Poolbeg Pharma has secured key partnerships to advance its Phase 2a clinical trial for POLB 001, a drug candidate designed to prevent cytokine release syndrome (CRS) in multiple myeloma patients receiving cancer immunotherapy. The clinical-stage biopharmaceutical company announced it has signed an agreement with Accelerating Clinical Trials Limited (ACT) to conduct the upcoming trial and secured supply of an approved bispecific antibody drug at no cost.
Trial Design and Leadership
The Phase 2a first-in-patient open-label, single-arm trial, titled TOPICAL (Trial of Prevention of ImmunoCytokine Adverse events in Myeloma), will be led by Dr Emma Searle, Consultant Haematologist at The Christie NHS Foundation Trust and Honorary Senior Lecturer at the University of Manchester. Dr Searle also serves as Chair of the British Society of Haematology Research and Grants Committee.
The study aims to investigate the safety and efficacy of POLB 001, specifically its ability to reduce the incidence of CRS in approximately 30 relapsed/refractory multiple myeloma patients receiving an approved bispecific antibody. The trial will take place at The Christie, a leading cancer research institute based in Manchester, along with other leading UK specialist cancer centres.
Clinical Development Timeline
Poolbeg already has sufficient supply of Good Manufacturing Practice (GMP) grade POLB 001, and the agreement represents an advanced stage of trial preparation. Interim data is anticipated in summer 2026, with the company's forecast cash runway extending into 2027, providing adequate funding to achieve key clinical development milestones.
"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," said Jeremy Skillington, PhD, Chief Executive Officer of Poolbeg Pharma. "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."
Addressing Unmet Medical Need
CRS represents a significant challenge in cancer immunotherapy delivery, requiring many patients to be hospitalized for treatment. Dr Emma Searle explained the clinical significance: "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."
The demand for effective CRS prevention solutions is driven by the rapid growth of CRS-inducing cancer immunotherapies, with more than 70% of patients receiving certain cancer immunotherapies affected by this side effect.
Transformative Potential
The directors believe POLB 001 has the potential to transform the cancer immunotherapy field by expanding administration from centralised specialist cancer centres into community hospitals by making treatments safer through CRS prevention. This could increase the number of patients able to receive life-saving treatments, thereby increasing the market opportunity.
"We are optimistic about the potential of POLB 001 to transform the delivery of cancer immunotherapies by expanding administration away from specialist centralised cancer centres and into the community setting, closer to patients' homes," Skillington noted. "This shift could make these life-saving treatments more widely accessible."
Dr Searle emphasized the broader implications: "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."
Market Opportunity and Commercial Potential
Independent research has identified a market opportunity exceeding $10 billion for POLB 001, and the company sees strong potential for partnering following positive data from the forthcoming trial. The recent FDA Orphan Drug Designation further validates POLB 001's scientific rationale and enhances its commercial appeal for prospective partners.
Dr Paul Sherrington, CEO of Accelerating Clinical Trials Ltd, expressed confidence in the collaboration: "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."
