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RCS - Poolbeg Pharma PLC - POLB 001 to feature in CRS research programme

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RNS Number : 5250K  Poolbeg Pharma PLC  08 December 2025

 

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 (https://www.poolbegpharma.com/)  (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
(https://polaris.brighterir.com/public/poolbeg_pharma/news/rns/story/x409mow)
, 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

 

 Poolbeg Pharma Plc                                            +44 (0) 207 183 1499

 Jeremy Skillington, CEO                                       ir@poolbegpharma.com (mailto:ir@poolbegpharma.com)

 Ian O'Connell, CFO

  
 Cavendish Capital Markets Ltd (NOMAD & Joint Broker)          +44 (0) 207 220 0500

 Geoff Nash, Trisyia Jamaludin (Corporate Finance)

 Nigel Birks (Life Science Specialist Sales)

 Harriet Ward (ECM)

  
 Shore Capital Stockbrokers Ltd (Joint Broker)                 +44 (0) 207 408 4090

 David Coaten, Harry Davies-Ball (Corporate Advisory)

Malachy McEntyre (Corporate Broking)
 J&E Davy (Joint Broker)                                       +353 (0) 1 679 6363

 Anthony Farrell, Niall Gilchrist

  
 Optimum Strategic Communications                              +44 (0) 208 078 4357

 Nick Bastin, Vici Rabbetts, Elena Bates                       poolbeg@optimumcomms.com (mailto:poolbeg@optimumcomms.com)

  

 

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 (http://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;

 

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