of the APL-10456 programme from preclinical research into clinical development.

Professor Sebastian Johnston, Co-Founder and Chief Medical Officer of VirTus Respiratory Research, and Professor of Respiratory Medicine & Allergy at Imperial College London’s National Heart and Lung Institute, said:

“Rhinovirus infections have remained an elusive target for vaccine development due to the ~180 antigenically different strains, despite the substantial burden they place on people with asthma and COPD. After our pivotal preclinical studies at VirTus, it is hugely encouraging to see APL-10456 now generating promising clinical data in man, and we are proud to have contributed to the programme’s development. This is exactly the kind of translational research we set VirTus up to support.”

The progression of APL-10456 demonstrates VirTus’s ability to support respiratory drug and vaccine development from early preclinical studies, to proof of concept, using specialist models of respiratory viral infection to help evaluate promising therapeutic approaches before they enter human studies.

About VirTus

VirTus Respiratory Research Ltd is a CRO co-led by Professor Sebastian Johnston and Dr Michael Edwards, both of Imperial College London, United Kingdom. VirTus is dedicated to accelerating the development of novel therapies for the treatment and prevention of respiratory virus infections, which are the leading cause of acute attacks (exacerbations) in chronic respiratory diseases such as asthma, COPD and bronchiectasis. VirTus conducts both pre-clinical and early-phase clinical studies, specialising in preclinical studies and human virus challenge models to generate high-quality data that supports the advancement of new therapeutics into later-stage development.

VirTus Respiratory Research

About Rhinoviruses

Rhinovirus infection is the most common cause of viral respiratory infection worldwide and the leading cause of the common cold. While typically mild in healthy individuals, rhinovirus infection is a major driver of exacerbations in chronic respiratory diseases such as asthma and COPD, leading to increased morbidity and healthcare utilisation. Despite its significant clinical impact, there are currently no approved targeted antiviral therapies or vaccines for rhinovirus infection, highlighting a substantial unmet medical need.

About Imperial College London

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As a global top ten university in London, we use science to try to understand more of the universe and improve the lives of more people in it. Across our nine campuses and throughout our Imperial Global network, our 22,000 students, 8,000 staff, and partners work together on scientific discovery, innovation and entrepreneurship. Their work navigates some of the world’s toughest challenges in global health, climate change, AI, business leadership and more.

Founded in 1907, Imperial’s future builds on a distinguished past, having pioneered penicillin, holography and fibre optics. Today, Imperial combines exceptional teaching, world-class facilities and a habit of interdisciplinary practice to unlock scientific imagination.

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