Great news : No wonder this is flying today25 Sep 2025 08:08
Https://www.londonstockexchange.com/news-article/POLB/polb-001-phase-2a-trial-update/17247751
ACT appointed for POLB 001 Phase 2a Trial and supply of approved bispecific antibody drug secured at no cost
Trial to take place at The Christie NHS Foundation Trust and other leading UK specialist cancer centres
25 September 2025 - Poolbeg Pharma (AIM: POLB, 'Poolbeg' or the 'Company'), a clinical-stage biopharmaceutical company with a core focus on transforming the cancer immunotherapy field, announces that the Company has signed an agreement for a specialist blood cancer trials organisation, Accelerating Clinical Trials Limited ("ACT"), to conduct the upcoming POLB 001 Phase 2a trial and has also secured the supply of an approved bispecific antibody drug for the trial at no cost to the Company.
The trial will be led by Dr Emma Searle, Consultant Haematologist at The Christie NHS Foundation Trust, Honorary Senior Lecturer at the University of Manchester, as well as Chair of the British Society of Haematology Research and Grants Committee. The Christie, a leading cancer research institute based in Manchester, and a number of other leading UK specialist cancer centres will participate.
The Phase 2a first-in-patient open-label, single-arm trial is titled TOPICAL (Trial of Prevention of ImmunoCytokine Adverse events in Myeloma). The study aims to investigate the safety and efficacy of POLB 001, in particular its ability to reduce the incidence of Cytokine Release Syndrome ("CRS") in approximately 30 relapsed/refractory multiple myeloma patients receiving an approved bispecific antibody.
The Company already has sufficient supply of Good Manufacturing Practice ("GMP") grade POLB 001 and this agreement represents an advanced stage of trial preparation, with interim data anticipated in summer 2026. The Company's forecast cash runway extends into 2027, providing more than adequate funding to achieve key clinical development milestones.
The Directors believe that POLB 001 has the potential to transform the cancer immunotherapy field by expanding administration from centralised specialist cancer centres into community hospitals by making the treatments safer through the prevention of the life-threatening side effect, CRS. As such, POLB 001 could increase the number of patients that can receive these life-saving treatments, thereby increasing the market opportunity.
Jeremy Skillington, PhD, Chief Executive Officer of Poolbeg Pharma, 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. With a cash runway into 2027, and multiple near-term clinical inflection points, we believe that we are well positioned to deliver value for our share