Poolbeg Pharma PLC (AIM:POLB, OTC:POLBF) has lined up a specialist clinical trials partner and secured free supply of a key drug for its upcoming study of POLB 001, an experimental treatment designed to make cancer immunotherapy safer.
The London-listed biotech said Thursday it has appointed Accelerating Clinical Trials (ACT), a UK-based blood cancer trials organisation, to run its phase IIa study.
The trial will be led by Dr Emma Searle, a consultant haematologist at The Christie NHS Foundation Trust in Manchester, one of Europe’s leading cancer research centres. Other specialist hospitals across the UK will also participate.
The study, called TOPICAL, will test POLB 001 in about 30 patients with relapsed or refractory multiple myeloma, a form of blood cancer.
Patients will receive POLB 001 alongside an approved “bispecific antibody” drug, which can recruit immune cells to target cancer.
The bispecific antibody, supplied to Poolbeg at no cost, is already in clinical use but can trigger a dangerous side effect known as cytokine release syndrome (CRS), a sudden immune overreaction that often requires hospitalisation.
POLB 001 is designed to reduce this risk.
Poolbeg said it already has enough POLB 001 manufactured under good manufacturing practice standards for the trial. Interim data are expected in summer 2026. The company reported that its cash runway extends into 2027, giving it financial headroom to reach several milestones.
Chief executive Jeremy Skillington said the agreement with ACT and the drug supply marked “major milestones” in the development of POLB 001.
He added that if successful, the therapy could allow cancer immunotherapies to be administered outside of centralised cancer centres and into community hospitals, broadening access and easing pressure on healthcare systems.
Searle, the study’s chief investigator, said POLB 001 “holds great promise” in making immunotherapies safer and more accessible, while ACT chief executive Paul Sherrington described the treatment as addressing a “critical unmet medical need.”
Poolbeg believes POLB 001 could expand the number of patients eligible for cutting-edge immunotherapies, a fast-growing field in oncology that has already transformed care for several hard-to-treat cancers.