Rhinovirus vaccine shows broad immune response in early Phase 1 trial

Apollo Therapeutics plans to launch a Phase 2 trial in the first half of 2027 to test whether its experimental vaccine APL-10456 can prevent disease flares in people with chronic obstructive pulmonary disease (COPD).

According to a company press release, Apollo has completed enrollment and dosing in a Phase 1 study (NCT07399132) evaluating the safety, tolerability and immune responses of APL-10456 in healthy adults. Early data from the first part of the study suggest the vaccine was well tolerated and triggered the intended immune responses.

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Phase 2 COPD trial planned for 2027

Apollo expects to report further data from the Phase 1 study later this year, and plans to launch a Phase 2 trial in the first half of 2027. The Phase 2 study is expected to test APL-10456 against a placebo in people with COPD, to evaluate whether the vaccine can prevent COPD exacerbations.

COPD is a disorder marked by inflammation in the lungs. People with COPD can experience exacerbations or flares in which symptoms suddenly worsen. These flares are often triggered by infections.

Rhinoviruses are a common type of virus that infect the respiratory system. These viruses can cause the common cold and may trigger exacerbations in people with COPD. APL-10456 is designed to train the immune system to mount a broad response against rhinoviruses, with the goal of helping the body clear the virus more quickly following infection.

“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,” said Richard Mason, CEO of Apollo Therapeutics.

There are three main species of rhinovirus, comprising about 180 genetically distinct strains. This diversity has made it difficult to develop a vaccine that provides broad protection. APL-10456 uses a protein target that is highly similar across rhinovirus strains, along with immune-stimulating molecules designed to trigger broad, cross-reactive responses from virus-fighting T cells.

Phase 1 tests vaccine safety and immune response

The ongoing Phase 1 trial has two parts: Part A evaluated three single-dose levels of APL-10456 in healthy adults ages 18-54, while Part B is evaluating a two-dose regimen in adults 55 and older. The study enrolled 144 participants.

According to Apollo, early data from the first part of the study in younger adults have been promising. APL-10456 was well tolerated, with no serious adverse events reported. Additional immune-response data from the trial showed that the vaccine triggered T-cell responses against all three rhinovirus species.

“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,” Mason said. “These first-in-human data provide important clinical validation of our approach and establish a strong foundation for continued clinical development.”

Virtus Respiratory Research, a specialist respiratory contract research organisation, supported the preclinical development of APL-10456, conducting more than 20 studies over more than five years.

“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,” Sebastian Johnston, PhD, co-founder and chief medical officer of Virtus, said in a company press release.