Poolbeg Pharma announces successful site activation for POLB 001 TOPICAL clinical trial
Poolbeg Pharma, a clinical-stage biopharmaceutical company with a core focus on transforming the cancer immunotherapy field, announces the first site activation for the first-in-patient POLB 001 TOPICAL* clinical trial has occurred. This follows the successful completion of the site initiation visit, with patient recruitment underway and interim data expected in summer 2026.
The trial, being conducted by specialist blood cancer trials organisation Accelerating Clinical Trials Limited (ACT), is investigating POLB 001 as a potential preventative for Cytokine Release Syndrome (CRS) in approximately 30 relapsed/refractory multiple myeloma patients that are receiving the approved bispecific antibody, teclistamab. This acute condition occurs within days to weeks of initiating bispecific antibody treatment, consequently, the TOPICAL trial is expected to generate a rapid read out of data.
The Company believes that the strong engagement and enthusiasm demonstrated by investigators and clinical teams reflects both the significant unmet medical need in cancer immunotherapy-induced Cytokine Release Syndrome and the potential of POLB 001 to prevent this condition.
Jeremy Skillington, PhD, Chief Executive Officer of Poolbeg Pharma, said:
The successful site activation marks a significant milestone for Poolbeg and our lead programme, POLB 001. We believe POLB 001 has the potential to transform the cancer immunotherapy field through the prevention of CRS. This could not only improve patient quality of life but also expand the number of patients that can receive these life-saving cancer immunotherapies. We look forward to receiving the first insights from the study and sharing these with prospective partners, the market, and the wider scientific community in due course.
Dr Paul Sherrington, CEO of Accelerating Clinical Trials Ltd said:
Site initiation and activation marks an important operational milestone for the study, as we now move forward to patient recruitment. We are pleased with the progress made to date and look forward to supporting efficient patient accrual recruitment and high-quality trial delivery as the study advances.
*TOPICAL: Trial of Prevention of ImmunoCytokine Adverse events in Myeloma. A single-arm, open-label trial investigating POLB 001 as a potential preventative for CRS in relapsed/refractory multiple myeloma patients receiving the approved bispecific antibody, teclistamab, provided by Johnson and Johnson at no cost to Poolbeg.
