Apollo Therapeutics announces positive Phase 1 trial of vaccine for the prevention of COPD exacerbations
Apollo Therapeutics, a biopharmaceutical company focused on translating breakthrough science from top global universities into differentiated medicines, today announced that it has completed enrollment and dosing in the Phase 1 clinical trial of APL-10456 and reported positive data from Part A of the study. APL-10456 is a first-in-class, adjuvanted recombinant protein subunit vaccine designed to prevent exacerbations of chronic obstructive pulmonary disease (COPD) and asthma, which are most frequently caused by rhinovirus infection, and is the only major pulmonary virus with no available vaccine.
Rhinoviruses comprise of approximately 180 genetically distinct strains across three species (RV-A, RV-B, and RV-C), creating a high degree of antigenic diversity that has long hindered the development of a broadly protective vaccine. APL-10456 is designed to address this challenge by using a conserved antigen and Th1-polarizing adjuvants to generate cross-reactive CD4+ and CD8+ T cell responses across rhinovirus species following infection.
The Phase 1 study (NCT07399132) is a randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, and immunogenicity of APL-10456 in healthy participants. Part A evaluated three single dose levels of APL-10456 in adults aged 18–54 years, while Part B is evaluating a two-dose regimen in adults aged ≥55 years. The study enrolled 144 participants, with Part B data expected in Q4 2026.
Dr. Richard Mason, CEO of Apollo Therapeutics, said:
Demonstrating that a single dose of APL-10456 can generate a broad, cross-reactive cellular immune response in humans represents an important milestone for the program. Rhinovirus is the leading cause of exacerbations for people living with moderate and severe COPD and asthma, yet there are 2 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. With Part B enrollment and dosing complete, we are focused on advancing the program toward its intended patient population and expect to report results in Q4 2026.
APL-10456 was well-tolerated in Part A. The most common adverse events were mild-to-moderate injection-site reactions, and no serious adverse events were reported. A single dose of APL 10456 induced rhinovirus-specific immunity, including seroconversion and Th1-skewed rhinovirus-specific cell mediated immunity. Importantly, APL-10456 induced T cell responses against peptide pools representing all three rhinovirus species, demonstrating the potential for broad, cross-reactive immunity. These findings support the vaccine’s ability to address the significant antigenic diversity of rhinoviruses and provide comprehensive immune coverage following a single administration. These findings are consistent with previously reported preclinical data demonstrating broad cross-strain immunity and rapid clearance of heterotypic rhinovirus. Building on these positive results, additional data is expected in Q4 2026, followed by initiation of a randomized, double-blind, placebo-controlled Phase 2 trial for the prevention of COPD exacerbations in 1H 2027.
Dr. Richard Butt, CSO of Apollo Therapeutics, added:
With around 180 circulating strains, overcoming the antigenic diversity of rhinovirus has long been considered an intractable scientific challenge. Observing that the data clearly demonstrates a single dose of APL-10456 induces T cell responses against strains representing all three rhinovirus species (RV-A, RV-B and RV-C) is precisely the broad, cross-reactive immunity we set out to achieve. This translates our preclinical findings into humans for the first time. We look forward to the Part B readout and to evaluating this approach in the patients with chronic respiratory diseases who need it most.