Poolbeg Pharma Regulatory News (POLB)

Poolbeg Pharma plc

POLB 001 trial to feature in groundbreaking cancer immunotherapy-induced CRS research programme

RISE programme led by The University of Manchester and The Christie NHS Foundation Trust and funded in part by MRC grant

Poolbeg will act as the lead business partner alongside Johnson & Johnson and other partners

8 December 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 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."

Enquiries

About CRS

Cytokine Release Syndrome (CRS) is a severe and potentially life-threatening side effect of cancer immunotherapies. Over 70% of patients undergoing treatment with certain T-cell engaging bispecific antibodies or CAR T-cell therapies are affected.1

About Poolbeg Pharma plc 

Poolbeg Pharma plc (AIM: POLB) is a clinical-stage biopharmaceutical company with a core focus on transforming the cancer immunotherapy field. The Company's lead asset, POLB 001, has the potential to expand administration of cancer immunotherapies from centralised specialist cancer centres into community hospitals by making the treatments safer through the prevention of the life-threatening side effect, Cytokine Release Syndrome (CRS). As such, POLB 001 could increase the number of patients that can receive these life-saving treatments, thereby increasing the market opportunity. Poolbeg is also advancing the development of a patient-friendly therapy for obesity with an oral encapsulated GLP-1, offering a differentiated approach within one of the world's largest markets. With multiple near-term clinical value inflection points, and an experienced team with a proven track record, Poolbeg is focussed on partnering its high value programmes that are targeting large markets and addressing critical unmet medical needs. 

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Forward-Looking Statements

This announcement may contain forward-looking statements and the words "expect", "anticipate", "intends", "plan", "estimate", "aim", "forecast", "project" and similar expressions (or their negative) identify certain of these forward-looking statements. The forward-looking statements in this announcement are based on numerous assumptions and Poolbeg's present and future business strategies and the environment in which Poolbeg expects to operate in the future. Forward-looking statements involve inherent known and unknown risks, uncertainties and contingencies because they relate to events and depend on circumstances that may or may not occur in the future and may cause the actual results, performance or achievements to be materially different from those expressed or implied by such forward-looking statements. These statements are not guarantees of future performance or the ability to identify and consummate investments. Many of these risks and uncertainties relate to factors that are beyond Poolbeg's ability to control or estimate precisely, such as future market conditions, currency fluctuations, the behaviour of other market participants, the outcome of clinical trials, the actions of regulators and other factors such as Poolbeg's ability to obtain financing, changes in the political, social and regulatory framework in which Poolbeg operates or in economic, technological or consumer trends or conditions. Past performance should not be taken as an indication or guarantee of future results, and no representation or warranty, express or implied, is made regarding future performance. No person is under any obligation to update or keep current the information contained in this announcement or to provide the recipient of it with access to any additional relevant information.

About The Christie NHS Foundation Trust

The Christie is a specialist cancer centre in Manchester and has more than 120 years of expertise in cancer care, research and education. It is one of Europe's leading cancer centres, treating over 60,000 patients a year. It is the largest provider of radiotherapy in the NHS (including high energy proton beam therapy and MR guided radiotherapy); it is home to the largest chemotherapy unit in the UK; and is a specialist surgical centre concentrating on rare cancers and complex procedures. The Christie is one of Europe's largest experimental cancer medicine centres and an international leader in research and development with around 750 clinical studies ongoing at any one time. The Christie charity provides enhanced services for patients over and above what the NHS funds.

Visit www.christie.nhs.uk to find out more or follow The Christie on social media @TheChristieNHS

[1] Average rate from Summary of Product Characteristics (SmPCs) for Yescarta, Tecartus, Abecma, Kymriah, Carvykti, Breyanzi, Elrexfio, Columvi, Epkinly, Tecvayli and Talvey;