Apollo Therapeutics: Phase 1 pan-rhinovirus vaccine data positive
Apollo Therapeutics has reported positive immunogenicity data from Part A of its Phase 1 trial of APL-10456, an adjuvanted recombinant protein subunit vaccine designed to prevent rhinovirus-driven exacerbations of chronic obstructive pulmonary disease and asthma. A single dose proved well-tolerated and generated Th1-polarised cellular immune responses spanning all three rhinovirus species, the company said.
The Phase 1 study enrolled 144 participants across two parts. Part A evaluated three single dose levels in adults aged 18 to 54 years; Part B is assessing a two-dose regimen in adults aged 55 and over. Enrolment and dosing across both parts are now complete. Apollo expects to report Part B data in Q4 2026, followed by the start of a randomised, double-blind, placebo-controlled Phase 2 trial targeting COPD exacerbation prevention in the first half of 2027.
Trial data
Part A results showed that APL-10456 induced seroconversion and rhinovirus-specific T cell responses against peptide pools representing RV-A, RV-B and RV-C strains. The most common adverse events were mild-to-moderate injection-site reactions, and no serious adverse events were recorded. Apollo says the breadth of cellular immunity observed is consistent with preclinical data demonstrating cross-strain activity and rapid clearance of heterotypic rhinovirus.
Richard Mason, chief executive of Apollo Therapeutics, said: "Rhinovirus is the leading cause of exacerbations for people living with moderate and severe COPD and asthma, yet there are no preventative approaches for this virus. These first-in-human data provide important clinical validation of our approach and establish a strong foundation for continued clinical development."
Chief scientific officer Richard Butt added that inducing T cell responses against all three rhinovirus species from a single dose addressed what had long been considered an intractable challenge given the approximately 180 genetically distinct circulating strains.
Market context
The absence of any approved rhinovirus vaccine or treatment represents a substantial unmet need. Rhinovirus is implicated in an estimated 25 to 50 per cent of COPD exacerbations and roughly half of asthma exacerbations, and is associated with more than 600,000 COPD-related hospitalisations annually in the United States, according to figures cited in the release.
The respiratory vaccines landscape is dominated by influenza, RSV and, more recently, COVID-19 products, leaving rhinovirus as the most clinically significant pulmonary virus without a prophylactic option. A handful of academic groups and early-stage companies have explored rhinovirus vaccine concepts, but none has progressed to late-stage development. If APL-10456 maintains its immunogenicity profile in older adults, who bear a disproportionate burden of COPD exacerbations, it would occupy a market with few direct comparators and a sizeable payer rationale given the hospitalisation costs associated with acute exacerbations.
Apollo, which is dual-headquartered in Boston and Cambridge, UK, draws its pipeline from partnerships with six leading universities and research institutes. The company has five programmes in clinical development. It has not disclosed the financial terms of its academic collaborations or provided guidance on APL-10456 partnering strategy ahead of Phase 2 data.