Apollo Therapeutics Announces Positive Immunogenicity Data and Cross-Species Activity from Phase 1 Trial of APL-10456, a Pan-Rhinovirus Vaccine for the Prevention of COPD Exacerbations
Enrollment and dosing completed in Phase 1 randomized controlled trial (n=144) evaluating the safety, tolerability,
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- Enrollment and dosing completed in Phase 1 randomized controlled trial (n=144) evaluating the safety, tolerability, immunogenicity and cross-species activity of APL-10456, an investigational rhinovirus vaccine
- Initial data show that a single dose of APL-10456 was well-tolerated, highly immunogenic, and induced Th1-polarized broad cross-rhinovirus species cellular immunity
- Additional data 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
BOSTON and CAMBRIDGE, United Kingdom, Aug. 25, 2026 (GLOBE NEWSWIRE) — 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.
“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,” said Dr. Richard Mason, CEO of Apollo Therapeutics. “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. 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.”
About APL-10456
APL-10456 is a first-in-class adjuvanted recombinant protein subunit vaccine designed to prevent rhinovirus-driven exacerbations of COPD and asthma. APL-10456 uses a protein antigen selected for its high homology across rhinovirus strains. Combined with Th1-polarizing adjuvants, it is designed to induce broadly cross-reactive CD4+ and CD8+ T-cell responses and accelerate the production of strain-specific neutralizing antibodies, supporting rapid viral clearance following infection. Preclinical studies have demonstrated broad cross-strain immunity and rapid clearance of heterotypic rhinovirus.
About Rhinovirus
Rhinovirus is the most common cause of the common cold1, and in individuals with chronic respiratory conditions such as COPD or asthma, it is a leading cause of serious exacerbations linked to increased morbidity and mortality.2 Rhinovirus is the pulmonary virus most often detected during COPD exacerbations and is implicated in an estimated 25–50%3–7 of these events, as well as in roughly half of asthma exacerbations8, and drives over 600,000 COPD-related hospitalizations annually in the US.9 Despite this burden, there are no approved vaccines or treatments. The ~180 genetically distinct strains across the three species (RV-A, RV-B, RV-C) have long blocked development of a broadly protective vaccine.10
About Apollo Therapeutics
Apollo Therapeutics, a biopharmaceutical company focused on translating breakthrough science from top global universities into differentiated medicines, is based in the UK and US. With five programs in clinical development and multiple preclinical programs, Apollo is building a diversified portfolio of novel therapeutics with uncorrelated risk. Apollo has a scalable R&D platform enabled by an unprecedented level of access to breakthroughs in biology and basic medical research made at six of the world’s leading universities and research institutes. Apollo also in-licenses or acquires clinical-stage programs where it has unique insights and synergies. For more information, please visit www.apollotx.com.
For Investor Inquiries
Apollo Therapeutics
Jamie Heath, CFO
Jamie.heath@apollotx.com
LifeSci Advisors
PJ Kelleher, 617-430-7579
pkelleher@lifesciadvisors.com
For Media Inquiries
Apollo Therapeutics
Clare Burles, VP People & Communications
Clare.burles@apollotx.com
1https://www.cdc.gov/rhinoviruses/about/index.html
2 Soler-Cataluña (2005) Thorax 60, p925
3 Cafferkey (2020) Expert Rev Respir Med. 14, p777
4 Gallego (2016) Int J Chron Obstruct Pulmon Dis. 11, p2633
5 Wilkinson (2019) ERJ Open Res. 5:00248-2018
6 George (2014) Eur Respir J. 44, p87
7 Huerta A (2015) Ann Am Thorac Soc. 12, p997
8 Jackson (2022) J Allergy Clin Immunol Pract. 10, p673
9 Press (2020) Chest 159, p996
10 Glanville (2015) Curr Opin Virol.11, p83
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