Poolbeg Pharma has appointed Accelerating Clinical Trials (ACT) to run its Phase 2a POLB 001 study and secured supply of an approved bispecific antibody for use in the trial at no cost.

The study, called Topical, will be led by Emma Searle, consultant haematologist at The Christie NHS Foundation Trust in Manchester, and will also involve other leading UK cancer centres. Around 30 patients with relapsed or refractory multiple myeloma will take part.

The first-in-patient open-label trial will assess the ability of POLB 001 to prevent cytokine release syndrome (CRS), a dangerous side effect of immunotherapy.

Poolbeg said it has already manufactured enough Good Manufacturing Practice grade POLB 001 for the study, with interim data expected in summer 2026. Its cash runway extends into 2027.

Chief executive Jeremy Skillington said: “The signing of this agreement, and the supply of the approved bispecific antibody at no cost to the Company, are major milestones for the upcoming POLB 001 Phase 2a trial. The trial is at an advanced stage of preparation and remains on track to deliver data in 2026, we look forward to sharing the data with prospective partners.”

Searle said: “I have seen first-hand the challenges that CRS presents to the delivery of cancer immunotherapies, requiring many of our patients to be hospitalised for treatment. These transformative therapies will continue to be restricted until there is a way to administer them more safely. POLB 001 holds great promise in tackling this issue; potentially leading to improved patient wellbeing, reducing the strain on healthcare systems while making these treatments more accessible to a broader patient population.”

Paul Sherrington, chief executive of ACT, added: “At ACT we work hand-in-hand with the haematological community to accelerate the delivery of clinical trials of new therapies, leveraging our wide network of research centres in the UK. We look forward to completing this study with POLB 001 which holds great potential to transform the cancer immunotherapy field and address this critical unmet medical need.”

Independent research has estimated the market for CRS prevention solutions at more than $10 billion. Earlier this year, POLB 001 was granted FDA orphan drug designation in multiple myeloma.