POLB 001 trial to feature in cancer immunotherapy-induced CRS research programme
Poolbeg Pharma, a clinical-stage biopharmaceutical company with a core focus on transforming the cancer immunotherapy field, announces that the POLB 001 TOPICAL trial is to feature in a groundbreaking cancer immunotherapy-induced cytokine release syndrome ("CRS") research programme.
Poolbeg will act as the lead business partner, alongside Johnson & Johnson and other partners, on The University of Manchester and The Christie NHS Foundation Trust research programme supported by a £3.4 million Prosperity Partnership grant from the Medical Research Council ("MRC"). The programme, titled RISE (Reducing Immune Stress from Excess cytokine release in advanced therapies), will facilitate wider research into cancer immunotherapy-induced CRS and the safer delivery of these treatments.
Central to the RISE programme will be the previously announced POLB 001 TOPICAL trial, for which Johnson & Johnson will provide the approved bispecific antibody, teclistamab. RISE will not impact the delivery of data from the POLB 001 clinical trial, anticipated in summer 2026. Poolbeg's participation in this programme will not impact the Company's cash runway into 2027.
The programme includes the collection of clinical data from patients treated with bispecific antibodies and CAR T-cell therapies and will involve additional research beyond the TOPICAL trial into the potential of POLB 001 to prevent cancer immunotherapy-induced CRS. The programme reflects the growing recognition of the unmet medical need in the management of CRS and other serious adverse effects, which is a significant bottleneck to the broader availability and uptake of these breakthrough cancer immunotherapies.
The RISE programme will be under the leadership of Dr Jonathan Lim, Clinical Senior Lecturer and Honorary Consultant Medical Oncologist in Advanced Immunotherapy and Cell Therapy and conducted at The University of Manchester and The Christie.
Jeremy Skillington, PhD, Chief Executive Officer of Poolbeg Pharma, said:
Advanced immunotherapies are the future of cancer treatment but can come with some severe adverse effects, such as CRS. This programme will deepen the understanding of CRS and could be beneficial for POLB 001, as we seek to bring its potential benefits to patients. Poolbeg is delighted to be working alongside The University of Manchester, The Christie, Johnson & Johnson and other leading partners, who are focussed on finding a solution for CRS. The Christie has an ambition to position the UK as a global leader in research focused on the safe delivery of cancer immunotherapies and we are very proud that POLB 001 can play a key part in this.
Dr Jonathan Lim, Clinical Senior Lecturer and Honorary Consultant Medical Oncologist in Advanced Immunotherapy and Cell Therapy at the Christie, said:
RISE harnesses Manchester's multidisciplinary strengths to explore the biology behind both the power and the risks of modern cancer immunotherapies. Supported by the MRC Prosperity Partnership, this initiative exemplifies how academic-industry collaboration can accelerate discovery and ensure these therapies are delivered safely and responsibly.
Dr Glenn Wells, MRC Deputy Executive Chair, said:
This project is part of a £9 million public sector investment through MRC's first Prosperity Partnerships. With additional contribution from industry and close collaboration with key regulatory bodies, we are addressing the safety and toxicity of advanced therapies. This research is critical to improving how gene, cell-based, and nucleic acid-dependent therapies are developed for conditions such as cancers and rare genetic disorders, so we can make meaningful improvements to patient outcomes.
