REG - Poolbeg Pharma PLC - POLB 001 Phase 2a Trial Update

Poolbeg PharmaAnnouncement

Thu 07:00

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RNS Number : 7038A  Poolbeg Pharma PLC  25 September 2025

 

Poolbeg Pharma plc

 

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
(https://url.avanan.click/v2/___http:/www.poolbegpharma.com/___.YXAxZTpzaG9yZWNhcDphOm86NmUxMjE5MmVmMDQxMWM1NDQ0MzEyNjAxM2Q4ZGMxNGQ6NjphMjdiOmNlODgwYTlkZDQzYzYxZDU0ODk4NmRhZDY2ZDU4MWIyYjFlNWE2ZTRmYWU0M2I5MzFhOWE2ZmE2ZTM1NDViZjE6cDpUOk4)
 (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
(https://url.avanan.click/v2/r02/___https:/www.act4patients.com/___.YXAxZTpzaG9yZWNhcDphOm86OWFkMzdlZmEzMTY3NzNiMWFkZWZmYWU1YWRhN2YzMzI6NzplYzBhOjE1ZDU3OGY4YTU3NDIzOGU2OGJmZTFkNTY2NDdlZjhlNzhkNDQwM2JjMzA1YWFhOTY2OWZmYzkwNTRlZTYxNGQ6cDpGOk4)
("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 shareholders."

 

"We are optimistic about the potential of POLB 001 to transform the delivery
of cancer immunotherapies by expanding administration away from specialist
centralised cancer centres and into the community setting, closer to patients'
homes. This shift could make these life-saving treatments more widely
accessible. POLB 001 has the potential to make cancer immunotherapies safer by
reducing the incidence of potentially life-threatening cancer
immunotherapy-induced cytokine release syndrome."

 

Dr Emma Searle, MBChB MA MRCP FRCPath PhD, Consultant Haematologist at The
Christie NHS Foundation Trust, and Chief Investigator of the forthcoming POLB
001 trial said: "I have seen first-hand the challenges that CRS presents to
the delivery of cancer immunotherapies, requiring many of our patients to be
hospitalised for treatment. These transformative therapies will continue to be
restricted until there is a way to administer them more safely. POLB 001 holds
great promise in tackling this issue; potentially leading to improved patient
wellbeing, reducing the strain on healthcare systems while making these
treatments more accessible to a broader patient population."

 

Dr Paul Sherrington, CEO of Accelerating Clinical Trials Ltd said: "At ACT we
work hand-in-hand with the haematological community to accelerate the delivery
of clinical trials of new therapies, leveraging our wide network of research
centres in the UK. We look forward to completing this study with POLB 001
which holds great potential to transform the cancer immunotherapy field and
address this critical unmet medical need."

 

Market Opportunity

The demand for effective CRS prevention solutions is driven by the rapid
growth of CRS-inducing cancer immunotherapies with more than 70% of patients
receiving certain cancer immunotherapies affected. Independent research has
identified a market opportunity of >US$10 billion for POLB 001 and as such,
the Company sees strong potential for partnering on positive data from the
forthcoming trial. The recent FDA Orphan Drug Designation further validates
POLB 001's scientific rationale and enhances its commercial appeal for
prospective partners.

 

Investor presentation

Poolbeg Pharma will provide a live presentation via the Investor Meet
Company platform on Monday 29 September 2025 at 5pm.

 

The presentation is open to analysts and investors, those who already follow
Poolbeg on the Investor Meet Company platform will automatically be
invited. Investors can sign up to Investor Meet for free and add Poolbeg
Pharma plc to their company dashboard here
(https://www.investormeetcompany.com/companies/poolbeg-pharma-plc) .

 

 

Enquiries

 

 Poolbeg Pharma Plc                                              +44 (0) 207 183 1499

 Jeremy Skillington, CEO                                         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 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.

 

 

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