Poolbeg Pharma PLC (AIM:POLB, OTC:POLBF, FRA:POLBF) said it has activated the first clinical site for its first-in-patient POLB 001 TOPICAL trial, moving its lead cancer immunotherapy programme into patient recruitment as interim data remains on track for summer 2026.
The AIM-listed company said the trial is assessing POLB 001 as a potential preventative for cytokine release syndrome, or CRS, in around 30 relapsed/refractory multiple myeloma patients receiving the approved bispecific antibody teclistamab.
The study is being conducted by specialist blood cancer trials organisation Accelerating Clinical Trials Limited. Teclistamab is being supplied by Johnson & Johnson at no cost to Poolbeg.
Poolbeg also said two posters featuring POLB 001 preclinical data are being presented at the European Hematology Association Congress in Stockholm. One poster showed POLB 001 reduced key CRS-associated cytokines and did not affect bispecific antibody-induced tumour cell-killing in preclinical models.
A second poster, presented by The University of Manchester, highlighted early preclinical evidence that POLB 001 may enhance the efficacy of azacitidine in aged mouse models of acute myeloid leukaemia, potentially opening AML as a new indication for the asset.
Chief executive Jeremy Skillington said site activation marked “a significant milestone” for Poolbeg and POLB 001, while principal scientist Liam Tremble said the CRS data reinforced the drug candidate’s potential to address “one of the most significant challenges associated with cancer immunotherapy”.
