An investigational rhinovirus vaccine called APL-10456 has shown promise in phase 1 clinical trial, demonstrating high tolerance, safety and immunity against multiple common cold strains. This first-in-class vaccine could potentially prevent common colds and reduce respiratory exacerbations in patients with COPD and asthma.
- Rhinovirus causes nearly 50% of asthma exacerbations and 25-50% of COPD exacerbations.
- The first-in-class vaccine, APL-10456, targets all three rhinovirus species (RV-A, RV-B, RV-C) encompassing approximately 180 genetically distinct strains, solving a major challenge in vaccine development.
- Phase 1 part A reported broad cross-rhinovirus species cellular immunity and no serious adverse events.
- Phase 1 part B data is expected in Q4 2026, with phase 2 trials for COPD exacerbation prevention planned for 1H 2027.
There may soon be a new defense against the common cold. The phase 1 clinical trial (NCT07399132) of an investigational rhinovirus vaccine (APL-10456) shared encouraging early results. Part A of the study demonstrated high tolerance of the vaccine in healthy individuals, immunity against multiple rhinovirus species and no serious adverse events.
Rhinovirus is the source of most common colds and can significantly exacerbate chronic respiratory conditions, such as COPD and asthma. It is linked to nearly 50% of asthma exacerbations and 25%–50% of COPD exacerbations. In the United States, it accounts more than 600,000 COPD-related hospitalizations each year. Despite this burden, there is currently no approved treatment or vaccine, largely due to rhinovirus encompassing roughly 180 genetically distinct strains across three species (RV-A, RV-B and RV-C), making it a difficult target for development of a broadly protective vaccine.
Boston-based biopharmaceutical company Apollo Therapeutics and Imperial College London in the United Kingdom co-developed APL-10456, a first-in-class, adjuvanted recombinant protein subunit vaccine. According to a press release, it is designed to prevent respiratory-related exacerbations by combining Th1-polarizing adjuvants with a conserved antigen to generate cross-reactive CD4+ and CD8+ T cell responses across rhinovirus species. The intent is to accelerate the production of neutralizing antibodies that support rapid viral clearance.
Part A of the randomized, double-blind, placebo-controlled phase 1 trial included 144 healthy volunteers aged 18–54, who received three single doses of either APL-10456 or placebo. It evaluated tolerability, safety and immunogenicity of the rhinovirus vaccine. Part B will evaluate a two-dose regimen in healthy volunteers aged 55 and older.
“We’ve now achieved a significant milestone in the rhinovirus vaccine program with the first human participants receiving our novel vaccine candidate, with initial results showing it is well tolerated and effective,” said Sebastian Johnston, MBBS, PhD, professor of respiratory medicine and allergy at Imperial College London’s National Heart and Lung Institute.
Apollo and Imperial researchers previously conducted more than 20 preclinical studies, which established broad cross-strain immunity and fast clearance of heterotypic rhinovirus. They collaborated with research organization VirTus Respiratory Research Ltd. to identify the most promising vaccine candidate and collect data to support clinical trials in humans.
Apollo said it expects to have Part B data in Q4 2026 and plans to initiate a phase 2 clinical trial for the prevention of COPD exacerbations in 1H 2027.
